{"id":"cohort-a-ormd-0801","safety":{"commonSideEffects":[{"rate":"10-20%","effect":"Nausea"},{"rate":"5-10%","effect":"Abdominal pain"},{"rate":"5-10%","effect":"Diarrhea"},{"rate":"2-5%","effect":"Vomiting"},{"rate":"null","effect":"Hypoglycemia"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"ORMD-0801 works by using a proprietary technology to deliver a liquid insulin formulation in a capsule, which is then absorbed in the gut and released into the bloodstream, mimicking the natural insulin production process. This allows for a more physiological and sustained insulin release, potentially reducing the risk of hypoglycemia and improving glycemic control.","oneSentence":"ORMD-0801 is an oral insulin capsule that mimics the natural insulin production process.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T03:27:03.782Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Type 1 diabetes"},{"name":"Type 2 diabetes"}]},"trialDetails":[{"nctId":"NCT03467932","phase":"PHASE2","title":"A Study to Evaluate the Efficacy and Safety of ORMD-0801 (Oral Insulin) in Patients With Type 2 Diabetes Mellitus","status":"COMPLETED","sponsor":"Oramed, Ltd.","startDate":"2018-05-29","conditions":"T2DM (Type 2 Diabetes Mellitus)","enrollment":373}],"_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":["Oral Insulin"],"phase":"phase_2","status":"active","brandName":"Cohort A: ORMD-0801","genericName":"Cohort A: ORMD-0801","companyName":"Oramed, Ltd.","companyId":"oramed-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"ORMD-0801 is an oral insulin capsule that mimics the natural insulin production process. Used for Type 1 diabetes, Type 2 diabetes.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}