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Roxadustat

Roxadustat
Clinical data
Trade namesEvrenzo
Other namesFG-4592, ASP1517, AZD9941
Routes of
administration		By mouth
ATC code
Legal status
Legal status
  • EU: Rx-only[1]
  • In general: ℞ (Prescription only)
Identifiers
  • 2-[(4-Hydroxy-1-methyl-7-phenoxyisoquinoline-3-carbonyl)amino]acetic acid
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
CompTox Dashboard (EPA)
ECHA InfoCard100.245.356 Edit this at Wikidata
Chemical and physical data
FormulaC19H16N2O5
Molar mass352.346 g·mol−1
3D model (JSmol)
  • CC1=NC(=C(C2=C1C=C(C=C2)OC3=CC=CC=C3)O)C(=O)NCC(=O)O
  • InChI=1S/C19H16N2O5/c1-11-15-9-13(26-12-5-3-2-4-6-12)7-8-14(15)18(24)17(21-11)19(25)20-10-16(22)23/h2-9,24H,10H2,1H3,(H,20,25)(H,22,23)
  • Key:YOZBGTLTNGAVFU-UHFFFAOYSA-N

Roxadustat, sold under the brand name Evrenzo, is an anti-anemia medication. Roxadustat is a HIF prolyl-hydroxylase inhibitor that increases endogenous production of erythropoietin and stimulates production of hemoglobin and red blood cells. It was investigated in clinical trials for the treatment of anemia caused by chronic kidney disease (CKD).[2][3] It is taken by mouth.[1] The drug was developed by FibroGen, in partnership with AstraZeneca.

The most common side effects include hypertension (high blood pressure), vascular access thrombosis (formation of blood clots in the blood vessels associated with dialysis), diarrhea, peripheral edema (swelling especially of the ankles and feet), hyperkalemia (high blood potassium levels) and nausea (feeling sick).[1]

Roxadustat received its first global approval in China on 17 December 2018,[4] for the treatment of anemia caused by CKD in patients who are dialysis-dependent.[5] It was approved in Japan in 2019, for the treatment of anemia caused by CKD in patients on dialysis, and in 2020 for patients not on dialysis.[6] Roxadustat was approved for medical use in the European Union in August 2021.[1][7]

  1. ^ a b c d Cite error: The named reference Evrenzo EPAR was invoked but never defined (see the help page).
  2. ^ Provenzano R, Besarab A, Sun CH, Diamond SA, Durham JH, Cangiano JL, et al. (June 2016). "Oral Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitor Roxadustat (FG-4592) for the Treatment of Anemia in Patients with CKD". Clinical Journal of the American Society of Nephrology. 11 (6): 982–991. doi:10.2215/CJN.06890615. PMC 4891748. PMID 27094610.
  3. ^ Becker K, Saad M (April 2017). "A New Approach to the Management of Anemia in CKD Patients: A Review on Roxadustat". Advances in Therapy. 34 (4): 848–853. doi:10.1007/s12325-017-0508-9. PMID 28290095.
  4. ^ Dhillon S (April 2019). "Roxadustat: First Global Approval". Drugs. 79 (5): 563–572. doi:10.1007/s40265-019-01077-1. PMID 30805897. S2CID 71147333.
  5. ^ Dhillon S (April 2019). "Roxadustat: First Global Approval". Drugs. 79 (5): 563–572. doi:10.1007/s40265-019-01077-1. PMID 30805897. S2CID 71147333.
  6. ^ "Astellas Receives Approval of Evrenzo (roxadustat) in Japan for the Treatment of Anemia of Chronic Kidney Disease in Adult Patients Not on Dialysis". Astellas. 27 November 2020.
  7. ^ "Evrenzo Product information". Union Register of medicinal products. Retrieved 3 March 2023.

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