Leflunomide
- Generic Name
- Leflunomide
- Brand Names
- Arava, Leflunomide medac, Leflunomide Zentiva (previously Leflunomide Winthrop), Leflunomide ratiopharm
- Drug Type
- Small Molecule
- Chemical Formula
- C12H9F3N2O2
- CAS Number
- 75706-12-6
- Unique Ingredient Identifier
- G162GK9U4W
- Background
Leflunomide is a pyrimidine synthesis inhibitor belonging to the DMARD (disease-modifying antirheumatic drug) class of drugs, which are chemically and pharmacologically very heterogeneous. Leflunomide was approved by FDA and in many other countries (e.g., Canada, Europe) in 1999.
- Indication
For the management of the signs and symptoms of active rheumatoid arthritis (RA) to improve physical function and to slow the progression of structural damage associated with the disease. Has also been used for the prevention of acute and chronic rejection in recipients of solid organ trasnplants and is designated by the FDA as an orphan drug for this use.
- Associated Conditions
- Juvenile Idiopathic Arthritis (JIA), Rheumatoid Arthritis
Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis.
- Conditions
- Rheumatoid Arthritis
- Interventions
- First Posted Date
- 2010-07-30
- Last Posted Date
- 2019-01-22
- Lead Sponsor
- P. Verschueren
- Target Recruit Count
- 400
- Registration Number
- NCT01172639
- Locations
- 🇧🇪
Reuma instituut Hasselt, Hasselt, Belgium
🇧🇪ZNA Jan Palfijn, Merksem, Belgium
🇧🇪Henri Serruys ziekenhuis, Oostende, Belgium
Leflunomide Versus Azathioprine for Maintenance Therapy of Lupus Nephritis
- First Posted Date
- 2010-07-29
- Last Posted Date
- 2010-08-11
- Lead Sponsor
- RenJi Hospital
- Target Recruit Count
- 200
- Registration Number
- NCT01172002
- Locations
- 🇨🇳
RenJi Hospital, ShangHai, Shanghai, China
To Demonstrate the Relative Bioavailability, Parallel Study Of Leflunomide 20 mg Tablets Under Fasting Conditions
- Conditions
- Rheumatoid ArthritisPsoriatic Arthritis
- Interventions
- First Posted Date
- 2009-07-27
- Last Posted Date
- 2017-03-28
- Lead Sponsor
- Sandoz
- Target Recruit Count
- 52
- Registration Number
- NCT00946686
Leflunomide 20 mg Tablets, Non-Fasting
- Conditions
- Healthy
- Interventions
- First Posted Date
- 2009-02-03
- Last Posted Date
- 2024-08-19
- Lead Sponsor
- Teva Pharmaceuticals USA
- Target Recruit Count
- 37
- Registration Number
- NCT00834405
- Locations
- 🇺🇸
Gateway Medical Research, Inc., Saint Charles, Missouri, United States
🇺🇸Bioassay Laboratory, Inc., Houston, Texas, United States
Leflunomide 20 mg Tablets Under Fasting Conditions
- Conditions
- Healthy
- Interventions
- Drug: ARAVA™ 20 mg Tablets
- First Posted Date
- 2009-02-03
- Last Posted Date
- 2024-08-20
- Lead Sponsor
- Teva Pharmaceuticals USA
- Target Recruit Count
- 84
- Registration Number
- NCT00834418
- Locations
- 🇺🇸
PRACS Institute, Ltd., Fargo, North Dakota, United States
Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid
- Conditions
- Bullous Pemphigoid
- First Posted Date
- 2008-12-04
- Last Posted Date
- 2008-12-04
- Lead Sponsor
- University Hospital, Limoges
- Target Recruit Count
- 54
- Registration Number
- NCT00802243
- Locations
- 🇫🇷
Bordeaux University Hospital, Pessac, France
🇫🇷Toulouse University Hospital, Toulouse, France
🇫🇷Limoges University Hospital, Limoges, France
BK Viremia After Renal Transplantation
- Conditions
- Terminal Renal FailureBK Virus Infection
- First Posted Date
- 2008-05-26
- Last Posted Date
- 2009-02-06
- Lead Sponsor
- Karolinska University Hospital
- Target Recruit Count
- 100
- Registration Number
- NCT00684372
- Locations
- 🇸🇪
Karolinska University Hospital, Stockholm, Sweden
Bioavailability Study of Leflunomide Tablets Under Fed Conditions
- Conditions
- To Determine Bioequivalence Under Fed Conditions
- Interventions
- First Posted Date
- 2008-04-04
- Last Posted Date
- 2017-09-26
- Lead Sponsor
- Par Pharmaceutical, Inc.
- Target Recruit Count
- 62
- Registration Number
- NCT00653003
Bioavailability Study of Leflunomide Tablets Under Fasting Conditions
- Conditions
- To Determine the Bioequivalence Study Under Fasting
- Interventions
- First Posted Date
- 2008-04-04
- Last Posted Date
- 2008-04-04
- Lead Sponsor
- Par Pharmaceutical, Inc.
- Target Recruit Count
- 52
- Registration Number
- NCT00652665
Leflunomide in Systemic Lupus Erythematosus
- Conditions
- Systemic Lupus Eythematosus (SLE)
- First Posted Date
- 2008-03-18
- Last Posted Date
- 2008-03-28
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 27
- Registration Number
- NCT00637819
- Locations
- 🇭🇰
Sanofi-Aventis, Hong Kong, Hong Kong
Drug Development Updates
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