Recent Updates
Recently added Catalysts

Milvexian

Phase 3

Ischemic Stroke; Ischemic Attack, Transient | Small molecule | Neurology |Johnson & Johnson|Last Updated: Jun 5, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment12,532
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05702034A Study of Milvexian in Participants After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack- LIBREXIA-STROKEPHASE3 ACTIVE NOT_RECRUITING 12,532Feb 15, 2023Dec 9, 2026Jun 5, 2026880 United States, Argentina +45
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Time to First Occurrence of Ischemic Stroke
Up to global targeted endpoint date (approximately 41 months)

Time to first occurrence of ischemic stroke will be reported.

Secondary Endpoints
Time to First Occurrence of any Component of the Composite of Cardiovascular Death (CVD), Myocardial Infraction (MI), or Ischemic Stroke
Up to global targeted endpoint date (approximately 41 months)
Time to First Occurrence of Ischemic Stroke
Up to Day 90
Time to First Occurrence of any Component of Major Adverse Vascular Events (MAVE)
Up to global targeted endpoint date (approximately 41 months)
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MilvexianEXPERIMENTALParticipants after an acute ischemic stroke or high-risk transient ischemic attack (TIA) who are receiving antiplatelet therapy standard-of-care (SAPT \[single antiplatelet therapy\] or DAPT \[dual antiplatelet therapy\]) will receive milvexian 25 milligrams (mg), orally, twice daily.
PlaceboPLACEBO_COMPARATORParticipants after an acute ischemic stroke or high-risk TIA who are receiving antiplatelet therapy standard-of-care (SAPT or DAPT) will receive placebo orally twice daily.
Interventions
NameTypeDescription
MilvexianDRUGMilvexian will be administered orally.
PlaceboDRUGPlacebo will be administered orally
Unlock Study Design Details
Eligibility Criteria
Age Range40 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites880

Inclusion Criteria: * Ischemic Stroke: a neurological deficit attributable to an acute brain infarction and national institute of health stroke score scale (NIHSS) score less than or equal to (\<=) 7 and at least 1 of the following: persistent signs or symptoms of the ischemic event at the time of ...

Countries:United StatesArgentinaAustraliaAustriaBelgiumBrazilBulgariaCanadaChileChinaCroatiaCzechiaDenmarkEstoniaFinlandFranceGermanyGreeceHong KongHungaryIndiaIsraelItalyJapanLatviaLithuaniaMalaysiaMexicoNetherlandsNew ZealandPhilippinesPolandPortugalRomaniaSerbiaSingaporeSlovakiaSouth AfricaSouth KoreaSpainSwedenSwitzerlandTaiwanThailandTurkey (Türkiye)United KingdomVietnam
Unlock Eligibility Criteria
Recent Changes (Last 90 Days)
LOWJun 5, 2026NCT05702034lastUpdatePostDate: changed
LOWJun 5, 2026NCT05702034lastUpdatePostDate: changed
LOWJun 5, 2026NCT05702034lastUpdatePostDate: changed
LOWJun 5, 2026NCT05702034lastUpdatePostDate: changed
MEDIUMMay 26, 2026NCT05702034Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 24, 2026NCT05702034studyFirstPostDate: changed