{"id":"axs-02-oral-zoledronate","safety":{"commonSideEffects":[{"rate":null,"effect":"Osteonecrosis of the jaw"},{"rate":null,"effect":"Atypical femoral fractures"},{"rate":null,"effect":"Renal impairment"},{"rate":null,"effect":"Hypocalcemia"},{"rate":null,"effect":"Gastrointestinal upset"}]},"_chembl":{"chemblId":"CHEMBL4746555","moleculeType":"Unknown","molecularWeight":"360.02"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Zoledronate is a potent bisphosphonate that binds to hydroxyapatite in bone and is taken up by osteoclasts, where it inhibits farnesyl pyrophosphate synthase, disrupting the mevalonate pathway and leading to osteoclast apoptosis. This reduces bone resorption and is used to treat conditions characterized by excessive bone loss or abnormal bone metabolism. The oral formulation (AXS-02) aims to improve patient convenience and compliance compared to intravenous administration.","oneSentence":"AXS-02 is an oral formulation of zoledronate, a bisphosphonate that inhibits osteoclast-mediated bone resorption by blocking farnesyl pyrophosphate synthase in the mevalonate pathway.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:03:05.639Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Osteoporosis"},{"name":"Bone metastases and hypercalcemia of malignancy (investigational oral formulation)"}]},"trialDetails":[{"nctId":"NCT02746068","phase":"PHASE3","title":"A Study to Assess the Efficacy and Safety of AXS-02 in Subjects With Knee OA Associated With Bone Marrow Lesions","status":"UNKNOWN","sponsor":"Axsome Therapeutics, Inc.","startDate":"2016-03","conditions":"Osteoarthritis, Knee","enrollment":346},{"nctId":"NCT02504008","phase":"PHASE3","title":"CREATE-1: A Study to Assess the Efficacy and Safety of AXS-02 in Patients With CRPS-1","status":"UNKNOWN","sponsor":"Axsome Therapeutics, Inc.","startDate":"2015-07","conditions":"Complex Regional Pain Syndrome, Reflex Sympathetic Dystrophy","enrollment":190}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":480,"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":"AXS-02 (oral zoledronate)","genericName":"AXS-02 (oral zoledronate)","companyName":"Axsome Therapeutics, Inc.","companyId":"axsome-therapeutics-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"AXS-02 is an oral formulation of zoledronate, a bisphosphonate that inhibits osteoclast-mediated bone resorption by blocking farnesyl pyrophosphate synthase in the mevalonate pathway. Used for Osteoporosis, Bone metastases and hypercalcemia of malignancy (investigational oral formulation).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}