COMP360 is not approved by the Food and Drug Administration (FDA). On November 9, 2026, Compass Pathways completed its New Drug Application (NDA) for COMP360 psilocybin for treatment-resistant depression (TRD). These statements rest on the Compass Pathways news release of November 9, 2026, the FDA program page for the Commissioner's National Priority Voucher (CNPV) pilot, and the federal regulation text.
COMP360 Status: What Is Known and Not Yet Known
| Milestone | Status as of November 12, 2026 | Source and date |
|---|---|---|
| NDA submission | Completed submission of a New Drug Application (NDA) announced for treatment-resistant depression (TRD). | Compass Pathways news release, November 9, 2026 |
| FDA acceptance of the filing | not reported in the sources reviewed | Compass Pathways release, November 9, 2026, and FDA program page, read November 12, 2026 |
| FDA decision | not reported in the sources reviewed | Compass Pathways release, November 9, 2026, and FDA program page, read November 12, 2026 |
| DEA rescheduling | not reported in the sources reviewed | 21 CFR 1308.11 (eCFR text through November 6, 2026) and Compass Pathways release, November 9, 2026 |
| State rescheduling | Compass Pathways stated on August 5, 2026 that approximately 90% of the U.S. patient population live in states that intend to reschedule within 30 days after federal DEA action. This is a company statement of intent. | Compass Pathways release, August 5, 2026 |
| Commercial launch | Compass Pathways reported launch readiness on track for expected launch in the first half of 2027, subject to FDA approval. | Compass Pathways news release, November 9, 2026 |
| Price | not reported in the sources reviewed | Compass Pathways news release, November 9, 2026 |
| Insurance coverage | not reported in the sources reviewed | Compass Pathways news release, November 9, 2026 |
Is COMP360 FDA-Approved Yet?
COMP360 is Compass Pathways' investigational synthetic, proprietary formulation of psilocybin, and the NDA submission seeks approval for treatment-resistant depression (TRD). The release says COMP360 holds Breakthrough Therapy designation from the FDA. Until the agency completes formal review and issues an approval letter, the compound remains an unapproved investigational drug.
The Compass Pathways news release defines treatment-resistant depression as depression that requires an inadequate response to two or more courses of antidepressants of adequate dose and duration. In its announcement, Compass Pathways estimated that 4 million people in the United States live with treatment-resistant depression, and that fewer than 5% of those individuals currently receive a treatment indicated for treatment-resistant depression. Clinical context is in the psilocybin for depression guide.
Compass Pathways stated that the application is supported by clinical data from two Phase 3 trials and one Phase 2b study. According to the sponsor, each of these three studies met its primary endpoint and together involved more than 1,000 participants living with chronic treatment-resistant depression. The sponsor characterized the Phase 3 trials as highly statistically significant. However, the November 9 news release did not report numerical effect sizes, exact safety figures, or dosing regimens. The release also says COMP360 has Innovative Licensing and Access Pathway (ILAP) designation in the United Kingdom. Trial evidence is covered in the psilocybin clinical trials guide.
What the November 9 NDA Submission Establishes
A completed submission is not an FDA acceptance, review or approval. The sources reviewed on November 12, 2026 report no FDA acceptance of the filing and no FDA decision. In the news release, Compass Pathways Chief Executive Officer Kabir Nath said the company looks forward to continuing the review process and is focused on delivering COMP360 to patients as quickly as possible, subject to FDA approval.
Compass Pathways previously disclosed that COMP360 received a voucher under the Commissioner's National Priority Voucher (CNPV) pilot program. The FDA program page describes the pilot as offering an ultra-fast timeline with a 1 to 2 month target compared to standard review times of 6 months or longer. The FDA page lists the 1 to 2 month figure as a target. The page also says the pilot maintains the agency's established safety and effectiveness approval standards. The vouchers issued under the program are nontransferable. Compass Pathways noted in its forward-looking statements that the rolling review and the voucher may not actually lead to a faster review process, and that efforts to obtain accelerated approval may be unsuccessful. The FDA priority vouchers for psychedelics guide covers the program.
The November 9 release stated that launch readiness remains on track for an expected commercial launch in the first half of 2027, subject to FDA approval. However, the release does not report an FDA filing acceptance or a Risk Evaluation and Mitigation Strategy (REMS). Commercial pricing and insurance reimbursement details were also not reported in the sources reviewed. The sponsor's public disclosures identified coverage and reimbursement decisions by third-party payors as unconfirmed business risks.
What Is Legal While COMP360 Is Under Review
In the Electronic Code of Federal Regulations (eCFR) text for 21 CFR 1308.11, current through November 6, 2026, psilocybin is listed in Schedule I under paragraph (d)(29) with Drug Enforcement Administration (DEA) drug code 7437, and psilocyn is listed under (d)(30) with code 7438.
Authorized clinical trials represent the federally sanctioned route to COMP360 in the sources reviewed. Trial opportunities can be verified on ClinicalTrials.gov. Outside authorized clinical trials, psilocybin remains listed in 21 CFR 1308.11 (Schedule I), as covered in the Controlled Substances Act and psychedelics.
State psilocybin programs operate under separate state statutory structures and do not constitute federal approval of COMP360. For example, under Oregon Revised Statutes Chapter 475A, established by Ballot Measure 109 in November 2020, the Oregon Health Authority licenses and regulates the manufacturing, transportation, delivery, sale, and purchase of state-regulated psilocybin products and services. That state framework functions strictly under Oregon law. It does not grant federal marketing authorization to COMP360. State-by-state status is covered in the are mushrooms legal guide.
What Has to Happen After Any Approval
Compass Pathways noted in its November 9 release that COMP360 contains Schedule I controlled substances and must be rescheduled before commercializing COMP360 in the U.S.
In its news release, Compass Pathways noted that the Drug Enforcement Administration (DEA) and individual states must reschedule COMP360 if the FDA approves the drug. The company identified the possibility that the DEA and states may not reschedule the drug on a timely basis, or at all, as a risk. In an earlier results release on August 5, 2026, Compass stated that approximately 90% of the United States patient population lives in states that intend to reschedule within 30 days following federal DEA action. That projection represents a corporate statement of intent, not an executed state legislative or administrative action.
The November 9 release does not report whether the FDA will require a Risk Evaluation and Mitigation Strategy (REMS); Compass's August 5 release lists REMS certification among its approval-stage preparations. The sources reviewed do not report how practitioner licensing will work or which insurance plans will provide coverage. No COMP360 list price appears in the sources reviewed. The COMP360 cost guide reports a management-stated expectation of about $50,000 to $65,000 a year, as reported by Investing.com on September 17, 2026.
Verdict on COMP360 Approval Status
COMP360 is not approved by the Food and Drug Administration (FDA) as of November 12, 2026. Compass Pathways completed its New Drug Application (NDA) on November 9, 2026, and the sources reviewed report no FDA acceptance or decision. Authorized clinical trials are the federally sanctioned route to COMP360 in the sources reviewed. This status applies to patients, clinicians and clinic operators alike.
An FDA-approved treatment option for treatment-resistant depression already exists, so waiting for COMP360 is not the sole path. The FDA approved Spravato (esketamine) nasal spray for treatment-resistant depression in 2019 alongside an oral antidepressant, and expanded that approval to monotherapy under supplemental NDA 211243/S-016. The ketamine and esketamine guide covers that option.
An FDA filing-acceptance notice or approval, a DEA rescheduling action, or state rescheduling would change this answer. This is not a source for dosing, efficacy figures or ways to obtain a substance; the November 9 Compass Pathways release gives none of them. Patients evaluating treatment-resistant depression care should discuss approved treatment options with a treating psychiatrist and check the FDA and Compass Pathways pages for dated updates.