Daprodustat
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Trade names | Duvroq, Jesduvroq |
Other names | GSK1278863 |
AHFS/Drugs.com | Monograph |
MedlinePlus | a623010 |
License data |
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Hypoxia-inducible factor prolyl hydroxylase inhibitor | |
ATC code | |
Legal status | |
Legal status | |
Identifiers | |
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JSmol) | |
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Daprodustat, sold under the brand name Duvroq among others, is a
The most common side effects include
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]
Medical uses
Daprodustat is
Daprodustat increases erythropoietin levels.[3]
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.[4]
The most common side effects include high blood pressure, thrombotic vascular events, abdominal pain, dizziness, and allergic reactions.[3][4]
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).
The FDA granted the approval of Jesduvroq to GlaxoSmithKline LLC.[3]
Society and culture
Due to its potential applications in
Research
Daprodustat is in phase III clinical trials for the treatment of anemia caused by chronic kidney disease.[12][13][14]
References
- FDA. Retrieved 22 October 2023.
- ^ a b c d e f "Jesduvroq- daprodustat tablet, film coated". DailyMed. 1 February 2023. Archived from the original on 11 February 2023. Retrieved 11 February 2023.
- ^ a b c d e f g h i "FDA Approves First Oral Treatment for Anemia Caused by Chronic Kidney Disease for Adults on Dialysis". U.S. Food and Drug Administration (FDA) (Press release). 1 February 2023. Archived from the original on 4 February 2023. Retrieved 3 February 2023. This article incorporates text from this source, which is in the public domain.
- ^ a b c d e f g h i j "Drug Trials Snapshots: Jesduvroq". U.S. Food and Drug Administration (FDA). 1 February 2023. Archived from the original on 24 February 2024. Retrieved 24 February 2024. This article incorporates text from this source, which is in the public domain.
- PMID 32880805.
- ^ "GSK receives first regulatory approval for Duvroq (daprodustat) in Japan for patients with anaemia due to chronic kidney disease" (Press release). GSK. 29 June 2020. Archived from the original on 4 February 2023. Retrieved 29 March 2021.
- PMID 36790833.
- ^ "Jesduvroq (daprodustat) approved by US FDA for anemia of chronic kidney disease in adults on dialysis" (Press release). GSK US. 1 February 2023. Archived from the original on 4 February 2023. Retrieved 24 February 2024.
- ^ New Drug Therapy Approvals 2023 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2024. Archived from the original on 10 January 2024. Retrieved 9 January 2024.
- ^ Clinical trial number NCT02879305 for "Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Dialysis (ASCEND-D)" at ClinicalTrials.gov
- PMID 26361079.
- S2CID 32493057.
- PMID 28928122.
- S2CID 243761990.