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APR 23 2027
UPCOMING · 266 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 a rare inherited disorder that causes unpredictable, severe swelling in the skin, gut, and throat, with throat attacks being potentially life-threatening. Deucrictibant is an oral pill that blocks the bradykinin B2 receptor, a key protein that triggers swelling. By directly inhibiting this receptor, the drug aims to stop the swelling process quickly during an attack, potentially providing a convenient oral treatment option.

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

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