{"id":"us-licensed-prolia","safety":{"commonSideEffects":[{"rate":"10-20%","effect":"Nausea"},{"rate":"10-20%","effect":"Headache"},{"rate":"5-10%","effect":"Injection site reaction"},{"rate":"5-10%","effect":"Musculoskeletal pain"},{"rate":"5-10%","effect":"Fatigue"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"By binding to RANKL, Prolia inhibits the formation of osteoclasts, which are cells responsible for bone breakdown. This leads to an increase in bone mass and a decrease in the risk of fractures. Prolia is administered via subcutaneous injection and has a half-life of approximately 28 days.","oneSentence":"Prolia is a human monoclonal antibody that targets RANKL, a protein involved in bone resorption.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:54:43.021Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Treatment of osteoporosis in postmenopausal women at high risk of fracture"},{"name":"Treatment of bone loss in patients with hormone ablation for non-metastatic prostate cancer"}]},"trialDetails":[{"nctId":"NCT04934072","phase":"PHASE3","title":"A Study to Evaluate the Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 in Postmenopausal Women With Osteoporosis","status":"COMPLETED","sponsor":"Fresenius Kabi SwissBioSim GmbH","startDate":"2021-06-16","conditions":"Postmenopausal Osteoporosis","enrollment":553},{"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":"NCT04757376","phase":"PHASE3","title":"A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis","status":"COMPLETED","sponsor":"Celltrion","startDate":"2021-06-17","conditions":"Postmenopausal Women With Osteoporosis","enrollment":479},{"nctId":"NCT06037395","phase":"PHASE1","title":"Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety Between CT-P41 and US-licensed Prolia in Healthy Male Subjects","status":"COMPLETED","sponsor":"Celltrion","startDate":"2021-10-06","conditions":"Healthy Subject","enrollment":154}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"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":"US-licensed Prolia","genericName":"US-licensed Prolia","companyName":"Celltrion","companyId":"celltrion","modality":"Biologic","firstApprovalDate":"","aiSummary":"Prolia is a human monoclonal antibody that targets RANKL, a protein involved in bone resorption. Used for Treatment of osteoporosis in postmenopausal women at high risk of fracture, Treatment of bone loss in patients with hormone ablation for non-metastatic prostate cancer.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}