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What this page does and does not contain — This page examines the clinical and regulatory landscape for psilocybin-based investigational drugs. It names clinical sponsors and trial programs only to identify their public research records and regulatory milestones. It does not: recommend or endorse any treatment, drug, or program; guide readers toward or away from any investigational therapy; facilitate trial enrollment; provide recruitment or site-location information; reproduce or endorse sponsor investor language as established efficacy; apply full-dose clinical trial findings to microdosing; or link to
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No psilocybin-based drug is FDA approved as of the date this page was last reviewed. Compass Pathways has reported positive results from two Phase 3 trials for COMP360 in treatment-resistant depression [1] sponsor-press-release Compass Pathways Successfully Achieves Primary Endpoint in First Phase 3 Trial Evaluating COMP360 Psilocybin for Treatment-Resistant Depression Link → [2] sponsor-press-release Compass Pathways Successfully Achieves Primary Endpoint in Second Phase 3 Trial Evaluating COMP360 Psilocybin for Treatment-Resistant Depression Link → and received FDA authorization for a rolling NDA submission along with a Commissioner’s National Priority Voucher. [3] sponsor-press-release Compass Pathways Announces FDA Granted NDA Rolling Review Request and Awarded Commissioner's National Priority Voucher Link → [4] primary-regulatory Commissioner's National Priority Voucher (CNPV) Pilot Program Link → These are development milestones. They accelerate the path to a potential approval decision but they are not approval. Psilocybin remains Schedule I federally.
The direct answer: not yet approved
The question “is psilocybin FDA approved?” has a direct answer as of mid-2026: no. No psilocybin-based drug has received FDA marketing approval. The regulatory milestones that have occurred — Breakthrough Therapy designations, a Commissioner’s National Priority Voucher, and an authorized rolling NDA review — are all development-process steps that precede a potential approval decision, not approval itself.
This page explains what those milestones are, what they mean, and what still has to happen before any approval decision is possible.
What has actually happened in the regulatory process
The FDA granted Breakthrough Therapy designation to psilocybin programs twice: to Compass Pathways for treatment-resistant depression in 2018, and to the Usona Institute for major depressive disorder in 2019. [5] primary-legal Breakthrough Therapy designation Link → This designation means the FDA agreed that early evidence suggested substantial potential improvement over existing therapies for a serious condition. It accelerated development engagement. It is not approval.
Compass Pathways subsequently completed two Phase 3 trials — COMP005 and COMP006 — both of which met their primary endpoints, as reported by the sponsor in June 2025 and February 2026 respectively. [1] sponsor-press-release Compass Pathways Successfully Achieves Primary Endpoint in First Phase 3 Trial Evaluating COMP360 Psilocybin for Treatment-Resistant Depression Link → [2] sponsor-press-release Compass Pathways Successfully Achieves Primary Endpoint in Second Phase 3 Trial Evaluating COMP360 Psilocybin for Treatment-Resistant Depression Link → These are sponsor-reported top-line results for one investigational drug in one indication. They are not peer-reviewed efficacy determinations applicable to other products or uses.
Following an April 2026 executive order directing federal agencies to accelerate psychedelic therapy review, the FDA issued a National Priority Voucher to the COMP360 program and authorized a rolling NDA review. [6] primary-regulatory FDA Accelerates Action on Treatments for Serious Mental Illness Following Executive Order Link → [3] sponsor-press-release Compass Pathways Announces FDA Granted NDA Rolling Review Request and Awarded Commissioner's National Priority Voucher Link → A rolling NDA allows the sponsor to submit completed sections of the application as they are finalized, rather than waiting until the full package is ready. The CNPV can compress the standard FDA review window once a complete NDA is filed. Neither mechanism changes the evidentiary standard the FDA applies.
| Milestone | What it means | What it does not mean |
|---|---|---|
| Breakthrough Therapy designation | FDA agrees early evidence is promising; closer FDA engagement | Approval; rescheduling; public access authorized |
| Positive Phase 3 top-line data (sponsor-reported) | Sponsor states the trial met its primary endpoint | Peer-reviewed efficacy; approval; findings apply to other uses |
| Commissioner’s National Priority Voucher | Review window compressed once NDA is complete | Approval guaranteed; evidentiary standard waived |
| Rolling NDA authorized | Sections of the application under active FDA review | Application complete; approval issued |
What would approval actually mean — and what it would not
If and when the FDA approves a psilocybin-based drug, that approval would apply to a specific product (such as COMP360) for a specific indication (such as treatment-resistant depression) at a specific dose and under specific protocol conditions. It would not:
- Approve psilocybin as a general substance for all uses
- Apply to natural psilocybin mushrooms, dietary supplements, or unprocessed products
- Authorize unsupervised use outside the approved clinical conditions
- Establish efficacy for other indications such as PTSD or major depressive disorder
- Establish efficacy for microdosing
- Reschedule psilocybin at the substance level, unless the DEA acts to reschedule it consistent with the approval
The DEA rescheduling question is separate. An approval of a specific drug product does not automatically reschedule the underlying substance; it creates the factual basis for rescheduling, but the process requires a separate DEA action.
What remains pending as of mid-2026
As of the lastReviewedDate on this page, the following milestones had not yet occurred: completion of the rolling NDA submission for COMP360; any FDA approval decision; any peer-reviewed publication of COMP005 or COMP006 full trial data; public announcement of Usona’s Phase 3 uAspire results; and DEA rescheduling.
See the Legal Status cluster for how federal scheduling and state access programs relate. See the Clinical Pipeline overview for the broader landscape.
- New Drug Application (NDA)
- The formal application a drug sponsor submits to the FDA requesting approval to market a new drug in the United States. Approval of an NDA is the final step in the standard pre-market approval pathway.
- Rolling NDA submission
- FDA allows the sponsor to submit completed sections before the full package is ready. This speeds the process but does not reduce the total evidence required.
- Schedule I controlled substance
- A federal classification for substances the DEA has determined have high abuse potential, no currently accepted medical use, and a lack of accepted safety for use under medical supervision. Psilocybin remained Schedule I as of mid-2026.
- NDA approval vs. scheduling
- FDA drug approval applies to a specific product for a specific use. Substance-level scheduling under the Controlled Substances Act is a separate DEA action. One does not automatically follow from the other.