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# Rusfertide Phase 3 Data Meet Endpoints
- URL: https://www.fdaweb.com/rusfertide-phase-3-data-meet-endpoints/
- Published: 2025-03-03T12:00:00.000Z
- Updated: 2026-09-14T14:54:25.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5158754

Protagonist Therapeutics and Takeda are announcing “positive topline results” for the Phase 3 VERIFY study, in which phlebotomy-dependent patients with polycythemia vera (PV) received rusfertide or placebo as an add-on to standard of care treatment. The study met its primary endpoint and all four key secondary endpoints, according to the companies. Rusfertide is described as a first-in-class investigational hepcidin mimetic peptide therapeutic. It has previously been awarded FDA orphan drug and fast track designations.

In meeting the primary endpoint, the companies say there was a significantly higher proportion of clinical responders among rusfertide-treated patients with PV (77%) compared to those who received placebo (33%) during weeks 20-32\. The primary endpoint was the proportion of patients achieving a response, which was defined as the absence of phlebotomy eligibility, they say.

“The positive results of the Phase 3 VERIFY study across the primary and all key secondary endpoints provide compelling evidence of the potential for rusfertide as a first-in-class erythrocytosis-specific agent to address unmet medical needs in patients with PV who are unable to achieve adequate hematocrit control despite standard of care treatments,” Protagonist chief medical officer **Arturo Molina** is quoted in a release as saying.

The companies say that patients with PV are at increased risk for life-threatening cardiovascular and thrombotic events. “Many patients with PV require regular phlebotomy, a process of removing blood to manage elevated hematocrit levels caused by an excess of red blood cells, as well as treatment with cytoreductive therapies,” they explain.