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Synvisc

Phase 3

Osteoarthritis | Unknown | Musculoskeletal |Sanofi|Last Updated: Sep 10, 2019

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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials3
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00131300A Study of the Safety and Efficacy of Synvisc in Patients With Symptomatic Shoulder OsteoarthritisPHASE3 COMPLETED -Apr 1, 2004Feb 1, 2006Mar 18, 20156 France, Germany
NCT00131768A Study of the Safety and Efficacy of Synvisc in Patients With Symptomatic Ankle OsteoarthritisPHASE3 COMPLETED -Nov 1, 2003Feb 1, 2006Mar 18, 20155 Germany, Italy +1
NCT00949494Effects of Synvisc on Cartilage in Knee Osteoarthritis (OA)PHASE1 COMPLETED 30Sep 1, 2006Feb 1, 2009Sep 10, 20192 United States
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Study Endpoints
Primary Endpoints
Pain relief
Percent change in dGEMRIC Index (T1(Gd)) in femoral and tibial compartments
3 and 6 months
Secondary Endpoints
Subjects' global assessment of disease using a 10 point Likert scale
3 and 6 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SynviscACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
Synvisc (hylan G-F 20)DEVICE -
SynviscDEVICEintra-articular, 3 weekly injections
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Patients with symptomatic OA pain of shoulder (gleno-humeral) Exclusion Criteria: * Patients with current or prior conditions or treatment that would impede measurement of efficacy or safety

Countries:FranceGermanyItalyNetherlandsUnited States
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