Legal status by country
Is Ruxolitinib legal?
Written by Aaron CuhaReviewed Sep 2026
How Ruxolitinib 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 | Jakafi (oral) and Opzelura (cream), both Incyte. Opzelura carries a boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis. Jakafi does not carry a boxed warning but is labelled with warnings for cytopenias, infection, non-melanoma skin cancer, lipid elevations, MACE, thrombosis and secondary malignancies. | Licensed as Jakavi for myelofibrosis and polycythaemia vera. Prescription only, specialist initiated. | TGA-registered as Jakavi. Prescription only. | Approved as Jakavi. Prescription only. |
US FDA status: FDA-approved as Jakafi for myelofibrosis, polycythaemia vera and steroid-refractory acute and chronic graft-versus-host disease, and as Opzelura cream for atopic dermatitis and non-segmental vitiligo. Not approved for ageing, frailty or any senescence indication, and not in a registered trial for one.. 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.