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Zilebesiran

Phase 3

High Risk Cardiovascular Disease | Small molecule | Cardiovascular |Alnylam Pharmaceuticals, Inc.|Last Updated: May 14, 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_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment11,000
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07181109Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular DiseasePHASE3 RECRUITING 11,000Sep 22, 2025Sep 30, 2030May 14, 2026742 United States, Argentina +30
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Study Endpoints
Primary Endpoints
Time to First Occurrence of a Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Heart Failure (HF) Event (Hospitalization for HF or Urgent HF Visit)
Up to approximately 5 years
Secondary Endpoints
Change from Baseline in Mean Seated Office Systolic Blood Pressure (SBP) at Month 6
Baseline and Month 6
Time to First Occurrence of a Composite Endpoint of CV Death, Nonfatal MI, or Nonfatal Stroke
Up to approximately 5 years
Composite Endpoint of CV Death and Total (First and Subsequent) HF Events (Hospitalization for HF or Urgent HF Visit)
Up to approximately 5 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Zilebesiran 300 mgEXPERIMENTALParticipants will be administered 300 mg zilebesiran subcutaneously (SC) once every 6 months as add-on therapy to their standard of care antihypertensive medications.
PlaceboPLACEBO_COMPARATORParticipants will be administered placebo SC once every 6 months as add-on therapy to their standard of care antihypertensive medications.
Interventions
NameTypeDescription
ZilebesiranDRUGZilebesiran will be administered SC
PlaceboDRUGPlacebo will be administered SC
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites742

Inclusion Criteria: * Is 18 years or older for patients with established cardiovascular disease (CVD) * Is 55 years or older for patients with high risk for CVD * Has established CVD (defined as coronary, cerebrovascular, or peripheral artery disease) or high risk for CVD * Has treated hypertension...

Countries:United StatesArgentinaAustraliaAustriaBelgiumBrazilBulgariaCanadaChileChinaCzechiaDenmarkFranceGermanyGreeceHungaryItalyJapanNetherlandsNew ZealandPolandPortugalRomaniaSerbiaSlovakiaSouth AfricaSouth KoreaSpainSwedenTaiwanTurkey (Türkiye)United Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07181109primaryCompletionDate: changed
LOWMay 24, 2026NCT07181109studyFirstPostDate: changed