Also known as: COMP360, COMP360 psilocybin
Psilocybin is a naturally occurring serotonergic psychedelic tryptamine alkaloid and an investigational drug, metabolized in vivo to psilocin. It is being studied for psychiatric indications such as major depression and treatment-resistant depression. U.S. DEA scheduling lists psilocybin as Schedule I, while Australia approved medical use in treatment-resistant depression in 2023.
Biotech companies posted Q2 2026 results: REGENXBIO's Duchenne trial met its primary endpoint, Compass Pathways' COMP360 NDA submission is on track for Q4, Puma raised full-year guidance on NERLYNX demand, and Evotec cut its 2026 outlook.
FDA final guidance sets standards for psychedelic clinical trials. Federal agencies and states are advancing psilocybin and ibogaine research, and Eli Lilly is acquiring AtaiBeckley for $2.8 billion.
Helus completed Phase 3 enrollment for HLP003 in depression; data due Q4 2026. Compass is on track for COMP360's NDA, and an ayahuasca ingredient showed promise in a phase 2a trial.
Compass Pathways reports six-month data from its second Phase III COMP006 trial of COMP360 psilocybin for treatment-resistant depression, showing 39% of patients achieved clinically meaningful response maintained through 26 weeks. NDA submission expected in Q4 2026.
Compass Pathways said COMP360 for treatment-resistant depression retains FDA Breakthrough Therapy designation as it advances in phase 3. A Trump executive order also directs faster federal review of psychedelic drugs with breakthrough status.
Psyence Biomedical dosed the first patient in a Phase IIb study of NPX-5 in Adjustment Disorder among cancer patients receiving palliative care. The randomized, double-blind trial is running across five Australian sites.
Compass Pathways reported positive late-stage COMP360 psilocybin data in treatment-resistant depression and plans FDA talks ahead of a filing between October and December. The update lifted shares across several psychedelics developers.
Trump signed an executive order to speed FDA review of ibogaine and other psychedelic drugs and said the U.S. would dedicate $50 million to ibogaine research. The FDA is also preparing priority vouchers and steps toward the first U.S. human trials, while ibogaine remains linked to serious heart risks.
New findings on psychedelic-based depression treatments included a UK DMT trial in 34 adults and a mouse study of modified psilocin compounds with fewer hallucinogenic-like effects.
A 34-person trial found that a single 21.5mg intravenous dose of DMT with psychotherapy produced rapid antidepressant effects lasting three to six months. Separate brain-scan research across five psychedelics found a shared pattern of weaker within-network links and stronger communication between brain networks.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07721467 |
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin |
NOT_YET_RECRUITING | PHASE2 |
| NCT07703722 |
Effect of Psilocybin and Structured Integrated Reframing Therapy on Gut-Brain Axis Biomarkers and Depression in Major Depressive Disorder |
RECRUITING | PHASE3 |
| NCT07693153 |
The Effects of Psilocybin on Social Connectedness |
NOT_YET_RECRUITING | PHASE1 |
| NCT07610135 |
Psilocybin Efficacy With or Without Pimavanserin Pretreatment |
RECRUITING | PHASE1/PHASE2 |
| NCT07607938 |
Psilocybin as a Novel Therapy for Residual Anhedonia |
NOT_YET_RECRUITING | PHASE1 |
| NCT07565909 |
Group Retreat Psilocybin Therapy for Healthcare Clinicians With Loss of Meaning in Their Work and Symptoms of Depression |
NOT_YET_RECRUITING | PHASE2 |
| NCT07565493 |
Psilocybin Administration With 5-HT1a Blockade |
RECRUITING | EARLY_PHASE1 |
| NCT07506395 |
Group Psilocybin-Assisted Therapy for Post-Traumatic Stress Disorder |
RECRUITING | PHASE1 |
| NCT07499583 |
Psilocybin Assisted Psychotherapy for Treatment Resistant Depression and Co-occurring Substance Use Disorder |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07360301 |
Consciousness and Psilocybin Effects on Well-Being: The CoPEWell Study |
NOT_YET_RECRUITING | PHASE1 |
