ZUG, Switzerland — September 8, 2026
Pharvaris announced positive topline results from the CHAPTER-3 pivotal Phase 3 study evaluating deucrictibant extended-release (XR) tablets for the prevention of hereditary angioedema (HAE) attacks. The global study met its primary endpoint, demonstrating an 83% reduction in mean monthly HAE attack rate versus placebo (p<0.0001) across all three HAE types evaluated. The company also reported an 87% reduction in attack rate versus placebo among participants with HAE Type 1 or Type 2, while all sequentially assessed secondary efficacy endpoints achieved statistical significance. The results represent a major clinical and regulatory milestone for Pharvaris, with the CHAPTER-3 dataset expected to support planned marketing authorization applications beginning in the first half of 2027. The company is developing deucrictibant as an oral alternative designed to combine strong efficacy with the convenience of oral administration.
CHAPTER-3 Supports Broad HAE Prophylaxis Development
CHAPTER-3 is the first and only prophylaxis Phase 3 study to evaluate an investigational therapy across all three types of HAE, according to Pharvaris. The randomized, double-blind, placebo-controlled study enrolled 85 adolescents and adults across 21 countries, with participants assigned in a 2:1 ratio to once-daily 40 mg deucrictibant XR or placebo for 24 weeks. Treatment produced an early onset of protection within the first week, with the reduction in attack frequency sustained throughout the 24-week treatment period. Pharvaris also reported robust reductions from baseline in attack rates and an increase in the proportion of participants who remained attack-free. The consistency of the primary endpoint across patient subgroups and the statistically significant results across secondary efficacy measures strengthen the clinical development package as the company prepares for regulatory submissions for prophylactic treatment of bradykinin-mediated angioedema.
Oral Deucrictibant XR Demonstrates Favorable Tolerability
The CHAPTER-3 safety profile further supports Pharvaris’ strategy of developing an oral prophylactic therapy for HAE. The company reported that deucrictibant XR was generally well tolerated, with most treatment-emergent adverse events described as mild or moderate. No treatment-related serious adverse events were reported, while one participant in each treatment group discontinued therapy because of an adverse event. Deucrictibant is a potent, orally bioavailable small-molecule antagonist of the bradykinin B2 receptor, targeting bradykinin signaling that contributes to attacks in bradykinin-mediated angioedema. Pharvaris is developing two oral formulations: the extended-release tablet for sustained exposure and prophylaxis, and an immediate-release capsule designed for rapid activity during acute attacks. The company believes the combination of efficacy, tolerability and oral administration could reduce treatment burden for people requiring long-term HAE management.
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Pharvaris Advances Dual-Formulation HAE Franchise
The CHAPTER-3 success strengthens Pharvaris’ broader strategy to establish deucrictibant as a two-formulation treatment franchise covering both prevention and on-demand management of HAE attacks. The company is currently advancing its immediate-release deucrictibant formulation through regulatory review for on-demand treatment, while preparing a U.S. New Drug Application for deucrictibant XR prophylaxis in the first half of 2027. The ongoing CHAPTER-4 open-label extension is evaluating longer-term prophylaxis with deucrictibant XR, while topline results from Part 1 of the pivotal Phase 3 CREAATE study in acquired angioedema due to C1 inhibitor deficiency are expected in the first quarter of 2027. Pharvaris plans to present additional CHAPTER-3 efficacy, safety and participant-experience data at upcoming medical congresses. With positive pivotal Phase 3 results and multiple regulatory programs advancing, Pharvaris is positioning deucrictibant as a potential oral standard-of-care option across prevention and acute treatment of bradykinin-mediated angioedema.
Source: Pharvaris, Deucrictiban press release
