← Back to feed FDA accepts Pharvaris's deucrictibant NDA for on-demand HAE treatment
Drug deucrictibant
Indication On-demand treatment of hereditary angioedema (HAE) attacks in patients 12 years and older More on Pharvaris ↗ Google News FDA accepted Pharvaris's New Drug Application for deucrictibant immediate-release (20 mg) for the on-demand treatment of hereditary angioedema (HAE) attacks in patients 12 years and older. The PDUFA target action date is set for April 23, 2027. Deucrictibant is a novel, potent, orally bioavailable small molecule bradykinin B2 receptor antagonist — a mechanism-of-action that would be unique among oral on-demand HAE treatments if approved.
Read original at ir.pharvaris.com ↗ Background Drug-class context · Wikipedia Hereditary angioedema (HAE) is a rare inherited disorder characterised by recurrent episodes of unpredictable, painful and potentially life-threatening swelling in the extremities, face, gastrointestinal tract, and larynx. HAE is caused by deficient or dysfunctional C1 esterase inhibitor (C1-INH), leading to unopposed activation of the bradykinin-producing kallikrein-kinin pathway. Bradykinin binding to the bradykinin B2 receptor drives the vasodilation and vascular permeability that produces attack symptoms. The current on-demand HAE treatment landscape is dominated by injectable products — icatibant (Firazyr, a bradykinin B2 antagonist), plasma-derived and recombinant C1-INH concentrates, and ecallantide (a kallikrein inhibitor). No oral on-demand option is currently marketed in the U.S., producing substantial unmet need for patients who prefer oral therapy or lack venous access. Deucrictibant is Pharvaris's oral, small-molecule bradykinin B2 receptor antagonist — pharmacologically related to icatibant but engineered for oral bioavailability. The NDA is supported by data from the RAPIDe-1 (Phase 2) and RAPIDe-3 (Phase 3 pivotal) on-demand trials, with a comprehensive clinical development program including treatment of over 1,300 HAE attacks demonstrating rapid onset of symptom relief and accelerated time to complete symptom resolution. Pharvaris is running a parallel Phase 3 study (CHAPTER-3) evaluating a deucrictibant extended-release tablet (40 mg once daily) for HAE prophylaxis — a separate formulation from the immediate-release capsule under this on-demand NDA. CHAPTER-3 topline data is anticipated in Q3 2026. The FDA's July 6, 2026 on-demand NDA acceptance sets a PDUFA target action date of April 23, 2027, consistent with Standard Review.
Source: Wikipedia · CC BY-SA
Topic hereditary angioedema
