{"id":"smecta","rwe":[],"tags":[],"trials":[],"_chembl":{"chemblId":"CHEMBL4298106","moleculeType":"Unknown"},"aliases":["Diosmectite Beaufour"],"patents":[],"pricing":[],"_fixedAt":"2026-03-30T12:58:36.535756","_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=Smecta","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T02:16:05.058823+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T02:16:12.089873+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Smecta","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T02:16:12.829483+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL4298106/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T02:16:13.302024+00:00"}},"offLabel":[],"timeline":[],"_dailymed":null,"ecosystem":[],"_scrapedAt":"2026-03-27T23:37:44.292Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"references":[],"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T02:16:15.211801+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"competitors":[],"_fixedFields":["pubmed(25)"],"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT07016737","phase":"PHASE3","title":"Immunochemotherapy ± Salvage Chemoradiation for Local Recurrence of Esophageal Squamous Cell Carcinoma After Definitive Chemoradiotherapy","status":"ENROLLING_BY_INVITATION","sponsor":"Ye jinjun","startDate":"2024-08-01","conditions":"Esophageal Squamous Cell Carcinoma (ESCC)","enrollment":79},{"nctId":"NCT06588036","phase":"EARLY_PHASE1","title":"A Comprehensive Analysis of the Comparative Efficacy of Multimodal Diarrhea Therapies in the Paediatric Population","status":"NOT_YET_RECRUITING","sponsor":"Combined Military Hospital Multan","startDate":"2024-09-15","conditions":"To Assess the Mean Time of Resolution of Diarrhea","enrollment":100},{"nctId":"NCT04293731","phase":"NA","title":"Smectite Gel and Probiotic for Obesity and Insulin Resistance","status":"COMPLETED","sponsor":"Bogomolets National Medical University","startDate":"2018-11-01","conditions":"Obesity, Insulin Resistance, Insulin Sensitivity","enrollment":55},{"nctId":"NCT04788485","phase":"PHASE4","title":"Evaluation of Smectite Effect As A Food Thickener On Gastroesophageal Reflux Disease In Neonates Using Combined Esophageal Multichannel Intraluminal Impedance","status":"COMPLETED","sponsor":"Ain Shams Maternity Hospital","startDate":"2017-09-01","conditions":"Gastroesophageal Reflux in Neonates","enrollment":20},{"nctId":"NCT02704091","phase":"PHASE4","title":"Efficacy of Diosmectite (Smecta®) in the Symptomatic Treatment of Acute Diarrhoea in Adults","status":"COMPLETED","sponsor":"Ipsen","startDate":"2016-03-17","conditions":"Acute Diarrhoea","enrollment":858},{"nctId":"NCT00276328","phase":"PHASE4","title":"Study to Evaluate Smecta® vs Placebo on the Time to Recovery Following an Acute Diarrhoea Episode in Adults","status":"COMPLETED","sponsor":"Ipsen","startDate":"2005-01","conditions":"Diarrhea","enrollment":346},{"nctId":"NCT00352989","phase":"PHASE3","title":"Effectiveness of Smecta in Combination With Oral Rehydration in the Treatment of Acute Watery Diarrhoea in Infants and Children","status":"COMPLETED","sponsor":"Ipsen","startDate":"2006-07","conditions":"Diarrhoea","enrollment":302},{"nctId":"NCT00352716","phase":"PHASE3","title":"Effectiveness of Smecta in the Treatment of Acute Diarrhoea in Children","status":"COMPLETED","sponsor":"Ipsen","startDate":"2006-06","conditions":"Diarrhoea","enrollment":300},{"nctId":"NCT03045926","phase":"PHASE1","title":"Chronic Administration of Diosmectite (SMECTA®) in Subjects With Chronic Diarrhoea","status":"COMPLETED","sponsor":"Ipsen","startDate":"2016-08","conditions":"Chronic Functional Diarrhea of Unknown Origin","enrollment":35},{"nctId":"NCT03614039","phase":"NA","title":"Effect of Probiotic and Smectite Gel on NAFLD","status":"COMPLETED","sponsor":"Nazarii Kobyliak","startDate":"2015-09-15","conditions":"Non-Alcoholic Fatty Liver Disease, Fatty Liver, Liver Diseases","enrollment":50},{"nctId":"NCT02354768","phase":"PHASE3","title":"Evaluation of Lanreotide Efficacity in High Output Stoma: a Multicentric Randomized Study","status":"TERMINATED","sponsor":"University Hospital, Strasbourg, France","startDate":"2015-10-22","conditions":"High Output Stoma","enrollment":19},{"nctId":"NCT02323516","phase":"PHASE2","title":"Evaluation of the Efficacy of Low-dose Acetylsalicylic Acid on Diarrhea Induced by Anti-cancer Targeted Therapies.","status":"WITHDRAWN","sponsor":"Centre Francois Baclesse","startDate":"2014-12","conditions":"Cancer","enrollment":""},{"nctId":"NCT01657032","phase":"PHASE4","title":"Efficacy of Lactobacillus GG With Diosmectite in Treatment Children With Acute Gastroenteritis","status":"COMPLETED","sponsor":"Medical University of Warsaw","startDate":"2010-08","conditions":"Diarrhea","enrollment":88}],"_emaApprovals":[],"_faersSignals":[{"count":281,"reaction":"DIARRHOEA"},{"count":167,"reaction":"ACUTE KIDNEY INJURY"},{"count":111,"reaction":"ANAEMIA"},{"count":96,"reaction":"ASTHENIA"},{"count":95,"reaction":"NEUTROPENIA"},{"count":91,"reaction":"PYREXIA"},{"count":87,"reaction":"THROMBOCYTOPENIA"},{"count":84,"reaction":"VOMITING"},{"count":81,"reaction":"GENERAL PHYSICAL HEALTH DETERIORATION"},{"count":70,"reaction":"OFF LABEL USE"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"crossReferences":{"chemblId":"CHEMBL4298106"},"formularyStatus":[],"_approvalHistory":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":25,"therapeuticAreas":["Other"],"biosimilarFilings":[],"recentPublications":[{"date":"2022 Feb 12","pmid":"35151268","title":"Long-term diosmectite use does not alter the gut microbiota in adults with chronic diarrhea.","journal":"BMC microbiology"},{"date":"2022","pmid":"35126816","title":"Studies on the Mechanism of the Volatile Oils from Caoguo-4 Decoction in Regulating Spleen Deficiency Diarrhea by Adjusting Intestinal Microbiota.","journal":"Oxidative medicine and cellular longevity"},{"date":"2019 Aug 12","pmid":"31397127","title":"[Umbilical therapy combined with moxibustion for autumn diarrhea in children].","journal":"Zhongguo zhen jiu = Chinese acupuncture & moxibustion"},{"date":"2019 Jan 22","pmid":"30678228","title":"Prevention and Treatment of Chemotherapy and Radiotherapy Induced Oral Mucositis.","journal":"Medicina (Kaunas, Lithuania)"},{"date":"2019 Mar 1","pmid":"30071269","title":"Shen-ling-bai-zhu-san, a spleen-tonifying Chinese herbal formula, alleviates lactose-induced chronic diarrhea in rats.","journal":"Journal of ethnopharmacology"}],"companionDiagnostics":[],"genericManufacturerList":[],"phase":"marketed","status":"active","brandName":"Smecta","genericName":"Smecta","companyName":"Ipsen","companyId":"ipsen","modality":"Small molecule","firstApprovalDate":"","aiSummary":"","enrichmentLevel":3,"visitCount":1,"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":1},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T02:16:15.211801+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"enriching","dataCompleteness":{"mechanism":false,"indications":false,"safety":false,"trials":true,"score":1}}