Diamond Therapeutics
Phase II1 active candidate2 trials
shared compound: Psilocybinsame indication: Anxiety DisordersPhase II peersame regulator: US FDA
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Lead program: Phase II
Categories
1 domain / 2 areas / 1 specialization
Incannex HealthcareASX: IHL | Nasdaq: IXHL
Data updated
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).
Pipeline Intelligence
Developer Momentum
- Active candidates
- 1
- Active programmes
- 1
- Lead stage
- Phase II
- Forecast coverage
- 1 of 1
All tracked candidates active
All tracked programmes active
Current furthest stage
1 active programme with forecast fields
Latest sourced update
ANZCTR ACTRN12621001358831 - Psi-GAD-1
Jun 27, 2026 - Registry update - ANZCTR - PSX-001 (Psilocybin + Psychotherapy)
Next known catalyst
Phase II topline
Timing not specified - PSX-001 (Psilocybin + Psychotherapy) / PSX-001 PsiGAD Phase 2 → Phase 2b (GAD) — NCT05942911 - Confidence: 55%
5 sources0 pipeline-linked trials0 pipeline-linked papers
Development Programmes
1PSX-001 (Psilocybin + Psychotherapy)
PsilocybinPhase II
Generalised anxiety disorder (GAD) — 25mg synthetic psilocybin + proprietary psychotherapy protocol
Programme Tracker
Anxiety Disorders
Primary: US (FDA)
Phase IIActive
Forecast
Phase II topline
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
CompletedActual: 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
CompletedActual: 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
CompletedActual: 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
Evidence Links
ANZCTR ACTRN12621001358831 - Psi-GAD-1
Registry update - ANZCTR - Jun 27, 2026 - Verified
Prospectively registered trial of psilocybin-assisted psychotherapy for generalised anxiety disorder, funded by Incannex and run at Monash.
Incannex Announces Positive Topline Results from Phase 2 Psi-GAD1
Press release - GlobeNewswire / Incannex - Feb 28, 2024 - Verified
Topline Phase 2 Psi-GAD1 results and plan to submit an IND for a multi-site Phase 2b trial.
Incannex Reports Positive Results from Phase 2 Clinical Trial of PSX-001
Press release - Incannex Healthcare - Aug 26, 2025 - Verified
Phase 2 results reported statistically significant and clinically meaningful improvements across HAM-A, GAD-7, SDS, PHQ-9, and quality-of-life measures.
Incannex Healthcare Delivers Transformational 2025 Progress
Press release - Incannex Healthcare - Jan 5, 2026 - Verified
Company reiterated positive Phase 2 PSX-001 results and continued development of the GAD programme.
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Quick Facts
- Type
- Public Biotech
- Ticker
- ASX: IHL | Nasdaq: IXHL
- Lead Stage
- Phase II
- Website
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