The FDA’s acceptance of Pharvaris’s NDA for deucrictibant IR supported by pivotal Phase 3 data from RAPIDe-3 (NCT06343779) showing rapid, sustained HAE attack relief sets a PDUFA action date of April 23, 2027, and opens the path to the first oral bradykinin B2 receptor antagonist for HAE attack treatment.
Written By: Anamika Koshti, Pharm D
Reviewed By: Pharmacally Editorial Team
The U.S. Food and Drug Administration has accepted the New Drug Application (NDA) submitted by Pharvaris for deucrictibant immediate-release (IR) capsule 20 mg as an on-demand treatment for hereditary angioedema (HAE) attacks, with a PDUFA target action date of April 23, 2027. Announced on July 6, 2026, the acceptance marks a significant regulatory milestone. If approved, deucrictibant IR will become the first oral bradykinin B2 receptor antagonist indicated for the treatment of HAE attacks, potentially introducing the first oral therapy of its class for on-demand treatment and expanding treatment options for people living with HAE.
Understanding Hereditary Angioedema
HAE is a rare, genetically inherited condition arising from deficiency or dysfunction of the C1 inhibitor protein, which leads to episodic, unpredictable attacks of swelling in the skin, gastrointestinal tract, and, most critically, the airway. Attacks are driven by excess bradykinin, a vasoactive peptide that increases vascular permeability and triggers tissue swelling. Without prompt treatment, attacks can persist for days, and laryngeal involvement carries the risk of life-threatening airway obstruction. Pharvaris is developing an oral on-demand treatment intended to address unmet needs for people living with HAE by providing a rapidly acting oral therapeutic option.
How Deucrictibant Works?
Deucrictibant is a novel, orally bioavailable small-molecule bradykinin B2 receptor antagonist that blocks bradykinin signalling directly at its receptor, targeting the molecular mechanism that drives swelling in HAE attacks. By inhibiting this pathway through oral administration, deucrictibant is designed to provide rapid on-demand treatment of HAE attacks. Pharvaris is developing two formulations: the IR capsule for rapid on-demand attack treatment, and an extended-release tablet for prophylaxis.
Pivotal Trial: RAPIDe-3
The NDA is supported by data from RAPIDe-3 (NCT06343779), a global, pivotal, placebo-controlled Phase 3 study of deucrictibant IR for on-demand treatment of attacks in participants aged 12 years and older with HAE, including those with HAE with normal C1 inhibitor. RAPIDe-3 met its primary endpoint and all 11 pre-specified secondary efficacy endpoints with statistical significance, demonstrating consistent efficacy across the study’s endpoint hierarchy. In total, the NDA encompasses data from the treatment of more than 1,300 HAE attacks across Pharvaris’ clinical development programme.
Key efficacy findings from RAPIDe-3 demonstrated rapid and sustained clinical benefit with deucrictibant IR. The study showed a median time to onset of symptom relief of 1.28 hours, while the median time to End of Progression™ (EoP) was 17.48 minutes, indicating rapid control of attack progression. Participants also achieved a median time to complete resolution of HAE attack symptoms of 11.95 hours. Across the clinical development programme, deucrictibant IR demonstrated a well-tolerated safety profile, supporting its potential as an oral on-demand treatment option for HAE attacks.
Clinical Implications
Berndt Modig, Chief Executive Officer of Pharvaris, noted that the FDA’s acceptance comes after a decade of sustained development effort by the company and highlighted the rapid onset of symptom relief and accelerated time to complete symptom resolution observed in clinical studies. He said these findings support deucrictibant IR’s potential to improve the standard of care for people living with HAE if approved. He also confirmed that Pharvaris has begun building its commercial infrastructure in preparation for a potential launch following a positive regulatory decision.
What This Means for Patients?
Deucrictibant IR is being developed as the first oral bradykinin B2 receptor antagonist for on‑demand treatment of hereditary angioedema (HAE) attacks. Unlike current injectable therapies, the oral capsule could allow patients to start treatment immediately when symptoms appear. The therapy has received orphan drug designation from the FDA, European Commission, and Swissmedic. With the FDA’s decision expected by April 23, 2027, patients and providers are awaiting whether this new oral option will expand treatment choices for HAE.
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About the Writer
Anamika Koshti (LinkedIn) is a PharmD professional and healthcare writer with interests in clinical research, pharmacovigilance, and evidence-based medicine. She has authored peer-reviewed publications on Alzheimer’s disease and PCOS, presented research at national conferences, and gained hands-on experience in medical content development and clinical data interpretation. She is committed to translating complex medical research into accurate, accessible content for healthcare professionals and patients.