A comprehensive review on prasugrel: Industrial synthesis, impurity profiling, pharmacokinetics & FDA assessment

Prasugrel, a Thienopyridine-class antiplatelet agent, is extensively used to prevent thrombus formation in people at high risk of cardiovascular disease. With a projected market CAGR of 8.0%, the global demand for Prasugrel continues to rise. The current review gives an extensive overview of industrial synthesis, focusing on patented strategies to enhance yield and minimize impurities such as CATP and OXTP. The standard industrial synthetic route involves the condensation of the thienopyridine moiety with 2-bromo-1-cyclopropyl-2-(2-fluorophenyl) ethenone, followed by an acetylation step. In addition, the review aims to assess Prasugrel’s key pharmacological aspects, including its mechanism of action, pharmacokinetic profile, and comparison with Clopidogrel. The polymorph forms of Prasugrel hydrochloride are also discussed in detail, alongside a critical evaluation of the risk-benefit profile, to provide a comprehensive understanding of its clinical and regulatory positioning.