Incannex HealthcareASX: IHL | Nasdaq: IXHL

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).