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Abelacimab

Phase 3

Atrial Fibrillation (AF) | Monoclonal antibody | Cardiovascular |Novartis AG|Last Updated: Mar 31, 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_CONTROLLEDDMC
Total Trials1
Total Enrollment1,900
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05712200Study to evaLuate the effIcacy and Safety of abeLacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral antiCoagulation (LILAC-TIMI 76)PHASE3 RECRUITING 1,900Dec 27, 2022Oct 31, 2026Mar 31, 2026734 United States, Argentina +32
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Study Endpoints
Primary Endpoints
Efficacy: Time to first event of ischemic stroke or systemic embolism (SE)
Up to 30 months
Safety: Time to first occurrence of Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding
Up to 30 months
Secondary Endpoints
Efficacy: Time to first event of ischemic stroke, systemic embolism (SE), myocardial infarctions (MI), venous thromboembolism (VTE), or acute limb ischemia
Up to 30 months
Efficacy: Time to first event of ischemic stroke, systemic embolism (SE), or Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding event
Up to 30 months
Efficacy: Cardiovascular (CV) mortality
Up to 30 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Abelacimab (MAA868)EXPERIMENTALPatients will be randomized in a 1:1 ratio to receive abelacimab 150 mg subcutaneous (SC) or matching placebo once monthly.
PlaceboPLACEBO_COMPARATORPatients will be randomized in a 1:1 ratio to receive abelacimab 150 mg subcutaneous (SC) or matching placebo once monthly.
Interventions
NameTypeDescription
AbelacimabBIOLOGICALAbelacimab provided as liquid in vial (150 mg/mL)
PlaceboDRUGDosage Formulation: Liquid (in vial) Dose Strength: Placebo to Abelacimab
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Eligibility Criteria
Age Range65 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites734

Inclusion Criteria: * Patient is able to understand and has provided written informed consent to participate in the trial * Diagnosed Atrial Fibrillation (AF) or atrial flutter (documented on an electrocardiogram (ECG) or monitor recording) * Age 65-74 and a CHA2DS2VASc ≥4 OR age ≥75 and a CHA2DS2V...

Countries:United StatesArgentinaBrazilBulgariaCanadaChileChinaColombiaCroatiaCzechiaEstoniaFinlandGermanyGreeceHungaryIndiaIsraelItalyJapanLatviaMalaysiaMexicoPeruPhilippinesPolandRomaniaSerbiaSlovakiaSouth AfricaSouth KoreaSpainSwedenTurkey (Türkiye)United Kingdom
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