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

The Clinical Efficacy of Immunomodulators in RA Patients

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 Treatment for MEN1 Patients - the LUMEN1 Trial

Not Applicable
Recruiting
Conditions
MEN1 Gene Mutation
Interventions
First Posted Date
2022-11-04
Last Posted Date
2025-01-29
Lead Sponsor
University Hospital, Basel, Switzerland
Target Recruit Count
15
Registration Number
NCT05605587
Locations
🇨🇭

Unispital Basel, Basel, Switzerland

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
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

New Clinical End-points in Patients With Primary Sjögren's Syndrome

First Posted Date
2021-11-09
Last Posted Date
2024-11-01
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Target Recruit Count
300
Registration Number
NCT05113004
Locations
🇫🇷

Eric Hachulla, Lille, France

🇫🇷

Raphaele Seror, Le Kremlin-Bicêtre, Ile De France, France

🇫🇷

Jacques Morel, Montpellier, France

and more 4 locations

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
First Posted Date
2021-08-20
Last Posted Date
2025-03-26
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
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

Leflunomide in Patients With PTEN-Altered Advanced Solid Malignancies

Phase 1
Recruiting
Conditions
PTEN-null Advanced Solid Tumors
Interventions
First Posted Date
2021-08-10
Last Posted Date
2024-06-25
Lead Sponsor
Deborah Doroshow
Target Recruit Count
24
Registration Number
NCT04997993
Locations
🇺🇸

Icahn School of Medicine at Mount Sinai, New York, New York, United States

Leflunomide for Musculoskeletal GVHD After Allogeneic Stem Cell Transplant

Phase 2
Conditions
Musculoskeletal Disease Other
GVHD, Chronic
Interventions
First Posted Date
2021-06-21
Last Posted Date
2021-06-21
Lead Sponsor
Tata Memorial Centre
Target Recruit Count
10
Registration Number
NCT04932564
Locations
🇮🇳

Tata Memorial Centre, Advanced Centre for Treatment, Research and Education in Cancer, Navi Mumbai, Maharashtra, India

Comparison of the Efficacy of Leflunomide and Azathioprine for the Maintenance Therapy of ANCA Associated Vasculitis

Not Applicable
Recruiting
Conditions
ANCA Associated Vasculitis
Maintenance Therapy
Interventions
First Posted Date
2021-02-03
Last Posted Date
2021-11-30
Lead Sponsor
Chinese SLE Treatment And Research Group
Target Recruit Count
114
Registration Number
NCT04737343
Locations
🇨🇳

Peking Union Medical College Hospital, Beijing, China

🇨🇳

AnHui provincial hospital, Hefei, Anhui, China

🇨🇳

the Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia, China

and more 1 locations

CHronic Nonbacterial Osteomyelitis International Registry

First Posted Date
2021-01-26
Last Posted Date
2024-07-30
Lead Sponsor
Seattle Children's Hospital
Target Recruit Count
2000
Registration Number
NCT04725422
Locations
🇺🇸

Seattle Children's Hospital, Seattle, Washington, United States

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