Daprodustat
Chemical compound
From Wikipedia, the free encyclopedia
Daprodustat, sold under the brand name Duvroq among others, is a medication that is used for the treatment of anemia due to chronic kidney disease.[1] It is a hypoxia-inducible factor prolyl hydroxylase inhibitor.[1] It is taken by mouth.[1][2][3]
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| Trade names | Duvroq, Jesduvroq |
| Other names | GSK1278863 |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a623010 |
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| Routes of administration | By mouth |
| Drug class | Hypoxia-inducible factor prolyl hydroxylase inhibitor |
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| ECHA InfoCard | 100.219.426 |
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| Formula | C19H27N3O6 |
| Molar mass | 393.440 g·mol−1 |
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The most common side effects include high blood pressure, thrombotic vascular events, abdominal pain, dizziness, and allergic reactions.[2][3]
Daprodustat was approved for medical use in Japan in June 2020,[4][5] and in the United States in February 2023.[1][2][6][7] making it the first oral treatment for anemia caused by chronic kidney disease for adults in the US.[2] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[8]
Medical uses
Daprodustat is indicated for the treatment of anemia due to chronic kidney disease.[1]
Daprodustat increases erythropoietin levels.[2]
Adverse effects
The FDA label for daprodustat has a boxed warning for an increased risk of thrombotic vascular (blood clotting) events including death, heart attack, stroke, and blood clots in the lung, legs, or dialysis access site.[3]
The most common side effects include high blood pressure, thrombotic vascular events, abdominal pain, dizziness, and allergic reactions.[2][3]
History
The efficacy and safety of daprodustat were evaluated in 2,964 adults with anemia due to chronic kidney disease on dialysis and receiving an erythropoiesis-stimulating agent at the time of study entry in a randomized, sponsor-blind, active-controlled, global, multicenter, event-driven clinical trial (ASCEND-D; NCT02879305).[3][9] Participants were stratified by dialysis type and were required to be on dialysis for at least four months prior to the first dose of daprodustat.[3] Participants on hemodialysis were randomized 1:1 to receive oral daprodustat (N=1,316) or intravenous epoetin alfa (N=1,308) while participants on peritoneal dialysis were randomized 1:1 to receive oral daprodustat (N=171) or subcutaneous darbepoetin alfa (N=169).[3] In this study, adults received either oral daprodustat or injected recombinant human erythropoietin (rhEPO) (a standard of care treatment for people with anemia due to chronic kidney disease).[2][3] Daprodustat raised and maintained the hemoglobin (the protein in red blood cells that carries oxygen and is a common measure of anemia) within the target range of 10 to 11 g/dL, similar to that of the rhEPO treatment.[2][3] The trial was conducted at 431 sites in 35 countries.[3]
The FDA granted the approval of Jesduvroq to GlaxoSmithKline LLC.[2]
Society and culture
Due to its potential applications in athletic doping, it has also been incorporated into screens for performance-enhancing drugs.[10]
Research
Daprodustat is in phase III clinical trials for the treatment of anemia caused by chronic kidney disease.[11][12][13]
