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Library · Heart, blood & kidney · Treatment of polycythemia vera and iron disorders

Rusfertide

PTG-300, Rusfertide sodium

An investigational hepcidin-mimicking peptide for polycythemia vera, holding FDA Breakthrough Therapy, Orphan Drug, and Fast Track status. The Phase 3 VERIFY trial met its main goal by cutting the need for phlebotomy, with an NDA filing expected by the end of 2025.

Research score 90/100. Reference only, not a dose.

  • Blood Pressure Regulation
  • Cardiovascular Health
  • Hormone Regulation
  • Anti-inflammatory
US status
Investigational
Approval
Phase 3 Clinical Trial (Breakthrough Therapy Designation granted August 2025)
Evidence
Phase 3 VERIFY study met its primary endpoint for polycythemia vera. Positive Phase 2 REVIVE trial results also published.
Research score
90 / 100
Indication
Investigational - Polycythemia Vera
Origin
USA
Source category
Heart & Cardiovascular
Status group
Investigational

Mechanism

Binds ferroportin, the cell's iron-export channel, triggering its internalization and breakdown via JAK/STAT-driven phosphorylation and ubiquitination, which lowers serum iron and limits excess red blood cell production.

Safety file

Generally well tolerated in trials; injection-site reactions are the most common adverse event.

  • Injection site reactions
  • Mild fatigue
  • Transient headache
  • Changes in iron parameters