{"id":"suprep-bowel-prep-kit","rwe":[],"tags":[],"safety":{"boxedWarnings":[],"drugInteractions":[],"commonSideEffects":[{"effect":"Nausea","drugRate":"24%","severity":"Moderate"},{"effect":"Vomiting","drugRate":"12%","severity":"Moderate"},{"effect":"Abdominal distension","drugRate":"10%","severity":"Mild"},{"effect":"Headache","drugRate":"8%","severity":"Mild"}],"contraindications":["Known hypersensitivity to any component of the product","Severe dehydration","Severe active ulcerative colitis or toxic megacolon"],"specialPopulations":{"Lactation":"Not recommended; unknown if excreted in human milk","Pregnancy":"Category C; use only if the potential benefit justifies the potential risk to the fetus","Renal impairment":"Use with caution; monitor for fluid and electrolyte imbalances","Hepatic impairment":"No specific precautions"}},"trials":[],"_chembl":null,"aliases":[],"patents":[{"title":"Bowel cleansing composition and method","number":"US7820198B2","issueDate":"2010-10-26","filingDate":"2006-03-24"}],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$0.3036/ML","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$109","description":"SUPREP BOWEL PREP KIT","retrievedDate":"2026-04-07"}],"offLabel":[],"timeline":[{"date":"2009","type":"Regulatory","milestone":"FDA approval","regulator":"FDA"},{"date":"2010","type":"Commercial","milestone":"Market launch","regulator":"N/A"}],"_dailymed":null,"aiSummary":"SUPREP Bowel Prep Kit is a prescription medication used for bowel cleansing before colonoscopy. It is manufactured by Braintree Laboratories and does not have an FDA label. The kit contains polyethylene glycol 3350, sodium sulfate, sodium chloride, and potassium chloride. Common side effects include nausea, vomiting, abdominal distension, and headache. SUPREP is generally well-tolerated but has specific contraindications and warnings. It competes in the bowel preparation market with other products like MoviPrep and Golytely.","ecosystem":[],"mechanism":{"target":"Intestinal lumen","novelty":"SUPREP is a reformulation of traditional polyethylene glycol-based bowel prep solutions, designed to improve tolerability and efficacy.","modality":"Oral solution","drugClass":"Osmotic laxative","explanation":"The osmotic laxative properties of polyethylene glycol 3350 and the electrolytes in SUPREP draw water into the intestines, causing a large volume of fluid to move through the colon and cleanse it.","oneSentence":"SUPREP works by drawing water into the intestines to flush out the contents, preparing the bowel for colonoscopy.","technicalDetail":"Polyethylene glycol 3350 is an osmotic agent that is not absorbed by the body, creating a high osmotic pressure in the intestinal lumen. This draws water from the surrounding tissues into the intestines, leading to a flushing effect."},"_scrapedAt":"2026-03-28T00:10:18.867Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"yoyGrowth":"Not available","launchDate":"2009","annualCostUS":"$60 - $120 per kit","currentRevenue":"Not available","patientPopulation":"Adults undergoing colonoscopy","peakSalesEstimate":"Not available"},"references":[],"biosimilars":[],"competitors":["MoviPrep","Golytely","Prepopik","Trilyte"],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"indications":{"approved":["Bowel cleansing before colonoscopy"],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT04504292","phase":"NA","title":"Pilot Study to Assess Tolerability and Feasibility of Oral Sulfate Solution (SUPREP) in Hospitalized Patients","status":"UNKNOWN","sponsor":"University of Virginia","startDate":"2020-08-01","conditions":"Inpatient Colonoscopy, Oral Sulfate Solution, Polyethelene Glycol","enrollment":124},{"nctId":"NCT02523911","phase":"NA","title":"Efficacy and Tolerability of Suprep With and Without Simethicone for Routine Colonoscopy for Colorectal Cancer Screening","status":"WITHDRAWN","sponsor":"MercyOne Des Moines Medical Center","startDate":"2016-03","conditions":"Colorectal Cancer","enrollment":""},{"nctId":"NCT01786629","phase":"PHASE4","title":"BLI800-480: A Safety and Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects","status":"COMPLETED","sponsor":"Braintree Laboratories","startDate":"2012-12","conditions":"Colonoscopy, Bowel Preparation, Endoscopy","enrollment":338}],"_emaApprovals":[],"_faersSignals":[{"count":14,"reaction":"NAUSEA"},{"count":14,"reaction":"VOMITING"},{"count":11,"reaction":"ABDOMINAL PAIN"},{"count":10,"reaction":"HEADACHE"},{"count":8,"reaction":"DIZZINESS"},{"count":7,"reaction":"ABDOMINAL DISTENSION"},{"count":7,"reaction":"DEHYDRATION"},{"count":6,"reaction":"MUSCLE SPASMS"},{"count":5,"reaction":"DIARRHOEA"},{"count":4,"reaction":"BLOOD POTASSIUM DECREASED"}],"genericFilers":["Dr. Reddy's Laboratories","Teva Pharmaceuticals","Mylan Pharmaceuticals"],"latestUpdates":[],"manufacturing":[],"formularyStatus":[],"_approvalHistory":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":0,"therapeuticAreas":["Metabolic"],"biosimilarFilings":[],"companionDiagnostics":[],"genericManufacturerList":[],"phase":"marketed","status":"active","brandName":"SUPREP Bowel Prep Kit","genericName":"SUPREP Bowel Prep Kit","companyName":"Braintree Laboratories","companyId":"braintree-laboratories","modality":"Small molecule","firstApprovalDate":"2009","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}