09/25/2026
💥 Have you heard about COMP360? 💥
We recently met with a representative from Compass Pathways to learn about COMP360, their proprietary synthetic formulation of psilocybin currently moving through the FDA regulatory process.
COMP360 has now demonstrated positive results in two Phase 3 clinical trials for treatment-resistant depression, with significant reductions in depressive symptoms and effects emerging rapidly after treatment. Longer-term data are also helping researchers understand how durable those improvements may be.
So, where are things now?
Compass has begun a rolling New Drug Application with the FDA and expects to complete its submission in late 2026. COMP360 has received Breakthrough Therapy designation and was selected for an FDA priority review program intended to accelerate the regulatory process.
If approved, Compass currently anticipates a commercial launch in the first half of 2027 🎉
Aether has spent years building the clinical expertise, infrastructure, and experience required to provide ketamine-based treatments safely and thoughtfully. While psilocybin is a different medicine with its own protocols and regulatory requirements, much of what we've learned through years of interventional psychiatry has positioned us well for the next generation of psychedelic treatments.
COMP360 is not currently FDA approved, and there are still important regulatory steps ahead. But after years of research into the therapeutic potential of psilocybin, we may be approaching an important milestone: the possibility of an FDA-approved psilocybin treatment entering mainstream psychiatric care.
We're grateful to the Compass Pathways team for spending time with us, and we'll be watching closely as COMP360 moves through the FDA process.
