{"id":"eflornithine-plus-sulindac","safety":{"commonSideEffects":[{"rate":null,"effect":"Gastrointestinal disturbances"},{"rate":null,"effect":"Hearing loss (eflornithine-associated)"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Abdominal pain"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Eflornithine irreversibly inhibits ornithine decarboxylase (ODC), a key enzyme in polyamine biosynthesis that is often elevated in cancer cells. Sulindac is a non-selective cyclooxygenase (COX) inhibitor with anti-inflammatory and pro-apoptotic properties. The combination is designed to synergistically reduce colorectal polyp formation and cancer risk by depleting polyamines and suppressing COX-mediated proliferative signaling.","oneSentence":"Eflornithine inhibits polyamine synthesis while sulindac acts as a non-selective NSAID to reduce inflammation and promote apoptosis, together targeting colorectal cancer prevention.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:10:41.231Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Colorectal cancer prevention in high-risk populations"}]},"trialDetails":[{"nctId":"NCT01349881","phase":"PHASE3","title":"S0820, Adenoma and Second Primary Prevention Trial","status":"ACTIVE_NOT_RECRUITING","sponsor":"SWOG Cancer Research Network","startDate":"2013-08-23","conditions":"Colorectal Neoplasms","enrollment":354},{"nctId":"NCT01483144","phase":"PHASE3","title":"Trial of Eflornithine Plus Sulindac in Patients With Familial Adenomatous Polyposis (FAP)","status":"COMPLETED","sponsor":"Cancer Prevention Pharmaceuticals, Inc.","startDate":"2013-10","conditions":"Familial Adenomatous Polyposis","enrollment":171},{"nctId":"NCT01245816","phase":"PHASE3","title":"A Trial of Low Dose Sulindac Combined With Eflornithine in Patients With Familial Adenomatous Polyposis (FAP)","status":"WITHDRAWN","sponsor":"Cancer Prevention Pharmaceuticals, Inc.","startDate":"2011-03","conditions":"Familial Adenomatous Polyposis","enrollment":""},{"nctId":"NCT00118365","phase":"PHASE3","title":"Eflornithine and Sulindac in Preventing Colorectal Cancer in Patients With Colon Polyps","status":"COMPLETED","sponsor":"National Cancer Institute (NCI)","startDate":"1998-07","conditions":"Precancerous Condition","enrollment":375},{"nctId":"NCT01636128","phase":"PHASE2","title":"Urinary Biomarker Study With Sulindac and Difluoromethylornithine","status":"WITHDRAWN","sponsor":"Cancer Prevention Pharmaceuticals, Inc.","startDate":"2014-03","conditions":"Focus of Study: Drug Response Biomarkers, Chemoprevention, Neoplasms","enrollment":""}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":8,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["DFMO"],"phase":"phase_3","status":"active","brandName":"Eflornithine plus Sulindac","genericName":"Eflornithine plus Sulindac","companyName":"Cancer Prevention Pharmaceuticals, Inc.","companyId":"cancer-prevention-pharmaceuticals-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Eflornithine inhibits polyamine synthesis while sulindac acts as a non-selective NSAID to reduce inflammation and promote apoptosis, together targeting colorectal cancer prevention. Used for Colorectal cancer prevention in high-risk populations.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}