Clinical data | |
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Trade names | Duvroq, Jesduvroq |
Other names | GSK1278863 |
AHFS/Drugs.com | Monograph |
MedlinePlus | a623010 |
License data |
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Routes of administration | By mouth |
Drug class | Hypoxia-inducible factor prolyl hydroxylase inhibitor |
ATC code | |
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Identifiers | |
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CAS Number | |
PubChem CID | |
DrugBank | |
ChemSpider | |
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KEGG | |
ChEBI | |
ChEMBL | |
ECHA InfoCard | 100.219.426 |
Chemical and physical data | |
Formula | C19H27N3O6 |
Molar mass | 393.440 g·mol−1 |
3D model (JSmol) | |
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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.[2] It is a hypoxia-inducible factor prolyl hydroxylase inhibitor.[2] It is taken by mouth.[2][3][4]
The most common side effects include high blood pressure, thrombotic vascular events, abdominal pain, dizziness, and allergic reactions.[3][4]
Daprodustat was approved for medical use in Japan in June 2020,[5][6] and in the United States in February 2023.[2][3][7][8] making it the first oral treatment for anemia caused by chronic kidney disease for adults in the US.[3] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[9]
Daprodustat is indicated for the treatment of anemia due to chronic kidney disease.[2]
Daprodustat increases erythropoietin levels.[3]
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.[4]
The most common side effects include high blood pressure, thrombotic vascular events, abdominal pain, dizziness, and allergic reactions.[3][4]
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).[4][10] 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.[4] 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).[4] 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).[3][4] 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.[3][4] The trial was conducted at 431 sites in 35 countries.[4]
The FDA granted the approval of Jesduvroq to GlaxoSmithKline LLC.[3]
Due to its potential applications in athletic doping, it has also been incorporated into screens for performance-enhancing drugs.[11]
Daprodustat is in phase III clinical trials for the treatment of anemia caused by chronic kidney disease.[12][13][14]