{"id":"eu-sourced-xgeva","safety":{"commonSideEffects":["Hypocalcemia","Musculoskeletal pain","Fatigue","Nausea","Dyspnea"],"contraindications":["Hypocalcemia","Pregnancy"]},"_chembl":null,"modality":"Small molecule","_dailymed":null,"mechanism":{"target":"RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand)","explanation":"Denosumab is a fully human monoclonal antibody that binds to RANKL with high affinity and specificity, preventing RANKL from activating its receptor RANK on osteoclast precursors and osteoclasts. This inhibition reduces osteoclast-mediated bone resorption and increases bone mass and strength.","oneSentence":"Binds to and inhibits RANKL, preventing osteoclast formation and bone resorption."},"_scrapedAt":"2026-03-28T05:03:39.943Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"_claudeStub":{"ts":1779123512,"model":"claude-sonnet-4-5-20250929"},"competitors":[{"name":"denosumab","brand":"Xgeva","company":"Amgen","rationale":"Reference product for this biosimilar candidate"},{"name":"zoledronic acid","brand":"Zometa","company":"Novartis","rationale":"Bisphosphonate used for bone metastases and skeletal-related events"},{"name":"pamidronate","brand":"Aredia","company":null,"rationale":"Bisphosphonate alternative for bone complications in cancer patients"}],"description":"EU-sourced Xgeva is a biosimilar candidate of denosumab being developed by mAbxience Research S.L. Denosumab is a monoclonal antibody that inhibits RANKL, used to prevent skeletal-related events in patients with bone metastases from solid tumors and to treat giant cell tumor of bone and osteoporosis.","indications":{"approved":[{"status":"investigational","condition":"Prevention of skeletal-related events in patients with bone metastases from solid tumors","patientPopulation":"Adult"},{"status":"investigational","condition":"Giant cell tumor of bone","patientPopulation":"Adult and skeletally mature adolescents"},{"status":"investigational","condition":"Osteoporosis","patientPopulation":"Postmenopausal women and men at high risk of fracture"}]},"trialDetails":[{"nctId":"NCT05245669","phase":"PHASE1","title":"Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Biosimilar Denosumab With Prolia® in Healthy Adult Male Volunteers","status":"COMPLETED","sponsor":"Enzene Biosciences Ltd.","startDate":"2022-01-10","conditions":"Healthy Male Subjects","enrollment":207},{"nctId":"NCT06310824","phase":"PHASE1","title":"Single Dose, Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia®","status":"COMPLETED","sponsor":"Xentria, Inc.","startDate":"2024-06-05","conditions":"Healthy Participants","enrollment":225},{"nctId":"NCT05338086","phase":"PHASE3","title":"A Study to Compare Efficacy, PK, PD, Safety and IMM of MB09 to Prolia® [EU-sourced] in Postmenopausal Osteoporosis.","status":"COMPLETED","sponsor":"mAbxience Research S.L.","startDate":"2022-03-16","conditions":"Postmenopausal Women With Osteoporosis","enrollment":558},{"nctId":"NCT05299073","phase":"PHASE1","title":"A Study Comparing the Pharmacokinetic Similarity of MB09 and EU/US-Sourced Xgeva","status":"COMPLETED","sponsor":"mAbxience Research S.L.","startDate":"2022-03-01","conditions":"Healthy Volunteers","enrollment":257},{"nctId":"NCT04621318","phase":"PHASE1","title":"Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity Study of SB16 in Healthy Male Subjects","status":"COMPLETED","sponsor":"Samsung Bioepis Co., Ltd.","startDate":"2020-10-19","conditions":"Healthy","enrollment":168}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["EU-licensed Xgeva"],"phase":"phase_1","status":"active","brandName":"EU-sourced Xgeva","genericName":"EU-sourced Xgeva","companyName":"mAbxience Research S.L.","companyId":"mabxience-research-s-l","firstApprovalDate":"","aiSummary":"","enrichmentLevel":3,"visitCount":2,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}