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laquinimod 0.3

Phase 2

Relapsing Remitting Multiple Sclerosis | Small molecule | Immunology |Teva Pharmaceutical Industries Limited|Last Updated: Apr 8, 2011

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 Trials1
Total Enrollment306
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00349193A Study to Evaluate the Effectiveness, Tolerability and Safety of LaquinimodPHASE2 COMPLETED 306Mar 1, 2005Aug 1, 2006Apr 8, 2011 -
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Study Endpoints
Primary Endpoints
Reduction of brain lesions in the last 4 months of the study
36 weeks
Secondary Endpoints
Relapse rate
36 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Laquinimod 0.3 mgACTIVE_COMPARATORLaquinimod 0.3 mg
Laquinimod 0.6 mgACTIVE_COMPARATORLaquinimod 0.6 mg
PlaceboPLACEBO_COMPARATORBlinded Placebo
Interventions
NameTypeDescription
laquinimod 0.3DRUGlaquinimod 0.3mg
laquinimod 0.6DRUGlaquinimod 0.6mg
PlaceboOTHERBlinded Placebo
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: 1. Willing and able to give written informed consent 2. Confirmed MS diagnosis as defined by the McDonald criteria 3. R-R MS disease course. 4. At least one gadolinium-enhanced lesion on screening MRI 5. Women of child-bearing potential must practice a reliable method of birth c...

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