No COMP360 approval date exists yet, but the timetable is short. Compass Pathways said its rolling new drug application (NDA) should finish “in the next two weeks”. It made the statement on 3 November 2026, in its third-quarter 2026 results release. The company expects a launch in the first half of 2027, subject to FDA approval.
COMP360 is a synthetic psilocybin formulation for treatment-resistant depression (TRD). The FDA has awarded it a Commissioner’s National Priority Voucher (CNPV). That voucher targets a review of one to two months. A target is not a promise. Several steps still sit between a completed filing and a prescription.
Where does the COMP360 NDA stand?
Compass announced on 24 April 2026 that the FDA had granted its rolling submission request and awarded the voucher. The company’s announcement gives the details. In a rolling submission, a sponsor sends completed sections of an application in stages. The final section is the one still outstanding.
On 3 November, Compass described the NDA as “nearing completion, with rolling review underway”. Cash and equivalents stood at $444.0 million on 30 September 2026. The company says that funds operations into 2028.
Kabir Nath, Chief Executive Officer of Compass, commented in April. He said “an NDA submission must still meet FDA’s established standards of clinical evidence”. The FDA’s own voucher programme page says the scheme “maintains the FDA’s established safety and effectiveness approval standards”.
In November, Nath said Compass is “executing with urgency and discipline” towards a first-half 2027 launch. That is a company statement, not an FDA commitment.
When could COMP360 approval happen under the voucher?
The FDA’s programme page lists a target of one to two months. It sets this against six months or more under other FDA priority review programmes. The target runs from the final application, as a guide to the national priority voucher explains.
Compass has not yet said that it has filed. If it finishes by mid-November, a one-to-two-month target would point to a decision between mid-December 2026 and mid-January 2027. That is arithmetic on company guidance, not a forecast.
One analyst leans towards the early end. BioSpace reported that Stifel said approval “should firmly come within the 1Q27 timeframe (if not earlier)”. That is one firm’s view.
A voucher does not guarantee a positive outcome. As at 15 October 2026, the same guide counted ten approvals and one complete response letter among voucher products. The FDA also reserves the right to extend a review if a submission is incomplete.
What do the two phase 3 trials show?
COMP005 compared a single 25 mg dose of COMP360 with placebo in 258 dosed participants. Compass’s June 2025 topline release reported a 3.6-point greater fall on the Montgomery-Åsberg Depression Rating Scale (MADRS). This was measured at week 6. The 95 per cent confidence interval ran from 1.5 to 5.7 points, with p below 0.001. Compass called these preliminary topline data at the time.
COMP006 dosed 581 participants with two fixed doses given three weeks apart. The arms were 25 mg (296 participants), 10 mg (142) and 1 mg (143). The 1 mg arm served as the comparator, not placebo.
Compass reported in its 17 February 2026 release that the 25 mg arm beat 1 mg. The MADRS difference at week 6 was 3.8 points. The 95 per cent confidence interval was 1.8 to 5.8 points, with p below 0.001.
A July 2026 update gave more detail on the 25 mg arm. Compass said 39 per cent had a clinically meaningful reduction by week 6. This meant a MADRS fall of at least 25 per cent. It said the benefit held, on average, through at least week 26. Nearly 30 per cent of week 6 responders reached remission after retreatment, it added.
The two trials used different comparators. Their treatment differences should therefore not be pooled or compared directly. The 3 November release also cited 52-week open-label COMP005 data. It said these showed “notable added benefit” from an additional 25 mg dose, with no figures given.
What does the safety record show?
The reported safety picture has favourable and less favourable elements. Both come from sponsor releases.
On the favourable side, the independent Data Safety Monitoring Board chair reported no new, unexpected or concerning findings. The chair also found no clinically meaningful imbalance in suicidality between arms in either study. Across both trials, the serious adverse event (SAE) rate for suicidal ideation was under 1 per cent. One SAE of suicidal behaviour occurred, in the 1 mg arm of COMP006.
Other findings are less reassuring. In the 25 mg arm, the most common adverse events were headache, nausea, anxiety and visual hallucination. Compass said 73 per cent of treatment-emergent adverse events occurred on dosing days. It said 83 per cent resolved within a day.
Serious events did occur. The February release reported six treatment-emergent SAEs in six participants (2 per cent). It lists these under the 25 mg arm in the trial’s first part. Compass said in July that 6.3 per cent of the 1 mg arm had serious adverse events over 26 weeks. The figure was 5.7 per cent for the 25 mg arm.
How does the Usona filing affect COMP360 approval?
On 2 November, Psychedelic Alpha reported that the Usona Institute had completed an NDA. The application covers psilocybin in major depressive disorder (MDD). It cited anonymous sources close to Usona, and Usona declined to comment. Healing Maps reported that neither Usona nor the FDA had confirmed the filing.
BioSpace reported that Compass shares fell more than 35 per cent on Monday 2 November after the news. It said both Compass and Usona hold national priority vouchers. The FDA did not name the April recipients, but BioSpace said the descriptions matched Compass, Transcend Therapeutics and Usona.
Why the two applications differ
Compass is seeking approval in TRD, a narrower group of patients who have failed earlier treatments. Usona’s reported application covers MDD, the broader diagnosis. Healing Maps argued that an MDD label would probably be broader than the current Spravato label.
Stifel said, according to BioSpace, that Usona’s phase 3 MDD data have never been disclosed. RBC Capital Markets argued that the market can support more than one competitor.
What could slow COMP360 approval?
Review risk is the first factor. Psychedelic Alpha reported that FDA site inspections of Compass began in September. That report is single-source. The Compass release does not mention inspections or a risk evaluation and mitigation strategy (REMS). Psychedelic Alpha also reported, citing anonymous sources, that Usona is working with the agency on a REMS design.
Controlled-substance scheduling is the second factor. Psilocybin is currently a Schedule I substance in the United States. Executive Order 14401, signed on 18 April 2026, covers this. It directs the Attorney General to “initiate and complete review of any product containing a Schedule I substance”. This applies to products that have successfully completed phase 3 trials for a serious mental health disorder.
The order says the aim is for rescheduling to proceed quickly for products later approved. The sources reviewed do not say how long rescheduling would take after an approval. The Compass release says only that the order directs the Drug Enforcement Administration to review “to support rapid rescheduling”.
Guidance is the third factor. The FDA finalised guidance titled “Psychedelic Drugs: Considerations for Clinical Investigations” in July 2026. It replaced a draft issued in June 2023.
What about COMP360 approval in the UK?
Compass is headquartered in London. Its November release notes Innovative Licensing and Access Pathway (ILAP) designation in the UK for TRD. That designation is a development support route, not an authorisation.
The release does not describe a UK or EU marketing application. Any MHRA timetable is therefore unannounced.
What will settle the COMP360 approval question?
Three events will settle most of it. The first is Compass confirming that its NDA is complete. The company guides to within two weeks of 3 November. The second is FDA action, which a voucher target places one to two months after filing.
The third is rescheduling by the Drug Enforcement Administration after any approval. Its timing is the least certain of the three. Any FDA statement on the Usona application would also change the competitive picture. Other pending decisions are listed in the FDA drug approval decisions tracker.
Until Compass announces completion, COMP360 approval remains a question of timing rather than of trial evidence. The FDA decides the outcome.
