Berotralstat

Berotralstat is a selective inhibitor of plasma kallikrein used in the prophylaxis of attacks of hereditary angioedema (HAE). It works by blocking the enzymatic activity of plasma kallikrein in releasing bradykinin, the major biologic peptide that promotes swelling and pain associated with attacks of HAE. Berotralstat is strictly used to prevent, but not treat, these attacks.

Developed by BioCryst Pharmaceuticals, berotralstat is marketed under the name Orladeyo as oral capsules. Berotralstat was first approved by the FDA on December 3, 2020, as the first once-daily oral therapy to prevent angioedema attacks of HAE in adults and pediatric patients 12 years and older. Berotralstat was approved by the European Commission on April 30, 2021 and by Health Canada on June 06, 2022.