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Hylastan

Phase 3

Osteoarthritis, Knee | Unknown | Musculoskeletal |Sanofi|Last Updated: Feb 5, 2014

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 Trials1
Total Enrollment -
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00139295Comparison of Hylastan to Methylprednisolone Acetate in Patients With Symptomatic Osteoarthritis of the KneePHASE3 COMPLETED -Oct 1, 2004Sep 1, 2007Feb 5, 201424 United States, Canada +3
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Study Endpoints
Primary Endpoints
pain relief
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
HylastanDEVICE -
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Eligibility Criteria
Age Range40 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion Criteria: * Diagnosed with OA of the knee * Have tried but not been sufficiently helped by conservative treatment, such as weight reduction and pain medications Exclusion Criteria: * Prior or concomitant treatments that would impede measurement of safety and efficacy

Countries:United StatesCanadaFranceGermanyUnited Kingdom
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