{"id":"muromonab-cd3","rwe":[{"pmid":"41864860","year":"2026","title":"Progress in Monoclonal Antibodies: From Lab Innovations to Life-Saving Therapies.","finding":"","journal":"Current drug discovery technologies","studyType":"Clinical Study"},{"pmid":"40639512","year":"2025","title":"Development of a novel CD3ε-specific human antibody for selective modulation of T cell activation.","finding":"","journal":"International journal of biological macromolecules","studyType":"Clinical Study"},{"pmid":"39812815","year":"2025","title":"Incidence and risk factors for skin cancer after heart transplantation: a systematic review and meta-analysis.","finding":"","journal":"Archives of dermatological research","studyType":"Clinical Study"},{"pmid":"38187075","year":"2023","title":"Teplizumab in Type 1 Diabetes Mellitus: An Updated Review.","finding":"","journal":"TouchREVIEWS in endocrinology","studyType":"Clinical Study"},{"pmid":"38018597","year":"2023","title":"Identification of potential therapeutic drugs targeting core genes for systemic lupus erythematosus (SLE) and coexisting COVID-19: Insights from bioinformatic analyses.","finding":"","journal":"Immunity, inflammation and disease","studyType":"Clinical Study"}],"tags":[{"label":"CD3 Blocker Immunosuppressant","category":"class"},{"label":"Monoclonal Antibody","category":"modality"},{"label":"T-cell surface glycoprotein CD3","category":"target"},{"label":"CD3D","category":"gene"},{"label":"CD3E","category":"gene"},{"label":"CD3G","category":"gene"},{"label":"L04AA02","category":"atc"},{"label":"Active","category":"status"},{"label":"Renal transplant rejection","category":"indication"},{"label":"Ortho Biotech","category":"company"},{"label":"Approved 1990s","category":"decade"},{"label":"Immunologic Factors","category":"pharmacology"},{"label":"Immunosuppressive Agents","category":"pharmacology"}],"phase":"marketed","safety":{"safetySignals":[{"llr":101.588,"date":"","count":21,"signal":"Post transplant lymphoproliferative disorder","source":"DrugCentral FAERS","actionTaken":"Reported 21 times (LLR=102)"}],"commonSideEffects":[]},"trials":[],"aliases":[],"company":"Ortho Biotech","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=MUROMONAB-CD3","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:40:04.023481+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:40:11.405825+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=MUROMONAB-CD3","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:40:12.171115+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: T cell surface glycoprotein CD3 inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:40:12.759127+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1201608/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:40:12.649522+00:00"}},"allNames":"orthoclone okt3","offLabel":[],"synonyms":["muromonab-CD3","orthoclone OKT3"],"timeline":[{"date":"1992-09-14","type":"positive","source":"DrugCentral","milestone":"FDA approval (Ortho Biotech)"}],"aiSummary":"Orthoclone Okt3 (MUROMONAB-CD3) is a CD3 blocker immunosuppressant originally developed by ORTHO BIOTECH and currently owned by the same company. It targets the T-cell surface glycoprotein CD3, a key component of the immune system. This drug is used to prevent renal transplant rejection and was FDA approved in 1992. As a proprietary product, its commercial status is patented, and key safety considerations include potential infections and allergic reactions. In plain terms, Orthoclone Okt3 works by blocking a specific protein on immune cells to prevent them from attacking the transplanted kidney.","approvals":[{"date":"1992-09-14","orphan":false,"company":"ORTHO BIOTECH","regulator":"FDA"}],"brandName":"Orthoclone Okt3","ecosystem":[{"indication":"Renal transplant rejection","otherDrugs":[{"name":"basiliximab","slug":"basiliximab","company":"Novartis"},{"name":"belatacept","slug":"belatacept","company":"Bristol Myers Squibb"},{"name":"daclizumab","slug":"daclizumab","company":"Hoffman-La Roche"},{"name":"tacrolimus","slug":"tacrolimus","company":"Astellas"}],"globalPrevalence":null}],"mechanism":{"target":"T-cell surface glycoprotein CD3","novelty":"First-in-class","targets":[{"gene":"CD3D","source":"DrugCentral","target":"T-cell surface glycoprotein CD3","protein":"T-cell surface glycoprotein CD3 delta chain"},{"gene":"CD3E","source":"DrugCentral","target":"T-cell surface glycoprotein CD3","protein":"T-cell surface glycoprotein CD3 epsilon chain"},{"gene":"CD3G","source":"DrugCentral","target":"T-cell surface glycoprotein CD3","protein":"T-cell surface glycoprotein CD3 gamma chain"}],"moaClass":"CD3 Receptor Antagonists","modality":"Monoclonal Antibody","drugClass":"CD3 Blocker Immunosuppressant","explanation":"","oneSentence":"","technicalDetail":"Orthoclone Okt3 is a monoclonal antibody that binds to the CD3 epsilon subunit of the T-cell receptor complex, preventing the activation of T-cells and subsequent immune response against the transplanted kidney."},"commercial":{"launchDate":"1992","_launchSource":"DrugCentral (FDA 1992-09-14, ORTHO BIOTECH)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5177","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=MUROMONAB-CD3","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=MUROMONAB-CD3","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T12:51:44.954539","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:40:14.697250+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"mycophenolic acid","drugSlug":"mycophenolic-acid","fdaApproval":"2004-02-27","relationship":"same-class"},{"drugName":"sirolimus","drugSlug":"sirolimus","fdaApproval":"1999-09-15","patentExpiry":"Oct 28, 2040","patentStatus":"Patent 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