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Deucrictibant

Phase 3

Hereditary Angioedema (HAE) | Small molecule | Other |Pharvaris N.V.|Last Updated: May 7, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment251
FDA Designations
ORPHAN_DRUG
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06679881Long-Term, Open-label Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAEPHASE3 RECRUITING 170Feb 1, 2025Dec 1, 2028May 7, 202662 United States, Argentina +20
NCT06669754Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAEPHASE3 ACTIVE NOT_RECRUITING 81Dec 1, 2024Aug 1, 2026Feb 13, 202656 United States, Argentina +22
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Study Endpoints
Primary Endpoints
Treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs), adverse events of special interest (AESIs), and TEAEs leading to study drug discontinuation
130 weeks
Change in heart rate
130 weeks
Change in blood pressure
130 weeks
Change in body temperature
130 weeks
Change in clinical laboratory tests from baseline
130 weeks

Hematology, blood chemistry, and urinalysis. Descriptive in nature, no formal statistical hypothesis testing will be performed.

Change in electrocardiograms (ECGs) from baseline
130 weeks

Digital triplicate 12-lead ECG. Descriptive in nature, no formal statistical hypothesis testing will be performed.

Time-normalized (per 4 weeks) number of Investigator-confirmed HAE attacks during the 24-week Treatment Period
24 weeks
Secondary Endpoints
Time-normalized number of Investigator-confirmed HAE attacks during the Treatment Period
130 weeks
Time-normalized number of Investigator-confirmed HAE attacks treated with on-demand medication during the Treatment Period
130 weeks
Time-normalized number of Investigator-confirmed moderate or severe HAE attacks during Treatment Period
130 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
DeucrictibantEXPERIMENTALDeucrictibant
ActiveEXPERIMENTALDeucrictibant 40mg extended-release tablet by mouth once daily
PlaceboEXPERIMENTALPlacebo 1 tablet by mouth once daily
Interventions
NameTypeDescription
DeucrictibantDRUGDeucrictibant extended-release tablet for once daily oral use
PlaceboDRUGPlacebo
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites62

Inclusion Criteria: 1. Provision of the signed ICF by the participant and/or legally designated representative. 2. Male or female, aged ≥12 years at the time of providing written informed consent/assent. 3. Diagnosis of hereditary angioedema (HAE) 4. For participants that did not participate in a p...

Countries:United StatesArgentinaAustraliaAustriaBrazilBulgariaCanadaChinaFranceGermanyHong KongHungaryIrelandItalyJapanPolandSlovakiaSouth AfricaSouth KoreaSpainTurkey (Türkiye)United KingdomNew ZealandPuerto RicoRomaniaSingaporeSwitzerland
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06679881primaryCompletionDate: changed
LOWMay 26, 2026NCT06669754primaryCompletionDate: changed
LOWMay 24, 2026NCT06679881studyFirstPostDate: changed
LOWMay 24, 2026NCT06669754studyFirstPostDate: changed