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.
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.
Studies of psilocybin found lasting shifts in life values in healthy volunteers and reduced fear of death in therapeutic settings. Trials have also reported benefits in cancer patients.
The FDA approved milsaperidone for bipolar I disorder and schizophrenia, while COMP360 psilocybin met its primary endpoint in a second phase 3 trial for treatment-resistant depression. Phase 2a data showed intravenous DMT (SPL026) significantly reduced depressive symptoms in major depressive disorder patients.
Clinical trials show psychedelic substances like psilocybin, LSD and MDMA combined with therapy can effectively treat depression, anxiety and addiction. Several substances are in Phase III trials, with esketamine already approved for treatment-resistant depression. Research suggests these treatments may work with fewer doses than traditional medications.
Compass Pathways announced positive Phase 3 data for COMP360 psilocybin therapy in treatment-resistant depression, showing statistically significant improvements in depression scores and durability through 26 weeks, with plans to file for FDA approval in Q4 2026.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| 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 |
NOT_YET_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 |
| NCT07336238 |
Group Retreat Psilocybin Therapy for the Treatment of Anxiety and Depression in Patients With Metastatic Solid Tumors or Incurable Hematologic Malignancies |
RECRUITING | PHASE2 |
| NCT07332143 |
Psilocybin-Assisted Therapy |
NOT_YET_RECRUITING | PHASE2 |
| NCT07296328 |
Effects of Psilocybin on Speech Fluency, Struggle, and Brain Activity in People Who Stutter |
NOT_YET_RECRUITING | PHASE2 |
| NCT07296094 |
Psilocybin-Assisted Psychotherapy for the Treatment of Severe Alcohol Use Disorder |
NOT_YET_RECRUITING | PHASE2 |
| NCT07226232 |
Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression |
NOT_YET_RECRUITING | PHASE3 |
