Psyence Biomedical
Phase II1 active candidate
shared compound: Psilocybin2 shared indicationsPhase II peersimilar active pipeline size
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Lead program: Phase II
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1 domain / 2 areas / 1 specialization
Diamond Therapeutics
Data updated
1 Drug Candidate2 Trials
Diamond Therapeutics is a private Canadian clinical-stage company pioneering sub-perceptual (non-hallucinogenic) psilocybin therapy. Their approach focuses on low-dose psilocybin that does not produce psychedelic experiences, enabling at-home outpatient administration — a differentiated strategy from the clinic-based, high-dose psychedelic-assisted therapy model. Founded in 2018 by CEO Judith Blumstock, Diamond completed a Phase 1 single ascending dose study in healthy volunteers (n=56, 7 cohorts, December 2022) establishing a safe non-hallucinogenic dose range. Their Phase 2a GAD programme received Health Canada approval in January 2023 — the first Health Canada NOL for a psychedelic trial in GAD — and enrolled first patients at Kingston Health Sciences Centre in 2025 in the first-ever at-home microdose psilocybin study. A parallel FDA-authorized Phase 2 demoralization trial is also underway at UAB. Diamond is funded by private investors and non-dilutive public grants, including a $1.1M+ CQDM/Brain Canada drug discovery consortium launched in May 2025.
Government funding received
1 grantARPA-H EVIDENT — Psilocybin for generalized anxiety disorder (Phase 2a data)
2025
Part of ARPA-H EVIDENT. Diamond Therapeutics (Toronto) in partnership with Tactical Mind Research Coalition (St. Petersburg, FL) — Phase 2a clinical trial of psilocybin for generalized anxiety disorder. Amount is an editorial estimate — funder has not published per-team award amounts; TO BE CONFIRMED.
SourcePipeline Intelligence
Developer Momentum
- Active candidates
- 1
- Active programmes
- 2
- Lead stage
- Phase II
- Forecast coverage
- 2 of 2
All tracked candidates active
All tracked programmes active
Current furthest stage
2 active programmes with forecast fields
Latest sourced update
Diamond Therapeutics - Company and News
Jun 26, 2026 - company-website - Diamond Therapeutics - Low-Dose Psilocybin
Next known catalyst
Phase II topline
Timing not specified - Low-Dose Psilocybin / Low-Dose Psilocybin Phase 2a Programme (GAD, Health Canada) - Confidence: 50%
6 sources0 pipeline-linked trials0 pipeline-linked papers
Development Programmes
1Low-Dose Psilocybin
PsilocybinPhase II
Generalised anxiety disorder / demoralization
Programme Tracker
Anxiety Disorders
Primary: Canada (HC)
Phase IIActive
Forecast
Phase II topline
Phase 2a ongoing at Kingston Health Sciences Centre (KHSC), Ontario; first-ever Health Canada-approved at-home microdose psychedelic trial; first patient July 30, 2025
Milestones
Phase I topline
CompletedActual: Dec 7, 2022
Phase 1 complete: safe, tolerable, non-hallucinogenic dose range established in 56 subjects (7 cohorts); no AEs precluding outpatient use
Why it matters: Phase 1 demonstrated that sub-perceptual (non-hallucinogenic) psilocybin doses are safe and tolerable, laying the groundwork for take-home daily microdosing trials without clinic supervision.
Phase II started
CompletedActual: Jul 30, 2025
Phase 2a first patient dosed at KHSC (July 30, 2025); 40–60 patients; daily take-home sub-perceptual dosing x4 weeks + OLE
Why it matters: First Phase 2 clinical data from a home-administered daily microdosing psilocybin schedule in GAD patients. Results will inform whether sub-perceptual dosing provides therapeutic benefit without the full psychedelic session model.
Watch next: Phase 2a primary endpoint results (anxiety reduction at 4 weeks + OLE follow-up)
Regulatory review accepted
CompletedActual: Jan 24, 2023
Health Canada No Objection Letter for Phase 2a GAD trial — first-ever HC approval for psychedelic Phase 2
Why it matters: First Health Canada approval of a Phase 2 psychedelic trial and the first approved at-home microdose psychedelic study globally — a regulatory milestone for the entire field.
Recorded Events
Jul 30, 2025: Phase II started
Jan 24, 2023: Regulatory review accepted
Dec 7, 2022: Phase I topline
Palliative & End-of-Life Distress
Primary: US (FDA)
Phase IIActive
Forecast
Phase II topline
Phase 2a ongoing at UAB (NCT06341426); 60 patients; 5-week randomised double-blind; PI: Dr. Peter Hendricks
Milestones
Phase II started
CompletedActual: Oct 17, 2023
First patient enrolled at UAB for demoralization study (NCT06341426); FDA-authorised IND
Why it matters: Demoralization (loss of meaning/hope) in medically ill patients is a distinct syndrome with no approved treatment. Diamond's sub-perceptual dosing approach tests whether regular low-dose psilocybin can address existential suffering without a macro-dose session.
Watch next: Primary endpoint results from NCT06341426
Recorded Events
Oct 17, 2023: Phase II started
Evidence Links
Diamond Therapeutics - Company and News
company-website - Diamond Therapeutics - Jun 26, 2026 - Verified
Company site lists low-dose psilocybin development, Health Canada Phase 2 approval, UAB demoralization study, and 2026 U.S. government funding for the anxiety Phase 2 trial.
Diamond Announces Health Canada Approval of Phase 2 Low-Dose Psilocybin Trial
Press release - PR Newswire - Jan 24, 2023 - Verified
Health Canada No Objection Letter for Phase 2 trial evaluating repeated low doses of psilocybin for generalized anxiety disorder.
Diamond Announces FDA-authorized Low-Dose Psilocybin Trial with UAB
Press release - PR Newswire - Mar 21, 2023 - Verified
FDA cleared an IND for a UAB study of repeated low-dose psilocybin in demoralization.
ClinicalTrials.gov NCT06969170 - Psilocybin Oral Solution for GAD
Registry update - ClinicalTrials.gov - May 13, 2025 - Verified
Registry lists a recruiting Phase 2 study of 3 mg psilocybin oral solution for generalized anxiety disorder, sponsored by Queen’s University.
Diamond Receives U.S. Government Funding for Phase 2 Anxiety Trial
Press release - EIN Presswire - May 11, 2026 - Verified
Recent press release says Diamond’s Phase 2 trial is evaluating repeated low doses of psilocybin for generalized anxiety disorder.
Diamond completes Phase 1 low-dose psilocybin study in healthy volunteers
Press release - Diamond Therapeutics / PR Newswire - Dec 8, 2022 - Verified
Release says the Phase 1 study established a safe, tolerable dose range for low, non-psychedelic doses of psilocybin.
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Quick Facts
- Type
- Private Biotech
- Lead Stage
- Phase II
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