{"id":"eu-prolia","safety":{"commonSideEffects":[{"rate":null,"effect":"Hypocalcemia"},{"rate":null,"effect":"Osteonecrosis of the jaw"},{"rate":null,"effect":"Atypical femoral fractures"},{"rate":null,"effect":"Infections"}]},"_chembl":{"chemblId":"CHEMBL5857501","moleculeType":null,"molecularWeight":"542.39"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"By binding to RANKL, EU-Prolia prevents the interaction between RANKL and its receptor RANK on osteoclast precursor cells, thereby suppressing osteoclast differentiation and activation. This leads to decreased bone resorption and increased bone mineral density, making it useful in conditions characterized by excessive bone loss.","oneSentence":"EU-Prolia is a monoclonal antibody that inhibits RANKL (receptor activator of nuclear factor kappa-B ligand) to reduce osteoclast formation and bone resorption.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:11:48.274Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Osteoporosis in postmenopausal women"},{"name":"Bone loss in patients with cancer or receiving cancer therapy"}]},"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":"NCT04534582","phase":"PHASE1","title":"Pharmacokinetic, Safety and Immunogenicity Phase I Study of HLX14 Versus Prolia® in Healthy Male Subjects","status":"COMPLETED","sponsor":"Shanghai Henlius Biotech","startDate":"2020-11-03","conditions":"Healthy Male Volunteers","enrollment":252},{"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":"NCT05853354","phase":"PHASE3","title":"Comparative Efficacy, Safety, PK, and Immunogenicity Study","status":"ACTIVE_NOT_RECRUITING","sponsor":"Luye Pharma Group Ltd.","startDate":"2023-04-05","conditions":"Osteoporosis, Postmenopausal","enrollment":392},{"nctId":"NCT06095427","phase":"PHASE1","title":"A Pharmacokinetic Similarity Study in Healthy Male Subjects to Evaluate Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of LY06006 Versus US-Prolia and EU-Prolia by Single-dose Subcutaneous Injection","status":"COMPLETED","sponsor":"Luye Pharma Group Ltd.","startDate":"2021-03-09","conditions":"Healthy","enrollment":300},{"nctId":"NCT03974100","phase":"PHASE3","title":"Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis","status":"COMPLETED","sponsor":"Sandoz","startDate":"2019-07-02","conditions":"Postmenopausal Women With Osteoporosis","enrollment":527},{"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},{"nctId":"NCT02132026","phase":"PHASE2","title":"Study Investigating the Effect of Drugs Used to Treat Osteoporosis on the Progression of Calcific Aortic Stenosis.","status":"COMPLETED","sponsor":"University of Edinburgh","startDate":"2014-11-12","conditions":"Calcific Aortic Stenosis","enrollment":152},{"nctId":"NCT04512872","phase":"PHASE1","title":"A Phase I Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy Male Subjects","status":"COMPLETED","sponsor":"Celltrion","startDate":"2020-10-20","conditions":"Healthy Male Subjects","enrollment":30}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"EU-Prolia","genericName":"EU-Prolia","companyName":"Luye Pharma Group Ltd.","companyId":"luye-pharma-group-ltd","modality":"Biologic","firstApprovalDate":"","aiSummary":"EU-Prolia is a monoclonal antibody that inhibits RANKL (receptor activator of nuclear factor kappa-B ligand) to reduce osteoclast formation and bone resorption. Used for Osteoporosis in postmenopausal women, Bone loss in patients with cancer or receiving cancer therapy.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}