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CV-18C3

Phase 2

Patients Undergoing Repeat Peripheral Artery Revascularization | Small molecule | Cardiovascular |Johnson & Johnson|Last Updated: Mar 30, 2025

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
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment43
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01270945Safety and Preliminary Efficacy Study of an Anti-inflammatory Therapeutic Antibody in Reducing Restenosis.PHASE2 COMPLETED 43Jun 30, 2011Apr 30, 2014Mar 30, 20258 United States
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Study Endpoints
Primary Endpoints
Safety and tolerability of CV-18C3
1 year

adverse events, vitals signs, physical examination results and clinical laboratory values

Secondary Endpoints
Time to restenosis and restenosis rates compared between CV-18C3 and controls
1 year
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CV-18C3 and standard of careEXPERIMENTALCV-18C3 and standard of care
standard of careACTIVE_COMPARATORPercutaneous revascularization
Interventions
NameTypeDescription
CV-18C3DRUG3.75mg/kg given IV for a period of 6 weeks, followed by subcutaneous administration
Standard of CarePROCEDURE -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Have suspected superficial femoro-popliteal artery occlusion due to lower extremity pain with exercise or at rest and are undergoing a planned arteriogram. * Subjects will be randomized after angiographic evidence of qualifying lesion Exclusion Criteria: * Acute critical lim...

Countries:United States
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