Daprodustat, sold under the brand name Duvroq among others, is a

medication Medication (also called medicament, medicine, pharmaceutical drug, medicinal product, medicinal drug or simply drug) is a drug used to medical diagnosis, diagnose, cure, treat, or preventive medicine, prevent disease. Drug therapy (pharmaco ...

that is used for the treatment of

anemia Anemia (also spelt anaemia in British English) is a blood disorder in which the blood has a reduced ability to carry oxygen. This can be due to a lower than normal number of red blood cells, a reduction in the amount of hemoglobin availabl ...

due to

chronic kidney disease Chronic kidney disease (CKD) is a type of long-term kidney disease, defined by the sustained presence of abnormal kidney function and/or abnormal kidney structure. To meet criteria for CKD, the abnormalities must be present for at least three mo ...

. It is a hypoxia-inducible factor prolyl hydroxylase inhibitor. It is taken

by mouth Oral administration is a route of administration whereby a substance is taken through the Human mouth, mouth, swallowed, and then processed via the digestive system. This is a common route of administration for many medications. Oral administ ...

. The most common side effects include

high blood pressure Hypertension, also known as high blood pressure, is a long-term medical condition in which the blood pressure in the arteries is persistently elevated. High blood pressure usually does not cause symptoms itself. It is, however, a major ri ...

, thrombotic vascular events, abdominal pain, dizziness, and allergic reactions. Daprodustat was approved for medical use in Japan in June 2020, and in the United States in February 2023. making it the first oral treatment for anemia caused by chronic kidney disease for adults in the US. The US

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...

(FDA) considers it to be a

first-in-class medication A first-in-class medication is a prototype drug that uses a "new and unique mechanism of action" to treat a particular medical condition. While the Food and Drug Administration's Center for Drug Evaluation and Research tracks first-in-class medic ...

Medical uses

Daprodustat is

indicated In medicine, an indication is a valid reason to use a certain test, medication, procedure, or surgery. There can be multiple indications to use a procedure or medication. An indication can commonly be confused with the term diagnosis. A diagnosis ...

for the treatment of anemia due to chronic kidney disease. Daprodustat increases

erythropoietin Erythropoietin (; EPO), also known as erythropoetin, haematopoietin, or haemopoietin, is a glycoprotein cytokine secreted mainly by the kidneys in response to cellular hypoxia; it stimulates red blood cell production ( erythropoiesis) in th ...

levels.

Adverse effects

The FDA label for daprodustat has a

boxed warning In the United States, a boxed warning (sometimes "black box warning", colloquially) is a type of warning that appears near the beginning of the package insert for certain prescription drugs, so called because the U.S. Food and Drug Administratio ...

for an increased risk of thrombotic vascular (blood clotting) events including death, heart attack, stroke, and blood clots in the lung, legs, or dialysis access site. The most common side effects include high blood pressure, thrombotic vascular events, abdominal pain, dizziness, and allergic reactions.

History

The efficacy and safety of daprodustat were evaluated in 2,964 adults with anemia due to chronic kidney disease on dialysis and receiving an erythropoiesis-stimulating agent at the time of study entry in a randomized, sponsor-blind, active-controlled, global, multicenter, event-driven clinical trial (ASCEND-D; NCT02879305). Participants were stratified by dialysis type and were required to be on dialysis for at least four months prior to the first dose of daprodustat. Participants on hemodialysis were randomized 1:1 to receive oral daprodustat (N=1,316) or intravenous

epoetin alfa Epoetin alfa, sold under the brand name Epogen among others, is a human erythropoietin produced in cell culture using recombinant DNA technology. Epoetin alfa is an erythropoiesis-stimulating agent. It stimulates erythropoiesis (increasing red ...

(N=1,308) while participants on

peritoneal dialysis Peritoneal dialysis (PD) is a type of kidney dialysis, dialysis that uses the peritoneum in a person's abdomen as the membrane through which fluid and dissolved substances are exchanged with the blood. It is used to remove excess fluid, correct e ...

were randomized 1:1 to receive oral daprodustat (N=171) or subcutaneous

darbepoetin alfa Darbepoetin alfa (INN) is a re-engineered form of erythropoietin containing 5 amino acid changes (N30, T32, V87, N88, T90) resulting in the creation of 2 new sites for N-linked carbohydrate addition. It has a 3-fold longer serum half-life compa ...

(N=169). In this study, adults received either oral daprodustat or injected recombinant human erythropoietin () (a standard of care treatment for people with anemia due to chronic kidney disease). 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 to 11 g/dL, similar to that of the treatment. The trial was conducted at 431 sites in 35 countries. The FDA granted the approval of Jesduvroq to GlaxoSmithKline LLC.

Society and culture

Due to its potential applications in

athletic doping In competitive sports, doping is the use of banned athletic performance-enhancing drugs (PEDs) by athletes, as a way of cheating. As stated in the World Anti-Doping Code by WADA, doping is defined as the occurrence of one or more of the anti-d ...

, it has also been incorporated into screens for

performance-enhancing drugs Performance-enhancing substances (PESs), also known as performance-enhancing drugs (PEDs), are substances that are used to improve any form of activity performance in humans. Many substances, such as anabolic steroids, can be used to improve at ...

Research

Daprodustat is in phase III clinical trials for the treatment of

caused by

References

{{Authority control Acetic acids Cyclohexyl compounds Drugs developed by GSK plc Pyrimidinediones