Legal status by country
Is Oveporexton legal?
Written by Aaron CuhaReviewed Sep 2026
How Oveporexton is classified in the United States, United Kingdom, Australia and Canada, side by side. Each country has its own page with a direct answer, the regulator's approval status and what the classification means in practice.
All four countries, side by side
| Attribute | United States · FDA | United Kingdom · MHRA | Australia · TGA | Canada · Health Canada |
|---|---|---|---|---|
| Status | Approved | Not approved | Not approved | Not approved |
| Classification | FDA-approved, prescription only | Not licensed | Not registered | Not approved |
| Note | Orzeyful, NDA 220860, approved 5 August 2026 for narcolepsy type 1 in adults; Drugs@FDA marketing status Prescription. Controlled substance schedule pending. | No MHRA licence located as of September 2026. | No TGA registration located as of September 2026. | No Health Canada approval located as of September 2026. |
US FDA status: FDA approved 5 August 2026 (Orzeyful, NDA 220860, orphan designation, priority review) for narcolepsy type 1 in adults. Controlled substance schedule pending DEA review at the time of labelling.. Reviewed Sep 2026.
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General information current as of Sep 2026, not legal advice. Classifications change; confirm with the regulator or a lawyer for a specific situation. Educational use only. This database summarizes published research. It is not medical advice and contains no dosing protocols or recommendations for personal use. The Longevity Archive has no vendor relationships.