Avatrombopag Maleate

Avatrombopag Maleate is a pivotal pharmaceutical intermediate and reference standard for the production of the clinically approved thrombopoietin receptor agonist marketed as Doptelet®. Avatrombopag Maleate was first approved by the FDA in May 2018 for the treatment of thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a procedure . Avatrombopag Maleate is also indicated for the treatment of chronic immune thrombocytopenia (ITP) and has been studied as an orally administered treatment that significantly reduces the need for platelet transfusions . The compound's biological activity is characterized by an EC₅₀ of 3.3 nM for TPO receptor activation . Avatrombopag Maleate is a substrate for cytochrome P450 enzymes CYP2C9 and CYP3A .

 Product Parameters

Efficacy and Action

Avatrombopag Maleate is a non-peptide oral thrombopoietin receptor agonist (TPO-RA). It interacts with the transmembrane domain of the human TPO receptor, initiates a signaling cascade, and stimulates the proliferation and differentiation of the megakaryocytic lineage in the bone marrow, thereby promoting the production and release of platelets. In vitro experiments show that avatrombopag and TPO do not compete with each other in promoting platelet production on Chemicalbook, and have an additive effect. Avatrombopag Maleate is safe and well tolerated. The oral administration method is not restricted by food types, which greatly improves the quality of life of patients with thrombocytopenia. It is the first-choice treatment for patients with liver cancer complicated with thrombocytopenia, and the first-choice treatment for patients with liver cirrhosis scheduled for invasive procedures complicated with thrombocytopenia. It has been jointly recommended by seven major global guidelines, as well as one domestic guideline and eight major consensus statements.

Pharmacological Action

Avatrombopag is an orally administrable small-molecule thrombopoietin (TPO) receptor agonist that stimulates the proliferation and differentiation of megakaryocytes in bone marrow progenitor cells, thereby increasing platelet production. Avatrombopag does not compete with TPO for binding to the TPO receptor, and has an additive effect with TPO in platelet production.

Product Quality Assurance

Cosperpharm has established a comprehensive quality assurance system for Avatrombopag Maleate that meets the rigorous expectations of both pharmaceutical intermediate manufacturing and impurity reference standard applications:

Thorough analytical characterization. Each batch undergoes multi-technique analytical release testing: HPLC purity verification (≥98% for research grade), appearance verification, and identity confirmation. Full chromatographic traceability and residual solvent analysis are provided.

Full batch traceability with retention samples. From raw material procurement through synthesis, purification, salt formation, and final packaging, every step is fully documented and traceable. Each batch receives a unique lot number with sufficient retention samples maintained in accordance with Cosperpharm quality procedures.

Stability monitoring program. Cosperpharm conducts ongoing stability studies under recommended storage conditions: –20°C and 4°C for powder, with stability summaries available to support customer regulatory submissions.

Documentation ready for regulatory submission. Every shipment includes a Certificate of Analysis (COA) with batch-specific purity and characterization data, a Material Safety Data Sheet (SDS), and customs documentation for international delivery. For customers preparing ANDA or NDA filings, Cosperpharm provides custom quality agreements and additional documentation upon request.

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Looking for Avatrombopag Maleate for your manufacturing campaign, impurity profiling program, or medicinal chemistry research? Cosperpharm makes it simple. Contact our team today to discuss your specifications or request a quote.