Berotralstat hydrochlorideProduct ingredient for Berotralstat

Berotralstat is a selective inhibitor of plasma kallikrein used in the prophylaxis of attacks of hereditary angioedema (HAE).⁵ 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.³ Berotralstat is strictly used to prevent, but not treat, these attacks.⁴

Developed by BioCryst Pharmaceuticals, berotralstat is marketed under the name Orladeyo as oral capsules.¹ 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.⁵ Berotralstat was approved by the European Commission on April 30, 2021 ⁷ and by Health Canada on June 06, 2022.⁶

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