Drugs / CRICTIBANT

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed US (FDA) — angioedema, hereditary, 4 2026-07-06

“FDA) has accepted its New Drug Application (NDA) for deucrictibant immediate-release (IR) capsule (20 mg) for the on-demand treatment (ODT) of Hereditary Angioedema (HAE) attacks.” pharvaris.com ↗

Filed EU (EMA) — angioedema, hereditary, 4 —

“In July 2026, the European Medicines Agency (EMA) validated the marketing authorization application (MAA) for deucrictibant IR and began its formal review” pharvaris.com ↗

Trials 8

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/21 trial
Phase 1/2 NCT07046806 Mar 2025 → Apr 2026 overdue C1 inhibitor deficiency, hereditary angioedema, non-histaminic angioedema Institute for Asthma and Allergy Recruiting No outcome recorded
Phase 22 trials · 2 met primary
Phase 2 NCT05047185 Apr 2022 → Jun 2025 C1 inhibitor deficiency, hereditary angioedema type 1, hereditary angioedema type 2 Pharvaris Netherlands B.V. Completed Met primary
Phase 2 NCT04618211 Feb 2021 → Sep 2022 C1 inhibitor deficiency, hereditary angioedema type 1, hereditary angioedema type 2 Pharvaris Netherlands B.V. Completed Met primary
Phase 2/31 trial
Phase 2/3 NCT05396105 Dec 2022 → Jun 2027 expected C1 inhibitor deficiency, hereditary angioedema type 1, hereditary angioedema type 2, hereditary angioedema type 3 +1 Pharvaris Netherlands B.V. Enrolling by invitation No outcome recorded
Phase 34 trials · 2 met primary
Phase 3 NCT07266805 Oct 2025 → Jun 2027 expected acquired angioedema with C1Inh deficiency Pharvaris Netherlands B.V. Recruiting No outcome recorded
Phase 3 NCT06679881 Feb 2025 → Dec 2028 expected hereditary angioedema Pharvaris Netherlands B.V. Recruiting No outcome recorded
Phase 3 NCT06669754 Dec 2024 → Aug 2026 overdue hereditary angioedema Pharvaris Netherlands B.V. Active not recruiting Met primary
Phase 3 NCT06343779 Feb 2024 → Oct 2025 C1 inhibitor deficiency, hereditary angioedema type 1, hereditary angioedema type 2, hereditary angioedema type 3 Pharvaris Netherlands B.V. Completed Met primary

News releases announcing trial results or a regulatory action · 7

DateIssuerRelease
2026-09-08 Pharvaris Netherlands B.V. Results Pharvaris Announces Positive Topline Data from CHAPTER-3 Pivotal Study of Deucrictibant XR for Prophylaxis of HAE Attacks pharvaris.com ↗
2026-09-03 Pharvaris Netherlands B.V. Results Pharvaris Presents Translational, Nonclinical, and Clinical Data at Bradykinin Symposium 2026 pharvaris.com ↗
In silico modeling analyses revealed the structural determinants of species-specific differences in deucrictibant binding to the human and rat bradykinin B2 receptor
2026-07-06 Pharvaris Netherlands B.V. Regulatory Pharvaris Announces FDA Acceptance of New Drug Application for Deucrictibant IR for On-Demand Treatment of Hereditary Angioedema Attacks pharvaris.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for deucrictibant immediate-release (IR) capsule (20 mg) for the on-demand treatment (ODT) of Hereditary Angioedema (HAE) attacks.
2026-06-15 Pharvaris Netherlands B.V. Results Data Supporting Differentiated Profile of Deucrictibant in HAE Management Presented at EAACI 2026 pharvaris.com ↗
“The data presented at EAACI continue to provide evidence supporting a potentially differentiated profile of deucrictibant in both the on-demand setting and the prophylactic setting,” said Berndt Modig, Chief Executive Officer of Pharvaris.
2026-04-20 Pharvaris Netherlands B.V. Results Evidence Supporting Combined Use of Deucrictibant IR with Deucrictibant XR Presented at CIIC Spring 2026 Conference pharvaris.com ↗
The comparable mean total duration of icatibant-treated attacks in the placebo-icatibant and the deucrictibant-icatibant groups provide initial evidence on the efficacy of combining use of a bradykinin B2 receptor antagonist for prophylaxis and on-demand treatment of attacks.
2026-03-20 Pharvaris Netherlands B.V. Results Evidence of Efficacy and Safety of Deucrictibant for Prophylaxis and On-Demand Treatment of Hereditary Angioedema Attacks Published Back-to-Back in The Lancet Haematology pharvaris.com ↗
RAPIDe-1, a double-blind, placebo-controlled Phase 2 study of deucrictibant immediate-release capsule for the on-demand treatment of HAE attacks, demonstrated a statistically significant reduction in severity of attack manifestations, as well as a reduced time to symptom relief and resolution.
2026-03-02 Pharvaris Netherlands B.V. Results Deucrictibant Data Supporting Potentially Differentiated Profile for the On-Demand and Prophylactic Treatment of Bradykinin-Mediated Angioedema Presented at AAAAI 2026 pharvaris.com ↗

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 10 sources stand behind the page.

FieldValueCited text
Known as CRICTIBANT ChEMBL registry synonym — accepted as the source's own label CHEMBL5095506 ↗
Known as deucrictibant ClinicalTrials.gov intervention name — accepted as the source's own label NCT05396105 ↗
7

NCT06343779 ↗

NCT05047185 ↗

NCT07266805 ↗

NCT06669754 ↗

NCT04618211 ↗

NCT06679881 ↗

NCT07046806 ↗

Known as PHA-022121 “Deucrictibant has been adopted as the international nonproprietary name (INN) for the active ingredient, previously referred to as PHA121 or PHA-022121.” NCT07046806 ↗
Known as PHA121 “Deucrictibant has been adopted as the international nonproprietary name (INN) for the active ingredient, previously referred to as PHA121 or PHA-022121.” NCT07046806 ↗
Known as PHVS-719 ChEMBL registry synonym — accepted as the source's own label CHEMBL5095506 ↗
Known as PHVS416 “Deucrictibant softgel capsules for oral use (PHVS416)” NCT05047185 ↗
Action Inhibit “Deucrictibant is an orally bioavailable bradykinin B2 receptor antagonist” PMID 41865747 ↗ Mar 2026
Modality Small molecule — CHEMBL5095506 ↗
Route Oral “deucrictibant soft capsules for oral use” NCT04618211 ↗