Last reviewed 2026-04-22 · How we verify

BCX7353 capsules

BCX7353 is a selective inhibitor of plasma kallikrein that reduces bradykinin generation in the contact system pathway.

BCX7353 is a selective inhibitor of plasma kallikrein that reduces bradykinin generation in the contact system pathway. Used for Hereditary angioedema (HAE) with C1-inhibitor deficiency or dysfunction.

At a glance

Mechanism of action

BCX7353 inhibits Factor XIIa-driven contact system activation by blocking plasma kallikrein, thereby reducing excessive bradykinin production. This mechanism is intended to prevent the inflammatory cascade and vascular permeability changes characteristic of hereditary angioedema (HAE). By targeting the upstream contact pathway rather than downstream bradykinin receptors, it may provide broader suppression of HAE attacks.

Approved indications

• Hereditary angioedema (HAE) with C1-inhibitor deficiency or dysfunction

Common side effects

• Headache
• Diarrhea
• Nausea
• Nasopharyngitis

Key clinical trials

• Berotralstat Treatment in Children With Hereditary Angioedema (PHASE3)
• Open-label Berotralstat Access to HAE Patients Previously Enrolled in Berotralstat Studies (PHASE3)
• Study to Evaluate the Efficacy and Safety of BCX7353 as an Oral Treatment for the Prevention of HAE Attacks in Japan (PHASE3)
• Efficacy and Safety Study of BCX7353 as an Oral Treatment for the Prevention of Attacks in HAE (PHASE3)
• A Long Term Safety Study of BCX7353 in Hereditary Angioedema (PHASE2, PHASE3)
• Efficacy and Safety of BCX7353 to Prevent Angioedema Attacks in Subjects With Hereditary Angioedema (PHASE2)
• Oral Berotralstat Expanded Access Program
• A Relative Bioavailability Study of Two Formulations of BCX7353 (PHASE1)

Primary sources

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