COMP360 timeline
Current statusInvestigational in the U.S. Sponsor-reported one-year follow-up now includes repeat dosing; rolling NDA completion remains targeted for Q4 2026.
05 / 07
Occurred9 Sep 2026sponsor open-label extension topline
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.
Approximately 70% of the original 258 participants entered the open-label extension. Selection, attrition and redosing limit causal interpretation; detailed adverse-event rates remain pending.
Step 5 of 7
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 Sep 18, 2026. Read the topic research