Peptide LibraryRusfertide dosage in published studies and labels
These are the doses used for Rusfertide in FDA labelling and published clinical studies, reported as each source states them, one row per regimen. They describe what was studied or approved for a specific population. They are not a recommendation, and none of them is a dose for any individual.
Research and educational reference only. This is not medical advice, and no figure on this page is a dosing recommendation.
Last checked against primary sources:
Studied regimens and sources
Rusfertide has an FDA-approved human dosage. As Mimrylo, approved in August 2026, it starts at 19 mg by subcutaneous injection once a week and is adjusted within a labeled range of 9.5 mg to 108 mg a week to keep hematocrit below 45%, for adults with erythrocytosis in polycythemia vera. Weekly doses above 54 mg take two injections, and doses above 82 mg are split across two days.
FDA Approved
| Human dosing established | Yes |
|---|---|
| Studied dose range | 9.5–108 mg weekly, starting at 19 mg |
| Route | Subcutaneous |
| Frequency | Once weekly; weekly doses above 82 mg are split between day 1 and day 4 or 5 |
| Duration studied | Continuous |
| Titration | Starts at 19 mg a week. After at least 2 weeks at a dose it can move up one step (9.5, 19, 28, 41, 54, 69, 82, 95, 108 mg), with at least 2 weeks between increases, to reach or hold hematocrit below 45%. Grade 2 or higher anemia or drug-related grade 3 or higher toxicity moves it down one step; at 9.5 mg, treatment stops. Blood counts are checked every 2 to 4 weeks during changes. |
| Half-life | About 28.6 hours after a single 19 mg dose in healthy adults |
| Evidence level | FDA Approved |
| Last reviewed | 2026-10-30 |
Research-reported dosing
Doses as studied, one row per regimen. Different trials used different regimens; they are listed separately rather than averaged.
| Study / context | Population | Dose | Route | Frequency | Duration | Outcome studied | Source |
|---|---|---|---|---|---|---|---|
| FDA label — MimryloFDA-approved label · FDA prescribing information | Adults with erythrocytosis due to polycythemia vera | 19 mg to start; 9.5–108 mg weekly, adjusted individually | Subcutaneous | Once weekly (split across two days above 82 mg) | Continuous | Control of erythrocytosis, keeping hematocrit below 45% | MIMRYLO (rusfertide) for injection — FDA prescribing information, DailyMed |
| Kuykendall et al., 2026 — VERIFY, phase 3Clinical trial · Randomised, double-blind, placebo-controlled phase 3 | Adults with phlebotomy-dependent polycythemia vera on standard care (147 on rusfertide, 146 on placebo) | Started at 19 mg, adjusted to hold hematocrit below 45%; 9.5 to 82 mg were given in the first 52 weeks | Subcutaneous | Once weekly | 32 weeks blinded, then open-label extension | 77% had no phlebotomy eligibility in weeks 20 to 32, versus 33% on placebo | Kuykendall AT et al. VERIFY: A Phase III Trial of Rusfertide Versus Placebo in Phlebotomy-Dependent Patients With Polycythemia Vera Receiving Standard-of-Care Therapy. J Clin Oncol. 2026. |
| Kremyanskaya et al., 2024 — REVIVE, phase 2Clinical trial · Phase 2 dose-finding and randomized withdrawal trial | Adults with phlebotomy-dependent polycythemia vera (n=70; 59 entered the randomized withdrawal part) | Individually adjusted in a 28-week dose-finding part; the abstract and registry give no dose range | Subcutaneous | — | 28 weeks of dose finding, then 12 weeks of randomized withdrawal | 60% responded on rusfertide versus 17% on placebo during the withdrawal part | Kremyanskaya M et al. Rusfertide, a Hepcidin Mimetic, for Control of Erythrocytosis in Polycythemia Vera. N Engl J Med. 2024. |
| Kowdley et al., 2023 — HFE hemochromatosis, phase 2 (not an approved use)Clinical trial · Open-label, proof-of-concept phase 2 | Adults with HFE-related hemochromatosis on maintenance phlebotomy (n=16) | 10 mg weekly to start; 10 to 40 mg once or twice weekly after individual adjustment | Subcutaneous | — | 24 weeks | 15 of 16 patients needed no phlebotomy during treatment | Kowdley KV et al. Rusfertide for the treatment of iron overload in HFE-related haemochromatosis: an open-label, multicentre, proof-of-concept phase 2 trial. Lancet Gastroenterol Hepatol. 2023. |
| Modi et al., 2025 — multiple-dose study in healthy adultsClinical trial · Phase 1 pharmacokinetic study | Healthy adults (n=18) | 60 mg | Subcutaneous (abdomen, thigh or upper arm) | Once weekly | 5 weeks | Pharmacokinetics and iron and blood-count effects did not differ meaningfully by injection site | Modi NB et al. Multiple-Dose Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Subcutaneous Rusfertide, a Hepcidin Mimetic, in Healthy Subjects. Clin Pharmacol Drug Dev. 2025. |
Preclinical and analog research
Not human dosing evidence. Listed for completeness and never extrapolated to a human dose.
| Study / context | Population | Dose | Route | Frequency | Duration | Outcome studied | Source |
|---|---|---|---|---|---|---|---|
| Preclinical — animal reproduction studiesPreclinical · Animal toxicology reported in the FDA label | Pregnant rats and rabbits | 0.3 to 3 mg/kg per dose in rats and 0.03 to 1 mg/kg per dose in rabbits; not convertible to a human dose | Subcutaneous | — | — | Malformations in rats and embryo-fetal death in rabbits at exposures below the human exposure at the maximum dose | MIMRYLO (rusfertide) for injection — FDA prescribing information, section 8.1, DailyMed |
Where sources disagree
- The label allows up to 108 mg a week, but the registry shows that doses in the first 52 weeks of VERIFY stopped at 82 mg. The 95 mg and 108 mg steps were used only in the later extension.
- The label splits weekly doses above 82 mg across day 1 and day 4 or 5. The VERIFY extension split doses above 90 mg, 3 to 4 days apart.
- The label's 56% injection-site reaction rate covers the 32-week randomized part (n=145). Its 47% rate covers all 285 patients exposed in VERIFY.
- Rusfertide is approved only for polycythemia vera. Hemochromatosis is research, and phase 2 beta-thalassemia trials (NCT03802201, NCT04054921) are completed with no results posted on the registry.
- Rusfertide works by limiting iron for red cell production, so iron measures move in unexpected ways: in VERIFY, mean ferritin rose from 21 mcg/L at baseline to 174 mcg/L at week 52.