Overview
Daprodustat is a small-molecule drug classified as a hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor. Developed by GlaxoSmithKline, it is primarily used to treat anemia in patients with chronic kidney disease (CKD) by stimulating endogenous erythropoietin production. Unlike traditional erythropoiesis-stimulating agents (ESAs), daprodustat offers an oral administration route, improving patient convenience. The drug received its first global approval in Japan in 2020 and has since been reviewed by other regulatory bodies, including the FDA and EMA. Its mechanism of action mimics the body's natural response to hypoxia, making it a promising therapeutic option for CKD-associated anemia.
Physical and Chemical Properties
Daprodustat is a white to off-white crystalline powder with a molecular weight of 386.35 g/mol. Its molecular formula is C19H16F2N4O3, indicating the presence of fluorine atoms, which contribute to its stability and pharmacokinetic properties. The compound is soluble in dimethyl sulfoxide (DMSO) and other organic solvents but has limited solubility in water. Stability studies suggest that daprodustat should be stored at 2-8°C in a tightly sealed container to prevent degradation. The drug exhibits high oral bioavailability, a critical feature for its therapeutic use. Its chemical structure includes a pyridine ring and a fluorinated phenyl group, which are essential for its HIF-PH inhibitory activity.
Main Applications
Daprodustat is specifically indicated for the treatment of anemia in adult patients with chronic kidney disease (CKD), including those not on dialysis and those undergoing dialysis. It is particularly beneficial for patients who cannot tolerate or do not respond adequately to traditional ESAs. By inhibiting HIF-PH, daprodustat stabilizes hypoxia-inducible factors, leading to increased erythropoietin production and improved red blood cell formation. Clinical trials have demonstrated its efficacy in maintaining hemoglobin levels within the target range, reducing the need for blood transfusions. Its oral administration route offers a significant advantage over injectable ESAs, enhancing patient adherence and quality of life. Ongoing research is exploring its potential in other anemia-related conditions.
Safety and Storage
Daprodustat should be handled with standard laboratory precautions to minimize exposure. Personal protective equipment (PPE), including gloves and safety goggles, is recommended when working with the compound. Avoid inhalation, ingestion, or direct skin contact, as it may cause irritation or adverse effects. For storage, maintain the drug in its original container at 2-8°C, protected from light and moisture. Improper storage conditions can lead to degradation, reducing its efficacy. In case of accidental exposure, rinse affected areas with water and seek medical advice if necessary. Dispose of unused or expired material in accordance with local regulations.
B2B Procurement Guide
When procuring daprodustat for B2B purposes, prioritize suppliers with verified regulatory compliance, such as FDA or EMA approvals. Request certificates of analysis (CoA) to ensure product purity and potency. Due to its therapeutic nature, batch-to-batch consistency is critical. Consider the supplier's track record, storage capabilities, and distribution network to ensure timely delivery and proper handling. Pricing varies based on quantity and supplier, so obtain multiple quotes for comparison. For large-scale procurement, negotiate long-term contracts to secure favorable terms. Always verify the supplier's Good Manufacturing Practice (GMP) certification to guarantee quality standards.