Vadadustat

Vadadustat
Clinical data
Trade names	Vafseo
Other names	AKB-6548, PG-1016548
License data	US DailyMed: Vadadustat;
Pregnancy; category	AU: C; ;
ATC code	B03XA08 (WHO) ;
Legal status
Legal status	AU: S4 (Prescription only); US: ℞-only; EU: Rx-only;
Identifiers
	IUPAC name 2-([5-(3-Chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino)acetic acid;
CAS Number	1000025-07-9;
PubChem CID	23634441;
DrugBank	DB12255;
ChemSpider	34958379;
UNII	I60W9520VV;
KEGG	D11078;
ChEMBL	ChEMBL3646221;
PDB ligand	A1Z (PDBe, RCSB PDB);
ECHA InfoCard	100.248.991
Chemical and physical data
Formula	C14H11ClN2O4
Molar mass	306.70 g·mol−1
3D model (JSmol)	Interactive image;
	SMILES Oc1cc(cnc1C(=O)NCC(=O)O)c2cccc(Cl)c2;
	InChI InChI=1S/C14H11ClN2O4/c15-10-3-1-2-8(4-10)9-5-11(18)13(16-6-9)14(21)17-7-12(19)20/h1-6,18H,7H2,(H,17,21)(H,19,20); Key:JGRXMPYUTJLTKT-UHFFFAOYSA-N;

Vadadustat, sold under the brand name Vafseo, is a medication used for the treatment of symptomatic anemia associated with chronic kidney disease.^[3]

The most common side effects include thromboembolic events (problems due to the formation of blood clots in the blood vessels), diarrhea, and hypertension (high blood pressure).^[3]

Vadadustat was approved for medical use in the European Union in April 2023.^[3]

Medical uses

Vadadustat is indicated for the treatment of symptomatic anemia associated with chronic kidney disease in adults on chronic maintenance dialysis.^[3]

Society and culture

Legal status

In February 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Vafseo, intended for the treatment of symptomatic anemia in adults with chronic kidney disease who are on chronic dialysis.^[4] The applicant for this medicinal product is Akebia Europe Limited.^[4] Vadadustat was approved for medical use in the European Union in April 2023.^[3]

Research

Vadadustat is in phase III clinical trials for the treatment of anemia caused by chronic kidney disease.^[5]^[6]^[7]^[8]^[9]

References

^ ^a ^b "Vafseo APMDS". Therapeutic Goods Administration (TGA). 17 October 2023. Archived from the original on 2 January 2024. Retrieved 7 March 2024.
^ https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215192Orig1s000ltr.pdf
^ ^a ^b ^c ^d ^e ^f "Vafseo EPAR". European Medicines Agency. 31 May 2023. Archived from the original on 3 June 2023. Retrieved 3 June 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^ ^a ^b "Vafseo: Pending EC decision". European Medicines Agency (EMA). 24 February 2023. Archived from the original on 25 February 2023. Retrieved 24 February 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^ Pergola PE, Spinowitz BS, Hartman CS, Maroni BJ, Haase VH (November 2016). "Vadadustat, a novel oral HIF stabilizer, provides effective anemia treatment in nondialysis-dependent chronic kidney disease". Kidney International. 90 (5): 1115–1122. doi:10.1016/j.kint.2016.07.019. PMID 27650732.
^ Gupta N, Wish JB (June 2017). "Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors: A Potential New Treatment for Anemia in Patients With CKD". American Journal of Kidney Diseases. 69 (6): 815–826. doi:10.1053/j.ajkd.2016.12.011. PMID 28242135.
^ Martin ER, Smith MT, Maroni BJ, Zuraw QC, deGoma EM (2017). "Clinical Trial of Vadadustat in Patients with Anemia Secondary to Stage 3 or 4 Chronic Kidney Disease". American Journal of Nephrology. 45 (5): 380–388. doi:10.1159/000464476. PMC 5452283. PMID 28343225.
^ Eckardt KU, Agarwal R, Aswad A, Awad A, Block GA, Bacci MR, et al. (April 2021). "Safety and Efficacy of Vadadustat for Anemia in Patients Undergoing Dialysis". The New England Journal of Medicine. 384 (17): 1601–1612. doi:10.1056/NEJMoa2025956. PMID 33913638.
^ Chertow GM, Pergola PE, Farag YM, Agarwal R, Arnold S, Bako G, et al. (April 2021). "Vadadustat in Patients with Anemia and Non-Dialysis-Dependent CKD". The New England Journal of Medicine. 384 (17): 1589–1600. doi:10.1056/NEJMoa2035938. PMID 33913637.

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[Vafseo_APMDS-1] "Vafseo APMDS". Therapeutic Goods Administration (TGA). 17 October 2023. Archived from the original on 2 January 2024. Retrieved 7 March 2024.

[2] ttps://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215192Orig1s000ltr.pdf

[Vafseo_EPAR-3] ^ ^a ^b ^c ^d ^e ^f "Vafseo EPAR". European Medicines Agency. 31 May 2023. Archived from the original on 3 June 2023. Retrieved 3 June 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

[Vafseo:_Pending_EC_decision-4] "Vafseo: Pending EC decision". European Medicines Agency (EMA). 24 February 2023. Archived from the original on 25 February 2023. Retrieved 24 February 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

[5] Pergola PE, Spinowitz BS, Hartman CS, Maroni BJ, Haase VH (November 2016). "Vadadustat, a novel oral HIF stabilizer, provides effective anemia treatment in nondialysis-dependent chronic kidney disease". Kidney International. 90 (5): 1115–1122. doi:10.1016/j.kint.2016.07.019. PMID 27650732.

[6] Gupta N, Wish JB (June 2017). "Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors: A Potential New Treatment for Anemia in Patients With CKD". American Journal of Kidney Diseases. 69 (6): 815–826. doi:10.1053/j.ajkd.2016.12.011. PMID 28242135.

[7] Martin ER, Smith MT, Maroni BJ, Zuraw QC, deGoma EM (2017). "Clinical Trial of Vadadustat in Patients with Anemia Secondary to Stage 3 or 4 Chronic Kidney Disease". American Journal of Nephrology. 45 (5): 380–388. doi:10.1159/000464476. PMC 5452283. PMID 28343225.

[8] Eckardt KU, Agarwal R, Aswad A, Awad A, Block GA, Bacci MR, et al. (April 2021). "Safety and Efficacy of Vadadustat for Anemia in Patients Undergoing Dialysis". The New England Journal of Medicine. 384 (17): 1601–1612. doi:10.1056/NEJMoa2025956. PMID 33913638.

[9] Chertow GM, Pergola PE, Farag YM, Agarwal R, Arnold S, Bako G, et al. (April 2021). "Vadadustat in Patients with Anemia and Non-Dialysis-Dependent CKD". The New England Journal of Medicine. 384 (17): 1589–1600. doi:10.1056/NEJMoa2035938. PMID 33913637.

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v t e Antianemic preparations (B03)
Erythropoietins	Erythropoietin Darbepoetin alfa Methoxy polyethylene glycol-epoetin beta Peginesatide
Iron supplements	Ferric hydroxide Ferric maltol Ferrous ascorbate Ferrous aspartate Ferrous carbonate Ferrous chloride Ferric derisomaltose Ferrous fumarate Ferrous gluconate Ferrous glycine sulfate Ferrous iodine Ferrous succinate Ferrous sulfate Ferrous tartrate Iron sucrose Sodium ferric gluconate complex
Vitamin B12 and folic acid supplements	Cyanocobalamin Cyanocobalamin tannin complex Hydroxocobalamin Cobamamide Mecobalamin Folic acid
HIF prolyl-hydroxylase inhibitors	Daprodustat Desidustat Enarodustat Molidustat Roxadustat Vadadustat
Other	Luspatercept