IbogainePhase 1 complete; Phase 2 targeted for 2027
DMX-1001 (Noribogaine) for Alcohol Use Disorder
DMX-1001 is oral noribogaine — ibogaine's primary active metabolite, not ibogaine itself — and in April 2026 it became the first ibogaine-class compound ever cleared for a US clinical trial, when the FDA accepted DemeRx's IND application. A Phase 1 multiple-ascending-dose study in healthy volunteers reported positive safety, tolerability, and pharmacokinetics; DemeRx is targeting a Phase 2 trial in alcohol use disorder patients for 2027. This is DemeRx's second ibogaine-derived program — see DMX-1002 below for the first, which ran into trouble.
IbogainePhase 1 complete (2023); Phase 2a not advanced
DMX-1002 (Ibogaine HCl) for Opioid Use Disorder
DMX-1002 was pharmaceutical-grade ibogaine hydrochloride — the actual compound, not a metabolite — developed through a 2019 joint venture between DemeRx and atai Life Sciences (atai invested $22M) specifically for opioid use disorder, the same indication Howard Lotsof patented ibogaine for in the 1980s. An MHRA-approved Phase 1/2a trial in the UK dosed its first subject in 2021. Phase 1 data reported in August 2023 was mostly reassuring, but one of two participants at the highest dose showed QTc prolongation — a cardiac risk signal — that resolved without intervention but was serious enough that the drug never advanced to Phase 2a and has been absent from atai's pipeline updates since. AtaiBeckley acquired the DemeRx IB joint-venture entity outright in November 2023; DemeRx, Inc. sued ATAI Life Sciences in Delaware federal court in 2025 (case 1:2025cv00321). DemeRx's newer noribogaine program (DMX-1001, above) is unrelated to this dispute and pursuing a different indication entirely.
COMPASS's synthetic psilocybin, COMP360, is the furthest along of any classic psychedelic in development. Two Phase 3 trials have now read out positive — COMP005 (single dose, US-only) and COMP006 (two doses, across the US, UK, and Canada) — with COMP006's benefit largely holding through six months. COMPASS completed its NDA on Nov. 9, 2026, six days after saying it would take two weeks, with $444M in cash funding it into 2028 and a launch targeted for the first half of 2027. It also holds an FDA National Priority Voucher, which compresses the review clock. If a classic psychedelic gets approved first, this is the one to watch.
Cybin renamed itself Helus Pharma in January 2026, moved its US listing to Nasdaq under ticker HELP, and renamed its lead compound from CYB003 to HLP003 — same deuterated psilocin, new names across the board. The pivotal APPROACH study, 223 participants testing HLP003 as an add-on to standard antidepressants for major depressive disorder, finished enrolling ahead of schedule in July 2026, with topline data expected by year-end. A companion study, EMBRACE, is still enrolling. Worth tracking the rename if you've seen this company under its old name.
uAspire — Psilocybin for Major Depressive Disorder
Usona is the rare non-profit in this field — donor-funded, no shareholders to answer to. Its Phase 3 trial, uAspire, gave roughly 240 people a single 25mg dose of synthetic psilocybin for major depressive disorder across nearly 30 US sites, including four VA medical centers. Enrollment finished in 2025, and topline results were never made public — but on Nov 2, 2026, Psychedelic Alpha reported Usona had completed its NDA filing with the FDA anyway, leaning on its Breakthrough Therapy Designation, rolling review, and the National Priority Voucher the FDA granted in April 2026, which compresses the review clock. That makes it the second psychedelic NDA before the FDA, after Resilient Pharmaceuticals' (formerly Lykos) MDMA refiling. Usona declined to comment on the filing; per Psychedelic Alpha's reporting, FDA has already inspected several Usona sites, including its Wisconsin headquarters, and a decision could land as soon as late 2026 or very early 2027.
Filament makes botanical psilocybin — extracted from whole mushrooms rather than synthesized from scratch — and is testing it for alcohol and opioid use disorder, not depression, which sets it apart from most of this list. A Copenhagen-based Phase 2 alcohol trial posted positive topline data, published in the Journal of Psychopharmacology; a Phase 2 opioid trial is authorized in both the US and Canada. Filament itself was acquired by Red Light Holland in April 2026 and now runs as a subsidiary — same programs, new parent company.
Low-Dose Psilocybin for Generalized Anxiety Disorder
Diamond is testing something most of this list isn't: sub-perceptual, take-home psilocybin — no guided session, no clinic day. Its Phase 2 trial for generalized anxiety disorder, running out of Kingston, Ontario, is past the halfway point on enrollment but hasn't reported results yet, despite some claims of "positive 2025 data" circulating that I couldn't actually verify. In May 2026, Diamond picked up US government funding through ARPA-H to expand the trial stateside. Worth watching, but treat any results claim before an actual readout with real skepticism.
PsilocybinPhase 2 (expanding to 8-indication basket trial)
TRP-8803 for Binge Eating Disorder and Beyond
This company has rebranded twice since 2024 — first from Tryp Therapeutics to Tryptamine Therapeutics, then to Entropy Neurodynamics — while its lead compound shifted from oral psilocybin to IV psilocin (TRP-8803). Early data looks strong: 50% remission in a binge eating disorder cohort, plus positive Phase 2a readouts in fibromyalgia and irritable bowel syndrome. In August 2026 the company got approval to run a 72-patient, nine-cohort trial testing TRP-8803 across eight different indications at once in Melbourne — an unusually broad basket trial for a compound this early.
Psilocybin-Assisted Therapy for Depression in Cancer Patients
Sunstone runs single-site psilocybin-assisted therapy trials out of Rockville, Maryland, focused specifically on depression in people with cancer — building on earlier work published in JAMA Oncology. The current Phase 2 study gives up to two 25mg doses about ten weeks apart, paired with psychotherapy. It's active but not recruiting, with results expected around 2027. Cancer-related depression and existential distress is one of the best-studied applications for psilocybin, going back to the original Johns Hopkins and NYU trials, and this is the natural next step.
DT120 for Generalized Anxiety Disorder and Depression
MindMed renamed itself Definium Therapeutics in January 2026, and its lead compound went from MM120 to DT120 in the same rebrand — it's LSD, delivered as an orally-disintegrating tablet. Voyage, its first Phase 3 trial for generalized anxiety disorder, reported positive results in August 2026, meeting its primary endpoint with a strong effect size. On Sept 14, 2026, Panorama, the second GAD trial, also read out positive — a statistically significant improvement over placebo across 245 participants, replicating Voyage's result. An earlier Phase 3 depression trial, Emerge, already read out positive in June. That's three of Definium's four late-stage trials positive, and two independent positive Phase 3s for the same drug and indication is a materially stronger position than one. Right now, this is the most advanced LSD program in clinical development, full stop — though DT120 still isn't FDA-approved for anything. On Nov. 9, 2026, Definium said it is on track to file an NDA in the first half of 2027, without saying which indication it will file for first.
Worth stating plainly, since it's easy to read the GAD story above and miss it: DT120's depression program is arguably the bigger opportunity. Emerge, the Phase 3 MDD trial referenced above, reported a -8.1 point placebo-adjusted MADRS improvement at Week 6 (p<0.0001) across 149 participants when it read out on June 22, 2026 — rapid (a -14.2 point gap at Week 1) and durable (still -7.3 points at Week 12). The FDA granted DT120 Breakthrough Therapy Designation for MDD on Aug 27, 2026 on the strength of that data. A second, confirmatory MDD Phase 3 (Ascend, now about 165 participants) dosed its first patient May 12, 2026, with topline data expected in 2027.
Not every trial on this list is good news, and this one belongs here precisely because it isn't. MindBio's take-home, self-titrated microdose LSD looked promising 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. It's a clean reminder that open-label results are the least reliable kind, and that a real control arm is where a lot of psychedelic optimism goes to get tested.
BPL-003 is intranasal, synthetic 5-MeO-DMT — the asset at the center of Eli Lilly's $3.8 billion bid to acquire AtaiBeckley, which I covered here on Altitude when it was announced in July. Earlier Phase IIa data, run as an add-on for people still taking an SSRI, showed a 55% response rate. A second dataset worth flagging, and one we hadn't previously logged here: the Phase 2b open-label extension, announced Nov 10, 2025, found that patients who got a second 12 mg dose eight weeks after their first hit 63% response and 48% remission at Week 8 of the extension — and that 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, which is underway now — though topline data isn't expected until around 2029, a long runway even with a major pharmaceutical company's money behind it. Note: GH Research's GH001 (below) is a separate company's 5-MeO-DMT program — the two are easy to conflate, but the dosing regimens and datasets are entirely distinct.
GH001 is inhaled, synthetic 5-MeO-DMT, and its Phase 2b data for treatment-resistant depression is some of the strongest in this list: a 15.5-point MADRS reduction over placebo at day 8, 57.5% of patients in remission within a week, and 73% still in remission at six months. The FDA lifted a clinical hold on the drug's IND in January 2026, clearing the way for a global Phase 3 program — though as of this writing, GH Research hasn't confirmed the trial has actually started enrolling yet.
4-OH-DiPTPhase 2 complete; single pivotal Phase 3 planned for 2026
Luvesilocin (RE104) for Postpartum Depression
Luvesilocin, formerly known as RE104, is a subcutaneously-administered prodrug of 4-OH-DiPT — the same tryptamine the DEA proposed placing in Schedule I in a Sept 23, 2026 Federal Register filing, a collision we covered in our DEA scheduling piece. In the RECONNECT Phase 2 trial, 84 women with moderate-to-severe postpartum depression got a single 30 mg dose or a 1.5 mg control. By Day 7, the 30 mg arm saw a 23.0-point MADRS reduction versus 17.2 points for control (p=0.0094), and 70% of the 30 mg group were in remission (MADRS ≤10) at both Day 7 and Day 28 — durable through the full four-week follow-up. Nausea (44%) and headache (34%) were the most common side effects, mostly on dosing day. The FDA granted Breakthrough Therapy Designation on Feb 23, 2026, and after an End-of-Phase-2 meeting, aligned with Reunion on a registrational path requiring only one successful Phase 3 trial rather than the usual two — a real regulatory tailwind, even as the drug's own parent compound sits in the DEA's scheduling crosshairs. Reunion went private in 2023 when MPM BioImpact bought the company off Nasdaq (formerly REUN), so there's no public ticker to track this through, and as of this writing the Phase 3 start hasn't been confirmed as actually enrolling.
CMND-100 is a new name in this tracker — Clearmind's oral formulation of MEAI (5-methoxy-2-aminoindane), a non-hallucinogenic, psychedelic-derived neuroplastogen distinct from any classic psychedelic on this list. MEAI produces a mild, alcohol-like euphoria while reportedly reducing the desire to keep drinking, acting through serotonergic (5-HT1a/2a/2b) and alpha-2-adrenergic receptors rather than the 5-HT2A mechanism behind classic psychedelic effects. The FDA-regulated Phase I/IIa trial cleared its safety-endpoint healthy-volunteer dose-escalation stage (Part A) by Aug 13, 2026, moved into Part C in September, and dosed its first two actual alcohol-use-disorder patients at Hadassah Medical Center on Sept 11, 2026 — the first time CMND-100 has been given to anyone with the condition it's meant to treat, not just healthy volunteers.
Basel's psychedelic research group — the same one that's run some of the field's most rigorous mechanistic LSD studies — is testing it against cluster headache, sometimes called "suicide headache" for how severe the pain gets. It's a genuinely different use case than the depression and anxiety trials dominating this list: cluster headache has its own small underground tradition of psychedelic self-treatment that this trial is finally putting through a controlled test. 30 participants, recruiting now.
A 60-person Basel trial testing LSD for the psychological weight of terminal illness — pain, anxiety, depression, fear of death, and the burden that falls on caregivers. It's the LSD analog to the psilocybin cancer-distress trials pioneered at Johns Hopkins and NYU a decade ago, running the same basic question through a different molecule. Primary completion isn't expected until September 2027.
LSD's oldest clinical history is actually in addiction treatment — some of the first controlled psychedelic trials, back in the 1960s, tested it on alcoholism. This 128-person Basel trial is picking that thread back up with modern trial design. It's the largest LSD study on this list by enrollment, and one of the only ones testing a substance-use indication rather than a mood or pain condition.
Every 5-MeO-DMT trial elsewhere on this list uses inhaled or intranasal delivery. Basel is testing it intravenously instead — a different route with different onset and control characteristics. This is an early, healthy-volunteer safety study, not a treatment trial, but it's the groundwork for a delivery method nobody else in the clinical pipeline is pursuing yet.
Every psychedelic trial on this list tests one compound at a time. Johns Hopkins is testing psilocybin and MDMA together for PTSD — a combination-therapy approach that's almost unheard of in this field, where regulators already want single-molecule evidence before anything gets more complicated. Early and small, 40 participants, but a genuinely different bet than anything else here.
Psilocybin-Assisted Therapy for Cancer Survivors (TRIPS)
One of the world's largest cancer centers running its own psilocybin-assisted therapy trial for depression and anxiety in cancer survivors — not during treatment, but after it, when the psychological aftermath often gets less attention than the disease itself. 20 participants, primary completion expected March 2027.
Psilocybin-Assisted Therapy for Sexual Assault-Related PTSD
Sunstone's second trial on this list, and a different population entirely from their cancer-depression work: 70 participants with PTSD specifically tied to sexual assault. It's a notably under-studied population in psychedelic research so far, which has focused heavily on combat veterans. Primary completion expected November 2027.
KetamineNDA planned; FDA has waived the need for new clinical trials
NRX-100 — Preservative-Free IV Ketamine for Severe Depression
NRX-100 is NRx's bid for an on-label psychiatric ketamine indication — severe depression, including patients with suicidal ideation — which would make it only the second ketamine-derived product with that kind of approval, after Spravato (esketamine). Unusually, the FDA told NRx in a Type C meeting that it's willing to accept the company's existing trial data, plus real-world evidence from more than 65,000 patients gathered through a partnership with Osmind, as substantial evidence of efficacy — no new clinical trials required. NRx said in March 2026 it intended to submit the NDA by June 2026; we found no confirmation, as of this writing, that the submission has actually happened, so treat the filing as planned rather than done. This is a separate program from KETAFREE, NRx's generic preservative-free ketamine for anesthesia, which won FDA approval via a different pathway (ANDA) on Oct 30, 2026.
