Is Rusfertide legal in the US?
Yes, FDA approved for polycythemia vera.
AStrong human evidenceFDA approvedas of 2026-10-26
Rusfertide was approved by the FDA on August 28, 2026, as Mimrylo (Takeda) for adults with polycythemia vera, to control red cell overproduction and reduce the need for therapeutic phlebotomy. It is the first hepcidin mimetic approved for any use. 23
Yes, since August 28, 2026, as Mimrylo for adults with polycythemia vera. It had priority review based on the VERIFY trial. 23
More on Rusfertide
Citations
- Kremyanskaya 2024, N Engl J Med: rusfertide, a hepcidin mimetic, for control of erythrocytosis in polycythemia vera (REVIVE) doi.org
- Mimrylo (rusfertide) prescribing information drugs.com
- ASCO Post, Aug 2026: FDA approves rusfertide for erythrocytosis in polycythemia vera (VERIFY results) ascopost.com
Reference information only, not medical advice. Drawn from the Rusfertide article, fact-checked against the cited sources. No dosing anywhere on this site.