HHS is funding the first-ever government-backed ibogaine trials, through the Advanced Research Projects Agency for Health (ARPA-H) and the National Institute on Drug Abuse, targeting opioid use disorder and PTSD. It's a direct result of President Trump's April executive order, which committed $50 million to federal ibogaine research as part of a broader push to accelerate psychedelic drug development across agencies.
Before any of that money reaches a patient, the FDA opened a public comment docket (No. FDA-2026-N-10429, open through Nov 20) laying out just how seriously it's treating ibogaine's known cardiac risk. The proposed trial design requires continuous heart-rhythm monitoring for up to 36 hours after a single dose, in an inpatient unit equipped for life-threatening arrhythmia — a physician-led advanced-cardiac-life-support team, bedside defibrillator, emergency pacing, and ventilator support all on standby. Monitoring continues until the QT interval returns near baseline; if it stays above 500 milliseconds for more than two days, the study has to pause. Anyone with structural heart disease, a baseline QT above 430ms, or a personal or family history of arrhythmia or sudden cardiac death is excluded outright, and starting doses are capped at 10 mg/kg.
None of this is hypothetical caution. We've already covered the cardiac signal that stalled DemeRx's own ibogaine HCl program after a Phase 1 participant showed QTc prolongation — this FDA proposal reads like the regulatory response to exactly that kind of result, applied before the next trial even starts rather than after.
A new longitudinal study found that U.S. adults whose most intense psychedelic experience in a given two-month window fell on a date close to the 2024 Democratic or Republican National Conventions, or near Election Day, reported more support for partisan political violence afterward — while those whose peak experience landed on the Fourth of July reported less. Led by Otto Simonsson at Sweden's Karolinska Institutet and published Oct 6 in the journal Psychedelic Medicine, the study tracked nearly 22,000 U.S. adults across two 2023–24 survey waves; of the roughly 12,000 who completed both, 505 reported psychedelic use in the interval and gave the exact date and estimated dose of their most intense experience. About four in five of those users identified as Democrats. The study doesn't say whether this was recreational or more controlled use — participants reported only the date and dose, not the context, so "naturalistic" here just means "outside a clinical trial," nothing more specific.
We've all read that Grindr usage spikes in host cities during party conventions — add psychedelics to the list of things apparently also happening on the convention floor this cycle.
The researchers frame the actual finding through set and setting — the idea that a psychedelic experience is shaped by a person's mindset going in and the environment around them — extended to the broader cultural and political mood on a given day, not just the room someone is sitting in. One notable, unplanned finding: among the small number of Republican respondents whose session fell on the date of the July 2024 assassination attempt on Donald Trump, support for partisan violence went down, not up.
Read the caveats as seriously as the headline. This is observational, not a controlled trial, so it can't establish that the drug caused the shift rather than correlating with who was already paying close attention to politics that day. Only the Fourth of July comparison was pre-registered; the convention, election, and assassination-date findings are exploratory, drawn from subsamples as small as 19 people, without correction for running multiple comparisons. None of this means psychedelics cause political violence; it's a preliminary signal that when someone uses may matter, not just whether they do.
A Cornell student's lawsuit alleging she was gang-raped by Chi Phi fraternity members in October 2024, after being given alcohol and ketamine that left her unable to resist or leave, has reopened a criminal investigation that initially produced no charges. On Oct 1, New York Gov. Kathy Hochul named state Attorney General Letitia James as special prosecutor, after losing confidence in the local DA's handling of the case; a separate dispute has emerged over whether phone-record preservation letters Cornell police drafted in Nov 2024 ever reached prosecutors. The allegations are disputed — some of the named students say the sex was consensual, others deny contact entirely — and nothing here is adjudicated. We're not re-reporting the legal case; PBS NewsHour and CNN are covering it in depth.
What's squarely in our lane is the pharmacology, because it's the same compound we've covered as a patent story and have an encyclopedia entry on: ketamine is an NMDA-receptor antagonist that produces dissociation, amnesia, and immobility at doses around 1.0–1.5 mg/kg IV or 3–4 mg/kg IM — the same mechanism underlying Spravato, an FDA-approved rapid-acting antidepressant for treatment-resistant depression, and the one that makes a person unable to resist or clearly recall what happened to them when it's administered without their knowledge. In a clinic, that dissociative state happens under supervision, with dosing controlled and consent established beforehand — the entire premise of ketamine-assisted therapy is that the setting and the consent are what make the drug's effects therapeutic rather than dangerous. Outside that setting, the same pharmacology is what makes ketamine one of the drugs documented in drug-facilitated sexual assault cases: a person can be conscious, compliant-looking, and have no reliable memory of it afterward.
The harm-reduction basics bear repeating because they're not abstract: never leave a drink unattended, watch drinks being poured, and know that a dissociative, amnesia-producing dose doesn't require a struggle to be incapacitating — the absence of resistance is not the same thing as consent. This is harm-reduction and pharmacology reporting, not legal commentary on an active, disputed case, and not medical advice.
One week after the FDA's historic public hearing on psychedelics — the one that drew over 1,800 registrants — the DEA published a proposed rule doing close to the opposite: placing five tryptamines in Schedule I. The compounds are 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT, published in the Federal Register Sept 23, 2026, with public comments due Oct 23.
The DEA's own cited evidence is thin: 518 law enforcement encounters and 65 poison-center exposure cases across an 18-year span (2003–2021), with zero deaths reported from single-substance exposures. The agency's filing even acknowledges the FDA found "no diversion from research or legitimate manufacturing." This is the DEA's second attempt at scheduling these specific compounds — it withdrew a similar effort in 2022 after public and legal pushback.
The real collision: one of the five, 4-OH-DiPT, is the parent compound behind Reunion Neuroscience's luvesilocin (RE104) — a patented prodrug that the FDA granted Breakthrough Therapy Designation for postpartum depression back in February 2026, on the strength of a Phase 2 trial where 70% of patients on the 30mg dose were in remission at both Day 7 and Day 28. Reunion is now working with the FDA on a single pivotal Phase 3 trial — funded privately after MPM BioImpact took the company off Nasdaq in a 2023 buyout, so there's no public ticker to watch this through. A Schedule I listing for the parent compound wouldn't necessarily halt luvesilocin's own development path, but it sets up a direct tension between two federal agencies moving in opposite directions on the same chemical scaffold.
"Schedule I has become the default for the DEA for any substance that is not FDA-approved," said Robert Rush of the Rights and Reason Project, calling out the contradiction directly: "We have the FDA attempting to move forward a promising new treatment while the DEA is doing everything they can to obstruct." MAPS's Ismail Ali put it more simply: "These five lesser-known psychedelic substances don't belong in Schedule I."
Dr. Sunil Aggarwal's petition to move psilocybin from Schedule I to Schedule II under the Controlled Substances Act — first filed in February 2022 — has been sitting at the Department of Health and Human Services since the DEA forwarded it there for scientific review on Aug 11, 2025. Fourteen months later, per Marijuana Moment, HHS still hasn't responded, and no timeline has been disclosed. Attorney Kathryn Tucker, representing Aggarwal, argues the DEA should "promptly move forward" in light of Trump's psychedelics executive order — but as of this writing, the order hasn't translated into movement on the one rescheduling petition actually working its way through the federal process.
This sits alongside the state-level picture we scored bill-by-bill a few days ago: most of the real legislative action in 2026 has happened in state capitols, not at the federal scheduling level, and a stalled HHS review is a real part of why.
AtaiBeckley (Nasdaq: ATAI) — the company Eli Lilly is paying up to $3.8 billion to acquire for BPL-003, its synthetic 5-MeO-DMT drug — has open-label extension data worth flagging that predates this site's coverage. Announced Nov 10, 2025: patients who got an initial active dose (8 mg or 12 mg) in the core Phase 2b study, then a second 12 mg dose eight weeks later, hit 63% response and 48% remission by Week 8 of the extension, for treatment-resistant depression. Two doses eight weeks apart produced antidepressant effects lasting up to four months. That data helped lock in the 8 mg dose for the pivotal Phase 3 program, branded ReConnection, now underway — though topline results aren't expected until around 2029.
Worth being precise about which company is which here, since it's an easy mix-up (one we briefly made ourselves pulling this together): 5-MeO-DMT is being developed in parallel by two separate companies with two separate drugs — AtaiBeckley's intranasal BPL-003 and GH Research's inhaled GH001 — and the datasets aren't interchangeable. Full trial history, including both programs side by side, is in our trials tracker.
This is business and clinical-trial reporting, not medical advice. BPL-003 remains investigational and is not FDA-approved for any use.
Our own anxiety-drug market piece scoped Definium Therapeutics' (Nasdaq: DFTX) DT120 — an orally-disintegrating LSD tablet — to its two positive Phase 3 trials in generalized anxiety disorder. That undersold it. DT120 also has a positive Phase 3 win in major depressive disorder: Emerge, which read out June 22, 2026, showed a -8.1 point placebo-adjusted improvement on the MADRS depression scale at Week 6 across 149 participants (p<0.0001) — rapid (-14.2 points at Week 1) and durable (-7.3 points at Week 12). The FDA granted DT120 Breakthrough Therapy Designation for depression on Aug 27, 2026 on the strength of that result. A second, confirmatory MDD Phase 3 (Ascend, roughly 175 participants) dosed its first patient May 12, 2026, with topline data expected in 2027.
Between the anxiety and depression programs, that's three of Definium's four late-stage readouts positive so far — arguably a bigger story than the anxiety angle alone, and one worth correcting for here. Full trial history is in our trials tracker.
This is business and clinical-trial reporting, not medical advice. DT120 remains investigational and is not FDA-approved for any use.
Clearmind Medicine (Nasdaq: CMND) hadn't shown up in our patent tracker or trials tracker before now — a gap in our coverage, not a new company. Two real developments this month: on Sept 11, the company enrolled its first actual alcohol-use-disorder patients (at Hadassah Medical Center in Jerusalem) in a trial of CMND-100, its oral formulation of MEAI — a non-hallucinogenic, psychedelic-derived compound distinct from any classic psychedelic, working through serotonergic and alpha-2-adrenergic receptors rather than the 5-HT2A pathway behind classic psychedelic effects. Then on Sept 23, the company disclosed three new US patent applications covering combinations of LSD, ketamine, and ibogaine with N-acylethanolamines (like PEA) — developed with NeuroThera Labs, aimed at depression, PTSD, pain, and substance-use disorders.
Company-reported figures put its broader portfolio at 19 patent families and 32 granted patents as of June 2026. We independently verified one — a MEAI-covering patent (US 12,357,590, "Binge Behavior Regulators") expiring Dec 3, 2037 — and have added the company to both trackers with that verification status noted plainly rather than taking the full portfolio figure on faith.
This is business and clinical-trial reporting, not medical advice. CMND-100 remains investigational and is not FDA-approved for any use.
A study published Sept. 3 in Science found that giving mice a dose of psilocybin before chemotherapy prevented much of the nerve damage and lasting pain that platinum-based drugs like cisplatin commonly cause — without blunting the chemo's effect on the tumors themselves. Mice given chemo alone stayed hypersensitive to pain for at least four months afterward; one dose of psilocybin beforehand cut that to about three months, and two doses given a week apart eliminated the hypersensitivity entirely, according to the MD Anderson Cancer Center team behind the work.
"The idea, instead of trying to put things back together that are broken, is to jump in and protect it from the very beginning," says study co-author Patrick Dougherty, a pain researcher at MD Anderson. Follow-up lab work suggests the mechanism may hold in human nerve cells too — psilocybin blocked cisplatin's disruption of mitochondrial transport inside neurons grown in a dish.
This is mouse and cell-culture data, not a human result yet, and it's worth being precise about that distinction. Cornell neuroscientist Alex Kwan, who wasn't involved in the study, called the effect "quite incredible" but said he'd want more data before drawing conclusions about people; University of Sydney neuroscientist Susanna Park raised a similar caution, noting a "large gap" in this field generally "between success in preclinical models and translation to effective therapies for humans." MD Anderson plans to launch a phase 2 trial next month testing psilocybin in roughly 80 patients undergoing chemotherapy for breast, colorectal, or head and neck cancer — the same phase-by-phase process we've broken down in detail before, and one that typically takes years to produce a definitive answer.
One detail for patients who'd rather not trip during cancer treatment: the same team tested an experimental, non-hallucinogenic psilocybin-like compound and found it replicated some of the protective effects in mice.
This is science reporting, not medical advice. Psilocybin remains a Schedule I substance in the US and is not an approved treatment for chemotherapy-induced nerve pain — this specific protective effect has so far only been demonstrated in mice and isolated cells, not people.
Ari Emanuel — the WME/Endeavor chief whose temper was the real-life template for Entourage's Ari Gold, and who now owns UFC, WWE, and a chunk of London's West End — has a new memoir out, Roll the Calls. In a wide-ranging interview with The Sunday Times Magazine, Emanuel — whose rage is well documented, by his own admission and everyone else's — credits a session with 5-MeO-DMT, the compound our own encyclopedia entry calls the "God Molecule," with taking real edge off it.
"I recently met a shaman in Santa Fe, New Mexico, and took 5-MeO-DMT, produced by the Sonoran Desert toad," Emanuel tells the paper. "I've explored many [hallucinogenics], but I think that's the most powerful. You realise you're a pimple on the ass of an ant. It's been an incredible help to me to disavow a bunch of shit. And give myself and my life and my parents a break." He's candid that it hasn't switched the anger off entirely — "Recently, somebody did something and I hit the rage button. Defcon one," he says, though he adds that this time he "put the call on mute" instead of yelling.
It's a striking, very public data point for a compound we've covered from the inside before — see our own personal account of a Bufo session — but it's one man's story, not a treatment. 5-MeO-DMT remains a Schedule I substance in the US with no approved medical use, "shaman"-led sessions are unregulated and carry real physical and psychological risk, and nothing here is a substitute for actual anger-management or mental-health care.
New chemical analysis is confirming something archaeologists have suspected for decades: Chavín de Huántar, a 3,000-year-old pilgrimage complex high in the Peruvian Andes, ran on drug rituals. In 2016, a team led by Stanford's John Rick began excavating a newly found underground gallery that yielded what he calls "the smoking gun" — 21 bone snuff tubes. "It was crazy, we started to find all this material," says Oscar Espinoza, the Tulane Ph.D. student who ran the analysis, published in May 2025. The tubes carried residue of tobacco and seeds from the vilca tree — a mix of bufotenine, DMT, and 5-MeO-DMT that produces short, extremely intense visions.
The pattern spreads well beyond Chavín, according to a new Science feature by Andrew Lawler. At San Pedro de Atacama in Chile, home to a 400,000-object collection assembled by a local priest, ethnobotanist Constantino Torres says drug paraphernalia from the Tiahuanaco era (roughly 250-1000 C.E.) turns up in "roughly one in three graves" — among them bird-bone tubes that archaeologist Verónica Lema identified as enema syringes with "millimeter-precise dosing openings." The Wari empire, meanwhile, appears to have spiked feasting chicha beer with ground vilca seed for a subtler, longer-lasting group effect. "I might have a vilca beer with you, [even if] I'm not going to snort that stuff," says archaeologist Justin Jennings — a bonding "afterglow" he compares to what modern ayahuasca users report. A separate 2018 discovery in Bolivia, a leather bundle of snuff tools analyzed by chemist Melanie Miller, produced the first direct evidence that ayahuasca's own ingredients were being traded into the Andean highlands at all, as early as 250-550 C.E.
Not everyone is convinced how far to take this: Lema, who also worked on the Chavín lab analysis, cautions there isn't yet enough evidence to say what was actually happening in those galleries, or for whom. But the pilgrimage never really stopped — Chavín now has two psychedelic retreat centers operating in its literal shadow. "These plants are powerful tools of knowledge, allowing access to different dimensions," says Ingrid Diaz, who runs one of them. Archaeologist Matt Sayre, who still excavates at the site, says modern visitors have occasionally bribed the park's guards to sneak in after dark.
Three days after the FDA's psychedelic-drugs hearing drew over 1,800 registrants, MAPS put its reaction on the record. Co-executive director Betty Aldworth: "The importance of therapy to these treatments cannot be understated — and it wasn't." Co-executive director Ismail Ali, J.D., was more direct: "Breakthrough clinical findings are promising, but mean little if the systems around them are not prepared to deliver them to patients." MAPS says it will submit formal written testimony to the FDA's public docket (open through Oct 5) addressing three specific gaps: systems readiness, therapist training capacity, and patient access — echoing the same provider-training and access themes the hearing itself surfaced. Separately, MAPS shared its recently published, open-science Ibogaine Investigator's Brochure directly with HHS, FDA, and the VA — a concrete document handoff, not just commentary. None of this changes the regulatory timeline on its own, but it's a marker of who's showing up to shape it: MAPS has pushed psychedelic policy since 1986 and has deployed over $150 million in philanthropic funding toward exactly this kind of infrastructure question.
One term worth slowing down on today, straight off yesterday's news.
DT120: Definium Therapeutics' lead LSD candidate — lysergide delivered as an orally-disintegrating tablet, rather than the traditional blotter or liquid form. It was developed under the code name MM120 before the company's January 2026 rebrand from MindMed to Definium. DT120 has now posted two independent positive Phase 3 trials for generalized anxiety disorder — Voyage and Panorama — making it the most advanced LSD program in clinical development, though it's still not FDA-approved for anything.
Full entry, plus 157 other terms, is in our Encyclopedia.
Panorama, Definium's second Phase 3 trial of DT120 (lysergide) for generalized anxiety disorder, met its primary endpoint on Sept 14 — a statistically significant and clinically meaningful improvement over placebo on the Hamilton Anxiety Rating Scale, across 245 participants. That's two-for-two: Panorama follows Voyage, DT120's first Phase 3 GAD trial, which also hit its primary endpoint back in August — full history on our Trials Tracker. Two independent positive Phase 3 readouts for the same drug and indication is a meaningfully stronger position than one — it's the kind of replication regulators specifically look for, and part of why Definium is currently the most valuable public psychedelic-adjacent company by market cap. DT120 still isn't FDA-approved for anything; an NDA filing hasn't been announced yet.
Yesterday's FDA public hearing — the one set up by this week's NEJM framework piece — drew over 1,800 registrants, hybrid in-person and virtual. FDA's Marta Sokolowska opened by framing it as "a whole of government effort to better understand the opportunities, challenges, and public health considerations" around psychedelic drug treatment. Panelists heard roughly 80 comments across two thematic waves: one on provider training, credentialing, and patient safety; the other on access and standardizing how outcome data gets collected across different providers and settings. None of this is a decision — it's the FDA listening, not ruling — but it's a real, sizable signal of how much public and clinical interest has built around psilocybin and methylone specifically, the two compounds furthest along the agency's own priority-review track. Worth noting: Michael Davis, FDA's newly appointed CDER director and lead author on this week's NEJM framework piece, spent years as Chief Medical Officer at Usona Institute — the nonprofit running one of the field's furthest-along psilocybin trials — before joining the agency now hearing the case for approving it.
DMT (N,N-Dimethyltryptamine): a classic psychedelic found naturally in plants and animals, and the principal psychoactive ingredient in ayahuasca. A single dose reversed depression-like symptoms in stressed mice by regrowing brain cells, according to research we've covered — animal data, not a human result yet.
Bicycle Day: April 19, 1943, the date Albert Hofmann deliberately dosed himself with 0.25mg of the LSD he'd synthesized five years earlier, then rode his bicycle home through Basel as the effects took hold — now marked informally every year as a psychedelic holiday. Hofmann himself later described becoming convinced his neighbor was a malevolent witch and that the drug had poisoned him — a real account of how disorienting an unplanned first dose can be, even for the person who invented the compound.
Full entries, plus 156 other terms, are in our Encyclopedia.
Four senior FDA officials — Michael Davis, Teresa Buracchio, Tiffany Farchione, and Bernard Fischer — published a perspective piece in the New England Journal of Medicine on Sept 9-10 laying out how the agency plans to actually evaluate psychedelic drugs, days ahead of today's public hearing on the topic. The piece confronts the field's core methodology problem directly: functional unblinding rates in psilocybin trials routinely exceed 80%, since it's hard to hide from a patient (or their clinician) that they just took a psychedelic. Rather than pretending the standard placebo-controlled model works here, the framework proposes active-placebo conditions, measuring patient expectancy at baseline, and statistical models that treat the therapeutic alliance itself as a variable to control for — not just accept as noise. It follows the FDA's finalized clinical-trial guidance from July and sets up the terms for today's hearing, where the agency is expected to hear public input on exactly these design questions.
We spent the past week tracking down every dollar we could verify moving through the psychedelic-therapeutics sector — public company market caps, private funding rounds, and government research budgets — and ranked what's left after correcting nine claims that didn't hold up. The gap between the three is the real story: over $11 billion in public market cap, $1.6 billion in disclosed private funding, and barely $140 million in verified government funding worldwide. Read the full rankings here. Part two, the trends and the graveyard, follows next Friday.
Governor Jenniffer González-Colón signed Executive Order 2026-037 on August 4, directing Puerto Rico's Department of Health to evaluate a pilot clinical research program covering ibogaine, psilocybin, and MDMA, with veterans first in line if it moves forward. The order creates a Scientific and Regulatory Advisory Committee — psychiatrists, pharmacologists, ethicists — to weigh the evidence, assess what infrastructure the island would need, and pursue funding and partnerships with the NIH, FDA, VA, and DEA. It's explicitly a feasibility study, not a green light: the order states outright that it does not authorize any clinical use of these compounds yet. That puts Puerto Rico alongside a growing list of U.S. jurisdictions — Texas, Colorado, Connecticut, New Jersey — exploring psychedelic research pilots ahead of any federal approval, each with its own scope and guardrails.
One term worth slowing down on today — picked from what readers are actually searching for.
Anandamide: the body's own natural cannabinoid, discovered in 1992 and named from the Sanskrit "ananda" (bliss). It binds the same receptors as THC and is sometimes called the "bliss molecule" — unrelated to classic psychedelics, but part of the same broader neurochemistry-of-wellbeing territory.
Example: A 2003 study (Sparling et al., published in NeuroReport) found anandamide levels rise in the blood after 50 minutes of moderate-intensity running or biking — real evidence for what's now considered the leading explanation of "runner's high." Unlike endorphins, anandamide is small and fat-soluble enough to cross the blood-brain barrier, which is part of why researchers now think it's a bigger piece of that effect than endorphins ever were.
Full entry, plus 155 other terms, is in our Encyclopedia.
A Wall Street Journal investigation traces a network of SpaceX and Tesla insiders funding psychedelic research and drug development. Antonio Gracias — a SpaceX director and Valor Equity Partners founder — personally cut a $25 million check from his family foundation to recapitalize what's now Resilient Pharmaceuticals after its 2024 FDA rejection, then moved the company to Chicago and took it over — an idea reportedly pitched to him by MAPS founder Rick Doblin at a Burning Man gathering in 2024. Gracias also endowed a $16 million psychedelics-in-society professorship at Harvard back in 2023. Fellow SpaceX director Steve Jurvetson and his wife Genevieve — a board member of the Psychedelic Science Funders Collaborative — have long supported MDMA trial funding, and Kimbal Musk and his wife Christiana have backed a separate academic fellowship. Elon Musk himself has disclosed a ketamine prescription for depression and has spoken favorably about MDMA. The piece also connects the dots to the DoD's active-duty MDMA-PTSD trials and April's presidential executive order fast-tracking psychedelic drug review — which Trump has said Joe Rogan prompted him toward, specifically on ibogaine.
Eli Lilly announced on July 16, 2026 that it will acquire AtaiBeckley — the company formed just months earlier when ATAI Life Sciences merged with Beckley Psytech — for $6.75 per share in cash upfront (about $2.8 billion) plus up to $2.50 per share more through a contingent value right tied to future milestones, putting the deal's total potential value at $3.8 billion. The acquisition is expected to close this quarter and is the first time a major pharmaceutical company has bought a psychedelic drug developer outright, rather than licensing or partnering. The deal centers on AtaiBeckley's 5-MeO-DMT candidate mebufotenin (BPL-003), which posted positive Phase 2b results for treatment-resistant depression earlier this year. It's a genuinely new kind of signal for the sector: after years of biotechs partnering with or licensing individual compounds to Big Pharma, this is the first full buyout — the closest thing yet to an answer on whether Big Pharma sees this as a real, ownable business or just a research bet worth watching from a distance.
New Zealand's medicines regulator, Medsafe, has approved two named psychiatrists — Dr. Gary Wynn in Wellington and Dr. Tom Paterson in Auckland — to prescribe pharmaceutical-grade MDMA as part of supervised psychotherapy for adults with PTSD that hasn't responded to conventional treatment. Each spent more than a year in the approval process. It's a narrow authorization, not a general legalization — access runs through exactly two clinicians for now — but it puts New Zealand in the same authorized-prescriber lane Australia opened for MDMA-assisted therapy back in 2023, while the U.S. still has no approved MDMA therapy on the market: Resilient Pharmaceuticals' resubmitted application (branded Rysanso) remains under FDA review with no decision yet.
Two more terms worth slowing down on — one pharmacology, one slang worth knowing precisely rather than guessing at.
Eugeroic: a class of wakefulness-promoting drugs, distinct from classic stimulants, that increase alertness without the same peripheral sympathetic activation. Modafinil is the prototypical example. Not a psychedelic at all — it shows up adjacent to this space mainly because people sometimes reach for eugeroics and psychedelics for overlapping reasons like focus or cognitive enhancement, despite the two drug classes working through entirely different mechanisms.
Space Jam: drug slang, not a Warner Bros. reference. In DEA slang documentation, "space" refers to PCP combined with cocaine, and "space jammin'" describes the disorienting, out-of-body-feeling high from combining the two. Polydrug combinations like this carry real, elevated risk precisely because the effects and interactions of the mixture are far less predictable than any one substance alone.
Full entries, plus 153 other terms, are in our Encyclopedia.
2C-B: a synthetic phenethylamine psychedelic with combined empathogenic and visual effects. Alexander Shulgin first synthesized it in 1974, called it part of his "magical half-dozen" of noteworthy phenethylamines, and described the effect as a "warm hug." A real safety note, not folklore: 2C-B is metabolized in part by the same MAO enzymes an MAOI blocks, and case reports link the combination to agitation.
MAOI (Monoamine Oxidase Inhibitor): an enzyme inhibitor that prevents the breakdown of DMT in the gut, which is what makes ayahuasca psychoactive when taken orally. Outside psychedelics entirely, MAOIs carry a genuine dietary restriction — combined with tyramine-rich foods like aged cheese or cured meats, they can trigger a real hypertensive crisis, not just an unpleasant interaction.
Full entries, plus 146 other terms, are in our Encyclopedia.
A trademark filing reveals what Resilient Pharmaceuticals (formerly Lykos, before that MAPS PBC) is calling its resubmitted MDMA-PTSD candidate: Rysanso, filed to cover pharmaceutical and psychedelic preparations. We've covered the resubmission itself — this doesn't change where that stands, but a brand name this far ahead of any approval is its own signal: the company is positioning for a market launch, not just another regulatory round. Read into the name what you want — it lands somewhere between "resilience" and "renaissance," which tracks for a drug that's already survived one rejection and a company-wide rename.
Under the new CBA finalized in May 2026, the WNBA removed cannabis from its prohibited substances list entirely, while adding psilocybin, psilocin, DMT, and ibogaine to it for the first time — the two drug categories moving in opposite directions in the same document. It's a small, specific data point in a much bigger pattern: legal and cultural comfort with cannabis keeps growing while psychedelics remain treated as the newer, less-settled risk, even as federal research funding and executive-branch attention move the other way. Worth noting the practical side too — several of the newly-banned compounds clear the bloodstream within 24 hours, which limits how much a ban like this can actually detect after the fact.
Mescaline: the psychedelic alkaloid found in peyote and San Pedro cacti, with ceremonial use tracing back well before any clinical interest existed. The Native American Church, founded in 1918 out of a peyote ceremony practiced since the 1880s among the Kiowa and Comanche, holds the only federal legal exemption of its kind in the US — see our Peyote Exemption entry for how that carve-out actually works.
DEA (Drug Enforcement Administration): the federal agency that would have to reschedule psilocybin, MDMA, or LSD out of Schedule I before an approved drug based on them could actually be prescribed. It hasn't done that, but in a January 2026 final order it raised the legal research-production quota for psilocybin from 30,000 to 50,000 grams and for 5-MeO-DMT from 11,000 to 30,000 grams — more supply for research, short of rescheduling anything.
Full entries, plus 140 other terms, are in our Encyclopedia.
We just came across this one — published August 3 in Nature Communications, so not breaking, but worth surfacing. Researchers at the University of Southern Denmark, led by Mikael Palner and Frederik Gudmundsen, used PET scans to track brain activity in rats given LSD, psilocybin, and 2C-B, both during the acute trip and a week later. The three drugs didn't converge on one shared pattern the way "classic psychedelic" as a category might imply: 2C-B mainly hit reward-related regions, LSD hit areas tied to habit and motivation, and psilocybin stood out for hitting emotion-processing regions specifically. If this replicates in humans, it's a real argument against treating psychedelics as interchangeable for a given condition — the right compound may depend on which circuit actually needs to change.
We missed this one when outgoing Governor Phil Murphy signed it on January 20, 2026, days before leaving office. S2283 creates the Psilocybin Behavioral Health Access and Therapy Pilot Program — a narrow, hospital-based research program supervised by the state Department of Health, with $6 million appropriated to run it. Worth being precise about what this actually is: despite headlines at the time suggesting New Jersey had "legalized" psilocybin, it hasn't. This creates no public access — it's a state-sanctioned clinical research pathway, similar in shape to Connecticut's expanded pilot and Louisiana's opioid-settlement-funded program, joining a growing list of states building this kind of infrastructure ahead of any federal approval rather than waiting for one.
We just came across this one and thought it was worth surfacing, even though it's not fresh — the underlying paper published in JACS in late 2025, and UC Davis put out its own writeup on January 7, 2026. Chemists Joseph Beckett and Trey Brasher, working with professor Mark Mascal, used a photochemistry technique — fusing tryptamine to amino acids with ultraviolet light — to generate candidate molecules from a library of 100 computationally modeled compounds. One of them, labeled D5, fully activated the 5-HT2A receptor without producing the head-twitch response mice show in response to actual hallucinogens. Brasher called it "the discovery of a brand-new therapeutic scaffold" — a genuinely new chemical starting point, not a tweak on an existing psychedelic, if it holds up in further testing well beyond a mouse-model screen.
Set and Setting: mindset and environment shaping the experience — a phrase that sounds like vibes but has real safety weight behind it. Our reporting on overseas clinic safety found that poor setting — unscreened staff, no medical oversight, patients dosed without real preparation — was a common thread across the worst documented outcomes, not just an aesthetic afterthought.
Fear Extinction: the process by which a learned fear response fades when the feared stimulus keeps occurring without the bad outcome attached to it — a leading model for how trauma therapy works. Animal studies found MDMA enhances this process through a BDNF-dependent mechanism in the amygdala, a proposed reason the VA's MDMA-PTSD trials pair the drug with therapy sessions rather than administering it alone.
Full entries, plus 140 other terms, are in our Encyclopedia.
We missed this one when Governor Ned Lamont signed it on June 4 — bubbling it up now because it's a bigger structural change than the headline size suggests. SB 191 passed the Connecticut Senate 35-0 and House 122-27, expanding a small, Yale-run pilot that had covered about 20 veterans into a program open to any adult 18+ who meets clinical criteria, including first responders and frontline health care workers with treatment-resistant depression or PTSD. The program stays under a state medical school's FDA-approved research umbrella — this isn't open access, it's still a supervised research pathway. The detail worth noting: the new law also removes the original sunset clause that would have ended the pilot once federal approval happened, which reads less like a stopgap now and more like Connecticut building permanent infrastructure ahead of an approval it expects to actually arrive.
Two more terms that come up constantly and rarely get explained plainly.
5-HT2A Receptor: the single receptor that psilocybin, LSD, DMT, and mescaline all act on as agonists, despite looking chemically quite different from each other. It's also why an antagonist at the same receptor can block a trip outright — see our Antagonist entry in the Encyclopedia. Definium's LSD-derived DT120 works through this exact receptor; we've covered where that drug and its patents stand.
Microdosing: taking a sub-perceptual dose, too small to produce a noticeable trip. The open-label, self-report evidence is enthusiastic. The rigorous evidence isn't there yet — a 2026 microdosed-LSD depression trial we covered looked strong with no control group, then failed to beat an active placebo once one was added. A useful reminder that open-label results and controlled results can point in opposite directions for the same compound.
Full entries, plus 140 other terms, are in our Encyclopedia.
Psychedelic coverage throws around a lot of jargon fast, so twice a week we're slowing down on two terms at a time.
Default Mode Network (DMN): the brain network active during self-referential thinking — mind-wandering, autobiographical memory, the running mental narrative about yourself. Neuroscientist Robin Carhart-Harris's "entropic brain" hypothesis proposes psychedelics work partly by collapsing this network's normal organization. When his team first scanned brains on psilocybin, they expected to see more activity and instead found a significant drop-off — the opposite of the prediction they went in with, and part of why the DMN became central to modern psychedelic neuroscience.
Ego Dissolution: the temporary loss of the felt boundary between self and everything else, one of the most commonly reported effects at higher psychedelic doses. Researchers measure it with the Ego-Dissolution Inventory, an 8-item scale validated in 2016. Scores on it rise with psychedelic dose but not with cocaine or alcohol dose — part of why researchers treat it as a specific, measurable effect rather than generic intoxication.
Full entries, plus 97 other terms, are in our Encyclopedia.
Ibogaine's original patents belong to Howard Lotsof, who discovered its anti-addictive effect on himself in 1962 and patented it in 1985 — all long expired. We mapped who holds the 53 patents filed since, and found that DemeRx's original opioid-use-disorder program stalled over a cardiac safety signal and ended in litigation with atai, while a different DemeRx drug, for a different disease, became the first ibogaine-class compound cleared for a US trial. Read it here.
Michigan's HB 6020, a bipartisan bill from Reps. Jaime Greene and Matt McFall, would put $50 million of the state's opioid settlement money into FDA-supervised ibogaine trials for opioid use disorder, PTSD, and other conditions — the same settlement-funding playbook Louisiana adopted a few weeks ago. What makes it more than another state pilot: Michigan would join a consortium — states, drug manufacturers, health systems, and research universities — that's reportedly grown to six states in under a year, aiming to pool each state's trial data into a single, consolidated New Drug Application to the FDA. If that actually holds together, it's a genuinely novel end-run around the fact that no single state can get a drug approved on its own — states can generate the data, but the FDA still has to accept a joint submission built that way, which has no real precedent we're aware of. Worth tracking, not yet a sure thing.
Researchers mapped nearly half a million individual brain cells from hippocampal tissue, comparing people with major depressive disorder to controls at single-cell resolution — the largest dataset of its kind. Adult neurogenesis, the hippocampus's ongoing production of new neurons throughout life, was measurably stalled in the depression group, alongside broader molecular disruptions in synaptic function, energy metabolism, inflammation, and cellular stress response. It's descriptive, not interventional — the study shows what's different in depressed brains, not that fixing neurogenesis treats depression — but it's a plausible mechanistic thread connecting to why several psychedelics and ketamine, which promote neuroplasticity and in some cases new neuron growth in animal models, show antidepressant effects distinct from traditional SSRIs.
Ketamine tops our patent tracker at 71 granted patents — more than psilocybin, more than MDMA — and almost all of it traces to one drug, Spravato. We dug into why the compound already approved and already prescribed isn't getting the gold-rush treatment the still-illegal psychedelics are. Read it here.
The drugs most Americans take for depression and anxiety are decades-old generics that make pharma almost nothing. We mapped the five newer, still-patented drugs actually driving revenue in this space — and how fast two of them are about to lose that protection. Read the brief here.
Border Force seized 1,300kg of ketamine in Q1 2026 alone — on pace to blow past the previous full-year record. That prior record, set in the year to March 2025, was itself 1.3 tonnes, a 55% jump from the year before, per Home Office data. If the pace holds, 2026 could roughly double the seizure total in a single year. We're covering the demand side of this the same week: why ketamine's patent-free, already-generic status has kept it out of the psychedelic industry's speculative gold rush even as use — and now interceptions — climb.
SB 43 became law on August 1 without Governor Jeff Landry's signature, after passing both chambers unanimously in May. It creates a psychedelic-assisted therapy pilot inside the Louisiana Department of Health, funded by the roughly $600 million the state is due through 2038 from opioid settlement payouts — money extracted from the companies that helped cause the crisis, redirected toward trials of psilocybin, ibogaine, and MDMA for opioid use disorder and co-occurring conditions. Any studies still have to clear the FDA's investigational drug process and get DEA Schedule I permits like anyone else's would. If a drug developed through the program is ever approved, the state gets a 20% cut of the profits — a funding model we haven't seen elsewhere in this space.
Normal antibodies are too large to get inside a cell, which rules them out against disease-causing proteins that never leave the cytoplasm — a real problem for neurodegenerative disease, where a lot of the damage happens intracellularly. A University of Essex team used AI to redesign 672 existing antibodies into "intrabodies," small enough to fold correctly and function inside human cells, targeting proteins implicated in Alzheimer's, Parkinson's, Huntington's, and motor neurone disease. Published in Nature Communications. It's a platform result, not a treatment — no human dosing data exists yet — but combined with gene-therapy delivery methods, it's a real answer to a targeting problem that's mostly kept intracellular disease proteins out of reach.
A New York Times investigation into overseas psychedelic clinics — most of it centered on Mexico, now home to at least 40 ibogaine clinics versus almost none a decade ago — puts real numbers behind something we've flagged before: there's no standardized oversight in this industry, and no official tally of how often that goes wrong. The anchor data point comes from a JAMA study led by Baylor's Amy McGuire, which surveyed 49 publicly-advertised psychedelic retreats and clinics in the US and abroad and found fewer than half employed a medical professional at all, and only about 10% had staff with emergency medical training. The Times ties that gap directly to documented harm: a fatal ibogaine-related cardiac arrest in Costa Rica (Aug 2024), a death during drug detox at a Mexican clinic (2025), a fatal ayahuasca reaction in Peru (Jun 2026), a Miami doctor now charged with manslaughter after a ketamine/MDMA death at an unlicensed "healing space," and a criminal rape case against a doctor at a Cancún ibogaine clinic, after he allegedly assaulted a patient who'd just been given 5-MeO-DMT. None of this is an argument that the underlying compounds don't work — the same reporting includes patients with real, positive outcomes — but it's a sharp illustration of what "no FDA approval, no standardized protocol, no US legal recourse" actually looks like in practice for the veterans and civilians we've written about traveling abroad for treatment that isn't yet legal at home.
The Army dosed 7,000 soldiers with psychedelics they weren't told they were taking, decades before Schedule I ended the program. We mapped where MDMA, psilocybin, ibogaine, ketamine, and LSD actually stand across the VA and Pentagon today — this time by consent. Read it here.
LSD has the smallest patent footprint of any compound in our tracker — 14 granted, 34 pending — and Roche's five grants turn out to be drug-testing patents, not therapeutics. Definium, the company closest to an actual approval, holds just one. Read the full breakdown here.
We missed this one when it happened back on July 22 — bubbling it up now because it's more consequential than the news cycle at the time gave it credit for. The House passed its version of the FY2027 defense authorization bill, 216-212, carrying two psychedelics amendments: one extends the Pentagon's psilocybin, MDMA, ibogaine, and 5-MeO-DMT research program for PTSD/TBI in active-duty service members from a 3-year window to 2033, the other codifies Trump's April 2025 psychedelics executive order into law and requires the VA to name an official within 90 days to coordinate psychedelic-therapy access across agencies. Ten co-sponsors, split roughly evenly R/D, led by Rep. Morgan Luttrell (R-TX). It still needs the Senate, which hadn't acted on it as of this writing — this is House passage, not final law.
5-MeO-DMT has 164 patents in play across our tracker, and Turtle Bear Holdings and Beckley Psytech hold the most — but the company with the strongest clinical data, GH Research, holds almost none of them. We dug into what that split says about how differently these companies are betting on the same compound. Read the full breakdown here.
Psilocybin leads every compound in our patent tracker on combined activity, and four holders — COMPASS Pathways, Enveric Biosciences, Turtle Bear Holdings, and CaaMTech — account for most of the granted patents between them. We dug into what each is actually claiming, why one nonprofit running an FDA-vouchered trial holds zero patents on purpose, and how Compass survived a million-dollar legal challenge to keep its patents alive. Read the full breakdown here.
The Times ran a broad explainer on treatment-resistant depression — roughly defined as not improving by half after two different antidepressants, which describes an estimated 31% of people treated for depression in the US. Yale's Gerard Sanacora and UC Davis's Debra Kahn walk through what's tried next: TMS (patients on TMS plus an antidepressant were 2.8x as likely to reach remission as sham TMS plus antidepressant, per a 2023 meta-analysis of 19 trials), esketamine/Spravato (52.5% response vs. about 31% on placebo in its approval trial), lithium, and combination approaches. Psilocybin, ibogaine, and 5-MeO-DMT get one line — "also being studied" — which is a useful reminder of where psychedelics actually sit in mainstream medical coverage right now: a footnote to ketamine and neuromodulation, not yet a headline treatment.
Monash University's Turner Institute gave 62 healthy adults psilocybin under four different conditions — resting, meditating, listening to music, watching a film — while scanning their brains, the largest single-site imaging study yet of psilocybin's acute effects. Brain networks that normally keep "inner world" and "outer world" processing distinct blurred together under the drug, but the specific shape of that blurring tracked whatever the person was actually doing at the time, and stronger reorganization correlated with more positive, less isolating experiences. It's healthy volunteers, not a depression trial, but it's a real mechanistic case for something clinicians already suspected: the setting during a session isn't incidental to psilocybin therapy, it's part of how the therapy works.
We missed this one when it published back on July 9 — bubbling it up now because it's a real step, not just a bill filing. State Rep. Marjorie Decker's five-year pilot program cleared the Massachusetts House, folded into a $561 million economic development bill: up to three DPH-licensed mental health clinics would be allowed to administer psilocybin or ibogaine on-site under medical supervision for PTSD, addiction, and depression, with cannabis companies, pharmaceutical companies, and psychedelic-molecule developers explicitly barred from holding a license. It still needs Senate approval and Governor Healey's signature, so it isn't law — and it's notably narrower than the broader legalization ballot measure Massachusetts voters rejected in 2024, built instead around licensed clinics rather than open access.
A Harvard team led by Paola Arlotta, with lead authors Irene Faravelli and Noelia Antón-Bolaños, sustained lab-grown human brain organoids for more than five years — three times the previous 694-day record set by UCLA and Stanford researchers in 2021. Each organoid grew past a million cerebral cortex cells and appears to retain a molecular record of its own developmental age: when the team combined older and younger cells in one organoid, the older cells jumped ahead and produced the more mature neuron types they were developmentally due to make months before the younger cells reached the same point, apparently through DNA methylation acting as an internal clock. It's a real answer to a practical problem — organoids have generally died before diseases like Alzheimer's have time to develop in them — more than it's progress toward "organoid intelligence," whatever else gets written about it elsewhere.
The University of Miami handed its original 1994 ibogaine Investigational New Drug application over to HHS Secretary Robert F. Kennedy Jr., which President Trump framed as accelerating ibogaine's path toward federal research and, eventually, veteran access. An IND is the foundational filing that lets researchers legally study a drug in humans — a three-decade-old one on file could shortcut groundwork any new ibogaine program would otherwise have to redo from scratch. It's the latest follow-through on Trump's April executive order directing $50 million toward psychedelic research: the VA now runs more than 20 active psychedelic-related studies, and VA and HHS signed a cooperation MOU on this exact area back in July. Ibogaine itself remains Schedule I and unapproved for any use.
Researchers from Bendable Therapy, Osmind, and UCSF — including psychedelic-neuroscience researcher Robin Carhart-Harris — tracked 88 people who went through Oregon's state-licensed psilocybin services between March 2024 and April 2025, outside any clinical trial. Depression, anxiety, and well-being all improved significantly 30 days after a session, holding up even among the nearly half of participants already taking psychiatric medication. Two people reported lingering visual aftereffects a day out that had resolved by 30 days; three reported psychological aftereffects at 30 days. It's naturalistic, with no control group and a small, self-selected sample — nearly half the participants traveled in from out of state — so it's not a substitute for a randomized trial, but it's an early read on whether Oregon's legal program is producing outcomes anywhere near what's shown up in clinical settings.
We pulled every patent we could find across seven compounds — psilocybin, MDMA, LSD, ketamine, ibogaine, DMT, and 5-MeO-DMT — and mapped who's filing, what they're claiming to treat, and where the FDA has already said no. Read the full breakdown here, or dig into the company-by-company data yourself on Altitude Intelligence.
MindMed renamed itself Definium Therapeutics, Inc. (NASDAQ: DFTX) in January, and its LSD compound went from MM120 to DT120 in the same move. This week, the company reported positive Phase 3 results from Voyage, its lead trial for generalized anxiety disorder — meeting the primary endpoint with a strong effect size. A second GAD trial and an already-positive depression trial are also underway. Right now, this is the most advanced LSD program in clinical development, by a wide margin.
HB26-1325 took effect this month, creating a state-run ibogaine research pilot inside Colorado's Behavioral Health Administration — up to five sites studying ibogaine for PTSD, opioid use disorder, and other conditions, building on the state's 2022 Natural Medicine Health Act. It requires mandated cardiac screening and medical oversight (ibogaine carries a real, well-documented arrhythmia risk), coordination with the FDA's IND process, and a benefit-sharing requirement with Indigenous communities historically associated with iboga. This is a research pilot, not legalization — no sites have been picked yet, and ibogaine remains Schedule I federally.
Resilient Pharmaceuticals — the company formerly known as Lykos, and before that MAPS PBC — has quietly resubmitted its New Drug Application for MDMA-assisted therapy for PTSD, roughly two years after the FDA's August 2024 rejection. No new Phase 3 trial this time: the filing reportedly leans on a small VA follow-up study, a new cardiac-safety study in healthy volunteers, and an audit of the original trial data addressing the unreported-adverse-events problem that helped sink it the first time. MAPS itself says it has no active role in the filing now. Worth flagging: Resilient hasn't confirmed the resubmission publicly — this is trade reporting citing people familiar with the filing, not a company statement. I go deeper on what this means for the wider patent and regulatory picture here.
Estonian researchers proposed a unifying mechanism for how serotonergic psychedelics work at the cellular level: 5-HT2A agonism on the apical dendrites of layer V pyramidal neurons — a specific class of cortical cells — loosens the usual boundaries around a thought or perception, letting it bleed into surrounding context more than it normally would. They're calling it "apical hypercontextualization," and the pitch is that it could explain the felt sense of interconnectedness that shows up across different psychedelics. Worth being clear about what this actually is: a theoretical framework built to organize existing findings, not a new experiment with its own data. It's a hypothesis for the field to test, not a result.
The VA just registered PIVOT, a 240-person randomized trial testing psilocybin for treatment-resistant depression in veterans, including those carrying PTSD alongside it. It hasn't started recruiting yet, and primary completion isn't expected until 2030, so this is a marker to watch, not a result. But a study this size, from the VA itself, is a signal in its own right.
PsiDeR, led by Professor James Rucker at King's College London and delivered through South London and Maudsley NHS Foundation Trust, is the UK's first publicly funded randomized trial of psilocybin therapy — funded by the NIHR, 60 patients with treatment-resistant depression, a single 25mg dose against a true placebo, with psychological support given to both arms. Published in Nature Medicine: 43% of the psilocybin group met response criteria at 3 weeks versus 3% on placebo, with 40% in remission, and both figures held at 6 weeks. The other detail worth noting: it was delivered in community NHS settings rather than a specialist research unit, which is as much a feasibility result as an efficacy one for a public health system weighing whether this could ever work outside a trial.
Quipazine is an old psychedelic that relieves depression-like symptoms in animal studies but also triggers nausea, because it activates a serotonin receptor in the gut (5-HT3) along with the one in the brain that does the therapeutic work (5-HT2A). Virginia Commonwealth University researchers redesigned the molecule into VCU-1012, engineered to hit the brain receptor selectively while leaving the gut one alone. In mice, it produced the same antidepressant- and anxiety-reducing effects as quipazine, plus more dendritic growth in the frontal cortex, without the GI symptoms. It's mice, not people, and there's no human safety or dosing data yet — but it's a concrete example of designing out a psychedelic's side effect without designing out the mechanism that makes it work.
Twelve veterans with severe, treatment-resistant PTSD went through psilocybin-assisted therapy in an Ohio State-led pilot. A month later, nine of them — 75% — were in remission, PTSD scores dropped by an average of 27.5 points, and there were no serious adverse events. It's tiny and open-label, with no placebo arm, so treat it as encouraging, not proof. And to be clear: this isn't the same study as PIVOT above — different sponsor, different size, different primary target.
Cybin rebranded to Helus Pharma Inc. (NASDAQ: HELP) in January, moved its US listing to Nasdaq, and renamed its lead compound from CYB003 to HLP003 — same deuterated psilocin, new name. The company just finished enrolling its pivotal Phase 3 trial, APPROACH, ahead of schedule: 223 participants testing HLP003 as an add-on to standard antidepressants for major depressive disorder. Topline data is expected by year-end.
UC San Diego has an open trial giving psilocybin-assisted therapy to its own physicians dealing with burnout, tracking outcomes on the Stanford Professional Fulfillment Index. It's Phase 1/2, feasibility-and-safety stage, not proof the treatment works for burnout specifically. But it's a notable shift in who's being studied — not just depression or PTSD patients, but the clinicians treating them.
The FDA confirmed a public hearing, "Considerations for Potential Future Therapeutic Use of Psychedelic Drugs," for September 14, 2026, gathering input on therapeutic use in supervised settings. The announcement itself is from mid-July, but it's news to us and the deadline to request to present is genuinely urgent: August 21, 2026, with written comments open through October 5. One more marker in a busier-than-usual year for the agency on this compound class.
Compass Pathways plc (NASDAQ: CMPS) followed its February COMP006 primary-endpoint announcement with 26-week durability data: the benefit from a single 25mg psilocybin dose largely held through six months, and patients who relapsed and got a second dose improved further — nearly 30% of early responders reached remission on retreatment. That's company-reported, ahead of peer review, about one formulation in one trial. Not a verdict on psilocybin generally.
A new Stanford trial, SPACE, will give psilocybin to people under general anesthesia — masking the subjective experience entirely — while tracking brain activity on EEG. It's small, ten participants, and hasn't started recruiting. But it's aimed at the field's open question: how much of psilocybin's effect depends on the trip itself, versus what's happening in the brain underneath it.
A new UCSF study gave 28 healthy volunteers — no depression, no prior psychedelic experience — a single 25mg dose of psilocybin and tracked their brains for a month after. EEG showed a spike in signal entropy within hours, and structural scans still showed changes a month out, with the biggest short-term entropy spikes predicting the most reported insight and well-being later. Worth naming plainly: this is healthy volunteers, not a depression trial — durable brain change correlating with subjective benefit, not proof of a clinical effect.
UNC's psilocybin-assisted therapy pilot for treatment-resistant depression has finished enrolling its 20 participants and completed its main treatment phase, with full data collection expected by March 2027. It's a small pilot, not a Phase 3 trial. But it's one more sign this kind of institutional research is now running everywhere at once — the VA, Stanford, and UNC, all in parallel.
Kevin Ryan's AlleyCorp helped found Transcend Therapeutics in 2021 to develop methylone — an MDMA analog — for PTSD. In March, Otsuka Holdings (TSE: 4578) agreed to buy it for $700 million upfront plus up to $525 million in milestones, a deal that closed in June. TSND-201, Transcend's lead compound, is the same one that picked up an FDA National Priority Voucher back in April — the fast-track program I wrote about here. It's Otsuka's second psychedelic-adjacent bet in three years, after its 2023 acquisition of Mindset Pharma.
Mice put through weeks of unpredictable stress lost interest in sugar water — a standard proxy for anhedonia — and got worse at maze tasks. A single dose of DMT reversed both, and the researchers traced it to new neuron growth in the hippocampus. It's mice, not people, and a sugar-water test isn't the same as a life. But it's one more data point that psychedelics may work partly by regrowing brain cells, not just adjusting mood chemically.
Cortical Labs' CL1 — 200,000 living human neurons grown on a microelectrode array — learned to play Doom earlier this year. In March, the company wired the neurons into a large language model so the cells' firing patterns help select the model's output. It's an early, strange proof of concept for hybrid biological-digital computing, not a sentient chip. But it's real, and it's moving fast.
Oxford researchers gave mice 5-MeO-DMT and found something odd: the animals stayed behaviorally active, with dilated pupils and normal muscle tone, while their brains showed the slow-wave activity you'd expect from sleep — a dissociated state that doesn't fit neatly into "awake" or "asleep." It's mice, not the felt experience of a Bufo session, but it's a real physiological signature for what the compound does to a brain in real time.
GH Research PLC's (NASDAQ: GHRS) GH001 — inhaled, synthetic 5-MeO-DMT — posted some of the strongest Phase 2b data in the field for treatment-resistant depression: 57.5% of patients in remission within a week, 73% still in remission at six months. In January, the FDA lifted a clinical hold on the drug's IND, clearing the way for a global Phase 3 program. As of now, the company hasn't confirmed the trial has actually started enrolling.
As brain organoids get more sophisticated, a new AJOB Neuroscience paper takes on a question that's about to matter more: when an organoid learns a task, is that intelligence, or is it something closer to felt experience? The paper argues those are different questions with different ethical stakes, and that electrical complexity or learning behavior alone doesn't settle either one. Worth watching as the organoid-AI field moves faster than the ethics conversation around it.
MindBio Therapeutics Corp.'s (CSE: MBIO) take-home, self-titrated microdose LSD looked strong in an open-label Phase 2a study — a 65% symptom reduction. But the controlled Phase 2b, 89 patients tested against an active placebo at the University of Auckland, didn't separate from placebo at all. Worth sitting with: open-label results are the least reliable kind, and a real control arm is where a lot of psychedelic optimism goes to get tested.
Germany's federal drug regulator, BfArM, approved what's reportedly the EU's first compassionate-use program for psilocybin in treatment-resistant depression — inpatient-only, at two sites in Mannheim and Berlin, using a botanical psilocybin candidate alongside psychotherapy. Capacity is small, roughly 50 patients in the first year, and compassionate use isn't approval — it's a narrow, case-by-case pathway for patients who've exhausted other options. Still, it's a real crack in the EU's otherwise cautious regulatory posture.
Beckley Psytech's Phase IIa data on BPL-003 — intranasal synthetic 5-MeO-DMT — showed a 55% response rate the day after dosing, sustained through day 85, in patients still taking an SSRI. That's notable because SSRIs are known to blunt psychedelics by downregulating the exact receptor they work through — I wrote about that interaction here on Altitude — so a signal this strong on top of one is worth watching. Side effects were mild: nasal discomfort, nausea, headache, no serious adverse events.
A placebo-controlled Phase 1 trial gave 36 adults with depression or anxiety weekly sublingual microdoses of 5-MeO-DMT — 6, 9, or 12mg — for four weeks. No serious adverse events, no organ toxicity, and no one reported an actual psychedelic effect at these doses. It's a safety study, not an efficacy one, but it's the groundwork any microdosing claim about this compound needs before it means anything clinically.
