Jesduvroq FDA Approval History
Last updated by Judith Stewart, BPharm on Feb 22, 2023.
FDA Approved: Yes (First approved February 1, 2023)
Brand name: Jesduvroq
Generic name: daprodustat
Dosage form: Tablets
Company: GlaxoSmithKline
Treatment for: Anemia Due to Chronic Kidney Disease
Jesduvroq (daprodustat) is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) for the treatment of patients with anemia of chronic kidney disease (CKD).
- Jesduvroq is indicated for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least four months. It is not indicated for use as a substitute for transfusion in patients requiring immediate correction of anemia or for use in patients not on dialysis.
- In people with chronic kidney disease who are on dialysis, the kidneys cannot produce enough erythropoietin which leads to anemia (decreased number of red blood cells).
- Jesduvroq works as a hypoxia-inducible factor (HIF) prolyl hydroxylase (PH) inhibitor to stabilize the HIF complex and stimulate endogenous erythropoietin to increase erythropoietin levels, which in turn signals the body to make red blood cells.
- Jesduvroq tablets are administered orally once daily.
- The Jesduvroq product label carries a Boxed Warning for the increased risk of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access.
- Warnings and precautions associated with Jesduvroq include increased risk of hospitalization for heart failure, worsening hypertension, gastrointestinal erosion, and unfavorable effects on cancer growth.
- Common adverse reactions include hypertension, thrombotic vascular events, and abdominal pain.
Development timeline for Jesduvroq
Further information
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