COMP360 timeline
Current statusInvestigational 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.
07 / 08
Occurred9 Nov 2026sponsor-reported completed regulatory submission
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.
Step 7 of 8
Evidence limitations. 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.
Dated events are ordered; spacing is schematic. Undated steps have no fixed timing. · Checked Nov 10, 2026. Read the topic research