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

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: Drug: Leflunomide

First Posted Date: 2024-12-03

Last Posted Date: 2024-12-03

Lead Sponsor: Sanofi

Target Recruit Count: 3500

Registration Number: NCT06714461

Locations: 🇫🇷
Sanofi-Aventis, Chilly-Mazarin, France

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
Drug: Cholestyramine
Procedure: Computed Tomography
Procedure: Diagnostic Imaging
Drug: Gemcitabine
Drug: Leflunomide
Procedure: Magnetic Resonance Imaging

First Posted Date: 2024-06-12

Last Posted Date: 2024-06-12

Lead Sponsor: City of Hope Medical Center

Target Recruit Count: 19

Registration Number: NCT06454383

Locations: 🇺🇸
City of Hope Medical Center, Duarte, California, United States

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
Drug: Leflunomide

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
Drug: Leflunomide

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: Drug: Leflunomide

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: Drug: Prednisone and Mycophenolate Mofetil
Drug: Mycophenolate Mofetil
Drug: Leflunomide

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

The Clinical Efficacy of Immunomodulators in RA Patients

Phase 4

Recruiting

Conditions: Arthritis, Rheumatoid

Interventions: Drug: Iguratimod
Drug: Adalimumab Injection
Drug: Methotrexate
Drug: Leflunomide
Drug: Hydroxychloroquine

First Posted Date: 2022-11-23

Last Posted Date: 2022-11-29

Lead Sponsor: Qilu Hospital of Shandong University

Target Recruit Count: 400

Registration Number: NCT05626348

Locations: 🇨🇳
Qilu Hospital, Jinan, Shandong, China

Leflunomide in Combination With Steroids for the Treatment of Acute Graft-versus-Host Disease After Donor Stem Cell Transplant for Hematologic Malignancies

Phase 1

Recruiting

Conditions: Acute Graft Versus Host Disease
Hematopoietic and Lymphoid System Neoplasm

Interventions: Drug: Cholestyramine
Drug: Leflunomide
Drug: Steroid Therapy

First Posted Date: 2022-07-05

Last Posted Date: 2024-06-21

Lead Sponsor: City of Hope Medical Center

Target Recruit Count: 18

Registration Number: NCT05443425

Locations: 🇺🇸
City of Hope Medical Center, Duarte, California, United States

Leflunomide for the Treatment of High-Risk Smoldering Multiple Myeloma in African-American and European-American Patients

Phase 2

Recruiting

Conditions: Smoldering Plasma Cell Myeloma

Interventions: Drug: Cholestyramine
Drug: Leflunomide

First Posted Date: 2021-08-20

Last Posted Date: 2024-05-31

Lead Sponsor: City of Hope Medical Center

Target Recruit Count: 56

Registration Number: NCT05014646

Locations: 🇺🇸
City of Hope Medical Center, Duarte, California, United States
🇺🇸
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

and more 1 locations

Targeting de Novo Pyrimidine Biosynthesis by Leflunomide for the Treatment of COVID-19 Virus Disease

Phase 3

Completed

Conditions: COVID-19

Interventions: Drug: leflunomide

First Posted Date: 2021-08-16

Last Posted Date: 2023-02-27

Lead Sponsor: Ashford and St. Peter's Hospitals NHS Trust

Target Recruit Count: 178

Registration Number: NCT05007678

Locations: 🇬🇧
Ashford and St Peters Hospital NHS Foundation Trust, Chertsey, United Kingdom

Drug Development Updates

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