Daprodustat
Clinical data
Trade namesDuvroq, Jesduvroq
Other namesGSK1278863
AHFS/Drugs.comMonograph
MedlinePlusa623010
License data
Routes of
administration		By mouth
Drug classHypoxia-inducible factor prolyl hydroxylase inhibitor
ATC code
Legal status
Legal status
Identifiers
  • 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
ChEMBL
ECHA InfoCard100.219.426
Chemical and physical data
FormulaC19H27N3O6
Molar mass393.440 g·mol−1
3D model (JSmol)
  • C3CCCCC3n(c(=O)c1C(=O)NCC(=O)O)c(=O)n(c1O)C2CCCCC2
  • InChI=1S/C19H27N3O6/c23-14(24)11-20-16(25)15-17(26)21(12-7-3-1-4-8-12)19(28)22(18(15)27)13-9-5-2-6-10-13/h12-13,26H,1-11H2,(H,20,25)(H,23,24)
  • Key:NVTKJBXOBFRPLQ-UHFFFAOYSA-N

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]

The most common side effects include high blood pressure, thrombotic vascular events, abdominal pain, dizziness and allergic reactions.[3] 

Daprodustat was approved for medical use in Japan in June 2020,[4][5] and in the United States in February 2023.,[2][3][6] 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.[7]

Medical uses

Daprodustat is indicated for the treatment of anemia due to chronic kidney disease.[2]

History

Daprodustat increases erythropoietin levels.[3] The effectiveness of daprodustat was established in a randomized study of 2,964 adult participants receiving dialysis.[3] In this study, participants received either oral daprodustat or injected recombinant human erythropoietin (a standard of care treatment for people with anemia due to chronic kidney disease).[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 10-11 grams/deciliter, similar to that of the recombinant human erythropoietin.[3] The US Food and Drug Administration (FDA) granted the approval of Jesduvroq to GlaxoSmithKline LLC.[3]

Society and culture

Due to its potential applications in athletic doping, it has also been incorporated into screens for performance-enhancing drugs.[8]

Research

Daprodustat is in phase III clinical trials for the treatment of anemia caused by chronic kidney disease.[9][10][11]

References

  1. ↑ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 October 2023.
  2. 1 2 3 4 5 6 "Jesduvroq- daprodustat tablet, film coated". DailyMed. 1 February 2023. Archived from the original on 11 February 2023. Retrieved 11 February 2023.
  3. 1 2 3 4 5 6 7 8 "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. Public Domain This article incorporates text from this source, which is in the public domain.
  4. ↑ Dhillon S (September 2020). "Daprodustat: First Approval". Drugs. 80 (14): 1491–1497. doi:10.1007/s40265-020-01384-y. PMC 7471535. PMID 32880805.
  5. ↑ "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.
  6. ↑ Harris E (15 February 2023). "FDA Approves First Oral Treatment for Kidney Disease–Induced Anemia". Medical News in Brief. JAMA. 329 (9): 704. doi:10.1001/jama.2023.1556. PMID 36790833.
  7. ↑ 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.
  8. ↑ Thevis M, Milosovich S, Licea-Perez H, Knecht D, Cavalier T, Schänzer W (August 2016). "Mass spectrometric characterization of a prolyl hydroxylase inhibitor GSK1278863, its bishydroxylated metabolite, and its implementation into routine doping controls". Drug Testing and Analysis. 8 (8): 858–63. doi:10.1002/dta.1870. PMID 26361079.
  9. ↑ Schmid H, Jelkmann W (August 2016). "Investigational therapies for renal disease-induced anemia". Expert Opinion on Investigational Drugs. 25 (8): 901–16. doi:10.1080/13543784.2016.1182981. PMID 27122198. S2CID 32493057.
  10. ↑ Ariazi JL, Duffy KJ, Adams DF, Fitch DM, Luo L, Pappalardi M, et al. (December 2017). "Discovery and Preclinical Characterization of GSK1278863 (Daprodustat), a Small Molecule Hypoxia Inducible Factor-Prolyl Hydroxylase Inhibitor for Anemia". The Journal of Pharmacology and Experimental Therapeutics. 363 (3): 336–347. doi:10.1124/jpet.117.242503. PMID 28928122.{{cite journal}}: CS1 maint: overridden setting (link)
  11. ↑ Singh AK, Carroll K, McMurray JJ, Solomon S, Jha V, Johansen KL, et al. (December 2021). "Daprodustat for the Treatment of Anemia in Patients Not Undergoing Dialysis". The New England Journal of Medicine. 385 (25): 2313–2324. doi:10.1056/NEJMoa2113380. PMID 34739196. S2CID 243761990.{{cite journal}}: CS1 maint: overridden setting (link)
  • 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


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