{"id":"denosumab-cp2","safety":{"commonSideEffects":[{"rate":null,"effect":"Hypocalcemia"},{"rate":null,"effect":"Osteonecrosis of the jaw"},{"rate":null,"effect":"Atypical femoral fractures"},{"rate":null,"effect":"Infections"},{"rate":null,"effect":"Fatigue"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Denosumab binds to RANKL, a key mediator of osteoclast differentiation and activation. By preventing RANKL from engaging its receptor RANK on osteoclast precursors, the drug suppresses bone resorption and increases bone mineral density. This mechanism makes it effective for conditions characterized by excessive bone loss or osteoclast-mediated bone destruction.","oneSentence":"Denosumab is a monoclonal antibody that inhibits RANKL (receptor activator of nuclear factor kappa-B ligand), blocking osteoclast formation and bone resorption.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:45:47.079Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of skeletal-related events in patients with bone metastases from solid tumors"},{"name":"Treatment of giant cell tumor of bone"},{"name":"Osteoporosis in postmenopausal women and men at high risk of fracture"}]},"trialDetails":[{"nctId":"NCT02053753","phase":"PHASE1","title":"Bioequivalence Study of Denosumab CP4 Drug Product and Commercially Available Denosumab CP2 Drug Product","status":"COMPLETED","sponsor":"Amgen","startDate":"2014-02","conditions":"Healthy Volunteer","enrollment":146},{"nctId":"NCT02157948","phase":"PHASE3","title":"A Double-blind Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis","status":"COMPLETED","sponsor":"Amgen","startDate":"2014-05","conditions":"Postmenopausal Osteoporosis","enrollment":394}],"_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":["XGEVA®"],"phase":"phase_3","status":"active","brandName":"Denosumab (CP2)","genericName":"Denosumab (CP2)","companyName":"Amgen","companyId":"amgen","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Denosumab is a monoclonal antibody that inhibits RANKL (receptor activator of nuclear factor kappa-B ligand), blocking osteoclast formation and bone resorption. Used for Prevention of skeletal-related events in patients with bone metastases from solid tumors, Treatment of giant cell tumor of bone, Osteoporosis in postmenopausal women and men at high risk of fracture.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}