Study-specific safety is not summarized in this timeline entry. See the research notes and primary source; missing safety data do not establish safety.
Study results apply to their own population, dose and analysis. They do not establish a ranking between therapies.
Evidence in the atlas
0 results
Each result belongs to its own study population, dose and analysis. Open a result for its chart, comparator, safety findings and limitations.
phase 3 topline; sponsor SEC filing · 23 Jun 2025
First phase 3 endpoint is met
COMP005 reports a 3.6-point advantage over placebo on the MADRS depression scale at six weeks. These are preliminary sponsor-reported results.
Between-group difference in score change: -3.6 points; 95% CI -5.7 to -1.5. Lower MADRS scores indicate fewer symptoms. Do not interpret 3.6 as a percentage or individual expected benefit.
Study-specific safety is not summarized in this timeline entry. See the research notes and primary source; missing safety data do not establish safety.
Detailed trial charts have not been added for this program. See its sourced development timeline and research notes.
Biology & identity
Status in this atlas: Investigational in the U.S. Sponsor-reported one-year follow-up now includes repeat dosing; rolling NDA completion remains targeted for Q4 2026.
Psilocybin is the active molecule in the sponsor’s proprietary COMP360 formulation.
Uses, doses and availability depend on the formulation, indication and country. Study doses below describe research; they are not prescribing instructions.
Investigational in the U.S. Sponsor-reported one-year follow-up now includes repeat dosing; rolling NDA completion remains targeted for Q4 2026. Short-term symptom improvement is not permanent remission. Noticeable psychoactive effects can reveal treatment assignment and influence expectations; durability, retreatment and safety need their own evidence.
A phase 2 trial in treatment-resistant depression finds a greater reduction in depression scores at three weeks in the higher-dose group than the low-dose comparator. Adverse effects also occur.
actual online publication; print issue November 3 · peer-reviewed randomized phase 2 trial Source
First phase 3 endpoint is met
COMP005 reports a 3.6-point advantage over placebo on the MADRS depression scale at six weeks. These are preliminary sponsor-reported results.
Compass says some rolling NDA modules are submitted and reports six-month benefit in a subset. Selection of responders and retreatment matter when judging durability.
actual sponsor status disclosure · sponsor development update Source
One-year follow-up includes repeat doses
COMP005 Part C follows selected participants through week 52, allowing additional COMP360 doses. The result is not randomized evidence that one dose lasts a year.
actual sponsor disclosure · sponsor open-label extension topline Source
Complete the rolling application
Compass targets submission of the remaining NDA modules. Completing a filing does not establish approval or determine its timing.
sponsor target; not FDA deadline · planned application milestone Source
Possible U.S. launch
The sponsor targets a first-half 2027 launch, subject to FDA approval and DEA rescheduling. No guaranteed approval date is established.
