{"id":"tesomet-high-dose-in-fed-condition","safety":{"commonSideEffects":[{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Insomnia"},{"rate":null,"effect":"Tachycardia"}]},"_chembl":{"chemblId":"CHEMBL5715933","moleculeType":null,"molecularWeight":"612.41"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Tesofensine inhibits the reuptake of serotonin, norepinephrine, and dopamine in the central nervous system, leading to increased appetite suppression and thermogenesis. Metformin improves insulin sensitivity and glucose metabolism. The combination is designed to address both weight loss and glycemic control in obese and overweight patients.","oneSentence":"Tesomet is a combination of tesofensine (a monoamine reuptake inhibitor) and metformin that promotes weight loss by increasing satiety and energy expenditure while improving metabolic control.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T06:27:01.830Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Chronic weight management in obese or overweight adults"}]},"trialDetails":[{"nctId":"NCT03286829","phase":"PHASE1","title":"Study to Investigate the Pharmacokinetic Profile","status":"COMPLETED","sponsor":"Saniona","startDate":"2017-12-18","conditions":"Healthy Male Subjects","enrollment":60}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[{"date":"20170131","type":"ORIG","sponsor":"MYLAN","applicationNumber":"ANDA207682"},{"date":"20210106","type":"SUPPL","sponsor":"MYLAN","applicationNumber":"ANDA207682"},{"date":"20110131","type":"ORIG","sponsor":"ELITE LABS","applicationNumber":"ANDA200272"},{"date":"20170531","type":"SUPPL","sponsor":"ELITE LABS","applicationNumber":"ANDA200272"},{"date":"20121205","type":"SUPPL","sponsor":"ELITE LABS","applicationNumber":"ANDA200272"},{"date":"20250603","type":"ORIG","sponsor":"PRECISION DOSE INC","applicationNumber":"ANDA217187"},{"date":"20150731","type":"ORIG","sponsor":"CSPC-NBP PHARM","applicationNumber":"ANDA202765"},{"date":"20210309","type":"ORIG","sponsor":"PHARMOBEDIENT","applicationNumber":"ANDA209597"}],"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":["Tesofensine","Metoprolol"],"phase":"marketed","status":"active","brandName":"Tesomet \"High dose\" in fed condition","genericName":"Tesomet \"High dose\" in fed condition","companyName":"Saniona","companyId":"saniona","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Tesomet is a combination of tesofensine (a monoamine reuptake inhibitor) and metformin that promotes weight loss by increasing satiety and energy expenditure while improving metabolic control. Used for Chronic weight management in obese or overweight adults.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}