Q1 2026 Psychedelic Drug Development Competitive Intelligence Briefing

Definium Therapeutics

LSD | phase-3 | Voyage (GAD Phase 3) - Enrollment ~80% complete as of Feb 2026; topline data expected early Q3 2026 - active

Definium Therapeutics

LSD | phase-3 | Panorama (GAD Phase 3) - Enrollment rapidly progressing; includes US and European sites. Topline data expected H2 2026. - active

Diamond Therapeutics

Psilocybin | phase-2 | Low-Dose Psilocybin Phase 2a Programme (GAD, Health Canada) - 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 - active

Incannex Healthcare

Psilocybin | phase-2 | PSX-001 PsiGAD Phase 2 → Phase 2b (GAD) — NCT05942911 - Phase 2 PsiGAD1 complete with positive results (73 patients). Preparing multi-jurisdiction Phase 2b. Open IND with FDA. Clinical Advisory Board formed. Well-funded: $70M+ cash, runway into 2027. Nasdaq:IXHL / ASX:IHL. - active

AtaiBeckley

MDMA | phase-2 | EMP-01 SAD — Phase 2a (UK) - Phase 2a complete; positive safety and exploratory efficacy signal. Phase 2b in larger population to follow. - completed

Psyence Biomedical

Psilocybin | phase-2 | active

Reunion Neuroscience

Psilocybin | phase-2 | RECLAIM — RE104 GAD Phase 2 - RECLAIM Phase 2 is recruiting for generalized anxiety disorder. ClinicalTrials.gov lists an actual study start in April 2026 and an estimated primary completion in February 2027; Reunion expects clinical data in Q2 2027. - active

Helus Pharma

DMT | phase-2 | HLP004 GAD — Phase 2 POC - Helus announced positive Phase 2 signal-detection topline results for HLP004 in GAD on 2026-03-05. The 20 mg adjunctive arm showed a 10.4-point mean HAM-A reduction at six weeks, with pooled six-month response/remission rates of 67%/39%. Next watch items are durability follow-up, a peer-reviewed publication, or Phase 3 guidance. - active

Registry status update: A Phase 1, Open-label, Single-arm Basket Trial of the Intravenously Administered Psilocin (TRP-8803): Safety, Anxiety, and Quality of Life Across Health Conditions Characterised by Cognitive Inflexibility, Emotional Distress, and Persistent Bodily Symptom Burden

trial-readout

Shareholder update: $70M+ cash, runway into 2027. 2026 priorities: advance PSX-001 Phase 2b clinical/regulatory planning, progress IHL-42X Phase 3.

Incannex Healthcare | 2026-01-14 | other

Why it matters: $70M+ cash provides runway for Phase 2b without immediate fundraising pressure. Dual pipeline (PSX-001 for GAD + IHL-42X for sleep apnea with FDA Fast Track) gives Incannex diversification that most psychedelic-focused companies lack.

Watch next: Phase 2b protocol finalisation and site activation

Study completion: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of up to Two Doses of Psilocybin for the Treatment of Major Depressive Disorder in Adults With Cancer

Sunstone Medical | 2026-02-01 | trial-readout

Phase 2a topline positive: safety primary met; exploratory efficacy LSAS reduction 11.85 pts (p=0.036 one-tailed, Hedges' g=0.45). No serious AEs, no suicidal ideation.

AtaiBeckley | 2026-02-26 | trial-readout

Why it matters: Safety and early efficacy signals support Phase 2b; SAD is an under-served indication with large patient population

Watch next: Phase 2b design and initiation

Study completion: A Phase 2b double-blind, randomized, low-dose comparator-controlled clinical trial to assess the efficacy and safety of PEX010 in psilocybin-assisted psychotherapy for the treatment of adjustment disorder due to incurable cancer diagnosis

2026-02-28 | trial-readout

Study completion: A Second Psilocybin Group Therapy for the Treatment of Cancer-Related Anxiety in Partial Responders With Metastatic Cancer

University of Washington | 2026-03-01 | trial-readout

Topline data expected Q1 2026 per company guidance

Helus Pharma | 2026-03-05 | trial-readout

Why it matters: Proof-of-concept readout for deuterated DMT in GAD — could open a new indication pathway

Watch next: Press release with HAM-A score results at 6 weeks

Study completion: Feasibility study testing the protocol of single dose of psilocybin given to people who have had little improvements with brief psychological intervention

2026-03-31 | trial-readout