SPECIALTY TOPICS · GUIDE
Medical Approval: What Is and Is Not Approved
Which psychedelic and related medicines the FDA has approved, which only hold a breakthrough designation, and which remain investigational, as read from the regulator and NIDA.
Content last updated . This page has not been medically reviewed.
Back to Psychedelic TherapyThis page describes regulatory status in the United States as read on 2026-10-22. It is information only, not a recommendation for or against any treatment, and not legal advice. Talk with a licensed prescriber about any prescription medicine. Do not start or stop any medicine because of what you read here.
Three different statuses
People often blur these together, so we keep them apart.- Approved medicine. A regulator has authorized a specific product for a specific use, with a label that states what it is for and its risks.
- Breakthrough Therapy designation. The FDA describes this as a process designed to expedite the development and review of drugs intended to treat a serious condition when preliminary clinical evidence suggests substantial improvement over available therapy. [1] It is a development status. It is not an approval, and it does not say the drug works.
- Investigational. The product is being studied in clinical trials. The FDA says investigational products have not been approved or cleared and that the agency has not found them safe and effective for their specific use. [2]
What we found, substance by substance
| Substance | Status as read | Source |
|---|---|---|
| Psilocybin | Breakthrough designation for two formulations being studied for depression; not approved in the sources we read | [4] |
Psilocybin. NIDA says the FDA has granted Breakthrough Therapy designation for two formulations of psilocybin being studied as potential treatments for depression. [4] The sponsor's progress toward approval is a company matter that we could not confirm from a regulator page: the company press releases we found could not be read in full this session. Proper evidence not found for an FDA approval of psilocybin; check the FDA's current approvals directly.
How the FDA is approaching psychedelic trials
The FDA has issued a final guidance titled "Psychedelic Drugs: Considerations for Clinical Investigations," which finalizes a draft issued in June 2023. [9] It gives general considerations for sponsors developing psychedelic drugs for medical and substance use conditions. [9] A guidance is advice to developers. It does not approve any product.Reading clinic and retreat claims
A clinic that says a treatment is "FDA-approved" should name the product and the condition. Approval for one product does not extend to a different drug, a different dose form or a different condition. See evaluating clinic claims and how to read a psychedelic clinical trial.Other countries
We did not read regulator pages from Health Canada, Australia's Therapeutic Goods Administration, the EMA or MHRA that were reachable this session, so we do not state status elsewhere. See how law differs by country.Frequently asked questions
Has the FDA approved psilocybin?
In the sources we read, no. NIDA describes breakthrough designations for two psilocybin formulations being studied. [4] Check the FDA's current approvals, because status can change.
What is the difference between "breakthrough" and "approved"?
Breakthrough Therapy designation is a way to speed development and review for drugs for serious conditions. [1] It does not mean a drug has been shown to work or is approved.
Does Schedule I mean no medical use is possible?
Schedule I is a legal listing. [6] Separately, a medicine can be studied under FDA rules; see controlled-substance status.
More details: evidence, limits and cautions
The details behind this page: cautions, limits of the evidence and where sources disagree. Open any note to read it.
How to read the evidence labels
Labels used on this page: approved medicine (name the regulator and use), investigational, and insufficient evidence where we found nothing to read.