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REGN7508

Phase 3

Atrial Fibrillation (AF) | Small molecule | Cardiovascular |Regeneron Pharmaceuticals, Inc.|Last Updated: Jul 23, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials3
Total Enrollment19,192
FDA Designations
No designations recorded
Clinical trial landscape

REGN7508 · 11 trials · 7 indications

Phase 3 8Phase 2 2Phase 1 1
NCT07697599Venous Thromboembolism (VTE) Prophylaxis With REGN7508 and REGN9933 in Adult and Adolescent Participants With a Peripherally Inserted Central Catheter (PICC)Venous Thromboembolism (VTE)
NOT YET_RECRUITING1,908 Analytics
NCT07626411Stroke and Systemic Embolism Prevention in Adult Participants With Atrial FibrillationAtrial Fibrillation (AF)
NOT YET_RECRUITING15,364 Analytics
NCT07318610Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery DiseasePeripheral Artery Disease (PAD)
RECRUITING7,050 Analytics
NCT07493304Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic CancersVenous Thromboembolism (VTE)
RECRUITING1,600 Analytics
NCT07430956Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation for Whom Oral Anticoagulation is UnsuitableAtrial Fibrillation (AF)
RECRUITING2,628 Analytics
NCT07410117REGN7508 in Adult Participants for Prevention of Cancer-Associated ThrombosisCancer-Associated Thrombosis (CAT)
RECRUITING1,120 Analytics
NCT07213778REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult ParticipantsSymptomatic Venous Thromboembolism (VTE)
RECRUITING2,000 Analytics
NCT07015905REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in AdultsVenous Thromboembolism (VTE)
RECRUITING2,000 Analytics
PHASE3NOT YET_RECRUITING
Venous Thromboembolism (VTE) Prophylaxis With REGN7508 and REGN9933 in Adult and Adolescent Participants With a Peripherally Inserted Central Catheter (PICC)
Venous Thromboembolism (VTE)Unlock trial analytics
PHASE3NOT YET_RECRUITING
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
Atrial Fibrillation (AF)Unlock trial analytics
PHASE3RECRUITING
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)Unlock trial analytics
PHASE3RECRUITING
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)Unlock trial analytics
PHASE3RECRUITING
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation for Whom Oral Anticoagulation is Unsuitable
Atrial Fibrillation (AF)Unlock trial analytics
PHASE3RECRUITING
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)Unlock trial analytics
PHASE3RECRUITING
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)Unlock trial analytics
PHASE3RECRUITING
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)Unlock trial analytics
Study Endpoints
Primary Endpoints
Time-to-first event of centrally adjudicated VTE [symptomatic VTE or incidental VTE or asymptomatic VTE]
Approximately 6 months
Time-to-first event of centrally adjudicated International Society on Thrombosis and Haemostasis (ISTH)-defined major bleeding or Clinically Relevant Non-Major (CRNM) bleeding
Approximately 6 months
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 a major thrombotic vascular event, consisting of Acute Limb Ischemia (ALI), major amputation (above the ankle) of vascular etiology, Myocardial Infarction (MI), ischemic stroke, or Cardiovascular (CV) death
Approximately up to 42 months

Cohort 1

Time-to-first occurrence of International Society of Thrombosis and Hemostasis (ISTH) major or Clinically Relevant Non-major (CRNM) bleeding
Approximately up to 42 months

Cohort 1 and 2

Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Approximately 6 months

Part 1

Severity of TEAEs
Approximately 6 months

Part 1

Time-to-first event of centrally adjudicated recurrent VTE [DVT (symptomatic or asymptomatic [proximal] or Non-fatal PE (symptomatic or asymptomatic [in a segmental or larger pulmonary artery] )or VTE-related death)]
Up to approximately 3.5 years

Part 2

Time-to-first event of centrally adjudicated International Society of Thrombosis and Hemostasis (ISTH)-defined major bleeding or Clinically Relevant Non-Major (CRNM) bleeding
Up to approximately 3.5 years

Part 2

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
Time-to-first event of centrally adjudicated VTE (DVT, PE) or ATE, or thromboembolism- or ATE-related death
Through 6 months
Time-to-first event of centrally adjudicated International Society of Thrombosis and Hemostasis (ISTH) major bleeding or Clinically Relevant Non-Major (CRNM) bleeding
Through 6 months
Incidence of the composite endpoint of symptomatic VTE and all-cause death
Through day 30 visit
Incidence of the composite endpoint of asymptomatic or symptomatic Venous Thromboembolism (VTE) [including VTE-related death]
Through day 12 visit, approximately 14 days
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

Percentage of Participants With Confirmed, Adjudicated Venous Thromboembolism (VTE)
Through day 12

Composite endpoint that includes asymptomatic deep DVT (deep venous thrombosis) detected by unilateral venography of the operated leg; confirmed symptomatic DVT of either leg; confirmed fatal or nonfatal pulmonary embolism (PE) including unexplained death for which PE cannot be ruled out.

Incidences of treatment-emergent adverse events (TEAE)
Up to 36 days

Treatment-emergent adverse events are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the on-treatment period.

Severity of TEAE
Up to 36 days

Treatment-emergent adverse events are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the on-treatment period.

Secondary Endpoints
Time-to-first event of centrally adjudicated symptomatic VTE [symptomatic Deep Vein Thrombosis (DVT) or symptomatic non-fatal Pulmonary Embolism (PE) or VTE-related death]
Approximately 6 months
Time-to-first event of symptomatic DVT
Approximately 6 months
Time-to-first event of symptomatic non-fatal PE
Approximately 6 months
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
REGN7508EXPERIMENTAL -
REGN9933EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
REGN7508 + PlaceboEXPERIMENTAL -
Apixaban + PlaceboACTIVE_COMPARATOR -
Cohort 1EXPERIMENTAL -
Cohort 2EXPERIMENTAL -
ApixabanACTIVE_COMPARATOR -
REGN7508 and PlaceboEXPERIMENTAL -
Placebo and ASAACTIVE_COMPARATOR -
IV REGN7508EXPERIMENTAL -
IV Placebo, SC REGN7508EXPERIMENTAL -
IV Placebo, apixabanACTIVE_COMPARATOR -
IV Placebo, enoxaparinACTIVE_COMPARATOR -
EnoxaparinACTIVE_COMPARATOR -
Cohort 1 Lowest IV DoseEXPERIMENTALRandomized 3:1
Cohort 2 Low IV DoseEXPERIMENTALRandomized 3:1
Cohort 3 Mid IV DoseEXPERIMENTALRandomized 3:1
Cohort 4 High IV DoseEXPERIMENTALRandomized 3:1
Cohort 5 Higher IV DoseEXPERIMENTALRandomized 3:1
Cohort 6 High SC DoseEXPERIMENTALRandomized 3:1
Cohort 7 Higher SC DoseEXPERIMENTALRandomized 3:1
Optional: Cohort 8 Highest IV or SC DoseEXPERIMENTALRandomized 3:1
Cohort 9 High SC DoseEXPERIMENTALRandomized 3:1
Optional: Cohort 10 Highest SC DoseEXPERIMENTALRandomized 3:1
Interventions
NameTypeDescription
REGN7508DRUGAdministered per the protocol
REGN9933DRUGAdministered per the protocol
PlaceboDRUGAdministered per the protocol
ApixabanDRUGAdministered per the protocol
RivaroxabanDRUGAdministered per the protocol
Acetylsalicylic Acid (ASA)DRUGAdministered per the protocol
EnoxaparinDRUGAdministered per the protocol
REGN7508 (IV)DRUGAdministered sequential, ascending single intravenous (IV) dose
REGN7508 (SC)DRUGAdministered sequential, ascending single subcutaneous (SC) dose
Matching Placebo (IV)DRUGAdministered sequential, ascending single intravenous (IV) dose
Matching Placebo (SC)DRUGAdministered sequential, ascending single subcutaneous (SC) dose
Unlock Study Design Details
Eligibility Criteria
Age Range15 Years to N/A
SexALL
Healthy VolunteersNo

Key Inclusion Criteria: 1. Is undergoing PICC placement for Intravenous (IV) administration of clinically indicated medications, including chemotherapy, antibiotics, TPN, and/or other indications as described in the protocol 2. Has Eastern Cooperative Oncology Group Performance (ECOG) Status ≤3 or ...

Countries:United StatesGeorgiaJapanGreeceMalaysiaMoldovaBulgariaHungaryLatviaLithuaniaPolandRomaniaArgentinaBrazilCanadaUnited Kingdom
Unlock Eligibility Criteria
Recent Changes (Last 90 Days)
LOWJul 24, 2026NCT07175428lastUpdatePostDate: changed
LOWJul 24, 2026NCT07175428lastUpdatePostDate: changed
LOWJul 22, 2026NCT07410117lastUpdatePostDate: changed
LOWJul 22, 2026NCT07213778lastUpdatePostDate: changed
LOWJul 22, 2026NCT07410117lastUpdatePostDate: changed
LOWJul 22, 2026NCT07213778lastUpdatePostDate: changed
LOWJul 13, 2026NCT07697599NEW_TRIAL: changed
LOWJul 13, 2026NCT07015905lastUpdatePostDate: changed
LOWJul 13, 2026NCT07697599NEW_TRIAL: changed
LOWJul 13, 2026NCT07015905lastUpdatePostDate: changed
LOWJul 10, 2026NCT07318610startDate: changed
LOWJul 10, 2026NCT07318610startDate: changed
LOWJul 9, 2026NCT07213778lastUpdatePostDate: changed
LOWJul 9, 2026NCT07213778lastUpdatePostDate: changed
LOWJul 8, 2026NCT07175428lastUpdatePostDate: changed
LOWJul 8, 2026NCT07175428lastUpdatePostDate: changed
MEDIUMJun 27, 2026NCT06454630TRIAL_REMOVED: changed
MEDIUMJun 27, 2026NCT06454630TRIAL_REMOVED: changed
LOWJun 23, 2026NCT07430956lastUpdatePostDate: changed
LOWJun 23, 2026NCT07430956lastUpdatePostDate: changed