Compass announced completion of the COMP360 NDA for treatment-resistant depression on November 9, 2026. FDA filing acceptance and a product-specific decision date await confirmation. U.S. access remains dependent on approval, DEA scheduling and commercial launch.
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
Current status: Compass announced completion of the COMP360 NDA for treatment-resistant depression on November 9, 2026. FDA filing acceptance and a product-specific decision date await confirmation. U.S. access remains dependent on approval, DEA scheduling and commercial launch. Source
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.
conditional sponsor launch target; not promised availability
Compass reiterates a possible first-half 2027 U.S. launch, conditional on FDA approval and scheduling. Submission completion establishes no guaranteed approval or availability date.
Investigational in the U.S. Compass announced completion of its rolling COMP360 NDA on November 9. FDA acceptance, an action date, approval and access remain separate milestones with no verified product-specific decision date. 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
Compass narrows its final COMP360 submission window to the next two weeks
At its November 3 announcement, Compass forecast the final rolling NDA within two weeks. The November 9 completion announcement is recorded separately below.
Actual announcement date; underlying clearance, filing or first-dose date is not established. · sponsor development/timing disclosure Source
The rolling application is complete
Compass announces final submission of the COMP360 NDA for treatment-resistant depression, fulfilling its earlier forecast. FDA acceptance, an action date and approval remain unverified.
Actual sponsor announcement of completed submission. · sponsor-reported completed regulatory submission Source
Possible U.S. launch
Compass reiterates a possible first-half 2027 U.S. launch, conditional on FDA approval and scheduling. Submission completion establishes no guaranteed approval or availability date.
