Medical Approval: What Is and Is Not Approved

This 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

Esketamine (Spravato). The FDA label lists treatment-resistant depression in adults, and depressive symptoms in adults with major depressive disorder who have acute suicidal ideation or behavior. [3] It is available only through a restricted program called the SPRAVATO REMS, with healthcare settings required to be certified and patients monitored for at least 2 hours after administration. [3] Esketamine is a different product from ketamine; see ketamine vs esketamine and the esketamine guide.

Ketamine. NIDA describes ketamine as a chemical compound used in prescription medications for anesthesia in humans and animals. [4] We did not read an FDA approval of ketamine for depression, and other uses of ketamine are covered on the ketamine guide.

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.

MDMA. NIDA says the FDA has not approved MDMA for any medical condition but has designated it a breakthrough therapy for PTSD research. [5] The FDA convened an advisory committee on June 4, 2024 to discuss a new drug application for MDMA capsules from a drug developer for PTSD. [8] We did not read the FDA's decision letter itself, so we do not describe its content here. For the trial evidence, see PTSD research and the MDMA guide.

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.