MedPath

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
Clinical Trials
Related News

Leflunomide in Combination With Decitabine for Treatment of Relapsed or Refractory Myelodysplastic Syndromes

Phase 1
Not yet recruiting
Conditions
Myelodysplastic Syndromes
Interventions
Drug: Leflunomide 10mg
First Posted Date
2025-04-11
Last Posted Date
2025-04-11
Lead Sponsor
West Virginia University
Target Recruit Count
26
Registration Number
NCT06923488
Locations
🇺🇸

West Virginia University Cancer Institute, Morgantown, West Virginia, United States

A Study of the Effectiveness of Additional Risk Minimization Measures Related to ARAVA® (Leflunomide) in Saudi Arabia

Not yet recruiting
Conditions
Rheumatoid Arthritis
Psoriatic Arthritis
Interventions
First Posted Date
2024-12-03
Last Posted Date
2025-04-30
Lead Sponsor
Sanofi
Target Recruit Count
3500
Registration Number
NCT06714461
Locations
🇫🇷

Sanofi-Aventis, Chilly-Mazarin, France

Phase II Clinical Study of Leflunomide in the Treatment of MEN-1 Neuroendocrine Tumor

Phase 2
Recruiting
Conditions
Neuroendocrine Tumors
Interventions
First Posted Date
2024-08-07
Last Posted Date
2024-08-07
Lead Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Target Recruit Count
50
Registration Number
NCT06540937
Locations
🇨🇳

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China

Gemcitabine and Leflunomide in Patients With Advanced Unresectable Pancreatic Cancer

Phase 1
Recruiting
Conditions
Advanced Pancreatic Adenocarcinoma
Stage III Pancreatic Cancer AJCC v8
Stage IV Pancreatic Cancer AJCC v8
Unresectable Pancreatic Ductal Adenocarcinoma
Interventions
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Diagnostic Imaging
Procedure: Magnetic Resonance Imaging
First Posted Date
2024-06-12
Last Posted Date
2025-04-10
Lead Sponsor
City of Hope Medical Center
Target Recruit Count
19
Registration Number
NCT06454383
Locations
🇺🇸

City of Hope Medical Center, Duarte, California, United States

Bioequivalence Study of Generic Leflunomide 20 mg Film-coated Tablets and Reference Product Under Fasting Conditions

Phase 1
Not yet recruiting
Conditions
Healthy Volunteer
Interventions
First Posted Date
2024-01-29
Last Posted Date
2024-01-29
Lead Sponsor
International Bio service
Target Recruit Count
48
Registration Number
NCT06228443

Leflunomide or Combination of MEK Inhibitor and Hydroxychloroquine for Refractory Patients With RAS Mutations

Phase 2
Recruiting
Conditions
RAS Mutation
Lung Cancer
Refractory Cancer
Ras (Kras or Nras) Gene Mutation
Pancreas Cancer
Colorectal Cancer Recurrent
Melanoma
Interventions
Drug: The combination of MEK inhibitor + hydroxychloroquine( plaquenil) ± bevacizumab
First Posted Date
2024-01-29
Last Posted Date
2024-01-29
Lead Sponsor
N.N. Petrov National Medical Research Center of Oncology
Target Recruit Count
20
Registration Number
NCT06229340
Locations
🇷🇺

Department of Tumor Growth Biology, N.N. Petrov Institute of Oncology, Saint Petersburg, Russian Federation, Saint Petersburg, Russian Federation

Leflunomide for Idiopathic Pulmonary Hemosiderosis in Children

Phase 1
Recruiting
Conditions
Idiopathic Pulmonary Hemosiderosis
Leflunomide
Interventions
Drug: Steroid Drug
First Posted Date
2023-07-10
Last Posted Date
2023-07-10
Lead Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Target Recruit Count
34
Registration Number
NCT05937191
Locations
🇨🇳

Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China

Leflunomide for Henoch-Schonlein Purpura

Not Applicable
Recruiting
Conditions
Henoch-Schonlein Purpura
Interventions
First Posted Date
2023-07-10
Last Posted Date
2023-07-10
Lead Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Target Recruit Count
36
Registration Number
NCT05937880
Locations
🇨🇳

Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China

Treatment Strategies for IgG4-RD Patients With Internal Organ Involvement

Not Applicable
Recruiting
Conditions
Autoimmune Diseases
Interventions
First Posted Date
2023-03-29
Last Posted Date
2024-05-28
Lead Sponsor
Peking Union Medical College Hospital
Target Recruit Count
60
Registration Number
NCT05789017
Locations
🇨🇳

Peking Union Medical College Hospital, Beijing, China

Treatment Strategies for IgG4-RD Patients With Superficial Organ Involvement

Not Applicable
Recruiting
Conditions
Autoimmune Diseases
Interventions
First Posted Date
2023-03-29
Last Posted Date
2023-03-29
Lead Sponsor
Peking Union Medical College Hospital
Target Recruit Count
90
Registration Number
NCT05789030
Locations
🇨🇳

Peking Union Medical College Hospital, Beijing, China

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy