The short version
- COMP006 Part B: 39% of patients responded after two 25 mg doses and kept the benefit through 26 weeks.
- The FDA granted a rolling NDA review and a Commissioner's National Priority Voucher in April 2026.
- Compass expects to complete its application in Q4 2026 and is targeting a launch in the first half of 2027.
- Launch also requires DEA rescheduling of the approved product.
The data
Compass Pathways ran two Phase 3 trials of COMP360, its synthetic psilocybin, in treatment-resistant depression. Both met their primary goals. The single-dose COMP005 trial reported a response rate of about 25%.3 COMP006, which tested two doses, met its primary endpoint at week 6 in February 2026, and in July Compass released six-month results:1
- 39% of patients in the 25 mg group had a clinically meaningful improvement by week 6 after two doses.
- On average, that benefit held through at least week 26.
- Almost 30% of those responders went into remission during the treatment period.2
Context matters for that 39%. These were very hard-to-treat patients, who in COMP006 had been in their current depressive episode for more than three years on average.3 For people who've already failed multiple treatments, a durable response in more than a third is a big deal.
The fast track
In April 2026, the FDA granted Compass a rolling New Drug Application, which lets the company submit sections as they're ready instead of all at once. It also selected COMP360 for the Commissioner's National Priority Voucher program, which comes with enhanced communication and a review target of about one to two months after the final filing.4 Compass expects to complete the application in Q4 2026 and has said it's targeting a commercial launch in the first half of 2027.5
That's fast. It's also contingent. The voucher speeds the review, not the standard. The FDA still has to be convinced.
What still has to happen
| Step | What it means |
|---|---|
| 1. Final NDA submission | Compass completes its application, expected Q4 20265 |
| 2. FDA approval | Possibly within months, given the priority voucher4 |
| 3. DEA rescheduling | Federal law requires the DEA to issue an interim scheduling rule within 90 days of approval6 |
| 4. State rules | Some states need their own scheduling changes. Virginia already passed a law to do this automatically7 |
Only the approved product, synthetic COMP360, would be rescheduled. Psilocybin mushrooms would stay Schedule I.6
Where you'd get it
Don't expect a pharmacy pickup. COMP360 is given in a supervised session lasting several hours. Compass has said it expects the treatment to fit into existing infrastructure, and analysts expect early rollout through the more than 1,000 clinics already certified to give Spravato, the esketamine nasal spray, which already have monitored treatment rooms and staff.7
What to watch
- The final NDA submission announcement in Q4 2026
- The FDA decision, and any advisory committee meeting
- The DEA's scheduling rule
- Price and insurance coverage, which will decide who actually gets access
For the full scientific story, read psilocybin for depression: what the research shows.
Sources
- Compass Pathways. Six month data from second Phase 3 trial confirming rapid and durable profile. July 7, 2026. businesswire.com
- PharmaTimes. Compass Pathways reports six-month data confirming durable profile of COMP360. July 7, 2026. pharmatimes.com
- Tablets & Capsules. Data in hand, Compass psychedelic on track for Q4 NDA submission. July 2026. tabletscapsules.com
- Compass Pathways. FDA granted NDA rolling review request and awarded Commissioner's National Priority Voucher. 2026. Business Wire via Infront
- Compass Pathways. Second quarter and first half 2026 financial results and business highlights. August 5, 2026. seekingalpha.com
- Mind Medicine Law. U.S. federal law explainer: the Controlled Substances Act and psychedelics. 2026. mindmedicinelaw.com
- HealingMaps. The first psilocybin clinics will probably be Spravato clinics. 2026. healingmaps.com
This article is for education only and is not medical or legal advice. Psilocybin is a Schedule I substance under U.S. federal law. Talk with a licensed clinician before making decisions about your health. In a crisis, call or text 988.