{"id":"lactitol","rwe":[{"pmid":"41763796","year":"2026","title":"The mechanism of reducing the oil content of fried instant noodles by adding sugar alcohol: microstructure, surface properties and molecular structure.","finding":"","journal":"Food research international (Ottawa, Ont.)","studyType":"Clinical Study"},{"pmid":"41391298","year":"2026","title":"Coordination zinc ion deposition kinetics through interfacial hydrogen bonding network for high-performance aqueous zinc ion batteries.","finding":"","journal":"Journal of colloid and interface science","studyType":"Clinical Study"},{"pmid":"41378067","year":"2025","title":"Targeting gut microbiota in liver disease: A pharmacological approach for hepatic encephalopathy and beyond.","finding":"","journal":"World journal of gastrointestinal pharmacology and therapeutics","studyType":"Clinical Study"},{"pmid":"41231736","year":"2026","title":"Lactitol-Induced Acute Kidney Injury with Oxalate Nephropathy: A Case Report.","finding":"","journal":"Nephron","studyType":"Clinical Study"},{"pmid":"41188470","year":"2025","title":"Stabilisation of waterlogged archaeological wood: the analysis of structural and dimensional changes of different conservation methods using magnetic resonance imaging and X-ray micro-computed tomography.","finding":"","journal":"Scientific reports","studyType":"Clinical Study"}],"tags":[{"label":"Osmotic Laxative","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"A06AD12","category":"atc"},{"label":"Oral","category":"route"},{"label":"Powder","category":"form"},{"label":"Active","category":"status"},{"label":"Chronic idiopathic constipation","category":"indication"},{"label":"Braintree Labs","category":"company"},{"label":"Approved 2020s","category":"decade"},{"label":"Cathartics","category":"pharmacology"},{"label":"Flavoring Agents","category":"pharmacology"},{"label":"Food Additives","category":"pharmacology"},{"label":"Gastrointestinal Agents","category":"pharmacology"},{"label":"Sweetening Agents","category":"pharmacology"}],"phase":"marketed","safety":{"safetySignals":[{"llr":99.1,"date":"","count":27,"signal":"Hepatic encephalopathy","source":"DrugCentral FAERS","actionTaken":"Reported 27 times (LLR=99)"}],"commonSideEffects":[],"contraindications":["Galactosemia","Gastrointestinal obstruction"],"specialPopulations":{"Pregnancy":"Lactitol is minimally absorbed systemically following oral administration and it is unknown whether maternal use will result in fetal exposure to the drug. Available data from case reports on lactitol use in pregnant women are insufficient to evaluate for any drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal developmental studies, no effects on embryo-fetal development were observed with oral administration of lactitol to rats and rabbits during organogenesis at doses much higher than the maximum recommended human dosage. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have background risk of birth defect, loss, or other adverse outcomes. In the United States general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively."}},"trials":[],"aliases":[],"company":"Braintree Labs","patents":[{"applNo":"N211281","source":"FDA Orange Book","status":"Active","expires":"May 12, 2037","useCode":"U-1516","territory":"US","drugProduct":false,"patentNumber":"10806743","drugSubstance":false}],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=LACTITOL","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:15:17.925148+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T03:15:14.961745+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Lactitol","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T03:15:24.827655+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:15:23.430437+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=LACTITOL","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:15:23.770084+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1661/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:15:24.479110+00:00"}},"allNames":"pizensy","offLabel":[],"synonyms":["pizensy","lactitol","lactite","lactiobiosit","lactositol"],"timeline":[{"date":"2020-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from BRAINTREE LABS to Braintree Labs"},{"date":"2020-02-12","type":"positive","source":"DrugCentral","milestone":"FDA approval (Braintree Labs)"}],"aiSummary":"Pizensy (LACTITOL) is an osmotic laxative developed by Braintree Labs, currently owned by the same company. It is a small molecule drug approved by the FDA in 2020 for the treatment of chronic idiopathic constipation. Pizensy works by drawing water into the intestines to soften and stimulate bowel movements. As a patented product with no generic manufacturers, its commercial status is unique. Key safety considerations include its short half-life of 2.4 hours.","approvals":[{"date":"2020-02-12","orphan":false,"company":"BRAINTREE LABS","regulator":"FDA"}],"brandName":"Pizensy","ecosystem":[{"indication":"Chronic idiopathic constipation","otherDrugs":[{"name":"linaclotide","slug":"linaclotide","company":"Forest Labs Llc"},{"name":"lubiprostone","slug":"lubiprostone","company":"Sucampo Pharma Llc"},{"name":"plecanatide","slug":"plecanatide","company":"Synergy Pharms Inc"},{"name":"tegaserod","slug":"tegaserod","company":""}],"globalPrevalence":1120000000}],"mechanism":{"novelty":"Follow-on","moaClass":"Osmotic Activity","modality":"Small Molecule","drugClass":"Osmotic Laxative","explanation":"","oneSentence":"","technicalDetail":"Pizensy (LACTITOL) is a polyol that acts as an osmotic laxative by drawing water into the intestinal lumen through osmosis, thereby softening stool and stimulating bowel movements."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Lactitol","title":"Lactitol","extract":"Lactitol is a disaccharide sugar alcohol produced from lactose. It is used as a replacement bulk sweetener for low calorie foods with 30–40% of the sweetness of sucrose. It is also used medically as a laxative.","wiki_history":"==History==\nThe U.S. Food and Drug Administration (FDA) approved Pizensy based on evidence from a clinical trial (Trial 1/ NCT02819297) of 594 subjects with CIC conducted in the United States. The FDA also considered other supportive evidence including data from Trial 2 (NCT02481947) which compared Pizensy to previously approved drug (lubiprostone) for CIC, and Trial 3 (NCT02819310) in which subjects used Pizensy for one year as well as data from published literature.\n\nThe benefit and side effects of Pizensy were evaluated in a clinical trial (Trial 1) of 594 subjects with CIC. In this trial, subjects received treatment with either Pizensy or placebo once daily for 6 months. Neither the subjects nor the health care providers knew which treatment was being given until after the trials were completed.\n\nIn the second trial (Trial 2) of three months duration, improvement in CSBMs was used to compare Pizensy to the drug lubiprostone which was previously approved for CIC. The third trial (Trial 3) was used to collect the side effects in subjects treated with Pizensy for one year."},"commercial":{"launchDate":"2020","_launchSource":"DrugCentral (FDA 2020-02-12, BRAINTREE LABS)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1534","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=LACTITOL","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=LACTITOL","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Lactitol","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T14:03:57.292096","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:15:26.038056+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"magnesium carbonate","drugSlug":"magnesium-carbonate","fdaApproval":"1990-10-02","relationship":"same-class"},{"drugName":"magnesium oxide","drugSlug":"magnesium-oxide","fdaApproval":"1982-06-22","relationship":"same-class"},{"drugName":"magnesium sulfate","drugSlug":"magnesium-sulfate","fdaApproval":"1981-10-06","genericCount":12,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"lactulose","drugSlug":"lactulose","fdaApproval":"1976-03-25","genericCount":24,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"sodium sulfate","drugSlug":"sodium-sulfate","fdaApproval":"1986-04-30","relationship":"same-class"},{"drugName":"macrogol","drugSlug":"macrogol","fdaApproval":"1984-07-13","relationship":"same-class"},{"drugName":"mannitol","drugSlug":"mannitol","fdaApproval":"1964-06-08","genericCount":6,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"sodium phosphate","drugSlug":"sodium-phosphate","fdaApproval":"1983-05-10","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"sorbitol","drugSlug":"sorbitol","fdaApproval":"1971-08-20","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"magnesium citrate","drugSlug":"magnesium-citrate","fdaApproval":"","relationship":"same-class"}],"genericName":"lactitol","indications":{"approved":[{"name":"Chronic idiopathic constipation","source":"DrugCentral","snomedId":82934008,"regulator":"FDA","eligibility":"adults","globalPrevalence":1120000000,"prevalenceMethod":"ai-extracted","prevalenceSource":"Am J Gastroenterol, 2011 (PMID:21606976)"}],"offLabel":[],"pipeline":[]},"currentOwner":"Braintree Labs","drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"magnesium-carbonate","brandName":"magnesium carbonate","genericName":"magnesium carbonate","approvalYear":"1990","relationship":"same-class"},{"drugId":"magnesium-oxide","brandName":"magnesium oxide","genericName":"magnesium oxide","approvalYear":"1982","relationship":"same-class"},{"drugId":"magnesium-sulfate","brandName":"magnesium sulfate","genericName":"magnesium sulfate","approvalYear":"1981","relationship":"same-class"},{"drugId":"lactulose","brandName":"lactulose","genericName":"lactulose","approvalYear":"1976","relationship":"same-class"},{"drugId":"sodium-sulfate","brandName":"sodium sulfate","genericName":"sodium sulfate","approvalYear":"1986","relationship":"same-class"},{"drugId":"macrogol","brandName":"macrogol","genericName":"macrogol","approvalYear":"1984","relationship":"same-class"},{"drugId":"mannitol","brandName":"mannitol","genericName":"mannitol","approvalYear":"1964","relationship":"same-class"},{"drugId":"sodium-phosphate","brandName":"sodium phosphate","genericName":"sodium phosphate","approvalYear":"1983","relationship":"same-class"},{"drugId":"sorbitol","brandName":"sorbitol","genericName":"sorbitol","approvalYear":"1971","relationship":"same-class"},{"drugId":"magnesium-citrate","brandName":"magnesium citrate","genericName":"magnesium citrate","approvalYear":"","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT02819297","phase":"PHASE3","title":"BLI400-302: A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults","status":"COMPLETED","sponsor":"Braintree Laboratories","isPivotal":true,"startDate":"2016-06","conditions":["Constipation","Chronic 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