Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
COMP360 psilocybin · 1 trial · 4 indications
The CAPS-5 (Clinician-Administered PTSD Scale for DSM-5) is a 30-item structured interview that yields a total severity score (0-80) reflecting PTSD symptoms. A higher CAPS-5 score indicates more severe, intense, and frequent PTSD symptoms.
| Arm | Type | Description |
|---|---|---|
| 1 mg COMP360 psilocybin | ACTIVE_COMPARATOR | - |
| 10 mg COMP360 psilocybin | EXPERIMENTAL | - |
| 25 mg COMP360 psilocybin | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| COMP360 psilocybin | DRUG | COMP360 psilocybin administered with monitoring and support |
Inclusion Criteria: * 18 years or older * Diagnosed with PTSD at least 6 months ago Exclusion Criteria: \- Diagnosed with certain psychiatric conditions such as bipolar disorder, schizophrenia, OCD, anorexia, or other conditions
COMP360 psilocybin is an investigational small molecule therapeutic being developed by COMPASS Pathways Plc, whose American Depositary Shares trade under the ticker CMPS. It is a synthetic form of psilocybin under study as a treatment for psychiatric conditions, and it is currently in Phase 2 clinical development for post-traumatic stress disorder.
COMP360 psilocybin is being studied as a treatment for post-traumatic stress disorder, or PTSD, and PTSD symptoms. It is investigational and has not been approved for any use. The ongoing Phase 2 program is evaluating its efficacy, safety, and tolerability in adults with PTSD.
COMP360 psilocybin targets the 5-HT2A receptor, a serotonin receptor in the brain. Its therapeutic activity is mediated through this receptor target, which is the mechanism under investigation in the PTSD clinical program.
COMP360 psilocybin is being developed by COMPASS Pathways Plc. The company's American Depositary Shares trade on the Nasdaq under the ticker CMPS. COMPASS Pathways is the sponsor of the Phase 2 clinical program evaluating COMP360 psilocybin in post-traumatic stress disorder.
COMP360 psilocybin is in Phase 2 clinical development for post-traumatic stress disorder. It is investigational and has not been approved by the FDA. The Phase 2 program is currently recruiting participants and has not yet been completed.
COMP360 psilocybin is being evaluated in the Redefine Study, a Phase 2 trial registered as NCT07570654. The study is recruiting approximately 300 participants aged 18 years and older in the United States and Canada. It is randomized, double blind, and active controlled, and it assesses efficacy, safety, and tolerability in people with PTSD.