Garadacimab-gxii—A Novel Prophylactic Treatment for Hereditary Angioedema: A Drug Review

Abstract

Objective:

To describe garadacimab-gxii, an antibody that inhibits factor XII, indicated for hereditary angioedema (HAE) prophylaxis, approved by the Food and Drug Administration in June 2025 for patients 12 years and older.

Data Sources:

A PubMed search used the keywords “garadacimab,” “hereditary angioedema,” and “garadacimab clinical trials,” from origin to October 15, 2025. We included phase I to III trials of garadacimab for HAE, post hoc analysis, and the package insert.

Study selection and data extraction:

We compiled 2 phase I, 1 phase II, 2 phase III trials, and 1 post hoc analysis to formulate an evidence-based review.

Data Synthesis:

In the phase II trial, garadacimab reduced mean monthly attack rate by up to 97.7%. In phase III trials, mean monthly attack rate was reduced by 91% while 62% of patients remained attack-free. In the open-label extension trial, mean monthly attack rate decreased by 95% and 60% of patients remained attack-free. No serious drug-related adverse events were reported.

Relevance to patient care and clinical practice in comparison with existing drugs:

By inhibiting factor XII, a novel target that prevents activation of the HAE cascade upstream of other agents, garadacimab may have more favorable outcomes than other drugs currently used in prophylactic treatment of HAE.

Conclusion and relevance:

Garadacimab reduces the frequency of HAE attacks with a safety profile comparable with existing prophylactic treatments. Its mechanism of targeting activated factor XII offers an alternative approach to HAE management. Ongoing monitoring and post-marketing data may further define its role in clinical practice.