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Leflunomide

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment52

FDA Designations

No designations recorded

Clinical trial landscape

Leflunomide · 1 trial · 2 indications

Phase 1 1
NCT00946686To Demonstrate the Relative Bioavailability, Parallel Study Of Leflunomide 20 mg Tablets Under Fasting ConditionsRheumatoid Arthritis
COMPLETED52 Analytics
PHASE1COMPLETED
To Demonstrate the Relative Bioavailability, Parallel Study Of Leflunomide 20 mg Tablets Under Fasting Conditions
Rheumatoid ArthritisUnlock trial analytics

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 to 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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Frequently asked questions about Leflunomide

What is Leflunomide used for?

Leflunomide is a small molecule being developed for the treatment of rheumatoid arthritis. It is also being studied in psoriatic arthritis. The drug is currently in Phase 1 clinical development and is being developed by Novartis AG.

Who makes Leflunomide?

Leflunomide is being developed by Novartis AG, which is publicly traded under the ticker symbol NVS. The drug is a small molecule in the immunology therapeutic area, currently in Phase 1 clinical development for rheumatoid arthritis.

What phase is Leflunomide in?

Leflunomide is in Phase 1 clinical development. It is an investigational drug being studied for rheumatoid arthritis. The drug has completed one Phase 1 clinical trial, and it is not yet approved by regulatory authorities.

What clinical trials is Leflunomide in?

Leflunomide has one completed clinical trial registered as NCT00946686. This Phase 1 study, titled "To Demonstrate the Relative Bioavailability, Parallel Study Of Leflunomide 20 mg Tablets Under Fasting Conditions," enrolled 52 participants and was an active-controlled, randomized trial.

Is Leflunomide the same as Arava?

Leflunomide is the generic name for the drug also known as Arava. It is being developed by Novartis AG for rheumatoid arthritis. The drug is currently in Phase 1 clinical development and is not yet approved.