Takeda and Protagonist Therapeutics have jointly submitted an application to the FDA for approval of rusfertide for the treatment of adult patients with polycythemia vera (PV).[1][6][8] Rusfertide is a first-in-class hepcidin peptide mimetic that regulates iron levels and red blood cell production to control hematocrit.[2][3][10] The application is based on the results of the phase 3 VERIFY study (NCT05210790), which included 283 phlebotomy-dependent patients with uncontrolled hematocrit.[1][2][9] In the rusfertide plus standard of care arm, the mean number of phlebotomies was reduced to 0.5 versus 1.8 in the placebo group over 32 weeks.[1] Rusfertide significantly improved hematocrit control (P < 0.0001) across patient subgroups.[1][3] Serious adverse events occurred in 3.4% of patients in the rusfertide arm versus 4.8% in the placebo arm, with no serious events attributed to rusfertide.[1][3] The drug previously received breakthrough therapy, drug syrup, and fast track designation from the FDA.[2][3]