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Lead program: Phase II
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Clairvoyant Therapeutics

Data updated

1 Drug Candidate

Clairvoyant Therapeutics is a Canadian clinical-stage biotech developing synthetic psilocybin for alcohol use disorder (AUD). The company ran a fully randomized, double-blinded Phase IIb multi-country trial in the EU and Canada enrolling 154 participants, with topline data anticipated in early 2025. Founded in 2021 in Vancouver, a proposed acquisition by Psyence Biomed (Nasdaq: PBM) for $500K in September 2024 fell through following due diligence.

Pipeline Intelligence

Developer Momentum

Programme tracker
Active candidates
1

All tracked candidates active

Active programmes
1

All tracked programmes active

Lead stage
Phase II

Current furthest stage

Forecast coverage
1 of 1

1 active programme with forecast fields

Latest sourced update

ClinicalTrials.gov NCT05646303 current registry snapshot for Clairvoyant AUD psilocybin Phase 2b

Jun 26, 2026 - Registry update - ClinicalTrials.gov - Synthetic Psilocybin (25mg)

Next known catalyst

No next milestone forecast yet.

5 sources0 pipeline-linked trials0 pipeline-linked papers

Development Programmes

1

Synthetic Psilocybin (25mg)

Psilocybin
Phase II

Alcohol use disorder

Programme Tracker

Alcohol Use Disorder (AUD)

Primary: EU (EMA)
Phase IIActive

Phase IIb (CLA-PSY-201) enrollment and treatment completed; 154 subjects randomized across 12 sites in EU + Canada; topline data anticipated but repeatedly delayed (originally mid-2023, then Q3 2024, then early 2025)

Milestones

phase-2-results

Planned

Topline data readout for CLA-PSY-201 Phase IIb (n=154)

Why it matters: Results from one of the largest randomized psilocybin AUD trials globally. If positive, Clairvoyant would be positioned for conditional market authorization in Canada (2025 target) and EU (2026 target). Topline data has been delayed multiple times — no public confirmation of release as of April 2026.

Watch next: Data publication; Phase 3 pivotal trial planning; Series A close

phase-2-initiated

Completed

Actual: Nov 1, 2022

First patient dosed in Phase 2 trial in Canada

Why it matters: Clairvoyant launched one of the largest randomized psilocybin trials for AUD globally (ultimately 154 subjects). Two dosing sessions at weeks 5 and 9 combined with Motivational Enhancement Therapy (MET) — a well-validated behavioral framework for AUD.

Trial start

Completed

Actual: Jan 1, 2023

First patient dosed in Europe (Phase 2b); trial upgraded from Phase 2 to Phase 2b designation

Why it matters: Multi-country EU + Canada trial generates regulatory-grade data for two major markets simultaneously. Finnish regulatory approval was among the first EU approvals for a psilocybin interventional trial.

Enrollment complete

Completed

Actual: Apr 1, 2024

90% randomization reached (>115 of original 128 target; later expanded to 154 subjects)

Why it matters: Rapid enrollment in a psychedelic trial of this size demonstrates strong investigator and patient interest. Expansion from 128 to 154 subjects increases statistical power.

Company milestone

Completed

Actual: Sep 6, 2024

Psyence Biomed announced $500K acquisition term sheet for Clairvoyant

Why it matters: Psyence Biomed sought to acquire Clairvoyant at a remarkably low valuation ($500K) for a company running a 154-patient Phase IIb trial — suggesting Clairvoyant was facing funding pressure.

Company milestone

Completed

Actual: Oct 1, 2024

Psyence Biomed halts Clairvoyant acquisition; Clairvoyant remains independent

Why it matters: Deal collapse leaves Clairvoyant independent but potentially underfunded. Series A financing was reportedly underway as of April 2024.

Recorded Events

Oct 1, 2024: Company milestone

Sep 6, 2024: Company milestone

Apr 1, 2024: Enrollment complete

Jan 1, 2023: Trial start

Nov 1, 2022: phase-2-initiated

Evidence Links

ClinicalTrials.gov NCT05646303 - Psilocybin-Assisted Psychotherapy in AUD

Registry update - ClinicalTrials.gov - Aug 15, 2024 - Verified

Registry lists Clairvoyant Therapeutics as sponsor of a Phase 2 trial of psilocybin-assisted psychotherapy in adults with alcohol use disorder.

First Participant Dosed in Clairvoyant Phase 2 Psilocybin AUD Trial

Press release - Headlands Research / Accesswire - Nov 3, 2022 - Verified

Clairvoyant announced first participant dosing in CLA-PSY-201, comparing 25 mg synthetic psilocybin to placebo with motivational enhancement therapy.

Psyence Biomed Announces Conditional Binding Term Sheet to Acquire Clairvoyant

Press release - Psyence Biomed - Sep 6, 2024 - Verified

Psyence states Clairvoyant completed enrollment and treatment of 154 randomized double-blinded AUD subjects, with topline anticipated in early 2025.

ClinicalTrials.gov NCT05646303 current registry snapshot for Clairvoyant AUD psilocybin Phase 2b

Registry update - ClinicalTrials.gov - Jun 26, 2026 - Verified

Registry page reviewed June 26, 2026 as current public status evidence for Clairvoyant CLA-PSY-201 while waiting on company/topline news.

Similar Developers

Reference points selected from shared pipeline stage, indications, compounds, regulatory pathways, and evidence footprint.

View landscape
Ceruvia Lifesciences
Phase II2 active candidates2 trials
shared compound: Psilocybinsame indication: Alcohol Use Disorder (AUD)Phase II peersimilar active pipeline size
Diamond Therapeutics
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shared compound: PsilocybinPhase II peersimilar active pipeline sizeboth have forecast coverage
Incannex Healthcare
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MSICS Pharma
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shared compound: PsilocybinPhase II peersimilar active pipeline sizeboth have forecast coverage

Quick Facts

Type
Private Biotech
Founded
2021
Lead Stage
Phase II
Website
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