The Front Room — a clinical regulatory commons
RSS
← Back to The Docket
APR 23 2027
UPCOMING · 206 DAYS TO PDUFA

Pharvaris — deucrictibant $PHVS

for on-demand treatment of hereditary angioedema (HAE) attacks in patients 12 years and older

NDA · Standard Review

Accepted JUL 6 2026.

About

Hereditary angioedema is an inherited disorder that causes unpredictable, recurrent swelling attacks in the hands, feet, face, gut, and throat, and swelling in the airway can be life-threatening. Deucrictibant is an oral small molecule that blocks the bradykinin B2 receptor, the docking site where a signaling protein called bradykinin triggers the fluid leakage behind these attacks. By blocking that receptor, the drug may calm an attack already underway, potentially offering people with HAE a pill they can take when swelling starts.

Pivotal trial

RAPIDe-3 Phase 3 completed NCT06343779

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, 2-period, 2-treatment cross-over study to evaluate the efficacy and safety of orally administered deucrictibant compared to placebo for the on-demand treatment of HAE attacks, including non-severe laryngeal attacks, in participants ≥12 to ≤75 years of age with HAE type 1, type 2, or type 3, a proportion of whom are using long-term prophylactic medication for HAE.

Source: ClinicalTrials.gov

Also in development