{"id":"mycophenolate-mofetil-low-dose-steroid","safety":{"commonSideEffects":[{"rate":"20-40","effect":"Gastrointestinal disturbances (diarrhea, nausea, abdominal pain)"},{"rate":"15-30","effect":"Infection (bacterial, viral, fungal)"},{"rate":"10-25","effect":"Leukopenia"},{"rate":"5-15","effect":"Anemia"},{"rate":"10-20","effect":"Headache"},{"rate":"10-20","effect":"Hypertension (steroid-related)"},{"rate":"5-15","effect":"Hyperglycemia (steroid-related)"}]},"_chembl":null,"_fixedAt":"2026-03-30T18:21:48.202166","_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Mycophenolate mofetil (MMF) is a prodrug that is converted to mycophenolic acid, which preferentially inhibits IMPDH type II, an enzyme critical for guanosine nucleotide synthesis in lymphocytes. This leads to selective depletion of T and B cell populations. The addition of low-dose corticosteroids enhances immunosuppression through glucocorticoid receptor-mediated inhibition of pro-inflammatory cytokine production and further lymphocyte suppression.","oneSentence":"Mycophenolate mofetil selectively inhibits inosine monophosphate dehydrogenase (IMPDH) in T and B lymphocytes, suppressing their proliferation, while low-dose corticosteroids provide additional anti-inflammatory and immunosuppressive effects.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:22:30.523Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Autoimmune diseases (likely lupus nephritis, vasculitis, or other systemic autoimmune conditions based on Phase 3 status)"}]},"_fixedFields":["pubmed(22)"],"trialDetails":[{"nctId":"NCT04773392","phase":"PHASE4","title":"Simplified IMmunosuppressive Protocol Utilizing Low Dose EnvarsusXR","status":"TERMINATED","sponsor":"University of Southern California","startDate":"2021-11-23","conditions":"Kidney Transplantation, Kidney Transplant Rejection","enrollment":20},{"nctId":"NCT01282073","phase":"PHASE3","title":"Mycophenolate Mofetil in Patients With Progressive Idiopathic Membranous Nephropathy","status":"COMPLETED","sponsor":"Kyungpook National University Hospital","startDate":"2011-03","conditions":"Glomerulonephritis, Membranous","enrollment":43},{"nctId":"NCT03112603","phase":"PHASE3","title":"A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3)","status":"COMPLETED","sponsor":"Incyte Corporation","startDate":"2017-06-29","conditions":"Graft-versus-host Disease (GVHD)","enrollment":330},{"nctId":"NCT01265537","phase":"NA","title":"A Pilot Study Comparing the Use of Low-target Versus Conventional Target Advagraf","status":"COMPLETED","sponsor":"University of British Columbia","startDate":"2011-06-24","conditions":"Acute Graft Rejection, Diabetes","enrollment":30},{"nctId":"NCT04118556","phase":"PHASE2","title":"Decidua Stroma Cells for Steroid Resistent Acute Graft-versus-host Disease After Allo-HSCT","status":"RECRUITING","sponsor":"Mats Remberger","startDate":"2021-12-01","conditions":"GVHD, Acute","enrollment":50},{"nctId":"NCT01002339","phase":"PHASE4","title":"Optimum Immunosuppression in Renal Transplant Recipients.New Onset Diabetes After Transplantation","status":"TERMINATED","sponsor":"Armando Torres Ramírez","startDate":"2010-02","conditions":"Diabetes Mellitus, Adult-Onset","enrollment":134},{"nctId":"NCT05789017","phase":"NA","title":"Treatment Strategies for IgG4-RD Patients With Internal Organ Involvement","status":"RECRUITING","sponsor":"Peking Union Medical College Hospital","startDate":"2022-07-01","conditions":"Autoimmune Diseases","enrollment":60},{"nctId":"NCT04936282","phase":"PHASE4","title":"Treatment of Early Borderline Lesions in Low Immunological Risk Kidney Transplant Patients (TRAINING)","status":"UNKNOWN","sponsor":"Fundación Canaria de Investigación Sanitaria","startDate":"2022-07-05","conditions":"Kidney Transplant Failure and Rejection","enrollment":80},{"nctId":"NCT05423496","phase":"NA","title":"KidneyCare Immuno-optimization in Renal Allografts (KIRA)","status":"WITHDRAWN","sponsor":"CareDx","startDate":"2022-08","conditions":"Kidney Transplant, Immunosuppression, Allograft","enrollment":""},{"nctId":"NCT02913261","phase":"PHASE3","title":"Safety and Efficacy of Ruxolitinib Versus Best Available Therapy in Patients With Corticosteroid-refractory Acute Graft vs. Host Disease After Allogeneic Stem Cell Transplantation","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2017-03-10","conditions":"Corticosteroid Refractory Acute Graft vs Host Disease","enrollment":310},{"nctId":"NCT02909335","phase":"PHASE3","title":"De Novo Everolimus Versus Tacrolimus in Combination With Mofetil Mycophenolate and Low Dose Corticosteroids to Reduce Tacrolimus Induced Nephrotoxicity in Liver Transplantation: a Prospective, Multicentric, Randomised Study","status":"WITHDRAWN","sponsor":"Rennes University Hospital","startDate":"2016-11","conditions":"Liver Transplantation","enrollment":""},{"nctId":"NCT05415579","phase":"","title":"Demyelinating Diseases of the Central Nervous System Registry for Patients With Traditional Chinese Medicine (DATE-TCM)","status":"NOT_YET_RECRUITING","sponsor":"Dongzhimen Hospital, Beijing","startDate":"2022-06-20","conditions":"Demyelinating Diseases of the Central Nervous System (DDC)","enrollment":2000},{"nctId":"NCT00579527","phase":"PHASE1, PHASE2","title":"Phase I/II Thymus Transplantation With Immunosuppression #950","status":"COMPLETED","sponsor":"Sumitomo Pharma Switzerland GmbH","startDate":"2005-12-19","conditions":"DiGeorge Anomaly, Complete DiGeorge Anomaly, Complete Atypical DiGeorge Anomaly","enrollment":14},{"nctId":"NCT03492255","phase":"NA","title":"CYCLONES - CYClophosphamide LOw Dose and No Extra Steroid","status":"TERMINATED","sponsor":"University of Sao Paulo General Hospital","startDate":"2018-04-12","conditions":"Systemic Lupus Erythematosus (SLE)","enrollment":49},{"nctId":"NCT04744623","phase":"PHASE2, PHASE3","title":"Clinical Evaluation of New Treatment Strategy of Mucous Membrane Pemphigoid Using Large Dose of Prednisolone Plus Intra-lesional of Triamcinolone Acetonide Followed by Combination of Mycophenolate Mofetil, Dapsone and Low Dose Prednisolone","status":"UNKNOWN","sponsor":"Tanta University","startDate":"2020-09-30","conditions":"Benign Mucous Membrane Pemphigoid","enrollment":10},{"nctId":"NCT02540395","phase":"NA","title":"Prospective Donor Specific T Response Measurment for IS Minimization in de Novo Renal Transplantation","status":"COMPLETED","sponsor":"Prof. Dr. Petra Reinke","startDate":"2015-03","conditions":"Disorder Related to Renal Transplantation, Effects of Immunosuppressant Therapy","enrollment":184},{"nctId":"NCT02083991","phase":"PHASE4","title":"Trial of Steroid Avoidance and Low-dose CNI by ATG-induction in Renal Transplantation","status":"COMPLETED","sponsor":"Vastra Gotaland Region","startDate":"2013-01","conditions":"Diabetes Mellitus","enrollment":224},{"nctId":"NCT01062555","phase":"PHASE1, PHASE2","title":"Calcineurin Inhibitor Sparing After Kidney Transplantation","status":"COMPLETED","sponsor":"University of Minnesota","startDate":"2006-10-01","conditions":"CNI Side Effects","enrollment":527},{"nctId":"NCT04438603","phase":"","title":"The Applicaiton of Immune Repertoire in the Diagnosis and Disease Monitoring of IgA Nephropathy","status":"UNKNOWN","sponsor":"Xinhua Hospital, Shanghai Jiao Tong University School of Medicine","startDate":"2020-10-01","conditions":"IgA Nephropathy","enrollment":180},{"nctId":"NCT01095172","phase":"PHASE4","title":"RituxiMab INDuction in Renal Transplantation","status":"UNKNOWN","sponsor":"Guy's and St Thomas' NHS Foundation Trust","startDate":"2010-11","conditions":"Function of Renal Transplant","enrollment":100},{"nctId":"NCT00656266","phase":"PHASE4","title":"Trial of Calcineurin Inhibitor-Sparing Immunosuppression Regimen in Pediatric Liver Transplantation","status":"TERMINATED","sponsor":"Baylor College of Medicine","startDate":"2004-11","conditions":"End-stage Liver Disease, Renal Insufficiency, Renal Failure","enrollment":13},{"nctId":"NCT03170323","phase":"PHASE4","title":"Mycophenolate Mofetil Plus Steroid in the Treatment Of Patients With Progressive Idiopathic Membranous Nephropathy","status":"UNKNOWN","sponsor":"Guangdong Provincial People's Hospital","startDate":"2018-07-01","conditions":"Idiopathic Membranous Nephropathy","enrollment":128},{"nctId":"NCT02084446","phase":"PHASE4","title":"Everolimus + Very Low Tacrolimus vs Enteric-coated Mycophenolate Sodium + Low Tacrolimus in de Novo Renal Transplant","status":"COMPLETED","sponsor":"Ronaldo de Matos Esmeraldo, MD","startDate":"2012-12","conditions":"Transplantation Infection, Cytomegalovirus Infections","enrollment":120},{"nctId":"NCT02029638","phase":"PHASE2","title":"BMT and High Dose Post-Transplant Cyclophosphamide for Chimerism Induction and Renal Allograft Tolerance","status":"TERMINATED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2014-01-07","conditions":"Kidney Transplantation","enrollment":4},{"nctId":"NCT02702960","phase":"PHASE2","title":"Sequential, Related Donor Partial Liver Transplantation Followed by Bone Marrow Transplantation for Hepatocellular Carcinoma (HCC)","status":"WITHDRAWN","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","startDate":"2016-03","conditions":"Fibrolamellar Hepatocellular Carcinoma, Hepatocellular Carcinoma (Fibrolamellar Variant), Hepatocellular Carcinoma","enrollment":""},{"nctId":"NCT01185197","phase":"PHASE4","title":"Myfortic® for Minimal Change Nephrotic Syndrome (MCNS): a Randomized Study","status":"COMPLETED","sponsor":"The University of Hong Kong","startDate":"2010-09","conditions":"Nephrosis, Lipoid","enrollment":20},{"nctId":"NCT00281879","phase":"PHASE2","title":"Donor Stem Cell Transplant or Donor White Blood Cell Infusions in Treating Patients With Hematologic Cancer","status":"TERMINATED","sponsor":"OHSU Knight Cancer Institute","startDate":"2006-02","conditions":"Chronic Myeloproliferative Disorders, Leukemia, Lymphoma","enrollment":200},{"nctId":"NCT01410448","phase":"PHASE3","title":"Everolimus in de Novo Kidney Transplant Recipients","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2011-11","conditions":"Kidney Transplantation","enrollment":383},{"nctId":"NCT00596947","phase":"PHASE4","title":"Prednisone Withdrawal Versus Prednisone Maintenance After Kidney Transplant","status":"TERMINATED","sponsor":"University of Pennsylvania","startDate":"2005-10","conditions":"Transplants and Implants","enrollment":18},{"nctId":"NCT00075478","phase":"PHASE3","title":"Total-Body Irradiation With or Without Fludarabine Phosphate Followed By Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer","status":"COMPLETED","sponsor":"Fred Hutchinson Cancer Center","startDate":"2003-10","conditions":"Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia in Remission, Aggressive Non-Hodgkin Lymphoma","enrollment":87},{"nctId":"NCT00551291","phase":"PHASE2","title":"A Study of NeoRecormon (Epoetin Beta), CellCept (Mycophenolate Mofetil) and Prednisone in Patients With Low or Intermediate Myelodysplastic Syndromes.","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2007-08","conditions":"Myelodysplastic Syndromes","enrollment":10},{"nctId":"NCT02683291","phase":"PHASE4","title":"Sirolimus Associated With Tacrolimus at Low Doses in Elderly Kidney Transplant Patients","status":"COMPLETED","sponsor":"Associação Médico Espírita de Botucatu","startDate":"2014-01","conditions":"Disorder Related to Renal Transplantation, Cytomegalovirus Infections","enrollment":48},{"nctId":"NCT01631058","phase":"PHASE4","title":"Renal Transplantation in the Elderly - nEverOld Study","status":"UNKNOWN","sponsor":"University of Sao Paulo General Hospital","startDate":"2012-07","conditions":"Chronic Renal Failure (CRF), Graft Failure, Transplant; Failure, Kidney","enrollment":90},{"nctId":"NCT01817322","phase":"PHASE4","title":"Kidney Graft Function Under the Immunosuppression Strategies","status":"COMPLETED","sponsor":"Samsung Medical Center","startDate":"2011-06","conditions":"Chronic Renal Disease","enrollment":140},{"nctId":"NCT01596062","phase":"PHASE2","title":"Pharmacodynamics, Efficacy and Safety of Basiliximab 40 or 80 mg in Combination With Ciclosporine Microemulsion or Everolimus, in Adult Low Risk de Novo Renal Transplant Recipients (IDEALE Study)","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2012-03","conditions":"Renal Transplantation","enrollment":16},{"nctId":"NCT01346085","phase":"PHASE1, PHASE2","title":"Calcineurin Inhibitor (CNI)-Free Immunosuppressive Regimen in T1D Patients Receiving Islet Transplantation","status":"COMPLETED","sponsor":"Ospedale San Raffaele","startDate":"2006-10","conditions":"Type 1 Diabetes","enrollment":10},{"nctId":"NCT02095418","phase":"NA","title":"Comparison of New-onset Diabetes After Transplantation Between Two Steroid Withdrawal Group With CellCept","status":"UNKNOWN","sponsor":"Samsung Medical Center","startDate":"2014-02","conditions":"Diabetes","enrollment":152},{"nctId":"NCT01203709","phase":"PHASE4","title":"Low-dose Combination of Mycophenolate Mofetil (MMF) and Tacrolimus (Tac) for Refractory Lupus Nephritis","status":"COMPLETED","sponsor":"Tuen Mun Hospital","startDate":"2010-08","conditions":"Lupus Nephritis","enrollment":20},{"nctId":"NCT01213394","phase":"PHASE3","title":"Mycophenolate Mofetil for Reducing Cardiovascular Risk in Renal Transplant Recipients","status":"TERMINATED","sponsor":"Ramesh Prasad","startDate":"2010-10","conditions":"Kidney Transplantation, Cardiovascular Diseases","enrollment":2},{"nctId":"NCT00423098","phase":"PHASE2","title":"Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Combination With Two Corticosteroid Regimens for the Treatment of Lupus Nephritis Flare","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2007-02","conditions":"Lupus Nephritis","enrollment":81},{"nctId":"NCT00956059","phase":"NA","title":"Therapeutic Effect of Low-dose Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis","status":"UNKNOWN","sponsor":"Xi'an Jiaotong University","startDate":"2009-09","conditions":"Focal Segmental Glomerulosclerosis","enrollment":40},{"nctId":"NCT00695344","phase":"PHASE4","title":"Study to Evaluate Effect of Everolimus in Progression of Graft Vascular Illness on Patients With Heart Transplant","status":"UNKNOWN","sponsor":"Fundacion Investigacion y Desarrollo","startDate":"2006-01","conditions":"Cardiac Transplant","enrollment":52},{"nctId":"NCT00309270","phase":"PHASE2","title":"Low Dose Sirolimus or CsA-Based Maintenance Immunosuppression After Induction With Campath-1 in Kidney Transplantation","status":"COMPLETED","sponsor":"Mario Negri Institute for Pharmacological Research","startDate":"2003-02","conditions":"Kidney Transplant","enrollment":21}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":22,"recentPublications":[{"date":"2025 Dec","pmid":"40926407","title":"Dapagliflozin reduces proteinuria in IgA nephropathy patients receiving immunosuppressive therapy.","journal":"Renal failure"},{"date":"2023 May 19","pmid":"37204477","title":"Immunosuppressive therapy for Vogt-Koyanagi-Harada disease: a retrospective study and review of literature.","journal":"Journal of ophthalmic inflammation and infection"},{"date":"2022","pmid":"36211389","title":"Basiliximab for the therapy of acute T cell-mediated rejection in kidney transplant recipient with BK virus infection: A case report.","journal":"Frontiers in immunology"},{"date":"2021 Jul","pmid":"33710500","title":"Efficacy and safety of mycophenolate mofetil in the treatment for IgA nephropathy: a meta-analysis of randomized controlled trials.","journal":"Clinical and experimental nephrology"},{"date":"2019 Jul 3","pmid":"31269922","title":"Immunosuppressive therapy in children with primary nephrotic syndrome: single center experience, Karachi, Pakistan.","journal":"BMC nephrology"}],"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Myconol, MMF"],"phase":"phase_3","status":"active","brandName":"Mycophenolate mofetil, low dose steroid","genericName":"Mycophenolate mofetil, low dose steroid","companyName":"Kyungpook National University Hospital","companyId":"kyungpook-national-university-hospital","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Mycophenolate mofetil selectively inhibits inosine monophosphate dehydrogenase (IMPDH) in T and B lymphocytes, suppressing their proliferation, while low-dose corticosteroids provide additional anti-inflammatory and immunosuppressive effects. Used for Autoimmune diseases (likely lupus nephritis, vasculitis, or other systemic autoimmune conditions based on Phase 3 status).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}