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Rusfertide

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From Wikipedia, the free encyclopedia

Rusfertide
Clinical data
Trade namesMimrylo
Other namesPTG-300; TAK-121
AHFS/Drugs.comMimrylo
License data
Routes of
administration		Subcutaneous
Drug classHepcidin mimetic
ATC code
  • None
Legal status
Legal status
Identifiers
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
ChEMBL
Chemical and physical data
FormulaC114H181N27O28S2
Molar mass2441.98 g·mol−1
3D model (JSmol)
  • CCCCCCCCCCCCCCCC(=O)N[C@@H](CCC(=O)NCCCC[C@H]1C(=O)N[C@H](C(=O)N[C@H](C(=O)N2CCC[C@H]2C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)NCC(=O)N[C@@H](CSSC[C@@H](C(=O)N[C@H](C(=O)N1)[C@@H](C)CC)NC(=O)[C@@H]3CCCN3C(=O)[C@H](CC4=CC=CC=C4)NC(=O)[C@H](CC5=CNC=N5)NC(=O)[C@H]([C@@H](C)O)NC(=O)[C@H](CC(=O)O)NC(=O)CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N)CCCCN)CO)CCCNC(=N)N)CCC(=O)O)CC6=CC=CC=C6)C(=O)O
  • InChI=InChI=1S/C114H181N27O28S2/c1-7-9-10-11-12-13-14-15-16-17-18-19-26-46-90(145)125-79(113(168)169)47-49-89(144)121-53-32-29-42-76-99(154)133-80(58-71-36-22-20-23-37-71)101(156)132-78(48-50-93(148)149)111(166)140-55-34-44-87(140)107(162)130-77(43-33-54-122-114(118)119)100(155)136-84(64-142)104(159)129-75(41-28-31-52-116)98(153)123-63-92(147)127-85(105(160)128-74(97(117)152)40-27-30-51-115)65-170-171-66-86(106(161)138-95(69(5)8-2)109(164)131-76)137-108(163)88-45-35-56-141(88)112(167)83(59-72-38-24-21-25-39-72)135-102(157)81(60-73-62-120-67-124-73)134-110(165)96(70(6)143)139-103(158)82(61-94(150)151)126-91(146)57-68(3)4/h20-25,36-39,62,67-70,74-88,95-96,142-143H,7-19,26-35,40-61,63-66,115-116H2,1-6H3,(H2,117,152)(H,120,124)(H,121,144)(H,123,153)(H,125,145)(H,126,146)(H,127,147)(H,128,160)(H,129,159)(H,130,162)(H,131,164)(H,132,156)(H,133,154)(H,134,165)(H,135,157)(H,136,155)(H,137,163)(H,138,161)(H,139,158)(H,148,149)(H,150,151)(H,168,169)(H4,118,119,122)/t69-,70+,74-,75-,76-,77-,78-,79-,80-,81-,82-,83-,84-,85-,86-,87-,88-,95-,96-/m0/s1
  • Key:JRVOBXXOZFTSRF-GVIPULMVSA-N
  • Key:XDGUXPSNNIXCRG-RKJDWXQOSA-N

Rusfertide, sold under the brand name Mimrylo, is a medication used for the treatment of polycythemia vera.[1] It is a hepcidin mimetic.[1] It was developed by Protagonist Therapeutics in partnership with Takeda Pharmaceuticals.[2] It is given by subcutaneous injection.[1]

The most common adverse reactions include injection site reactions and anemia.[3]

Rusfertide was approved for medical use in the United States in August 2026.[4][3] It is the first approved treatment for polycythemia vera that mimics hepcidin, a hormone that naturally regulates iron in the body.[3]

Medical uses

[edit]

Rusfertide is indicated for the treatment of erythrocytosis in adults with polycythemia vera.[1]

Polycythemia vera ia a rare blood disorder that causes the body to make too many red blood cells.[3] The excess cells can thicken the blood and increase the risk of cardiovascular issues, such as blood clots, stroke and heart attack.[3]

History

[edit]

The safety and efficacy of rusfertide were evaluated in the VERIFY trial, a multicenter, randomized, double-blind, placebo-controlled phase III study of 293 adults with polycythemia vera who required frequent phlebotomies despite ongoing standard-of-care therapy.[3] Participants were randomized 1:1 to receive either rusfertide or placebo over 32 weeks.[3] Mimrylo treatment started at 19 mg, administered subcutaneously (under the skin) once weekly, and was titrated to maintain hematocrit levels below 45%.[3]

Efficacy was measured by the proportion of participants who did not meet criteria for phlebotomy between weeks 20 and 32 of the study.[3] Overall, 76.9% of participants on rusfertide required no phlebotomies during the 32-week period compared to 32.9% on placebo.[3]

Society and culture

[edit]
[edit]

Rusfertide was approved for medical use in the United States in August 2026.[5] The US Food and Drug Administration (FDA) granted the application for rusfertide priority review.[3] The FDA granted the approval of Mimrylo to Takeda Pharmaceuticals America.[3]

Names

[edit]

Rusfertide is the international nonproprietary name.[6]

Rusfertide is sold under the brand name Mimrylo.[5]

References

[edit]
  1. 1 2 3 4 5 "Mimrylo (rusfertide) for injection, for subcutaneous use" (PDF). August 2026. Retrieved 31 August 2026.
  2. ↑ "FDA Accepts NDA and Grants Priority Review for Rusfertide". Takeda Oncology (Press release). 2 March 2026. Retrieved 31 August 2026.
  3. 1 2 3 4 5 6 7 8 9 10 11 12 "FDA Approves First Drug of Its Kind for Polycythemia Vera, a Rare Blood Disorder". U.S. Food and Drug Administration (FDA). 28 August 2026. Retrieved 31 August 2026. Public Domain This article incorporates text from this source, which is in the public domain.
  4. ↑ "Novel Drug Approvals for 2026". U.S. Food and Drug Administration (FDA). 28 August 2026. Retrieved 31 August 2026.
  5. 1 2 "FDA Approves Mimrylo (rusfertide) for Polycythemia Vera". Takeda Pharmaceuticals (Press release). 28 August 2026. Retrieved 31 August 2026.
  6. ↑ World Health Organization (2022). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 87". WHO Drug Information. 36 (1). hdl:10665/352794.

Further reading

[edit]
  • Kremyanskaya M, Ginzburg YZ, Hoffman R (March 2026). "Modulators of the hepcidin pathway in polycythemia vera and myelofibrosis". Blood. 147 (12): 1278–1288. doi:10.1182/blood.2025028643. PMID 41100735.
[edit]
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