For laboratory and research use only. Not for human consumption.
Hormonal

Rusfertide

Also known as: Mimrylo, PTG-300, Rusfertide injection

FDA Approved
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Key Facts: Rusfertide

Category
Hormonal
FDA Status
FDA Approved
Clinical Status
FDA Approved (August 28, 2026) - MIMRYLO (rusfertide) for erythrocytosis in adults with polycythemia vera. First hepcidin mimetic peptide approved anywhere in the world. Phase 3 VERIFY trial: 76.9% of patients achieved clinical response (maintained hematocrit control, reduced phlebotomy burden) during weeks 20-32. Co-developed by Takeda and Protagonist Therapeutics.
Banned in Sport (WADA)
Not on the WADA Prohibited List (2026).
Administration
Subcutaneous injection, once weekly
Typical Dose
40-80 mg weekly
Frequency
Once weekly
Duration
Ongoing - designed for chronic use
Also Known As
Mimrylo, PTG-300, Rusfertide injection

How does Rusfertide work?

Hepcidin is the hormone that decides how much iron enters the bloodstream by controlling the iron exporter ferroportin. When hepcidin is high, ferroportin is degraded, so iron stays locked in storage and gut cells instead of feeding red blood cell factories in the marrow. Rusfertide is a synthetic hepcidin mimetic that imposes this iron restriction on purpose, starving the overactive marrow in PV of the iron it needs to overproduce red cells. The result is better-controlled hematocrit without constant phlebotomy. This is a well-characterized, on-target mechanism, not a speculative hypothesis.

What does the research show?

The randomized phase 2 REVIVE trial, published in the New England Journal of Medicine, showed rusfertide kept hematocrit under control and sharply cut phlebotomy in PV patients. The pivotal phase 3 VERIFY trial (293 patients) then met its primary endpoint and all four key secondary endpoints: 77% of rusfertide-treated patients were free of phlebotomy eligibility during weeks 20 to 32 versus 33% on placebo, with results presented at the 2025 ASCO Annual Meeting and durability data through week 52 reported afterward. The FDA approved it as Mimrylo on August 28, 2026, given once weekly under the skin. On the label, the most common side effects were injection-site reactions (56%) and anemia (16%), with warnings for rising platelet counts (thrombocytosis) and possible harm to an unborn baby. This is one of the few peptides on this list with genuine, high-quality randomized human evidence rather than animal-only data.

Trial Progress:FDA Approved
Pre
I
II
III
IV
FDA

What doses have been studied?

FDA Approved·FDA approved August 28, 2026 (Mimrylo) for erythrocytosis in adults with polycythemia vera

Typical Dosingⓘ

Community experience

Common Dose

40-80 mg weekly

Range

10-120 mg weekly (trial range)

Frequency

Once weekly

Trial protocols titrated the amount against hematocrit response. In the REVIVE trial most patients stabilized at 40-80 mg weekly. It is designed as a chronic therapy, studied primarily in polycythemia vera, with potential application in testosterone-therapy-induced erythrocytosis (elevated hematocrit).

Research Dosingⓘ

Scientific studies

Doses from clinical trials only

Duration

Ongoing - designed for chronic use

Administration

Subcutaneous injection, once weekly

When and how is Rusfertide taken?

Best Time to Take

Once weekly, consistent day

Once weekly

Food Recommendation

With or without food

Why This Timing?

Long-acting hepcidin mimetic with weekly dosing schedule. Designed for once-weekly subcutaneous injection for convenience and compliance.

What are the side effects of Rusfertide?

Not everyone experiences these effects. Individual responses vary based on dosage, duration, and personal factors.

  • ●Injection site reactions (most common, 56% on the label)
  • ●Anemia (16%)
  • ●Iron deficiency (expected mechanism of action)
  • ●Thrombocytosis (rising platelets, label warning)
  • ●Embryo-fetal harm (label warning, contraception needed)
  • ●Fatigue
  • ●Dizziness
  • ●Headache
  • ●Nausea

References

Research This Peptide Further

Frequently Asked Questions

What does Rusfertide do?

Rusfertide (brand name Mimrylo) is an injectable peptide that mimics hepcidin, the body's master hormone for controlling iron, and it is used to manage polycythemia vera (PV), a blood cancer that makes too many red blood cells. By limiting iron availability, it throttles red blood cell production and reduces the need for repeated blood draws (phlebotomy). It is not a research-only or gray-market peptide: the FDA approved it on August 28, 2026 for adults with PV, after a positive phase 3 trial.

How does Rusfertide work?

Hepcidin is the hormone that decides how much iron enters the bloodstream by controlling the iron exporter ferroportin. When hepcidin is high, ferroportin is degraded, so iron stays locked in storage and gut cells instead of feeding red blood cell factories in the marrow. Rusfertide is a synthetic hepcidin mimetic that imposes this iron restriction on purpose, starving the overactive marrow in PV of the iron it needs to overproduce red cells. The result is better-controlled hematocrit without constant phlebotomy. This is a well-characterized, on-target mechanism, not a speculative hypothesis.

Is Rusfertide FDA approved?

Yes, Rusfertide is FDA approved. FDA Approved (August 28, 2026) - MIMRYLO (rusfertide) for erythrocytosis in adults with polycythemia vera. First hepcidin mimetic peptide approved anywhere in the world. Phase 3 VERIFY trial: 76.9% of patients achieved clinical response (maintained hematocrit control, reduced phlebotomy burden) during weeks 20-32. Co-developed by Takeda and Protagonist Therapeutics.

Is Rusfertide banned in sport?

Not on the WADA Prohibited List (2026).

What are the side effects of Rusfertide?

Reported side effects include: Injection site reactions (most common, 56% on the label), Anemia (16%), Iron deficiency (expected mechanism of action), Thrombocytosis (rising platelets, label warning), Embryo-fetal harm (label warning, contraception needed). Individual responses vary based on dosage, duration, and personal health factors.

What is the typical dose of Rusfertide?

Community-reported common dose: 40-80 mg weekly (Once weekly). Range: 10-120 mg weekly (trial range). Administration: Subcutaneous injection, once weekly. FDA-approved prescription drug (Mimrylo) for polycythemia vera; dose is titrated by the prescriber against hematocrit. Doses here are from published trial data. Use for TRT-related high hematocrit is off-label and untested. Not medical advice.

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Hormonal

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