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Leflunomide

Phase 1

Rheumatoid Arthritis | Small molecule | Immunology |Novartis AG|Last Updated: Mar 28, 2017

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
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment52
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00946686To Demonstrate the Relative Bioavailability, Parallel Study Of Leflunomide 20 mg Tablets Under Fasting ConditionsPHASE1 COMPLETED 52Sep 1, 2002Sep 1, 2002Mar 28, 2017 -
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Study Endpoints
Primary Endpoints
Bioequivalence based on AUC and Cmax
11 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALLeflunomide 20 mg Tablets (Geneva Pharmaceutical)
2ACTIVE_COMPARATORArava 20 mg Tablets (Aventis Pharmaceutical, Inc.)
Interventions
NameTypeDescription
Leflunomide 20 mg Tablets (Geneva Pharmaceutical)DRUG -
Arava 20 mg Tablets (Aventis Pharmaceutical, Inc.)DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes

Inclusion Criteria: * No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: * Positive test results for HIV or hepatitis B or C. * Treatment for drug or alcohol dependence.

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