Legal status by country
Is Danazol legal?
Written by Aaron CuhaReviewed Sep 2026
How Danazol 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 | Approved | Approved | Approved |
| Classification | FDA-approved, prescription only | Licensed, prescription only (MHRA) | TGA-registered, prescription only | Health Canada approved, prescription only |
| Note | Approved with a boxed warning covering use in pregnancy, thromboembolism, peliosis hepatis and benign intracranial hypertension. Use for telomeres or ageing is off label. | Licensed prescription medicine; the telomere indication is not licensed anywhere. | None recorded | None recorded |
US FDA status: FDA approved for endometriosis, fibrocystic breast disease and hereditary angioedema, with a boxed warning. Not approved for telomere disease, ageing or any longevity indication. Its use in telomere biology disorders is off label and was studied under an investigational protocol.. 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.