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FDA Medication Tracker

← All approvals · Heart & blood · 2026

Mimrylo (rusfertide)

The FDA approved Mimrylo (rusfertide) on August 28, 2026 to treat erythrocytosis in adults with polycythemia vera.
Brand name
Mimrylo
Generic name
rusfertide
FDA approval date
August 28, 2026
Approved use (FDA wording)
To treat erythrocytosis in adults with polycythemia vera
Company
Takeda Pharms Am
Application
NDA220605
Dosage form / route
POWDER · SUBCUTANEOUS
Boxed warning on label
Not listed
Category on this site
Heart & blood

Indications and usage, from the FDA label

MIMRYLO is indicated for the treatment of erythrocytosis in adults with polycythemia vera (PV). MIMRYLO is a hepcidin mimetic indicated for the treatment of erythrocytosis in adults with polycythemia vera (PV). ( 1 )

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.