{"id":"mizoribine","rwe":[],"tags":[{"label":"mizoribine","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Active","category":"status"},{"label":"Analgesics","category":"pharmacology"},{"label":"Analgesics, Non-Narcotic","category":"pharmacology"},{"label":"Anti-Bacterial Agents","category":"pharmacology"},{"label":"Anti-Infective Agents","category":"pharmacology"},{"label":"Anti-Inflammatory Agents","category":"pharmacology"},{"label":"Anti-Inflammatory Agents, Non-Steroidal","category":"pharmacology"},{"label":"Antibiotics, Antineoplastic","category":"pharmacology"},{"label":"Antimalarials","category":"pharmacology"},{"label":"Antineoplastic Agents","category":"pharmacology"},{"label":"Antiparasitic Agents","category":"pharmacology"},{"label":"Antiprotozoal Agents","category":"pharmacology"},{"label":"Antirheumatic Agents","category":"pharmacology"},{"label":"Enzyme Inhibitors","category":"pharmacology"},{"label":"Immunologic Factors","category":"pharmacology"},{"label":"Immunosuppressive Agents","category":"pharmacology"},{"label":"Peripheral Nervous System Agents","category":"pharmacology"},{"label":"Sensory System Agents","category":"pharmacology"}],"phase":"phase_3","safety":{"safetySignals":[{"llr":56.344,"date":"","count":26,"signal":"Cytomegalovirus infection","source":"DrugCentral FAERS","actionTaken":"Reported 26 times (LLR=56)"},{"llr":40.628,"date":"","count":19,"signal":"Osteonecrosis","source":"DrugCentral FAERS","actionTaken":"Reported 19 times (LLR=41)"},{"llr":37.755,"date":"","count":13,"signal":"Kidney transplant rejection","source":"DrugCentral FAERS","actionTaken":"Reported 13 times (LLR=38)"},{"llr":37.678,"date":"","count":5,"signal":"N-telopeptide urine increased","source":"DrugCentral FAERS","actionTaken":"Reported 5 times (LLR=38)"},{"llr":36.455,"date":"","count":16,"signal":"Pharyngitis","source":"DrugCentral FAERS","actionTaken":"Reported 16 times (LLR=36)"},{"llr":35.625,"date":"","count":6,"signal":"Hypocomplementaemia","source":"DrugCentral FAERS","actionTaken":"Reported 6 times (LLR=36)"},{"llr":34.961,"date":"","count":10,"signal":"Varicella zoster virus infection","source":"DrugCentral FAERS","actionTaken":"Reported 10 times (LLR=35)"},{"llr":34.147,"date":"","count":16,"signal":"Hyperlipidaemia","source":"DrugCentral FAERS","actionTaken":"Reported 16 times (LLR=34)"},{"llr":32.628,"date":"","count":15,"signal":"Iron deficiency anaemia","source":"DrugCentral FAERS","actionTaken":"Reported 15 times (LLR=33)"},{"llr":32.313,"date":"","count":12,"signal":"Hyperuricaemia","source":"DrugCentral FAERS","actionTaken":"Reported 12 times (LLR=32)"},{"llr":31.661,"date":"","count":9,"signal":"Upper respiratory tract inflammation","source":"DrugCentral FAERS","actionTaken":"Reported 9 times (LLR=32)"},{"llr":30.317,"date":"","count":22,"signal":"Diabetes mellitus","source":"DrugCentral FAERS","actionTaken":"Reported 22 times (LLR=30)"},{"llr":29.949,"date":"","count":13,"signal":"Pneumonia bacterial","source":"DrugCentral FAERS","actionTaken":"Reported 13 times (LLR=30)"},{"llr":28.262,"date":"","count":15,"signal":"Disseminated intravascular coagulation","source":"DrugCentral FAERS","actionTaken":"Reported 15 times (LLR=28)"},{"llr":27.892,"date":"","count":11,"signal":"Diffuse large B-cell lymphoma","source":"DrugCentral FAERS","actionTaken":"Reported 11 times (LLR=28)"}],"commonSideEffects":[{"effect":"Cytomegalovirus infection","drugRate":"LLR 56","severity":"common"},{"effect":"Osteonecrosis","drugRate":"LLR 41","severity":"common"},{"effect":"Kidney transplant rejection","drugRate":"LLR 38","severity":"common"},{"effect":"N-telopeptide urine increased","drugRate":"LLR 38","severity":"common"},{"effect":"Pharyngitis","drugRate":"LLR 36","severity":"common"},{"effect":"Hypocomplementaemia","drugRate":"LLR 36","severity":"common"},{"effect":"Varicella zoster virus infection","drugRate":"LLR 35","severity":"common"},{"effect":"Hyperlipidaemia","drugRate":"LLR 34","severity":"common"},{"effect":"Iron deficiency anaemia","drugRate":"LLR 33","severity":"common"},{"effect":"Hyperuricaemia","drugRate":"LLR 32","severity":"common"},{"effect":"Upper respiratory tract inflammation","drugRate":"LLR 32","severity":"common"},{"effect":"Diabetes mellitus","drugRate":"LLR 30","severity":"common"},{"effect":"Pneumonia bacterial","drugRate":"LLR 30","severity":"common"},{"effect":"Disseminated intravascular coagulation","drugRate":"LLR 28","severity":"common"},{"effect":"Diffuse large B-cell lymphoma","drugRate":"LLR 28","severity":"common"}]},"trials":[],"aliases":[],"patents":[],"pricing":[],"allNames":"bredinin","offLabel":[],"synonyms":["mizoribine","bredinin","beta-Bredinin"],"timeline":[],"approvals":[],"brandName":"Bredinin","ecosystem":[],"mechanism":{"modality":"Small Molecule","drugClass":"mizoribine","explanation":"Think of it like a roadblock in a factory. Guanine nucleotides are like the raw materials needed to build important molecules in our cells. By blocking the enzyme that makes these raw materials, mizoribine slows down the production of these molecules, which can help to reduce inflammation and other symptoms of autoimmune diseases.","oneSentence":"Mizoribine blocks the production of guanine nucleotides by inhibiting the enzyme inosine monophosphate dehydrogenase.","technicalDetail":"Mizoribine acts as a competitive inhibitor of inosine monophosphate dehydrogenase (IMPDH), an enzyme involved in the de novo synthesis of guanine nucleotides. By inhibiting IMPDH, mizoribine reduces the production of guanine nucleotides, which are essential for the proliferation of lymphocytes and other immune cells."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/3363","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=MIZORIBINE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=MIZORIBINE","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T12:49:23.748426","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T10:52:53.339715+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"competitors":[],"genericName":"mizoribine","indications":{"approved":[],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT06114953","phase":"PHASE4","title":"Comparative Efficacy of Mizoribine With Mycophenolate Mofetil for Living Related Kidney Transplantation Recipients","status":"UNKNOWN","sponsor":"Lee's Pharmaceutical Limited","startDate":"2023-01-01","conditions":["Kidney Transplant Immunosuppression"],"enrollment":152,"completionDate":"2025-03-01"},{"nctId":"NCT05293704","phase":"PHASE4","title":"An Open Study on the Preventive Effect of Early Mizoribine Conversion on BKV Nephropathy in Renal Transplant Recipients","status":"UNKNOWN","sponsor":"Lee's Pharmaceutical Limited","startDate":"2022-05-01","conditions":["Kidney Transplant Recipients","BK Virus"],"enrollment":30,"completionDate":"2024-05-01"},{"nctId":"NCT02256150","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of Mizoribine in the Treatment of Lupus Nephritis","status":"COMPLETED","sponsor":"Asahi Kasei Pharma Corporation","startDate":"2014-11","conditions":["Lupus Nephritis"],"enrollment":250,"completionDate":"2019-03"},{"nctId":"NCT02257697","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of Mizoribine in the Treatment of Refractory Nephrotic Syndrome","status":"COMPLETED","sponsor":"Asahi Kasei Pharma Corporation","startDate":"2014-11","conditions":["Nephrotic Syndrome"],"enrollment":239,"completionDate":"2018-11"},{"nctId":"NCT02373202","phase":"PHASE3","title":"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)","status":"COMPLETED","sponsor":"Sanofi","startDate":"2015-02","conditions":["Rheumatoid Arthritis"],"enrollment":91,"completionDate":"2016-11"},{"nctId":"NCT02005757","phase":"PHASE2","title":"Efficacy and Safety Study of Mizoribine in Active Rheumatoid (AMOLED)","status":"UNKNOWN","sponsor":"Chong Kun Dang Pharmaceutical","startDate":"2013-11","conditions":["Rheumatoid Arthritis"],"enrollment":60,"completionDate":"2016-10"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"crossReferences":{"UNII":"4JR41A10VP","CHEBI":"CHEBI:31858","INN_ID":"5120","UMLSCUI":"C0128608","ChEMBL_ID":"CHEMBL245019","KEGG_DRUG":"D01392","DRUGBANK_ID":"DB12617","PDB_CHEM_ID":" MZR","PUBCHEM_CID":"104762","SNOMEDCT_US":"772627008","MESH_SUPPLEMENTAL_RECORD_UI":"C010052"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[],"pharmacokinetics":{"source":"DrugCentral","bioavailability":"91%"},"publicationCount":651,"therapeuticAreas":["Immunology"],"biosimilarFilings":[],"recentPublications":[],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","companyName":"","companyId":"","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Bredinin is a small molecule inhibitor of inosine-5'-monophosphate dehydrogenase (IMPDH). It has been studied in clinical trials for various conditions, including kidney transplant recipients, BK virus, kidney transplant immunosuppression, rheumatoid arthritis, and lupus nephritis.","enrichmentLevel":5,"visitCount":0,"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T10:52:53.339715+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":false,"safety":true,"trials":true,"score":3}}