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REGN7508

Phase 3

Atrial Fibrillation (AF) | Small molecule | Cardiovascular |Regeneron Pharmaceuticals, Inc.|Last Updated: Jun 4, 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-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials3
Total Enrollment19,192
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07626411Stroke and Systemic Embolism Prevention in Adult Participants With Atrial FibrillationPHASE3 NOT YET_RECRUITING 15,364Jul 31, 2026Dec 10, 2029Jun 4, 2026 -
NCT07430956Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation for Whom Oral Anticoagulation is UnsuitablePHASE3 RECRUITING 2,628Apr 3, 2026Jun 26, 2029May 29, 202613 United States
NCT07175428Safety in Adult Participants With Atrial Fibrillation Who Are Treated With AnticoagulationPHASE2 RECRUITING 1,200Oct 20, 2025Apr 21, 2027May 29, 202645 United States, Canada
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Study Endpoints
Primary Endpoints
Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type) or systemic embolism
Approximately 36 months
Time to first occurrence of International Society on Thrombosis and Haemostasis (ISTH) major bleeding or ISTH Clinically Relevant Non-Major (CRNM) bleeding
Approximately 36 months
Time to first occurrence of ischemic stroke or systemic embolism
Up to 36 months
Time to first occurrence of International Society on Thrombosis and Haemostasis (ISTH) major bleeding
Up to 36 months
Incidence of any bleeding
12 weeks

Defined as the composite of International Society on Thrombosis and Haemostasis (ISTH) major bleeding, ISTH Clinically Relevant Non-Major (CRNM) bleeding, or minor bleeding

Secondary Endpoints
Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type), systemic embolism, ISTH major bleeding, or ISTH CRNM bleeding
Approximately 36 months
Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type), systemic embolism, or ISTH major bleeding
Approximately 36 months
Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type), systemic embolism, ISTH major bleeding, or all-cause death
Approximately 36 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
REGN7508 + PlaceboEXPERIMENTAL -
Apixaban + PlaceboACTIVE_COMPARATOR -
REGN7508EXPERIMENTAL -
REGN9933EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
ApixabanACTIVE_COMPARATOR -
Interventions
NameTypeDescription
REGN7508DRUGAdministered per the protocol
ApixabanDRUGAdministered per the protocol
PlaceboDRUGAdministered per the protocol
REGN9933DRUGAdministered per the protocol
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Key Inclusion Criteria: 1. Has AF or flutter (paroxysmal or persistent), not considered to be secondary to a reversible cause, and an indication for indefinite anticoagulation treatment as described in the protocol 2. Meets one of the following: 1. CHA2DS2-VA \[C: Congestive heart failure; H: H...

Countries:United StatesCanada
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Recent Changes (Last 90 Days)
LOWJun 4, 2026NCT07626411NEW_TRIAL: changed
LOWJun 4, 2026NCT07626411NEW_TRIAL: changed
LOWJun 4, 2026NCT07626411NEW_TRIAL: changed
LOWJun 4, 2026NCT07626411NEW_TRIAL: changed
LOWMay 29, 2026NCT07175428lastUpdatePostDate: changed
LOWMay 29, 2026NCT07430956lastUpdatePostDate: changed
LOWMay 29, 2026NCT07175428lastUpdatePostDate: changed
LOWMay 29, 2026NCT07430956lastUpdatePostDate: changed
LOWMay 29, 2026NCT07175428lastUpdatePostDate: changed
LOWMay 29, 2026NCT07430956lastUpdatePostDate: changed
LOWMay 26, 2026NCT07175428primaryCompletionDate: changed
LOWMay 26, 2026NCT07430956Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 24, 2026NCT07175428studyFirstPostDate: changed
LOWMay 24, 2026NCT07430956studyFirstPostDate: changed