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Arava

(Leflunomide)

ApprovedSmall molecule

Leflunomide is used to reduce pain, swelling, and stiffness caused by rheumatoid arthritis and helps slow down joint damage. It works by calming down the immune system when it mistakenly attacks the body's own joints.[2] Arava is currently approved and in use across 26 indications[4].[1]

Arava is one of 546 small molecule programs targeting HIV infection. It is currently in Approved.

26

Indications

79

Total Trials

19

Active Trials

545

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

HIV InfectionApproved

Breast DiseaseApproved

Asymptomatic MyelomaApproved

ArthritisActive, not recruiting

Rheumatic DiseaseRecruiting

VasculitisActive, not recruiting

Central Nervous System NeoplasmApproved

Henoch-Schoenlein PurpuraApproved

Takayasu ArteritisActive, not recruiting

Acute Graft Versus Host DiseaseRecruiting

HIV InfectionApproved

Approved

Breast DiseaseApproved

Approved

Asymptomatic MyelomaApproved

Approved

ArthritisApproved

Active, not recruiting

Rheumatic DiseasePhase 2

Recruiting

VasculitisPreclinical

Active, not recruiting

Central Nervous System NeoplasmApproved

Approved

Henoch-Schoenlein PurpuraApproved

Approved

Takayasu ArteritisPreclinical

Active, not recruiting

Acute Graft Versus Host DiseasePhase 1

Recruiting

Showing 10 of 26 indications

Competition

Competitive Landscape

706 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Arava

Adenocard

Lexiscan

Voltaren

Zolymbus

Methylthioninium Chloride

PProvepharm SAS

MS Contin

HHikma Pharmaceuticals LLC

Duragesic-100

MS Contin

HHikma Pharmaceuticals LLC

Spravato

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Active, not recruiting

Multiple Myeloma

NCT04370483

Phase 1Recruiting

Advanced Pancreatic Adenocarcinoma

NCT06454383

Phase 1/2Recruiting

Hemosiderosis

NCT05937191

Post-ApprovalRecruiting

Efficacy

NCT05626348

Q1 2027

Phase 1Recruiting

Acute Graft Versus Host Disease

NCT05443425

Phase 2Active, not recruiting

Multiple Myeloma

NCT05014646

Clinical

Trials by Indication[1]

Rheumatoid Arthritis17 trials

Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response

Recruiting·UUniversity of Nebraska·Phase 3·NCT03414502·400 enrolled

Acupuncture Study on Rheumatoid Arthritis, Monitoring Microbiome and Blood

Completed·CChinese Academy of Sciences·N/A·NCT01619176·10 enrolled

Triple III Comparison of Leflunomide Alone Versus Two DMARD Combinations in the Treatment of Rheumatoid Arthritis

Completed·UUniversity of Nebraska·Phase 3·NCT00579878·69 enrolled

Show 14 more trials

Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis.

Completed·PP. Verschueren·Phase 4·NCT01172639·400 enrolled

Leflunomide Versus Sulfasalazine/Methotrexate in Rheumatoid Arthritis:an Ultrasound/Magnetic Resonance Imaging Study

Terminated·SSingapore General Hospital·Phase 4·NCT01659242·1 enrolled

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)

Terminated· Roche logo

Roche·Phase 3·NCT00476996·836 enrolled

Study of Iguratimod Plus Methotrexate Compared to Leflunomid Plus Methotrexate in Patients With Rheumatoid Arthritis

Unknown status· Jiangsu Simcere Pharmaceutical Co., Ltd. logo

Jiangsu Simcere Pharmaceutical Co., Ltd.·Phase 4·NCT02275299·240 enrolled

A Study of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Rheumatoid Arthritis

Completed· Roche logo

Roche·Phase 3·NCT01941095·100 enrolled

Leflunomide + Methotrexate in Rheumatoid Arthritis

Completed· Sanofi logo

Sanofi·Phase 4·NCT00563849·74 enrolled

Comparison of Combination Disease Modifying Antirheumatic Drugs With Methotrexate Therapy in Early Rheumatoid Arthritis

Completed·JJawaharlal Institute of Postgraduate Medical Education & Research·Phase 4·NCT02644499·186 enrolled

Effect of Sarilumab on Patient-reported Outcomes in Patients With Active Rheumatoid Arthritis

Completed· Sanofi logo

Sanofi·Phase 4·NCT03449758·84 enrolled

A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA)

Completed· Sanofi logo

Sanofi·Phase 3·NCT02373202·91 enrolled

To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis

Completed· Sanofi logo

Sanofi·Phase 3·NCT02057250·217 enrolled

Leflunomide EfficAcy Response Related to Dosing Regimen in Early Rheumatoid Arthritis

Completed· Sanofi logo

Sanofi·Phase 3·NCT00596206·124 enrolled

Leflunomide in Rheumatoid Arthritis

Completed· Sanofi logo

Sanofi·Phase 4·NCT00280644·60 enrolled

A Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patients With Active Rheumatoid Arthritis

Completed· Roche logo

Roche·Phase 2·NCT01225393·211 enrolled

Objective Study in Rheumatoid Arthritis

Completed· Sanofi logo

Sanofi·Phase 4·NCT00451971·249 enrolled

Leflunomide5 trials

Effect of Leflunomide on T Cell Proliferation in HIV-Infected Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00101374·41 enrolled

Bioavailability Study of Leflunomide Tablets Under Fed Conditions

Completed·PPar Pharmaceutical, Inc.·Phase 1·NCT00653003·62 enrolled

Leflunomide 20 mg Tablets, Non-Fasting

Completed· Teva logo

Teva·Phase 1·NCT00834405·37 enrolled

Show 2 more trials

Leflunomide Treatment for MEN1 Patients - the LUMEN1 Trial

Terminated·UUniversity Hospital, Basel, Switzerland·N/A·NCT05605587·3 enrolled

Leflunomide for Henoch-Schonlein Purpura

Recruiting·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·N/A·NCT05937880·36 enrolled

Multiple Myeloma5 trials

Leflunomide, Pomalidomide, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma

Recruiting·—·Phase 2·NCT04508790·29 enrolled

Leflunomide in Treating Patients With High-Risk Smoldering Multiple Myeloma

Withdrawn·—·Phase 2·NCT03952832

Leflunomide in Treating Patients With Relapsed or Refractory Multiple Myeloma

Completed·—·Phase 1/2·NCT02509052·12 enrolled

Show 2 more trials

Leflunomide for the Treatment of High-Risk Smoldering Multiple Myeloma

Active, not recruiting·—·Phase 1·NCT04370483·1 enrolled

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

Active, not recruiting·—·Phase 2·NCT05014646·27 enrolled

Fasting Conditions4 trials

Bioavailability Study of Leflunomide Tablets Under Fasting Conditions

Completed·PPar Pharmaceutical, Inc.·Phase 1·NCT00652665·52 enrolled

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

Unknown status·IInternational Bio service·Phase 1·NCT06228443·48 enrolled

Leflunomide 20 mg Tablets Under Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT00834418·84 enrolled

Show 1 more trial

To Demonstrate the Relative Bioavailability, Parallel Study Of Leflunomide 20 mg Tablets Under Fasting Conditions

Completed· Novartis logo

Novartis·Phase 1·NCT00946686·52 enrolled

COVID-193 trials

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

Completed·—·Phase 3·NCT05007678·178 enrolled

Leflunomide for the Treatment of Severe COVID-19 in Patients With a Concurrent Malignancy

Completed·—·Phase 1/2·NCT04532372·2 enrolled

Leflunomide in Mild COVID-19 Patients

Terminated·UUniversity of Chicago·Phase 1·NCT04361214·11 enrolled

38 more indications

Treatment3 trials

A Clinical Study of Xin'an Medicine in the Treatment of Bi Syndrome

Completed·TThe First Affiliated Hospital of Anhui University of Traditional Chinese Medicine·N/A·NCT01774877·304 enrolled

The Research of Standard Diagnosis and Treatment for HSPN in Children

Unknown status·NNanjing Children's Hospital·Phase 2·NCT02532777·100 enrolled

Treatment Strategies for IgG4-RD Patients With Internal Organ Involvement

Recruiting·PPeking Union Medical College Hospital·N/A·NCT05789017·60 enrolled

Psoriatic Arthritis2 trials

Severe Psoriatic Arthritis - Early intervEntion to Control Disease: the SPEED Trial

Completed·UUniversity of Oxford·Phase 4·NCT03739853·192 enrolled

Impact of Tapering Immunosuppressants on Maintaining Minimal Disease Activity in Adult Subjects With Psoriatic Arthritis

Unknown status·UUniversity of Erlangen-Nürnberg Medical School·Phase 3·NCT04610476·270 enrolled

Takayasu arteritis2 trials

The Registry Study of Takayasu Arteritis in East China

Recruiting·SShanghai Zhongshan Hospital··NCT03893136·1,000 enrolled

Takayasu Arteritis Clinical Trial in China

Completed·JJiang lindi·N/A·NCT02981979·116 enrolled

Stem Cell Transplant2 trials

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

Withdrawn·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00230035

Leflunomide for Musculoskeletal GVHD After Allogeneic Stem Cell Transplant

Terminated·TTata Memorial Centre·Phase 2·NCT04932564·1 enrolled

Lupus Nephritis2 trials

A Study to Compare the Efficacy and Safety of Tacrolimus Capsules With Leflunomide Tablets in Lupus Nephritis Patients

Terminated· Astellas logo

Astellas·Phase 3·NCT01342016·84 enrolled

Leflunomide Versus Azathioprine for Maintenance Therapy of Lupus Nephritis

Unknown status·RRenJi Hospital·N/A·NCT01172002·200 enrolled

Efficacy2 trials

Predictability Studies on the Efficacy of TNF-α Inhibitors in Chinese RA From "Real World"

Unknown status·FFen Li·Phase 4·NCT02878161·240 enrolled

The Clinical Efficacy of Immunomodulators in RA Patients

Recruiting·QQilu Hospital of Shandong University·Phase 4·NCT05626348·400 enrolled

Drug1 trial

To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

Completed· Sanofi logo

Sanofi·Phase 3·NCT01709578·546 enrolled

Combination Therapy1 trial

Disease-Modifying Antirheumatic Drugs Cycle Combination Therapy Research

Unknown status·SShanxi Medical University·N/A·NCT01617590·500 enrolled

RAS Mutation1 trial

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

Recruiting·NN.N. Petrov National Medical Research Center of Oncology·Phase 2·NCT06229340·20 enrolled

Hemosiderosis1 trial

Leflunomide for Idiopathic Pulmonary Hemosiderosis in Children

Recruiting·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 1/2·NCT05937191·34 enrolled

Myasthenia Gravis1 trial

The Efficacy and Safety of Leflunomide or Azathioprine Therapy in Myasthenia Gravis Patients After Expand Thymectomy

Completed·FFirst Affiliated Hospital, Sun Yat-Sen University·Phase 3·NCT01727193·290 enrolled

Juvenile Idiopathic Arthritis1 trial

Efficacy Study of Leflunomide to Treat Juvenile Idiopathic Arthritis

Unknown status·MMashhad University of Medical Sciences·Phase 4·NCT02024334·30 enrolled

Anaplastic Astrocytoma1 trial

Leflunomide in Treating Patients With Anaplastic Astrocytoma in First Relapse

Completed· Pfizer logo

Pfizer·Phase 2·NCT00003775·60 enrolled

Methotrexate1 trial

Comparison of Disease Modifying Antirheumatic Drugs Therapy in Patients With RA Failing Methotrexate Monotherapy

Terminated·JJawaharlal Institute of Postgraduate Medical Education & Research·Phase 3·NCT02930343·136 enrolled

Prostate Cancer1 trial

Mitoxantrone and Prednisone With or Without Leflunomide in Treating Patients With Stage IV Prostate Cancer

Completed· Pfizer logo

Pfizer·Phase 2/3·NCT00004071

Arthritis1 trial

Psoriatic Oligoarthritis Intervention With Symptomatic thErapy

Completed·UUniversity of Oxford·Phase 4·NCT03797872·1 enrolled

ESS1 trial

IL-7 and IL-7R Expression in RA Patients With Active vs. Inactive Disease Treated With DMARD or CIMZIA

Completed·UUniversity of Illinois at Chicago·Phase 4·NCT02451748·32 enrolled

Osteomyelitis1 trial

CHronic Nonbacterial Osteomyelitis International Registry

Recruiting·SSeattle Children's Hospital··NCT04725422·2,000 enrolled

Bullous Pemphigoid1 trial

Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid

Unknown status·UUniversity Hospital, Limoges·Phase 2·NCT00802243·54 enrolled

Glioblastoma Multiforme1 trial

SU-101 Compared With Procarbazine in Treating Patients With Glioblastoma Multiforme

Completed· Pfizer logo

Pfizer·Phase 3·NCT00003293

Breast Cancer1 trial

Leflunomide in Patients With PTEN-Altered Advanced Solid Malignancies and HER2 Negative Breast Cancer

Recruiting·DDeborah Doroshow·Phase 1·NCT04997993·24 enrolled

Tocilizumab1 trial

To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

Completed· Sanofi logo

Sanofi·Phase 3·NCT01768572·202 enrolled

IgG4 Related Disease1 trial

Leflunomide for Maintenance of Remission in IgG4 Related Disease

Completed·—·Phase 4·NCT02703194·68 enrolled

Effectiveness1 trial

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

Active, not recruiting· Sanofi logo

Sanofi··NCT06714461·3,500 enrolled

Triple Negative1 trial

Leflunomide in Previously Treated Metastatic Triple Negative Cancers

Completed·JJoseph Sparano·Phase 1/2·NCT03709446·17 enrolled

Myelodysplastic Syndromes1 trial

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

Recruiting·WWest Virginia University·Phase 1/2·NCT06923488·26 enrolled

Polymyalgia Rheumatica1 trial

Treatment With Leflunomide in Patients With Polymyalgia Rheumatica

Unknown status·EElisabeth Brouwer·Phase 3·NCT03576794·94 enrolled

Renal Transplantation1 trial

BK Viremia After Renal Transplantation

Unknown status·KKarolinska University Hospital·N/A·NCT00684372·100 enrolled

Vasculitis1 trial

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

Unknown status·CChinese SLE Treatment And Research Group·N/A·NCT04737343·114 enrolled

Lymphoproliferative Disorders1 trial

Leflunomide for the Treatment of Relapsed or Refractory CD30+ Lymphoproliferative Disorders

Completed·—·Phase 2·NCT04463615·1 enrolled

Melanoma1 trial

Leflunomide+Vemurafenib in V600 Mutant Met. Melanoma

Terminated·MMassachusetts General Hospital·Phase 1·NCT01611675·3 enrolled

Systemic Lupus Erythematosus1 trial

Leflunomide in Systemic Lupus Erythematosus

Completed· Sanofi logo

Sanofi·Phase 2·NCT00637819·27 enrolled

Uveitis1 trial

Leflunomide to Treat Uveitis

Completed·NNational Eye Institute (NEI)·Phase 2·NCT00001863·16 enrolled

Advanced Pancreatic Adenocarcinoma1 trial

A Phase 1b Study of Gemcitabine and Leflunomide in Patients With Unresectable Pancreatic Cancer

Recruiting·CCity of Hope Medical Center·Phase 1·NCT06454383·19 enrolled

Chronic Graft Versus Host Disease1 trial

A Safety and Feasibility Trial of Leflunomide in Patients With Steroid Dependent Chronic Graft-Versus-Host Disease

Active, not recruiting·CCity of Hope Medical Center·Phase 1·NCT04212416·18 enrolled

Hematologic Malignancies1 trial

Use of Leflunomide as Primary Prophylaxis Against Cytomegalovirus (CMV) Reactivation in Haploidentical Haematopoietic Stem Cell Transplant (HIT) - Single, Arm, Phase 2 Clinical Trial

Recruiting·TTata Memorial Centre·Phase 2·NCT07709013·22 enrolled

Rheumatic Disease1 trial

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

Recruiting·NNYU Langone Health·Phase 2·NCT07138898·80 enrolled

Acute Graft Versus Host Disease1 trial

Pilot Trial of Leflunomide in Combination With Steroids for the Treatment of Acute Graft-versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation for Hematologic Malignancies

Recruiting·CCity of Hope Medical Center·Phase 1·NCT05443425·18 enrolled

Regulatory

FDA Approval Timeline[5]

Sep 10, 1998

ARAVA

NDA NDA020905

Sources

References

[1]
ClinicalTrials.gov — 79 trial records for Leflunomide. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Arava drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Leflunomide compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Leflunomide. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA020905). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Sanofi company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Dihydroorotate Dehydrogenase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Sanofi

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