Back to Stakeholders
Lead program: Phase II
Categories

1 domain / 2 areas / 1 specialization

Research, Drug Development & Manufacturing
Company-Led Drug Development & CommercializationClinical Research & Pipeline Products
Research, Drug Development & Manufacturing

Incannex HealthcareASX: IHL | Nasdaq: IXHL

1 Drug Candidate

Incannex Healthcare is an Australian clinical-stage pharmaceutical company (ASX: IHL, Nasdaq: IXHL) developing psilocybin-assisted therapy and novel fixed-dose combinations. Their lead psychedelic programme PSX-001 is synthetic psilocybin combined with a proprietary psychotherapy protocol for Generalised Anxiety Disorder (GAD) — the world's first RCT of psilocybin-assisted therapy for a primary anxiety disorder. The Phase 2 PsiGAD1 trial (n=73) at Monash University delivered strongly positive results in August 2025: HAM-A reduction of 12.8 vs 3.6 points for placebo (p<0.0001), with 44% clinical response vs 11% for placebo. FDA cleared a Phase 2b IND (PsiGAD2) in August 2024 for US and UK sites; MHRA Clinical Trial Authorisation also granted. Incannex entered 2026 well-funded (~$70M cash) and with PsiGAD2 site start-up underway. The company also has non-psychedelic programmes: IHL-42X (dronabinol + acetazolamide for OSA, Phase 2/3, FDA Fast Track) and IHL-675A (CBD + hydroxychloroquine for rheumatoid arthritis, Phase 2).

Development Programmes

1

PSX-001 (Psilocybin + Psychotherapy)

Psilocybin
Phase II
Anxiety Disorders

Generalised anxiety disorder (GAD) — 25mg synthetic psilocybin + proprietary psychotherapy protocol

Programme Tracker

Anxiety Disorders

Primary: US (FDA)
Phase IIActive

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.

Milestones

Phase II topline

Completed

Actual: Feb 28, 2024

PsiGAD1 Phase 2 positive topline: HAM-A reduction 12.8 vs 3.6 placebo (p<0.0001); 44% response rate vs placebo; 27% remission rate

Why it matters: PsiGAD1 is one of the strongest Phase 2 results for psilocybin in any indication — the HAM-A effect size (12.8 vs 3.6, p<0.0001) is highly significant and the 44% response rate in GAD is clinically meaningful. GAD is a massive market (~6.8% adult prevalence) with limited treatment options beyond SSRIs/SNRIs/buspirone. This positions PSX-001 as the leading psilocybin programme for anxiety disorders.

Watch next: Phase 2b design and initiation

Phase II publication

Completed

Actual: Aug 26, 2025

Full Phase 2 results published: 73 patients, RCT, double-blind. Confirmed topline findings. PHQ-9 depression reduction 3.9 vs 0.3. PWI quality-of-life improvement 10.6 vs 2.7. No serious adverse events. One withdrawal.

Why it matters: Full publication with secondary endpoints strengthens the evidence package: psilocybin for GAD also improved depression symptoms and quality of life. The benign safety profile (no SAEs, 1 withdrawal) supports the Phase 2b expansion.

Company milestone

Completed

Actual: Jan 14, 2026

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

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

Recorded Events

Jan 14, 2026: Company milestone

Aug 26, 2025: Phase II publication

Feb 28, 2024: Phase II topline

Quick Facts

Type
Public Biotech
Ticker
ASX: IHL | Nasdaq: IXHL
Lead Stage
Phase II
Website
Visit