• Results from RAPIDe-3 demonstrate that treatment with deucrictibant IR resulted in faster time to onset of symptom relief (1.28 hours) and to complete symptom resolution (11.95 hours)
• Deucrictibant IR showed a well-tolerated safety profile
• NDA and MAA of deucrictibant IR for the on-demand treatment of HAE attacks under review by regulatory authorities

Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing oral bradykinin B2 receptor antagonists to help address unmet needs of those living with bradykinin-mediated angioedema, such as hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH), announced that results of RAPIDe-3, a phase 3, global, randomized, double-blind, placebo-controlled crossover study evaluating oral deucrictibant immediate-release (IR) capsule (20 mg) for the on-demand treatment of HAE attacks in adolescents and adults have been published in The Lancet (Journal Impact Factor: 109.0).

“Bradykinin B2 receptor antagonism is a validated and reliable mechanism currently being widely used for the on-demand treatment of HAE attacks,” said Marc A. Riedl, M.D., M.S., Professor of Medicine, Clinical Director of the U.S. Hereditary Angioedema Association (HAEA) Angioedema Center at the University of California San Diego (UCSD), principal RAPIDe-3 study investigator, and lead Author of the publication. “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. Publication in The Lancet, one of the world’s highest-impact academic journals, maximizes the visibility of these data to a global network of clinicians, researchers, and patients. If approved, deucrictibant IR will be the first approved oral bradykinin B2 receptor antagonist, with the potential to address unmet needs of people living with HAE by providing reliable symptom relief and resolution with a single convenient oral capsule.”

RAPIDe-3 (NCT06343779) met its primary endpoint and all 11 secondary endpoints with high statistical significance. Deucrictibant IR achieved End of Progression™¹ (EoP) of attack symptoms, symptom relief, and complete symptom resolution significantly faster than placebo, with most attacks being adequately controlled with a single capsule. Deucrictibant IR was well tolerated with no safety signals observed. Results were consistent across subgroups of participants defined according to age, geographic location, HAE type (including HAE with normal C1 inhibitor), use of long-term prophylaxis, and attack severity and location (including non-severe laryngeal attacks).

Peng Lu, M.D., Ph.D., President of Pharvaris, added, “the consistent results from RAPIDe-3 across subgroups underscores the clinical relevance of antagonizing the bradykinin B2 receptor, a downstream target that stops the effects of excess bradykinin regardless of the pathways through which it is generated. These findings represent the first pivotal step in Pharvaris’ broader clinical development strategy of investigating deucrictibant across both on-demand and prophylactic settings with the goal of delivering new treatment options that may address unmet medical needs of those living with bradykinin-mediated angioedema.”

The full article can be found here: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(26)01296-1/fulltext 

Results of the RAPIDe-3 study are consistent with results of RAPIDe-1, which were published in April 2026 in The Lancet Haematology. An open-label extension study of deucrictibant IR for the on-demand treatment of HAE attacks, RAPIDe-2 (NCT05396105), is ongoing. An expanded access program (EAP) (NCT07759141) for deucrictibant IR for the on-demand treatment of HAE attacks is also available to people in U.S. meeting eligibility requirements.

A New Drug Application (NDA) for deucrictibant IR for the on-demand treatment of HAE attacks is currently under review with the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of April 23, 2027. A Marketing Authorization Application (MAA) for deucrictibant IR for on-demand treatment of HAE attacks is also currently under review with the European Medicines Agency (EMA).