deucrictibant IR (PHVS416) - (RAPIDe-3)

July 6, 2026: Pharvaris (NASDAQ: PHVS) said the FDA has accepted its New Drug Application for deucrictibant immediate-release (IR) 20 mg capsules for on-demand treatment of hereditary angioedema (HAE) attacks. The FDA set a PDUFA target action date of April 23, 2027.

The NDA includes a clinical program covering treatment of more than 1,300 HAE attacks. In the global pivotal Phase 3 RAPIDe-3 trial (NCT06343779) in participants ≥12 years (including HAE with normal C1 inhibitor), deucrictibant IR met the primary and all 11 secondary efficacy endpoints with statistical significance. Reported median times were 1.28 hours to onset of symptom relief, 17.48 minutes to End of Progression (EoP), and 11.95 hours to complete symptom resolution; safety was described as well tolerated.

Deucrictibant is an oral small-molecule bradykinin B2 receptor antagonist; Pharvaris is also developing an extended-release tablet formulation intended for prophylaxis. Deucrictibant received FDA orphan drug designation in 2022 (and orphan designation in the EU and Switzerland per the release).