{"id":"ocrelizumabu-200mg","rwe":[],"tags":[],"phase":"discontinued","safety":{"boxedWarnings":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{"Pregnancy":"Data not available","Geriatric use":"Data not available","Paediatric use":"Data not available","Renal impairment":"Data not available","Hepatic impairment":"Data not available"},"seriousAdverseEvents":[]},"status":"discontinued","trials":["NCT00779220"],"aliases":[],"patents":[],"pricing":[],"offLabel":[],"timeline":[{"date":"","type":"neutral","milestone":"Ocrelizumab development initiated by Chugai Pharmaceutical","regulator":"none","description":"Chugai Pharmaceutical began development of ocrelizumab as a CD20-targeting monoclonal antibody for autoimmune diseases."},{"date":"","type":"neutral","milestone":"Phase 2 trial initiated in rheumatoid arthritis","regulator":"none","description":"Phase 2 clinical trial (N=152) sponsored by Chugai Pharmaceutical commenced to evaluate efficacy, safety, and PK/PD of ocrelizumab in RA patients."},{"date":"","type":"negative","milestone":"Phase 2 trial terminated in rheumatoid arthritis","regulator":"none","description":"Phase 2 trial in RA was terminated; reasons for termination not publicly disclosed; likely due to insufficient efficacy signals or safety concerns."},{"date":"","type":"negative","milestone":"Ocrelizumab program discontinued","regulator":"none","description":"Chugai Pharmaceutical discontinued development of ocrelizumab; no further clinical advancement or regulatory submissions pursued."}],"aiSummary":"Ocrelizumab 200 mg is a monoclonal antibody developed by Chugai Pharmaceutical that targets CD20-expressing B cells, designed for the treatment of rheumatoid arthritis and other autoimmune conditions. The drug mechanism involves selective depletion of B lymphocytes, which play a central role in the pathogenesis of autoimmune diseases by producing autoantibodies and pro-inflammatory cytokines. Ocrelizumab entered clinical development with a Phase 2 trial in rheumatoid arthritis (N=152) sponsored by Chugai Pharmaceutical; however, this trial was terminated, and the program was subsequently discontinued. The discontinuation suggests either insufficient efficacy signals, safety concerns, or strategic portfolio decisions by Chugai, as the competitive landscape for B-cell-targeting biologics in RA was already well-established with approved agents such as rituximab and ocrelizumab (Ocrevus, developed by Roche/Genentech for MS). No FDA approval, EMA marketing authorization, or regulatory designation was achieved. The commercial and clinical significance of this asset is minimal given its discontinued status and lack of regulatory advancement beyond early-stage clinical evaluation.","brandName":"ocrelizumabu 200mg","companyId":"chugai-pharmaceutical","ecosystem":[],"mechanism":{"target":"CD20 (cluster of differentiation 20)","novelty":"me-too","modality":"monoclonal antibody","drugClass":"B-cell depleting monoclonal antibody; immunosuppressant","explanation":"Ocrelizumab is a monoclonal antibody that binds to CD20, a cell surface antigen expressed on B lymphocytes at various stages of maturation. By targeting CD20, the drug triggers B-cell destruction through multiple mechanisms including antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and direct induction of apoptosis. In autoimmune diseases like rheumatoid arthritis, B cells contribute to disease pathology by producing autoantibodies (such as rheumatoid factor and anti-CCP antibodies), presenting antigens to T cells, and secreting pro-inflammatory cytokines including TNF-α, IL-6, and IL-10. By depleting these B-cell populations, ocrelizumab aims to interrupt the autoimmune cascade and reduce joint inflammation, synovitis, and progression of structural damage. The selective targeting of CD20 allows for B-cell depletion while largely sparing other immune cell populations, though some immunosuppression is expected.","oneSentence":"Ocrelizumab selectively depletes CD20+ B lymphocytes to suppress autoimmune-mediated inflammation.","technicalDetail":"Ocrelizumab is a chimeric monoclonal antibody (human-mouse) that binds with high affinity to CD20 (cluster of differentiation 20), a transmembrane phosphoprotein expressed on the surface of B lymphocytes from the pre-B cell stage through mature B cells but absent on hematopoietic stem cells, pro-B cells, and plasma cells. The antibody mediates B-cell depletion via Fc-receptor engagement (ADCC through NK cells and macrophages) and classical complement pathway activation (CDC). Pharmacokinetically, monoclonal antibodies of this class typically exhibit a half-life of 2–4 weeks in serum, with peak concentrations achieved 3–7 days post-infusion; however, specific PK/PD data for ocrelizumab were not published in the available literature."},"commercial":{"notes":"Drug discontinued; no commercial launch or revenue data available.","yoyGrowth":"","launchDate":"","marketShare":"","revenueYear":"","annualCostUS":"","currentRevenue":"","percentOfCompany":"","patientPopulation":"","peakSalesEstimate":"","genericCompetition":"no"},"references":[],"biosimilars":[],"companyName":"Chugai Pharmaceutical","competitors":[{"name":"Rituximab","slug":"rituximab","company":"Roche/Genentech","advantage":"First-in-class CD20-targeting monoclonal antibody; approved for RA and multiple other autoimmune indications; established clinical efficacy and safety profile."},{"name":"Ocrevus (ocrelizumab)","slug":"ocrevus","company":"Roche/Genentech","advantage":"Humanized CD20-targeting monoclonal antibody with improved ADCC; approved for multiple sclerosis and rheumatoid arthritis; superior B-cell depletion kinetics."},{"name":"Ofatumumab","slug":"ofatumumab","company":"Novartis","advantage":"Fully human anti-CD20 monoclonal antibody; approved for chronic lymphocytic leukemia and rheumatoid arthritis; alternative B-cell depletion mechanism."},{"name":"Belimumab","slug":"belimumab","company":"GlaxoSmithKline","advantage":"BLyS (B-lymphocyte stimulator) inhibitor; approved for systemic lupus erythematosus; alternative mechanism targeting B-cell survival pathway."}],"genericName":"ocrelizumabu 200mg","indications":{"approved":[],"offLabel":[],"pipeline":[{"name":"Rheumatoid Arthritis","notes":"Phase 2 trial (N=152) sponsored by Chugai Pharmaceutical was terminated; program subsequently discontinued. No efficacy or safety data published.","phase":"Phase 2","status":"completed"}]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT00779220","phase":"PHASE2","title":"A Study to Evaluate the Efficacy, Safety and Pharmacokinetics/Pharmacodynamics (PK/PD) of Ocrelizumab in Patients With Rheumatoid Arthritis","status":"TERMINATED","sponsor":"Chugai Pharmaceutical","startDate":"2008-10","conditions":"Rheumatoid Arthritis","enrollment":152}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"💉","route":"IV","frequency":"Data not available","formulation":"Intravenous injection"},"formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[{"notes":"Chugai Pharmaceutical developed ocrelizumab as an in-house program; program discontinued after Phase 2 trial termination in rheumatoid arthritis.","period":"Development–discontinued","companyName":"Chugai Pharmaceutical","relationship":"Originator"}],"therapeuticAreas":["Immunology"],"trialPhaseCounts":{"PHASE2":1},"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"Small molecule","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}