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navenibart

Phase 3

Hereditary Angioedema (HAE) | Small molecule | Other |Astria Therapeutics, Inc.|Last Updated: Jun 5, 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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials2
Total Enrollment290
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07204938A Long-Term Study of Navenibart in Participants With Hereditary AngioedemaPHASE3 ENROLLING BY_INVITATION 145 — — Oct 1, 2025Dec 1, 2031Jun 2, 202628 United States, Brazil +12
NCT06842823A Study of Navenibart in Participants With Hereditary AngioedemaPHASE3 ENROLLING BY_INVITATION 145 — — Mar 20, 2025Sep 1, 2027Jun 5, 202686 United States, Australia +22
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Study Endpoints
Primary Endpoints
Incidence of treatment-emergent adverse events (TEAEs)
Day 1 through Month 48
Number of time-normalized investigator-confirmed HAE attacks during the 6-month Treatment Period.
Day 1 through Day 181
Secondary Endpoints
Number of time-normalized investigator-confirmed HAE attacks
Day 1 through Month 48
Number of moderate or severe investigator-confirmed HAE attacks
Day 1 through Month 48
Number of investigator-confirmed HAE attacks that require on-demand treatment
Day 1 through Month 48
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Adult Dosing Regimen 1EXPERIMENTALParticipants will receive 600 mg of navenibart every 3 months.
Adult Dosing Regimen 2EXPERIMENTALParticipants will receive 300 mg of navenibart every 3 months.
Adult Dosing Regimen 3EXPERIMENTALParticipants will receive 600 mg of navenibart every 6 months.
Adolescent Dosing Regimen 1EXPERIMENTALParticipants will receive 300 mg of navenibart every 3 months.
Adult Navenibart Dosing Regimen 1EXPERIMENTALParticipants will receive 600 mg of navenibart every 3 months.
Adult Navenibart Dosing Regimen 2EXPERIMENTALParticipants will receive 600 mg of navenibart on Day 1 and 300 mg every 3 months starting at month 3.
Adult Navenibart Dosing Regimen 3EXPERIMENTALParticipants will receive 600 mg of navenibart every 6 months.
Placebo (adult)PLACEBO_COMPARATORParticipants will receive placebo every 3 months.
Adolescent Navenibart Dosing Regimen 1EXPERIMENTALParticipants will receive 600 mg of navenibart on Day 1 and 300 mg every 3 months starting at month 3.
Interventions
NameTypeDescription
navenibartDRUGNavenibart will be administered as a subcutaneous injection.
PlaceboDRUGPlacebo will be administered as a subcutaneous injection.
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites28

Inclusion Criteria: 1\. Participants from STAR-0215-301 who met one of the following conditions: 1. Completed STAR-0215-301 through the Day 181 visit 2. Withdrew from STAR-0215-301 but met the following criteria: i. Received 2 doses of IP ii. completed ≥ 2 months of trial follow-up after the seco...

Countries:United StatesBrazilBulgariaCanadaGermanyHong KongIsraelJapanNetherlandsNorth MacedoniaPolandSouth AfricaSpainUnited KingdomAustraliaAustriaCzechiaFranceHungaryItalyNew ZealandPortugalPuerto RicoSouth Korea
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Competitive Landscape -Hereditary Angioedema 10 trials
CompanyTickerTrialsLead PhaseDrugs
Intellia Therapeutics, Inc.NTLA3PHASE3NTLA-2002, Normal Saline Administration, Biological NTLA-2002
BioCryst Pharmaceuticals, Inc.BCRX2PHASE3Berotralstat, berotralstat
Ionis Pharmaceuticals, Inc.IONS1PHASE3Donidalorsen
KalVista Pharmaceuticals, Inc.KALV1PHASE3KVD900, Drug: KVD900
Pharvaris N.V.PHVS1PHASE2deucrictibant
BioMarin Pharmaceutical Inc.BMRN1PHASE1Dose 1 of BMN 331
Astria Therapeutics, Inc.ATXS1PHASE2STAR-0215
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Recent Changes (Last 90 Days)
LOWJun 5, 2026NCT06842823Status: RECRUITING → ENROLLING_BY_INVITATION
LOWJun 5, 2026NCT06842823Status: RECRUITING → ENROLLING_BY_INVITATION
LOWJun 5, 2026NCT06842823Status: RECRUITING → ENROLLING_BY_INVITATION
LOWJun 5, 2026NCT06842823Status: RECRUITING → ENROLLING_BY_INVITATION
LOWJun 2, 2026NCT07204938lastUpdatePostDate: changed
LOWJun 2, 2026NCT07204938lastUpdatePostDate: changed
LOWJun 2, 2026NCT07204938lastUpdatePostDate: changed
LOWMay 26, 2026NCT06842823primaryCompletionDate: changed
LOWMay 26, 2026NCT07204938primaryCompletionDate: changed
LOWMay 24, 2026NCT06842823studyFirstPostDate: changed
LOWMay 24, 2026NCT07204938studyFirstPostDate: changed