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
- Associated Therapies
- -
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
Leflunomide EfficAcy Response Related to Dosing Regimen in Early Rheumatoid Arthritis
- First Posted Date
- 2008-01-16
- Last Posted Date
- 2010-10-13
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 124
- Registration Number
- NCT00596206
- Locations
- 🇷🇴
Sanofi-Aventis Administrative Office, Bucuresti, Romania
Triple III Comparison of Leflunomide Alone Versus Two DMARD Combinations in the Treatment of Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis
- Interventions
- Drug: Methotrexate-Sulfasalazine-HydroxychloroquineDrug: Leflunomide-Sulfasalazine-HydroxychloroquineDrug: Leflunomide
- First Posted Date
- 2007-12-24
- Last Posted Date
- 2023-10-02
- Lead Sponsor
- University of Nebraska
- Target Recruit Count
- 69
- Registration Number
- NCT00579878
- Locations
- 🇺🇸
University of Nebraska Medical Center, Omaha, Nebraska, United States
Leflunomide + Methotrexate in Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis
- First Posted Date
- 2007-11-26
- Last Posted Date
- 2007-12-05
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 74
- Registration Number
- NCT00563849
- Locations
- 🇰🇷
Sanofi-Aventis, Pusan, Korea, Republic of
A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Don't Have a Response to Anti-TNF-α Therapy (SCRIPT)
- Conditions
- Rheumatoid Arthritis
- Interventions
- First Posted Date
- 2007-05-22
- Last Posted Date
- 2019-08-12
- Lead Sponsor
- Genentech, Inc.
- Target Recruit Count
- 836
- Registration Number
- NCT00476996
- Locations
- 🇺🇸
Pinnacle Research Group; Llc, Central, Anniston, Alabama, United States
🇺🇸Center For Arthritis & Osteoporosis, Elizabethtown, Kentucky, United States
🇺🇸Arthritis Consultants, Saint Louis, Missouri, United States
Objective Study in Rheumatoid Arthritis
- Conditions
- Arthritis, Rheumatoid
- First Posted Date
- 2007-03-26
- Last Posted Date
- 2008-09-05
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 249
- Registration Number
- NCT00451971
- Locations
- 🇦🇺
Sanofi-Aventis, Sydney, Australia
Leflunomide in Rheumatoid Arthritis
- Conditions
- Arthritis, Rheumatoid
- First Posted Date
- 2006-01-23
- Last Posted Date
- 2011-01-11
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 60
- Registration Number
- NCT00280644
- Locations
- 🇹🇷
Sanofi-Aventis, Istanbul, Turkey
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.