{"id":"leflunomide-lef","safety":{"commonSideEffects":[{"rate":"15–20","effect":"Diarrhea"},{"rate":"10–15","effect":"Elevated liver enzymes (ALT/AST)"},{"rate":"10","effect":"Alopecia (hair loss)"},{"rate":"10","effect":"Hypertension"},{"rate":"8–10","effect":"Nausea"},{"rate":"5–10","effect":"Respiratory tract infection"}]},"_chembl":null,"_dailymed":{"setId":"91712aad-d96c-4ef0-97e7-b31ed18ca6d8","title":"LEFLUNOMIDE TABLET [BRYANT RANCH PREPACK]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Leflunomide's active metabolite, teriflunomide, reversibly inhibits dihydroorotate dehydrogenase (DHODH), a mitochondrial enzyme critical for de novo pyrimidine nucleotide synthesis. This selectively impairs the proliferation of activated lymphocytes, which depend heavily on de novo pyrimidine synthesis, leading to immunosuppression. The drug is used to reduce inflammation and slow disease progression in autoimmune conditions.","oneSentence":"Leflunomide inhibits dihydroorotate dehydrogenase, an enzyme required for pyrimidine synthesis, thereby suppressing T-cell and B-cell proliferation.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T02:41:59.478Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Rheumatoid arthritis"},{"name":"Active psoriatic arthritis"},{"name":"Active ankylosing spondylitis"}]},"trialDetails":[{"nctId":"NCT07428551","phase":"PHASE4","title":"Comparative Study of Leflunomide Plus Methotrexate Versus Methotrexate Monotherapy in Refractory Polyarticular Juvenile Idiopathic Arthritis Patients","status":"COMPLETED","sponsor":"Bangladesh Medical University","startDate":"2024-03-01","conditions":"Juvenile Idiopathic Arthritis, Polyarticular Juvenile Idiopathic Arthritis, Refractory Polyarticular Juvenile Idiopathic Arthritis","enrollment":50},{"nctId":"NCT02981979","phase":"NA","title":"Takayasu Arteritis Clinical Trial in China","status":"COMPLETED","sponsor":"Jiang lindi","startDate":"2016-12-22","conditions":"Takayasu Arteritis","enrollment":116},{"nctId":"NCT05113004","phase":"PHASE2","title":"New Clinical End-points in Patients With Primary Sjögren's Syndrome","status":"RECRUITING","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2022-01-20","conditions":"Primary Sjögren's Syndrome (pSS)","enrollment":300},{"nctId":"NCT05626348","phase":"PHASE4","title":"The Clinical Efficacy of Immunomodulators in RA Patients","status":"RECRUITING","sponsor":"Qilu Hospital of Shandong University","startDate":"2021-12-22","conditions":"Arthritis, Rheumatoid","enrollment":400},{"nctId":"NCT02930343","phase":"PHASE3","title":"Comparison of Disease Modifying Antirheumatic Drugs Therapy in Patients With RA Failing Methotrexate Monotherapy","status":"TERMINATED","sponsor":"Jawaharlal Institute of Postgraduate Medical Education & Research","startDate":"2016-09","conditions":"Rheumatoid Arthritis","enrollment":136},{"nctId":"NCT02532777","phase":"PHASE2","title":"The Research of Standard Diagnosis and Treatment for HSPN in Children","status":"UNKNOWN","sponsor":"Nanjing Children's Hospital","startDate":"2015-08","conditions":"Henoch-Schoenlein Purpura Nephritis","enrollment":100},{"nctId":"NCT02878161","phase":"PHASE4","title":"Predictability Studies on the Efficacy of TNF-α Inhibitors in Chinese RA From \"Real World\"","status":"UNKNOWN","sponsor":"Fen Li","startDate":"2016-01","conditions":"Rheumatoid Arthritis","enrollment":240},{"nctId":"NCT01600521","phase":"NA","title":"A Clinical Study of a Natural Remedy for Rheumatoid Arthritis vs. Commonly Used Conventional Medications","status":"COMPLETED","sponsor":"University of Minnesota","startDate":"2004-11","conditions":"Rheumatoid Arthritis","enrollment":1748},{"nctId":"NCT01659242","phase":"PHASE4","title":"Leflunomide Versus Sulfasalazine/Methotrexate in Rheumatoid Arthritis:an Ultrasound/Magnetic Resonance Imaging Study","status":"TERMINATED","sponsor":"Singapore General Hospital","startDate":"2012-07","conditions":"Rheumatoid Arthritis","enrollment":1},{"nctId":"NCT01617590","phase":"NA","title":"Disease-Modifying Antirheumatic Drugs Cycle Combination Therapy Research","status":"UNKNOWN","sponsor":"Shanxi Medical University","startDate":"2012-05","conditions":"Rheumatoid Arthritis","enrollment":500},{"nctId":"NCT00637819","phase":"PHASE2","title":"Leflunomide in Systemic Lupus Erythematosus","status":"COMPLETED","sponsor":"Sanofi","startDate":"2003-01","conditions":"Systemic Lupus Eythematosus (SLE)","enrollment":27}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":284,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Leflunomide(LEF)","genericName":"Leflunomide(LEF)","companyName":"Nanjing Children's Hospital","companyId":"nanjing-children-s-hospital","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Leflunomide inhibits dihydroorotate dehydrogenase, an enzyme required for pyrimidine synthesis, thereby suppressing T-cell and B-cell proliferation. Used for Rheumatoid arthritis, Active psoriatic arthritis, Active ankylosing spondylitis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}