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 being studied for the treatment of post-traumatic stress disorder (PTSD). It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities. The drug is being evaluated in the Redefine Study, a randomized, double-blind, active-controlled trial.
COMP360 psilocybin is a small molecule that acts as a psychedelic compound. While its exact mechanism in PTSD is under investigation, it is believed to modulate brain networks involved in emotional processing and memory. The drug is being studied for its potential to provide therapeutic benefits in PTSD, though its precise mechanism of action is not fully established.
COMP360 psilocybin is being developed by COMPASS Pathways Plc, a biopharmaceutical company listed on the NASDAQ under the ticker symbol CMPS. The company is conducting clinical trials to evaluate the efficacy, safety, and tolerability of COMP360 in participants with post-traumatic stress disorder.
COMP360 psilocybin is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 2 trial is actively recruiting participants to assess the drug's efficacy and safety in treating PTSD.
COMP360 psilocybin is being evaluated in the Redefine Study (NCT07570654), a Phase 2 trial with an enrollment of 300 participants. This randomized, double-blind, active-controlled study is recruiting in the United States and includes adults aged 18 years and older with PTSD. The trial is currently in the recruiting stage.
COMP360 psilocybin is a proprietary formulation of psilocybin, the active ingredient found in certain psychedelic mushrooms. It is being developed specifically by COMPASS Pathways for therapeutic use in psychiatric conditions such as PTSD. While it contains the same active compound, it is being studied as a standardized pharmaceutical product.