{"id":"miglitol","rwe":[],"tags":[{"label":"alpha-Glucosidase Inhibitor","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Lysosomal alpha-glucosidase","category":"target"},{"label":"GAA","category":"gene"},{"label":"SI","category":"gene"},{"label":"MGAM","category":"gene"},{"label":"A10BF02","category":"atc"},{"label":"Oral","category":"route"},{"label":"Tablet","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Mature","category":"status"},{"label":"Diabetes mellitus type 2","category":"indication"},{"label":"Pfizer","category":"company"},{"label":"Approved 1990s","category":"decade"},{"label":"Enzyme Inhibitors","category":"pharmacology"},{"label":"Glycoside Hydrolase Inhibitors","category":"pharmacology"},{"label":"Hypoglycemic Agents","category":"pharmacology"}],"phase":"marketed","safety":{"safetySignals":[{"llr":172.231,"date":"","count":77,"signal":"Hypoglycaemia","source":"DrugCentral FAERS","actionTaken":"Reported 77 times (LLR=172)"},{"llr":155.464,"date":"","count":65,"signal":"Hepatic function abnormal","source":"DrugCentral FAERS","actionTaken":"Reported 65 times (LLR=155)"},{"llr":94.356,"date":"","count":40,"signal":"Cerebral infarction","source":"DrugCentral FAERS","actionTaken":"Reported 40 times (LLR=94)"},{"llr":83.177,"date":"","count":31,"signal":"Diabetes mellitus inadequate control","source":"DrugCentral FAERS","actionTaken":"Reported 31 times (LLR=83)"},{"llr":65.57,"date":"","count":37,"signal":"Liver disorder","source":"DrugCentral FAERS","actionTaken":"Reported 37 times (LLR=66)"},{"llr":58.082,"date":"","count":17,"signal":"Pneumatosis intestinalis","source":"DrugCentral FAERS","actionTaken":"Reported 17 times (LLR=58)"},{"llr":52.35,"date":"","count":19,"signal":"Pemphigoid","source":"DrugCentral FAERS","actionTaken":"Reported 19 times (LLR=52)"},{"llr":48.829,"date":"","count":41,"signal":"Renal impairment","source":"DrugCentral FAERS","actionTaken":"Reported 41 times (LLR=49)"},{"llr":47.034,"date":"","count":10,"signal":"Ketosis","source":"DrugCentral FAERS","actionTaken":"Reported 10 times (LLR=47)"},{"llr":46.436,"date":"","count":8,"signal":"Anti-insulin antibody positive","source":"DrugCentral FAERS","actionTaken":"Reported 8 times (LLR=46)"},{"llr":41.699,"date":"","count":27,"signal":"Hyperglycaemia","source":"DrugCentral FAERS","actionTaken":"Reported 27 times (LLR=42)"},{"llr":36.147,"date":"","count":7,"signal":"Portal venous gas","source":"DrugCentral FAERS","actionTaken":"Reported 7 times (LLR=36)"},{"llr":35.626,"date":"","count":16,"signal":"Glycosylated haemoglobin increased","source":"DrugCentral FAERS","actionTaken":"Reported 16 times (LLR=36)"},{"llr":34.576,"date":"","count":7,"signal":"Hypoglycaemic encephalopathy","source":"DrugCentral FAERS","actionTaken":"Reported 7 times (LLR=35)"},{"llr":34.159,"date":"","count":50,"signal":"Decreased appetite","source":"DrugCentral FAERS","actionTaken":"Reported 50 times (LLR=34)"}],"drugInteractions":[{"url":"/drug/ciprofloxacin","drug":"ciprofloxacin","action":"Monitor closely","effect":"May interact with Ciprofloxacin","source":"DrugCentral","drugSlug":"ciprofloxacin"},{"url":"/drug/gatifloxacin","drug":"gatifloxacin","action":"Monitor closely","effect":"May interact with Gatifloxacin","source":"DrugCentral","drugSlug":"gatifloxacin"},{"url":"/drug/levofloxacin","drug":"levofloxacin","action":"Monitor closely","effect":"May interact with Levofloxacin","source":"DrugCentral","drugSlug":"levofloxacin"},{"url":"/drug/norfloxacin","drug":"norfloxacin","action":"Monitor closely","effect":"May interact with Norfloxacin","source":"DrugCentral","drugSlug":"norfloxacin"},{"url":"/drug/ofloxacin","drug":"ofloxacin","action":"Monitor closely","effect":"May interact with Ofloxacin","source":"DrugCentral","drugSlug":"ofloxacin"},{"url":"/drug/pramlintide","drug":"pramlintide","action":"Avoid combination","effect":"May interact with Pramlintide","source":"DrugCentral","drugSlug":"pramlintide"}],"commonSideEffects":[{"effect":"Flatulence","drugRate":"41.5%","severity":"common"},{"effect":"Diarrhea","drugRate":"28.7%","severity":"common"},{"effect":"Abdominal pain","drugRate":"11.7%","severity":"common"},{"effect":"Low serum iron","drugRate":"9.2%","severity":"common"},{"effect":"Skin rash","drugRate":"4.3%","severity":"mild"},{"effect":"Abdominal distention","drugRate":"reported","severity":"unknown"},{"effect":"Gastrointestinal pain","drugRate":"reported","severity":"unknown"},{"effect":"Nausea","drugRate":"reported","severity":"unknown"},{"effect":"Ileus","drugRate":"reported","severity":"unknown"},{"effect":"Pneumatosis cystoides intestinalis","drugRate":"reported","severity":"unknown"}],"contraindications":["Gastrointestinal obstruction","Hypoglycemic disorder","Infectious disease","Inflammatory bowel disease","Kidney disease","Prolonged-Severe Nausea and Vomiting","Surgical procedure","Traumatic injury","Ulceration of intestine","Ulcerative colitis"],"specialPopulations":{"Pregnancy":"The safety of miglitol tablets in pregnant women has not been established. Developmental toxicology studies have been performed in rats and rabbits.","Geriatric use":"No overall differences in safety and effectiveness were observed between elderly subjects and younger subjects.","Paediatric use":"Safety and effectiveness of miglitol tablets in pediatric patients have not been established."}},"trials":[],"aliases":[],"company":"Pfizer","patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-04-17","unitCost":"$1.7805/EA","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$650","description":"MIGLITOL 50 MG TABLET","retrievedDate":"2026-04-07"}],"allNames":"glyset","offLabel":[],"synonyms":["miglitol","diastabol","seibule","glyset"],"timeline":[{"date":"1996-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from PHARMACIA AND UPJOHN to Pfizer"},{"date":"1996-12-18","type":"positive","source":"DrugCentral","milestone":"FDA approval (Pharmacia And Upjohn)"},{"date":"2015-02-24","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 1 manufacturer approved"}],"aiSummary":"Glyset (Miglitol) is a small molecule alpha-glucosidase inhibitor developed by Pharmacia and Upjohn, now owned by Pfizer. It targets lysosomal alpha-glucosidase to delay carbohydrate absorption, making it a treatment for type 2 diabetes mellitus. Glyset was FDA-approved in 1996 and is now off-patent, with a generic version available. The drug has a half-life of 2.3 hours and 60% bioavailability. Key safety considerations include gastrointestinal side effects.","approvals":[{"date":"1996-12-18","orphan":false,"company":"PHARMACIA AND UPJOHN","regulator":"FDA"}],"brandName":"Glyset","ecosystem":[{"indication":"Diabetes mellitus type 2","otherDrugs":[{"name":"acarbose","slug":"acarbose","company":"Bayer Hlthcare"},{"name":"acetohexamide","slug":"acetohexamide","company":"Lilly"},{"name":"albiglutide","slug":"albiglutide","company":"Glaxosmithkline Llc"},{"name":"alogliptin","slug":"alogliptin","company":"Takeda Pharms Usa"}],"globalPrevalence":537000000}],"mechanism":{"target":"Lysosomal alpha-glucosidase","novelty":"Follow-on","targets":[{"gene":"GAA","source":"DrugCentral","target":"Lysosomal alpha-glucosidase","protein":"Lysosomal alpha-glucosidase"},{"gene":"SI","source":"DrugCentral","target":"Sucrase-isomaltase, intestinal","protein":"Sucrase-isomaltase, intestinal"},{"gene":"MGAM","source":"DrugCentral","target":"Maltase-glucoamylase, intestinal","protein":"Maltase-glucoamylase, intestinal"},{"gene":"LCT","source":"DrugCentral","target":"Lactase-phlorizin hydrolase","protein":"Lactase-phlorizin hydrolase"},{"gene":"GBA","source":"DrugCentral","target":"Glucosylceramidase","protein":"Glucosylceramidase"},{"gene":"AMY2A","source":"DrugCentral","target":"Pancreatic alpha-amylase","protein":"Pancreatic alpha-amylase"}],"moaClass":"alpha Glucosidase Inhibitors","modality":"Small Molecule","drugClass":"alpha-Glucosidase Inhibitor","explanation":"Mechanism of Action. In contrast to sulfonylureas, miglitol tablets do not enhance insulin secretion. The antihyperglycemic action of miglitol results from reversible inhibition of membrane-bound intestinal -glucoside hydrolase enzymes. Membrane-bound intestinal -glucosidases hydrolyze oligosaccharides and disaccharides to glucose and other monosaccharides in the brush border of the small intestine. In diabetic patients, this enzyme inhibition results in delayed glucose absorption and lowering of postprandial hyperglycemia.Because its mechanism of action is different, the effect of miglitol tablets to enhance glycemic control is additive to that of sulfonylureas when used in combination. In addition, miglitol tablets diminish the insulinotropic and weight-increasing effects of sulfonylureas.Miglitol has minor inhibitory activity against lactase and consequently, at the recommended doses, would not be expected to induce lactose intolerance.","oneSentence":"Glyset works by delaying the breakdown of carbohydrates in the gut, allowing less glucose to enter the bloodstream.","technicalDetail":"Glyset inhibits the activity of lysosomal alpha-glucosidase, a key enzyme involved in the breakdown of carbohydrates in the small intestine, thereby delaying carbohydrate absorption and reducing postprandial glucose peaks."},"commercial":{"launchDate":"1996","_launchSource":"DrugCentral (FDA 1996-12-18, PHARMACIA AND UPJOHN)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1806","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=MIGLITOL","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=MIGLITOL","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T12:45:24.401083","biosimilars":[],"competitors":[{"drugName":"acarbose","drugSlug":"acarbose","fdaApproval":"1995-09-06","genericCount":8,"patentStatus":"Off-patent — generic available","relationship":"same-class"}],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"genericName":"miglitol","indications":{"approved":[{"name":"Diabetes mellitus type 2","source":"DrugCentral","snomedId":44054006,"regulator":"FDA","eligibility":"adults","usPrevalence":37300000,"globalPrevalence":537000000,"prevalenceMethod":"curated","prevalenceSource":"IDF Diabetes Atlas, 2024"}],"offLabel":[],"pipeline":[]},"currentOwner":"Pfizer","drugCategory":"mature","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"acarbose","brandName":"acarbose","genericName":"acarbose","approvalYear":"1995","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT03492580","phase":"","title":"A Study for Comparison of Canagliflozin Versus Alternative Antihyperglycemic Treatments on Risk of Heart Failure Hospitalization and Amputation for Participants With Type 2 Diabetes Mellitus and the Subpopulation With Established Cardiovascular Disease","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2018-02-22","conditions":["Diabetes Mellitus, Type 2","Cardiovascular Diseases"],"enrollment":714582,"completionDate":"2018-06-25"},{"nctId":"NCT01242202","phase":"PHASE3","title":"A Study to Assess the Safety and Efficacy of ASP1941 in Combination With α-glucosidase Inhibitor in Type 2 Diabetic Patients","status":"COMPLETED","sponsor":"Astellas Pharma Inc","startDate":"2010-10-21","conditions":["Type 2 Diabetes Mellitus"],"enrollment":113,"completionDate":"2012-05-25"},{"nctId":"NCT06449235","phase":"PHASE4","title":"Real-World Evaluation of Omarigliptin for Type 2 Diabetes Meliitus in Bangladesh","status":"NOT_YET_RECRUITING","sponsor":"Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders","startDate":"2024-09","conditions":["Type2diabetes"],"enrollment":938,"completionDate":"2025-06"},{"nctId":"NCT01697592","phase":"PHASE3","title":"Omarigliptin (MK-3102) Clinical Trial - Add-on to Oral Antihyperglycemic Agent Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-3102-015)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2012-10-24","conditions":["Type 2 Diabetes Mellitus"],"enrollment":585,"completionDate":"2014-05-08"},{"nctId":"NCT02476760","phase":"","title":"Incretin-based Drugs and Acute Pancreatitis","status":"COMPLETED","sponsor":"Canadian Network for Observational Drug Effect Studies, CNODES","startDate":"2014-03","conditions":["Diabetes Mellitus, Type 2"],"enrollment":1417914,"completionDate":"2015-04"},{"nctId":"NCT02456428","phase":"","title":"Incretin-based Drugs and the Risk of Heart Failure","status":"COMPLETED","sponsor":"Canadian Network for Observational Drug Effect Studies, CNODES","startDate":"2014-03","conditions":["Type 2 Diabetes Mellitus"],"enrollment":1499650,"completionDate":"2015-05"},{"nctId":"NCT02475499","phase":"","title":"Incretin-based Drugs and Pancreatic Cancer","status":"COMPLETED","sponsor":"Canadian Network for Observational Drug Effect Studies, CNODES","startDate":"2014-03","conditions":["Diabetes Mellitus, Type 2"],"enrollment":886172,"completionDate":"2015-04"},{"nctId":"NCT01099839","phase":"PHASE1","title":"A Study to Assess Drug-Drug Interaction Between ASP1941 and Miglitol","status":"COMPLETED","sponsor":"Astellas Pharma Inc","startDate":"2010-02","conditions":["Healthy Volunteers","Pharmacokinetics of ASP1941"],"enrollment":30,"completionDate":"2010-04"},{"nctId":"NCT00334399","phase":"PHASE3","title":"Double-Blind Trial of Miglitol in Type 2 Diabetic Patients Treated With Biguanide","status":"COMPLETED","sponsor":"Sanwa Kagaku Kenkyusho Co., Ltd.","startDate":"","conditions":["Type 2 Diabetes Mellitus"],"enrollment":0,"completionDate":""},{"nctId":"NCT00334503","phase":"PHASE3","title":"Open Trial of Miglitol in Type 2 Diabetic Patients Treated With Biguanide","status":"COMPLETED","sponsor":"Sanwa Kagaku Kenkyusho Co., 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