Pharvaris says Lancet study shows rapid relief with deucrictibant

• RAPIDe-3 met its primary endpoint and all 11 secondary endpoints.
• Deucrictibant IR was said to be well tolerated, with no safety signals observed.
• FDA and EMA reviews of the NDA and MAA are under way.

Study results

Pharvaris said results from RAPIDe-3 were published in The Lancet on Oct. 8, 2026. The phase 3 study evaluated oral deucrictibant immediate-release 20 mg for the on-demand treatment of hereditary angioedema attacks in adolescents and adults.

Pharvaris says Lancet study shows rapid relief with deucrictibant

The company said treatment with deucrictibant IR led to faster onset of symptom relief, at 1.28 hours, and complete symptom resolution, at 11.95 hours.

It said RAPIDe-3 met its primary endpoint and all 11 secondary endpoints with high statistical significance. It also said most attacks were adequately controlled with a single capsule.

Safety and subgroups

Pharvaris said deucrictibant IR showed a well-tolerated safety profile. It said no safety signals were observed.

The company said results were consistent across subgroups defined by age, geographic location, HAE type, use of long-term prophylaxis, and attack severity and location, including non-severe laryngeal attacks.

The results of the RAPIDe-3 study demonstrate that deucrictibant IR, an orally-administered bradykinin B2 receptor antagonist, rapidly ended attack progression and accelerated the time to complete symptom resolution.

— Marc A. Riedl, M.D., M.S., principal RAPIDe-3 study investigator and lead author of the publication

Regulatory review

Pharvaris said a New Drug Application for deucrictibant IR is under review by the U.S. Food and Drug Administration, with a PDUFA target action date of April 23, 2027. It said a Marketing Authorization Application is also under review by the European Medicines Agency.

The company said the results were consistent with RAPIDe-1, published in April 2026 in The Lancet Haematology. It also said RAPIDe-2 is ongoing and an expanded access program is available to eligible people in the U.S.