{"id":"dapagliflozin-reference-product","phase":"phase_1","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":["Genital mycotic infections","Urinary tract infections","Increased urination","Hypotension","Hypoglycemia (when combined with insulin or insulin secretagogues)"],"contraindications":["Severe renal impairment","End-stage renal disease","Dialysis","Hypersensitivity to dapagliflozin"],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"active","trials":["NCT06233045"],"aliases":[],"patents":[],"pricing":[],"modality":"Small molecule","timeline":[],"aiSummary":"","brandName":"Dapagliflozin-Reference product","companyId":"bio-innova-co-ltd","mechanism":{"target":"SGLT2 (Sodium-glucose co-transporter 2)","novelty":"","modality":"Small molecule","drugClass":"","explanation":"Dapagliflozin selectively inhibits SGLT2 in the proximal renal tubule, blocking reabsorption of filtered glucose and lowering blood glucose levels independent of insulin. This mechanism also reduces sodium reabsorption, leading to osmotic diuresis and beneficial cardiovascular and renal effects.","oneSentence":"Inhibits sodium-glucose co-transporter 2 (SGLT2) in the kidney, reducing glucose reabsorption and increasing urinary glucose excretion.","technicalDetail":""},"commercial":null,"_claudeStub":{"ts":1779123367,"model":"claude-sonnet-4-5-20250929"},"companyName":"Bio-innova Co., Ltd","competitors":[{"name":"Empagliflozin","brand":"Jardiance","company":"Boehringer Ingelheim/Eli Lilly","rationale":"SGLT2 inhibitor for diabetes, heart failure, and chronic kidney disease"},{"name":"Canagliflozin","brand":"Invokana","company":"Janssen","rationale":"SGLT2 inhibitor for type 2 diabetes and diabetic nephropathy"},{"name":"Ertugliflozin","brand":"Steglatro","company":"Merck/Pfizer","rationale":"SGLT2 inhibitor for type 2 diabetes management"}],"description":"Dapagliflozin-Reference product is a Phase 1 investigational formulation being developed by Bio-innova Co., Ltd. Dapagliflozin is an SGLT2 inhibitor that blocks glucose reabsorption in the kidneys, used for type 2 diabetes, heart failure, and chronic kidney disease treatment.","genericName":"Dapagliflozin-Reference product","indications":{"approved":[{"status":"investigational","condition":"Type 2 diabetes mellitus","patientPopulation":"Adults"},{"status":"investigational","condition":"Heart failure","patientPopulation":"Adults"},{"status":"investigational","condition":"Chronic kidney disease","patientPopulation":"Adults"}],"offLabel":[],"pipeline":[]},"labelChanges":[],"trialDetails":[],"manufacturing":[],"administration":{"icon":"","route":"","frequency":"","formulation":""},"formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"rwe":[],"genericFilers":[],"relatedDrugs":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":false,"score":3}}