Recent Updates
Recently added Catalysts

Cenvacibart

Phase 3

Secondary Stroke | Small molecule | Neurology |Regeneron Pharmaceuticals, Inc.|Trials Updated: Oct 15, 2026

Cenvacibart development status

Highest phase Phase 3
Registered trials 15 across 1 sponsor since Mar 2024

Cenvacibart target and mechanism

ModalitySmall molecule

Also known as REGN7508

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials11
Total Enrollment41,155

FDA Designations

No designations recorded

Cenvacibart clinical trials

Cenvacibart · 11 trials · 7 indications

Phase 3 9Phase 2 2
NCT07876492A Study to Evaluate Cenvacibart (REGN7508) for Secondary Stroke Prevention in Adult ParticipantsSecondary Stroke
NOT YET_RECRUITING6,106 Analytics
NCT07697599Venous Thromboembolism (VTE) Prophylaxis With REGN7508 and REGN9933 in Adult and Adolescent Participants With a Peripherally Inserted Central Catheter (PICC)Venous Thromboembolism (VTE)
RECRUITING1,908 Analytics
NCT07493304Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic CancersVenous Thromboembolism (VTE)
RECRUITING1,600 Analytics
NCT07626411Stroke and Systemic Embolism Prevention in Adult Participants With Atrial FibrillationAtrial Fibrillation (AF)
RECRUITING15,364 Analytics
NCT07318610Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery DiseasePeripheral Artery Disease (PAD)
RECRUITING7,050 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
A Study to Evaluate Cenvacibart (REGN7508) for Secondary Stroke Prevention in Adult Participants
Secondary Stroke
NCT078764926,106
Unlock trial analytics
PHASE3RECRUITING
Venous Thromboembolism (VTE) Prophylaxis With REGN7508 and REGN9933 in Adult and Adolescent Participants With a Peripherally Inserted Central Catheter (PICC)
Venous Thromboembolism (VTE)
NCT076975991,908
Unlock trial analytics
PHASE3RECRUITING
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
NCT074933041,600
Unlock trial analytics
PHASE3RECRUITING
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
Atrial Fibrillation (AF)
NCT0762641115,364
Unlock trial analytics
PHASE3RECRUITING
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
NCT073186107,050
Unlock trial analytics
PHASE3RECRUITING
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation for Whom Oral Anticoagulation is Unsuitable
Atrial Fibrillation (AF)
NCT074309562,628
Unlock trial analytics
PHASE3RECRUITING
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
NCT074101171,120
Unlock trial analytics
PHASE3RECRUITING
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
NCT072137782,000
Unlock trial analytics
PHASE3RECRUITING
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
NCT070159052,000
Unlock trial analytics

Study Endpoints

Primary Endpoints

Time to first occurrence of ischemic stroke
Approximately 33 months
Time to first occurrence of International Society on Thrombosis and Haemostasis (ISTH) major bleeding
Approximately 33 months
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
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 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

Time to first occurrence of ischemic stroke or systemic embolism
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.

Secondary Endpoints

Total (first and subsequent) ischemic strokes
Approximately 33 months
Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type)
Approximately 33 months
Time to first occurrence of disabling stroke (ischemic, hemorrhagic, or of unspecified type)
Approximately 33 months
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
CenvacibartEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
REGN7508EXPERIMENTAL -
REGN9933EXPERIMENTAL -
ApixabanACTIVE_COMPARATOR -
REGN7508 + PlaceboEXPERIMENTAL -
Apixaban + PlaceboACTIVE_COMPARATOR -
Cohort 1EXPERIMENTAL -
Cohort 2EXPERIMENTAL -
REGN7508 and PlaceboEXPERIMENTAL -
Placebo and ASAACTIVE_COMPARATOR -
IV REGN7508EXPERIMENTAL -
IV Placebo, SC REGN7508EXPERIMENTAL -
IV Placebo, apixabanACTIVE_COMPARATOR -
IV Placebo, enoxaparinACTIVE_COMPARATOR -
EnoxaparinACTIVE_COMPARATOR -

Interventions

NameTypeDescription
CenvacibartDRUGAdministered per the protocol
PlaceboDRUGAdministered per the protocol
REGN7508DRUGAdministered per the protocol
REGN9933DRUGAdministered per the protocol
ApixabanDRUGAdministered per the protocol
RivaroxabanDRUGAdministered per the protocol
Acetylsalicylic Acid (ASA)DRUGAdministered per the protocol
EnoxaparinDRUGAdministered per the protocol
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Key Inclusion Criteria: 1. Has a recent onset of neurological deficit attributed to non-cardioembolic focal brain ischemia as described in the protocol 2. Has index event (non-cardioembolic, non-procedural ischemic stroke, or high-risk TIA) within 30 days prior to randomization as described in the ...

Countries:GeorgiaUnited StatesBulgariaJapanRomaniaSouth KoreaCanadaGreeceMalaysiaMoldovaSpainHungaryLatviaLithuaniaPolandArgentinaBrazil
Unlock Eligibility Criteria

Recent Changes (Last 90 Days)

LOWOct 15, 2026NCT07876492NEW_TRIAL: changed
LOWOct 15, 2026NCT07318610lastUpdatePostDate: changed
LOWOct 15, 2026NCT07876492NEW_TRIAL: changed
LOWOct 15, 2026NCT07318610lastUpdatePostDate: changed
LOWOct 14, 2026NCT07430956lastUpdatePostDate: changed
LOWOct 14, 2026NCT07430956lastUpdatePostDate: changed
LOWOct 13, 2026NCT07410117lastUpdatePostDate: changed
LOWOct 13, 2026NCT07410117lastUpdatePostDate: changed
LOWOct 9, 2026NCT07175428lastUpdatePostDate: changed
LOWOct 9, 2026NCT07175428lastUpdatePostDate: changed
LOWOct 8, 2026NCT07626411lastUpdatePostDate: changed
LOWOct 8, 2026NCT07213778lastUpdatePostDate: changed
LOWOct 8, 2026NCT07015905lastUpdatePostDate: changed
LOWOct 8, 2026NCT07626411lastUpdatePostDate: changed
LOWOct 8, 2026NCT07213778lastUpdatePostDate: changed
LOWOct 8, 2026NCT07015905lastUpdatePostDate: changed
LOWSep 29, 2026NCT07410117lastUpdatePostDate: changed
LOWSep 29, 2026NCT07697599Status: NOT_YET_RECRUITING → RECRUITING
LOWSep 29, 2026NCT07410117lastUpdatePostDate: changed
LOWSep 29, 2026NCT07697599Status: NOT_YET_RECRUITING → RECRUITING

Explore more on BiopharmaWatch

Regeneron Pharmaceuticals, Inc. (REGN)Pipeline, catalysts, financials, insiders and newsBiotech disease mapWho is developing what in each indication, and how crowded it isFDA calendarUpcoming PDUFA dates, AdComs and approval oddsPDUFA calendarEvery scheduled FDA decision date, month by monthHistorical FDA calendarPast decisions and how the stock moved on eachCatalyst SyncUpcoming readouts and decisions, screened by runway and phaseBiotech stock screenerFilter by clinical phase, cash runway and market capDrugs A to ZEvery drug page starting with CCompanies A to ZEvery biotech and pharma company we track