{"id":"indigotindisulfonate-sodium-0-8","safety":{"commonSideEffects":[{"rate":null,"effect":"Discoloration of urine (blue)"},{"rate":null,"effect":"Hypersensitivity reactions"},{"rate":null,"effect":"Transient hypertension"}]},"_chembl":{"chemblId":"CHEMBL2105023","moleculeType":"Small molecule","molecularWeight":"466.36"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Indigotindisulfonate sodium is an azo dye that is excreted unchanged in the urine, imparting a blue color that allows visualization of ureteral jets and urine flow during cystoscopic examination. It is administered intravenously and rapidly appears in the urine, enabling clinicians to assess upper urinary tract function and identify ureteral obstruction or other abnormalities during endoscopic procedures.","oneSentence":"Indigotindisulfonate sodium is a vital dye that is used diagnostically to visualize the urinary tract and bladder during cystoscopy and other urological procedures.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-27T23:48:34.011Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Diagnostic visualization of ureteral function and urine flow during cystoscopy"},{"name":"Assessment of upper urinary tract patency and obstruction"}]},"trialDetails":[{"nctId":"NCT06054880","phase":"PHASE4","title":"Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency","status":"RECRUITING","sponsor":"Prove pharm","startDate":"2023-10-12","conditions":"Ureter Injury","enrollment":116},{"nctId":"NCT06448143","phase":"PHASE3","title":"Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency in Pediatric Patients","status":"NOT_YET_RECRUITING","sponsor":"Prove pharm","startDate":"2026-01","conditions":"Ureter Injury","enrollment":18},{"nctId":"NCT06085183","phase":"PHASE4","title":"Indigotindisulfonate Sodium as an Aid in Determination of Ureteral Patency in Patient's With Renal Impairment","status":"RECRUITING","sponsor":"Prove pharm","startDate":"2023-12-20","conditions":"Ureter Injury","enrollment":48}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":35,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Bludigo","Bludigo®"],"phase":"marketed","status":"active","brandName":"Indigotindisulfonate sodium 0.8%","genericName":"Indigotindisulfonate sodium 0.8%","companyName":"Prove pharm","companyId":"prove-pharm","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Indigotindisulfonate sodium is a vital dye that is used diagnostically to visualize the urinary tract and bladder during cystoscopy and other urological procedures. Used for Diagnostic visualization of ureteral function and urine flow during cystoscopy, Assessment of upper urinary tract patency and obstruction.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}