Pharvaris (PHVS) FDA Approvals

Pharvaris' Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Pharvaris (PHVS). Over the past two years, Pharvaris has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Deucrictibant. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Deucrictibant FDA Regulatory Timeline and Events

Deucrictibant is a drug developed by Pharvaris for the following indication: For bradykinin-B2-receptor. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Publication - March 20,2026

• Drug: Deucrictibant
• Announced Date: March 20, 2026
• Indication: For bradykinin-B2-receptor

Pharvaris announced that two articles have been published back-to-back in the same issue of The Lancet Haematology.

Pharvaris announced that two articles were published back-to-back in the same issue of The Lancet Haematology, reporting Phase 2 results for deucrictibant, a bradykinin B2 receptor antagonist, in hereditary angioedema (HAE). The papers cover two double-blind, placebo-controlled studies—CHAPTER-1 and RAPIDe-1—and highlight the potential of B2 receptor antagonism as a treatment approach for HAE.

CHAPTER-1, a prophylactic study, showed a statistically significant reduction in attack frequency and meaningful improvements in disease control and quality of life, with deucrictibant well tolerated at both doses tested. RAPIDe-1, an on-demand study, demonstrated reduced attack severity and faster time to symptom relief and resolution, with good tolerability across doses. The full articles are available in The Lancet Haematology for detailed data and analysis.

Data - December 3,2025

• Drug: Deucrictibant
• Announced Date: December 3, 2025
• Indication: For bradykinin-B2-receptor

Pharvaris announced RAPIDe-3 pivotal data confirming the potential of deucrictibant's differentiated profile for the on-demand treatment of HAE attacks.

Pharvaris reported RAPIDe-3 pivotal Phase 3 results showing deucrictibant’s strong potential as an on‑demand oral treatment for hereditary angioedema (HAE) attacks. In 134 participants age 12 and up from 24 countries, the primary endpoint was met: median time to onset of symptom relief was 1.28 hours versus >12 hours for placebo (p<0.0001). All 11 secondary efficacy endpoints were also statistically significant (p<0.0001), including End of Progression™ at 17.47 minutes versus 228.67 minutes and median time to complete symptom resolution of 11.95 hours versus >24 hours.

Deucrictibant was well tolerated with no treatment‑related serious adverse events and no discontinuations due to adverse events. Most attacks (83.0%) were treated with a single capsule, and 93.2% of deucrictibant‑treated attacks required no rescue medication. Efficacy and safety were consistent across HAE types, attack severities, ages and body locations, supporting deucrictibant’s differentiated on‑demand profile.

Abstract Presentation - June 27,2025

• Drug: Deucrictibant
• Announced Date: June 27, 2025
• Indication: For bradykinin-B2-receptor

Pharvaris announced the acceptance of abstracts for presentation at the US Hereditary Angioedema Association's 2025 National Summit to be held from July 10-13, 2025, in Baltimore, Maryland.

Pharvaris, a late-stage biopharmaceutical company focused on developing oral bradykinin B2 receptor antagonists for hereditary angioedema, announced that abstracts have been accepted for presentation at the US Hereditary Angioedema Association’s 2025 National Summit. This important event will take place in Baltimore, Maryland from July 10-13, 2025.

The accepted abstracts showcase research on the long-term safety and efficacy of oral deucrictibant, a treatment designed for both prophylaxis and on-demand relief of hereditary angioedema attacks. Multiple studies, including open-label extension trials and a Phase 3 trial design, are set to be presented as poster sessions. These sessions highlight the potential of deucrictibant in improving disease control and overall quality of life for patients. Pharvaris’ participation in the summit underscores its commitment to advancing treatment options for those with bradykinin-mediated angioedema, providing a new hope for better patient outcomes.

Data Presentation - June 2,2025

• Drug: Deucrictibant
• Announced Date: June 2, 2025
• Indication: For bradykinin-B2-receptor

Pharvaris announced a summary of data that were presented at the 14th C1-Inhibitor Deficiency and Angioedema Workshop.

Pharvaris announced a summary of data presented at the 14th C1-Inhibitor Deficiency and Angioedema Workshop focusing on the oral bradykinin B2 receptor antagonist, deucrictibant. The data showed promising results in both prophylactic and on-demand settings for treating bradykinin-mediated angioedema, especially hereditary angioedema (HAE). In the on-demand treatment studies, a single dose of deucrictibant provided early symptom relief and a durable response without the reoccurrence of symptoms in most attacks. Additionally, the prophylactic data demonstrated that patients maintained a low rate of attacks over a period exceeding 18 months, with high levels of treatment satisfaction and improved quality of life. These findings support the drug’s potential to be used in both prevention and treatment scenarios, enhancing convenience for patients. Pharvaris is planning further pivotal data readouts in the next 18 months as part of its ongoing clinical development. 

Provided Update - April 7,2025

• Drug: Deucrictibant
• Announced Date: April 7, 2025
• Indication: For bradykinin-B2-receptor

Pharvaris provided a business update.

Pharvaris provided an update on its business progress with a focus on its clinical programs for deucrictibant. The company successfully reached target enrollment in RAPIDe-3, its pivotal Phase 3 study designed to evaluate the immediate-release capsule for on-demand treatment of hereditary angioedema (HAE) attacks. CEO Berndt Modig mentioned that high engagement from the HAE community helped achieve these aggressive timelines, underlining strong confidence in the clinical data to come.

In addition to RAPIDe-3, enrollment for the CHAPTER-3 study is progressing on schedule. This robust Phase 3 trial is assessing an extended-release formulation intended for routine prophylaxis against HAE attacks, with topline results anticipated in the second half of 2026. Pharvaris’ update reinforces its commitment to addressing the unmet medical needs of patients with bradykinin-mediated angioedema, underpinned by a solid financial position of €281 million in cash and equivalents as of December 31, 2024.

Efficacy and Safety Data - March 3,2025

Phase 3

• Drug: Deucrictibant
• Announced Date: March 3, 2025
• Indication: For bradykinin-B2-receptor

Pharvaris highlighted safety and efficacy data of deucrictibant, which is currently being evaluated in two pivotal Phase 3 studies, following long-term dosing in the prophylactic and on-demand settings at the American Academy of Allergy, Asthma, & Immunology's Annual Scientific Meeting (AAAAI) and World Allergy Organization (WAO) Joint Congress, which was held from February 28–March 3, 2025, in San Diego, CA.

Pharvaris recently highlighted compelling safety and efficacy data for its oral drug, deucrictibant, during the AAAAI and WAO Joint Congress in San Diego (Feb 28–Mar 3, 2025). The data comes after long-term dosing in both prophylactic and on-demand settings, reinforcing the drug’s potential as a new treatment option for hereditary angioedema (HAE). In the prophylactic studies, patients showed significant benefits, with many experiencing a median of zero days per month with HAE symptoms and notable improvements in quality of life. Meanwhile, the on-demand study demonstrated that a single dose of deucrictibant led to rapid symptom relief—about 0.9 hours in upper airway attacks. These promising outcomes support the continued evaluation of deucrictibant in two pivotal Phase 3 studies, potentially meeting the urgent need for effective HAE management.

Provided Update - September 5,2024

• Drug: Deucrictibant
• Announced Date: September 5, 2024
• Indication: For bradykinin-B2-receptor

Pharvaris is highlighting the differentiated profile of deucrictibant as a prophylactic and on-demand treatment of HAE attacks at the Bradykinin Symposium 2024, being held in Berlin from September 5-6, 2024.

Pharvaris is set to spotlight the unique benefits of its oral bradykinin B2 receptor antagonist, deucrictibant, at the Bradykinin Symposium 2024 in Berlin, held from September 5-6, 2024. The company will present data that underscores deucrictibant’s dual role in both prophylactic and on-demand therapy for hereditary angioedema (HAE) attacks. Clinical and long-term extension study results will be shared to demonstrate the drug’s sustained efficacy, favorable tolerability, and convenience as a once-daily treatment, offering an oral option with benefits similar to injectable therapies.

This presentation aims to clearly differentiate deucrictibant from other treatment options by highlighting its robust profile and potential impact on improving patient quality of life. Attendees can expect a detailed review of the studies confirming how the drug meets unmet needs in HAE management.