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
Impact of Tapering Immunosuppressants on Maintaining Minimal Disease Activity in Adult Subjects With Psoriatic Arthritis
- Conditions
- ReductionPsoriatic ArthritisWithdrawal
- Interventions
- First Posted Date
- 2020-10-30
- Last Posted Date
- 2022-11-14
- Lead Sponsor
- University of Erlangen-Nürnberg Medical School
- Target Recruit Count
- 270
- Registration Number
- NCT04610476
- Locations
- 🇩🇪
Universitätsklinikum Erlangen, Erlangen, Bavaria, Germany
Leflunomide for the Treatment of Severe COVID-19 in Patients With a Concurrent Malignancy
- Conditions
- Hematopoietic and Lymphoid Cell NeoplasmSymptomatic COVID-19 Infection Laboratory-ConfirmedMalignant Solid Neoplasm
- Interventions
- First Posted Date
- 2020-08-31
- Last Posted Date
- 2024-07-03
- Lead Sponsor
- City of Hope Medical Center
- Target Recruit Count
- 2
- Registration Number
- NCT04532372
- Locations
- 🇺🇸
City of Hope Medical Center, Duarte, California, United States
Leflunomide, Pomalidomide, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma
- Conditions
- Recurrent Plasma Cell MyelomaRefractory Plasma Cell Myeloma
- Interventions
- First Posted Date
- 2020-08-11
- Last Posted Date
- 2024-08-06
- Lead Sponsor
- City of Hope Medical Center
- Target Recruit Count
- 29
- Registration Number
- NCT04508790
- Locations
- 🇺🇸
City of Hope Medical Center, Duarte, California, United States
Leflunomide for the Treatment of Relapsed or Refractory CD30+ Lymphoproliferative Disorders
- Conditions
- Recurrent Lymphoproliferative DisorderRefractory Lymphoproliferative Disorder
- Interventions
- First Posted Date
- 2020-07-09
- Last Posted Date
- 2023-12-05
- Lead Sponsor
- City of Hope Medical Center
- Target Recruit Count
- 1
- Registration Number
- NCT04463615
- Locations
- 🇺🇸
City of Hope Medical Center, Duarte, California, United States
Leflunomide for the Treatment of High-Risk Smoldering Multiple Myeloma
- Conditions
- Smoldering Plasma Cell Myeloma
- Interventions
- Other: Quality-of-Life Assessment
- First Posted Date
- 2020-05-01
- Last Posted Date
- 2025-03-26
- Lead Sponsor
- City of Hope Medical Center
- Target Recruit Count
- 1
- Registration Number
- NCT04370483
- Locations
- 🇺🇸
City of Hope Medical Center, Duarte, California, United States
Leflunomide in Mild COVID-19 Patients
- First Posted Date
- 2020-04-24
- Last Posted Date
- 2024-02-07
- Lead Sponsor
- University of Chicago
- Target Recruit Count
- 11
- Registration Number
- NCT04361214
- Locations
- 🇺🇸
University of Chicago, Chicago, Illinois, United States
Leflunomide in Treating Patients With Steroid Dependent Chronic Graft Versus Host Disease
- Conditions
- Chronic Graft Versus Host DiseaseSteroid Refractory Graft Versus Host Disease
- Interventions
- First Posted Date
- 2019-12-27
- Last Posted Date
- 2024-12-17
- Lead Sponsor
- City of Hope Medical Center
- Target Recruit Count
- 18
- Registration Number
- NCT04212416
- Locations
- 🇺🇸
City of Hope Medical Center, Duarte, California, United States
Assessment of Leflunomide Efficacy and Hepatotoxicity in Patients With Rheumatoid Arthritis Through Pharmacokinetic and Genetic Approaches
- First Posted Date
- 2019-07-17
- Last Posted Date
- 2020-09-09
- Lead Sponsor
- Assiut University
- Target Recruit Count
- 80
- Registration Number
- NCT04022525
- Locations
- 🇪🇬
Assiut University Hospital, Assiut, Egypt
Leflunomide Plus Low Dose Corticosteroid in Immunoglobulin A (IgA) Nephropathy With Renal Insufficiency
- Conditions
- Renal Insufficiency, ChronicGlomerulonephritis, IGA
- Interventions
- First Posted Date
- 2019-07-16
- Last Posted Date
- 2020-02-18
- Lead Sponsor
- Shenzhen Second People's Hospital
- Target Recruit Count
- 70
- Registration Number
- NCT04020328
- Locations
- 🇨🇳
Xu Yi, Shenzhen, Guangdong, China
Leflunomide in Treating Patients With High-Risk Smoldering Multiple Myeloma
- Conditions
- Smoldering Plasma Cell Myeloma
- Interventions
- First Posted Date
- 2019-05-16
- Last Posted Date
- 2019-11-14
- Lead Sponsor
- City of Hope Medical Center
- Registration Number
- NCT03952832
- Locations
- 🇺🇸
City of Hope Medical Center, Duarte, California, United States
Drug Development Updates
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