Last reviewed 2026-04-20 · How we verify

BEROTRALSTAT HYDROCHLORIDE

BEROTRALSTAT HYDROCHLORIDE is a drug. It is currently FDA-approved (first approved 2020) for Prophylaxis to prevent HAE attacks.

Berotralstat inhibits plasma kallikrein to reduce bradykinin generation and control angioedema in HAE.

Berotralstat hydrochloride is a marketed drug used for the prophylaxis to prevent HAE attacks by inhibiting plasma kallikrein. Its key strength lies in its mechanism of action, which effectively reduces bradykinin generation and controls angioedema, providing a targeted approach to managing HAE. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.

At a glance

Mechanism of action

Berotralstat works by binding to and inhibiting plasma kallikrein, a protease involved in generating bradykinin, a potent vasodilator. By reducing bradykinin levels, it helps control the swelling and pain associated with hereditary angioedema (HAE).

Approved indications

• Prophylaxis to prevent HAE attacks

Common side effects

• Abdominal Pain
• Vomiting
• Diarrhea
• Back Pain
• Gastroesophageal Reflux Disease

Drug interactions

• P-gp inducers
• CYP2D6 substrates
• CYP3A4 substrates
• Desogestrel
• P-gp substrates

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• BEROTRALSTAT HYDROCHLORIDE CI brief — competitive landscape report
• BEROTRALSTAT HYDROCHLORIDE updates RSS · CI watch RSS

Frequently asked questions about BEROTRALSTAT HYDROCHLORIDE

Related

• Target: All drugs targeting plasma kallikrein
• Indication: Drugs for Prophylaxis to prevent HAE attacks

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing