Leflunomide

Generic Name: Leflunomide

Brand Names: Arava, Leflunomide medac, Leflunomide Zentiva (previously Leflunomide Winthrop), Leflunomide ratiopharm

Drug Type: Small Molecule

Chemical Formula: C_₁₂H_₉F_₃N_₂O_₂

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: -

Clinical Trials

Bioavailability Study of Leflunomide Tablets Under Fed Conditions

Phase 1

Completed

Conditions: To Determine Bioequivalence Under Fed Conditions

Interventions: Drug: Leflunomide
Drug: ARAVA

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

Phase 1

Completed

Conditions: To Determine the Bioequivalence Study Under Fasting

Interventions: Drug: Leflunomide
Drug: ARAVA

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

Phase 2

Completed

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

Phase 3

Completed

Conditions: Arthritis, Rheumatoid

Interventions: Drug: leflunomide

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

Phase 3

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Methotrexate-Sulfasalazine-Hydroxychloroquine
Drug: Leflunomide-Sulfasalazine-Hydroxychloroquine
Drug: 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

Phase 4

Completed

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)

Phase 3

Terminated

Conditions: Rheumatoid Arthritis

Interventions: Drug: Leflunomide
Drug: Methotrexate
Drug: Ocrelizumab
Drug: Placebo

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

and more 261 locations

Objective Study in Rheumatoid Arthritis

Phase 4

Completed

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

Phase 4

Completed

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

Lupus Immunosuppressive/Immunomodulatory Therapy or Stem Cell Transplant (LIST)

Phase 2

Withdrawn

Conditions: Systemic Lupus Erythematosus

Interventions: Procedure: Plasmapheresis
Procedure: Leukapheresis
Drug: Rabbit anti-thymocyte globulin
Procedure: Non-myeloablative high dose immunosuppressive therapy conditioning (HDIT)
Procedure: Autologous CD34+HPC transplantation (HSCT)
Drug: Methylprednisolone
Drug: Growth colony stimulating factor (G-CSF)
Drug: Corticosteroids
Drug: Mycophenolate mofetil
Drug: Azathioprine
Drug: Intravenous immunoglobulin
Drug: Methotrexate
Drug: Rituximab
Drug: Leflunomide

First Posted Date: 2005-09-30

Last Posted Date: 2013-02-01

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Registration Number: NCT00230035

Locations: 🇺🇸
Duke University Medical Center, Durham, North Carolina, United States
🇺🇸
UCSD, Thornton Hospital, La Jolla, California, United States
🇺🇸
Northwestern University, Chicago, Illinois, United States

and more 2 locations

Drug Development Updates

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