Rusfertide
Also known as: Mimrylo, PTG-300, Rusfertide injection
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
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.
What doses have been studied?
Typical Dosingⓘ
Community experience
40-80 mg weekly
10-120 mg weekly (trial range)
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
Doses from Studies
40-80 mg weekly maintenance
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
- https://www.nejm.org/doi/full/10.1056/NEJMoa2308809
- https://ascopubs.org/doi/10.1200/JCO.2025.43.17_suppl.LBA3
- https://www.sciencedirect.com/science/article/pii/S0006497125026564
- https://www.takeda.com/newsroom/newsreleases/2025/positive-topline-results-from-verify-study/
- https://www.takeda.com/newsroom/newsreleases/2026/fda-approval-mimrylo/
- https://www.drugs.com/pro/mimrylo.html
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.
Related Peptides
Peptides commonly compared with Rusfertide or used in similar applications.
Oxytocin
FDAOxytocin is a 9-amino-acid hormone made in the hypothalamus, famous as the chemistry behind labor contractions, breastfeeding, and social bonding. As an injectable drug it is FDA-approved to induce labor and control postpartum bleeding, but the intranasal 'love hormone' versions sold for trust, anxiety, and autism are experimental and the human results are genuinely mixed. The hype runs well ahead of the evidence.
HormonalCetrorelix
FDACetrorelix is a GnRH antagonist: a modified 10-amino-acid version of the brain's gonadotropin-releasing hormone that blocks its receptor instead of activating it. Sold as Cetrotide and FDA-approved since August 2000, its job in IVF is narrow and important: it stops the body's own LH surge from releasing eggs too early while the ovaries are being stimulated. It is a well-established fertility drug with decades of use, and it is not a tool for anything else people sometimes imagine it for.
HormonalHCG (Human Chorionic Gonadotropin)
FDAHCG is a hormone produced in pregnancy that happens to be an almost perfect mimic of luteinizing hormone. That single fact is why it has two completely unrelated uses: it is an approved fertility medicine, and it is the standard tool for keeping the testicles working during testosterone therapy. It is also the basis of the discredited HCG diet, which is a separate story and not supported by evidence.
HormonalLeuprolide
FDALeuprolide (brand name Lupron) is a synthetic GnRH agonist, a modified peptide far more potent than natural GnRH, and it is FDA-approved for advanced prostate cancer, endometriosis, uterine fibroids, and central precocious puberty. The clever part is counterintuitive: it works by overstimulating the GnRH system so hard that the pituitary shuts down sex hormone production. It is a real, long-established prescription drug (first US approval 1985), not a research peptide, and it carries meaningful side effects from the low-hormone state it creates.
HormonalDesmopressin
FDADesmopressin (dDAVP) is a synthetic tweak of the natural hormone vasopressin, redesigned to keep the water-retaining effect while dropping most of the blood-pressure effect. First approved in the US in 1978, it is used for central diabetes insipidus, bedwetting, nocturia, and two bleeding disorders: hemophilia A and type 1 von Willebrand disease. This is settled medicine, not an experimental peptide, and its main real-world danger is straightforward: it can drop your blood sodium dangerously low if you drink too much fluid on it.
HormonalOctreotide
FDAOctreotide is a synthetic eight-amino-acid mimic of the natural hormone somatostatin, the body's main 'off switch' for hormone secretion. It shuts down excess growth hormone, so it is a frontline FDA-approved drug for acromegaly, and it also tames the flushing and diarrhea of hormone-secreting carcinoid and other neuroendocrine tumors. This is real, approved medicine with decades of clinical data behind it, sold as Sandostatin (injectable, since 1988), Sandostatin LAR (monthly depot), and Mycapssa (oral capsule, approved 2020).
HormonalWant updates on Rusfertide research?
Get an email when we add new research here, when it is back in stock, or when the price drops.