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Trials

Pipeline Tracker

Trials

Who's running what, at what stage, for synthetic and botanical psilocybin, LSD, and 5-MeO-DMT.

Trial NameCompanyLocationStageFindings
COMP360 for Treatment-Resistant DepressionCOMPASS PathwaysLondon, UKPhase 3 complete (NDA in progress)View →
HLP003 for Major Depressive DisorderHelus Pharma (formerly Cybin)Toronto, CanadaPhase 3 (enrollment complete)View →
uAspire — Psilocybin for Major Depressive DisorderUsona Institute (non-profit)Madison, Wisconsin, USPhase 3 (results pending)View →
PEX010 for Alcohol and Opioid Use DisorderFilament Health (a Red Light Holland subsidiary)Burnaby, CanadaPhase 2View →
Low-Dose Psilocybin for Generalized Anxiety DisorderDiamond TherapeuticsToronto, CanadaPhase 2 (actively dosing)View →
TRP-8803 for Binge Eating Disorder and BeyondEntropy Neurodynamics (formerly Tryp Therapeutics)Melbourne, AustraliaPhase 2 (expanding to 8-indication basket trial)View →
Psilocybin-Assisted Therapy for Depression in Cancer PatientsSunstone TherapiesRockville, Maryland, USPhase 2 (active, not recruiting)View →
DT120 for Generalized Anxiety Disorder and DepressionDefinium Therapeutics (formerly MindMed)New York, USPhase 3 (positive results reported)View →
MB22001 Microdosed LSD for DepressionMindBio TherapeuticsVancouver, CanadaPhase 2b complete (did not beat placebo)View →
BPL-003 for Treatment-Resistant DepressionAtaiBeckleyOxford, UK / Berlin, GermanyPhase 3 (ReConnection, ongoing)View →
GH001 for Treatment-Resistant DepressionGH ResearchDublin, IrelandPhase 2b complete; Phase 3 plannedView →
LSD for Cluster HeadacheUniversity Hospital BaselBasel, SwitzerlandPhase 2 (recruiting)View →
LSD in Palliative CareUniversity Hospital BaselBasel, SwitzerlandPhase 2 (recruiting)View →
LSD for Alcohol Use DisorderUniversity Hospital BaselBasel, SwitzerlandPhase 2 (recruiting)View →
Intravenous 5-MeO-DMT in Healthy ParticipantsUniversity Hospital BaselBasel, SwitzerlandPhase 1 (recruiting)View →
Psilocybin and MDMA Combined for PTSDJohns Hopkins UniversityBaltimore, Maryland, USPhase 1 (recruiting)View →
Psilocybin-Assisted Therapy for Cancer Survivors (TRIPS)M.D. Anderson Cancer CenterHouston, Texas, USPhase 2 (recruiting)View →
Psilocybin-Assisted Therapy for Sexual Assault-Related PTSDSunstone TherapiesRockville, Maryland, USPhase 2 (recruiting)View →
Psilocybin Phase 3 complete (NDA in progress)

COMP360 for Treatment-Resistant Depression

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 is rolling in an NDA submission now, targeting completion by Q4 2026, with a possible launch in 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.

Trial Information
Psilocybin Phase 3 (enrollment complete)

HLP003 for Major Depressive Disorder

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.

Trial Information
Psilocybin Phase 3 (results pending)

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 results haven't been announced yet. In April 2026, the FDA handed Usona a National Priority Voucher, which compresses the review timeline once data comes in — a strong signal of where the agency's appetite is, even ahead of a readout.

Trial Information
Psilocybin Phase 2

PEX010 for Alcohol and Opioid Use Disorder

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.

Trial Information
Psilocybin Phase 2 (actively dosing)

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.

Trial Information
Psilocybin Phase 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.

Trial Information
Psilocybin Phase 2 (active, not recruiting)

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.

Trial Information
LSD Phase 3 (positive results reported)

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. Two days before I'm writing this, the company reported positive Phase 3 results from Voyage, its lead trial for generalized anxiety disorder, meeting its primary endpoint with a strong effect size. A second GAD trial, Panorama, is fully enrolled, and an earlier Phase 3 depression trial, Emerge, already read out positive in June. Right now, this is the most advanced LSD program in clinical development, full stop.

Trial Information
LSD Phase 2b complete (did not beat placebo)

MB22001 Microdosed LSD for Depression

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.

Trial Information
5-MeO-DMT Phase 3 (ReConnection, ongoing)

BPL-003 for Treatment-Resistant Depression

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. The trial is worth tracking on its own terms too: earlier Phase IIa data, run as an add-on for people still taking an SSRI, showed a 55% response rate. The pivotal Phase 3 program, branded ReConnection, 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.

Trial Information
5-MeO-DMT Phase 2b complete; Phase 3 planned

GH001 for Treatment-Resistant Depression

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.

Trial Information
LSD Phase 2 (recruiting)

LSD for Cluster Headache

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.

Trial Information
LSD Phase 2 (recruiting)

LSD in Palliative Care

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.

Trial Information
LSD Phase 2 (recruiting)

LSD for Alcohol Use Disorder

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.

Trial Information
5-MeO-DMT Phase 1 (recruiting)

Intravenous 5-MeO-DMT in Healthy Participants

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.

Trial Information
Psilocybin Phase 1 (recruiting)

Psilocybin and MDMA Combined for PTSD

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.

Trial Information
Psilocybin Phase 2 (recruiting)

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.

Trial Information
Psilocybin Phase 2 (recruiting)

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.

Trial Information