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Daprodustat

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This is an old revision of this page, as edited by 188.74.92.26 (talk) at 10:42, 22 August 2023 (it's only the first oral approved in the US, roxadustat was the first in Japan and the rest of the world). The present address (URL) is a permanent link to this revision, which may differ significantly from the current revision.

Daprodustat
Clinical data
Trade namesDuvroq, Jesduvroq
Other namesGSK1278863
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
CompTox Dashboard (EPA)
ECHA InfoCard100.219.426 Edit this at Wikidata
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]

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.[7]

Research

Daprodustat is in phase III clinical trials for the treatment of anemia caused by chronic kidney disease.[8][9][10]

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. ^ 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.
  3. ^ a b c d e f g h "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, Emily (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. ^ 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.
  8. ^ 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.
  9. ^ 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.
  10. ^ Singh, Ajay K.; Carroll, Kevin; McMurray, John J.V.; Solomon, Scott; Jha, Vivekanand; Johansen, Kirsten L.; Lopes, Renato D.; Macdougall, Iain C.; Obrador, Gregorio T.; Waikar, Sushrut S.; Wanner, Christoph; Wheeler, David C.; Więcek, Andrzej; Blackorby, Allison; Cizman, Borut (16 December 2021). "Daprodustat for the Treatment of Anemia in Patients Not Undergoing Dialysis". New England Journal of Medicine. 385 (25): 2313–2324. doi:10.1056/NEJMoa2113380. ISSN 0028-4793. PMID 34739196. S2CID 243761990.
  • 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