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NXY-059

Phase 3

Cerebral Stroke | Small molecule | Neurology |AstraZeneca PLC|Last Updated: Nov 15, 2010

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-BlindUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment4,900
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00119626Safety and Effectiveness of NXY-059 for the Treatment of Patients Who Have Suffered From a StrokePHASE3 COMPLETED 1,700Jun 1, 2003Feb 1, 2005Nov 15, 20102 Sweden, United Kingdom
NCT00061022Safety and Effectiveness of NXY-059 for the Treatment of Patients Who Have Suffered From a StrokePHASE3 COMPLETED 3,200May 1, 2003Sep 1, 2006Nov 15, 2010256 United States, Argentina +28
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Study Endpoints
Primary Endpoints
Global disability on modified Rankin scale at 90 days.
Secondary Endpoints
NIH stroke scale (termed "co-primary" in study protocol), Barthel Index, Stroke Impact Scale, EQ-5D all at 90 days, Safety outcomes.
NIH stroke scale
Barthel Index
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
NXY-059DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Males and females * Acute ischemic stroke with limb weakness, onset of symptoms within 6 hours * Full functional independence prior to the present stroke Exclusion Criteria: * Unconsciousness * Subjects who are unlikely to complete the infusion of investigational product and...

Countries:SwedenUnited KingdomUnited StatesArgentinaAustraliaAustriaBelgiumBrazilBulgariaCanadaChileChinaCzechiaFranceGermanyGreeceHong KongHungaryIsraelMexicoNew ZealandPhilippinesPolandPortugalRussiaSlovakiaSouth AfricaSouth KoreaSpainSwitzerlandTaiwan
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