{"id":"mhos-shp615","safety":{"commonSideEffects":[{"rate":null,"effect":"Increased appetite"},{"rate":null,"effect":"Weight gain"},{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Headache"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"SHP615 activates the ghrelin receptor (growth hormone secretagogue receptor 1a) to promote endogenous growth hormone secretion. This mechanism aims to restore physiological growth hormone levels in patients with growth hormone deficiency, potentially offering advantages over recombinant human growth hormone therapy through stimulation of the body's own GH production.","oneSentence":"MHOS/SHP615 is a long-acting growth hormone secretagogue (ghrelin receptor agonist) that stimulates growth hormone release.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:50:01.020Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Growth hormone deficiency in adults"}]},"trialDetails":[{"nctId":"NCT03336450","phase":"PHASE3","title":"Study of Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in Pediatric Patients With Status Epilepticus (Convulsive) in the Community Setting","status":"COMPLETED","sponsor":"Shire","startDate":"2018-04-23","conditions":"Nervous System Diseases","enrollment":3},{"nctId":"NCT03336645","phase":"PHASE3","title":"Open-label Study of Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in Children With Status Epilepticus (Convulsive) in a Healthcare Setting in Japan","status":"COMPLETED","sponsor":"Shire","startDate":"2017-10-23","conditions":"Nervous System Diseases","enrollment":25}],"_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":"MHOS/SHP615","genericName":"MHOS/SHP615","companyName":"Shire","companyId":"shire","modality":"Small molecule","firstApprovalDate":"","aiSummary":"MHOS/SHP615 is a midazolam hydrochloride oromucosal solution used to treat status epilepticus in children. It is being studied in a Phase 3 clinical trial (NCT03336645) sponsored by Takeda.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}