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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.

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

Quick Facts

Type
Private Biotech
Founded
2021
Lead Stage
Phase II
Website
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