Rusfertide
Also referenced as: Mimrylo
A hepcidin-mimetic peptide used to control excessive erythrocytosis in polycythemia vera.
- Evidence grade
- BModerate Human Evidence
Moderate Human Evidence
- Regulatory status
- FDA Approved for Specific Indication
Mimrylo received initial FDA approval in 2026 for erythrocytosis in adults with polycythemia vera; not a wellness or performance indication.
- Human data
- Yes
Registered clinical trials exist
- Last reviewed
- October 27, 2026
Overview
A hepcidin-mimetic peptide used to control excessive erythrocytosis in polycythemia vera.
Mimrylo received initial FDA approval in 2026 for erythrocytosis in adults with polycythemia vera; not a wellness or performance indication.
Control of excessive erythropoiesis is disease-specific and not a general iron or endurance intervention.
Why It's Being Studied
- Polycythemia vera
- Erythrocytosis
- Hepcidin signalling
Mechanism of Action
Regulation of ferroportin restricts iron availability for red-cell production.
Regulation of ferroportin restricts iron availability for red-cell production. Control of excessive erythropoiesis is disease-specific and not a general iron or endurance intervention.
From molecular target to clinical evidence
Tap each stage to see what happens.
Background: Clinical Peptide Medicines
Clinical peptide medicines include endocrine treatments, antimicrobial drugs, receptor blockers and targeted diagnostic or cancer agents. They do not share one mechanism or one set of indications.
An approval belongs to a specific medicine and indication. A diagnostic tracer, an antibiotic and a hormone are not interchangeable wellness products; read each profile's own mechanism and prescribing source.
Research Areas & Routes Studied
- Polycythemia vera
- Erythrocytosis
- Hepcidin signalling
- Subcutaneous approved medicine
Evidence Summary
Phase 3 research supports hematocrit control and reduced phlebotomy burden, not proof of cure or improved survival.
Higher tiers carry more weight. Filled tiers have evidence for Rusfertide; tap to read it.
- Phase 3 research supports hematocrit control and reduced phlebotomy burden, not proof of cure or improved survival.
2 cited sources.
- Prescribing label1
- Regulatory document1
Human clinical evidence
- Phase 3 research supports hematocrit control and reduced phlebotomy burden, not proof of cure or improved survival.
Reported Adverse Events in Research
- Worsening thrombocytosis, injection-site reactions and embryo-fetal toxicity are label concerns.
Limitations of Current Evidence
- Control of excessive erythropoiesis is disease-specific and not a general iron or endurance intervention.
- Findings apply to the product, route and population studied; they do not establish benefits or safety for unrelated wellness uses or research-vial products.
How to Read This Research
- Is this a single molecule or a family of medicines?
- Is the use diagnostic, therapeutic or investigational?
- Does the quoted outcome match the exact product, formulation and population?
- Use the compound-specific mechanism above; this diagram describes drug development, not a shared biological pathway.
- Historical approval, present availability and off-label use are distinct questions.
- For radiopharmaceuticals and hospital medicines, specialist handling is part of the treatment context.
- Indication
- The condition and population for which a medicine is approved.
- Antagonist
- A compound that blocks activity at a receptor.
- Radiopharmaceutical
- A medicine containing a radioactive isotope for imaging or treatment.
Compare With Other Compounds
| Rusfertide | Trofinetide | |
|---|---|---|
| Evidence grade | B — Moderate Human Evidence | B — Moderate Human Evidence |
| Regulatory status | FDA Approved for Specific Indication | FDA Approved for Specific Indication |
| Human data | Yes | Yes |
| Clinical trials | Registered trials exist | Registered trials exist |
| Research routes | Subcutaneous approved medicine | Oral approved medicine |
| Cited sources | 2 | 2 |
Frequently Asked Questions
Research References
- Prescribing label
Rusfertide — prescribing label
- Regulatory document
FDA approval letter