{"id":"tegaserod","rwe":[],"tags":[{"label":"Serotonin-4 Receptor Agonist","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"5-hydroxytryptamine receptor 2B","category":"target"},{"label":"HTR2B","category":"gene"},{"label":"HTR4","category":"gene"},{"label":"HTR3A","category":"gene"},{"label":"A06AX06","category":"atc"},{"label":"Oral","category":"route"},{"label":"Tablet","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Active","category":"status"},{"label":"Chronic idiopathic constipation","category":"indication"},{"label":"Irritable bowel syndrome characterized by constipation","category":"indication"},{"label":"Approved 2000s","category":"decade"},{"label":"Neurotransmitter Agents","category":"pharmacology"},{"label":"Serotonin Agents","category":"pharmacology"},{"label":"Serotonin Receptor Agonists","category":"pharmacology"}],"phase":"marketed","safety":{"commonSideEffects":[{"effect":"Headache","drugRate":"","severity":"common","organSystem":""},{"effect":"Abdominal pain","drugRate":"","severity":"common","organSystem":""},{"effect":"Nausea","drugRate":"","severity":"common","organSystem":""},{"effect":"Diarrhea","drugRate":"","severity":"common","organSystem":""},{"effect":"Flatulence","drugRate":"","severity":"common","organSystem":""},{"effect":"Dyspepsia","drugRate":"","severity":"common","organSystem":""},{"effect":"Dizziness","drugRate":"","severity":"common","organSystem":""},{"effect":"Anemia","drugRate":"","severity":"less common","organSystem":""},{"effect":"Vertigo","drugRate":"","severity":"less common","organSystem":""},{"effect":"Rectal hemorrhage","drugRate":"","severity":"less common","organSystem":""},{"effect":"Asthenia","drugRate":"","severity":"less common","organSystem":""},{"effect":"Increased blood creatine phosphokinase","drugRate":"","severity":"less common","organSystem":""},{"effect":"Increased appetite","drugRate":"","severity":"less common","organSystem":""},{"effect":"Arthropathy","drugRate":"","severity":"less common","organSystem":""},{"effect":"Tendonitis","drugRate":"","severity":"less common","organSystem":""},{"effect":"Migraine","drugRate":"","severity":"less common","organSystem":""}],"contraindications":["Acute nephropathy","Adhesion of Gastrointestinal Tract","Angina pectoris","Breastfeeding (mother)","Cerebrovascular accident","Dehydration","Diarrhea","Disease of liver","Disorder of biliary tract","Disorder of gallbladder","Hypovolemia","Intestinal obstruction","Ischemic colitis","Myocardial infarction"],"specialPopulations":{"Lactation":"There are no data regarding the presence of tegaserod in human milk, the effects on the breastfed infant, or the effects on milk production. Tegaserod and its metabolites are present in rat milk; the milk to plasma concentration ratio for tegaserod is very high (see Data). When drug is present in animal milk, it is likely that the drug will be present in human milk. Because of the potential for serious reactions in the breastfed infant, including tumorigenicity [see No","Pregnancy":"Available data from case reports with ZELNORM use in pregnant women have not identified drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, decreased survival of rat pups was observed with maternal dietary administration of tegaserod at 71 times the recommended dose during organogenesis and through lactation. Decreased body weight and delays in developmental landmarks in rat pups were observed with maternal dietary administration of 45 times the recommended dose (see Data). 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 U.S. 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.","Geriatric use":"ZELNORM is not indicated in patients 65 years of age and older.","Paediatric use":"Safety and effectiveness of ZELNORM in pediatric patients have not been established."},"seriousAdverseEvents":[{"effect":"Cardiovascular ischemic events","drugRate":"0.06%","severity":"serious"},{"effect":"Major adverse cardiovascular events (MACE)","drugRate":"0.06%","severity":"serious"},{"effect":"Suicidal ideation/behavior","drugRate":"","severity":"serious"}]},"trials":[],"aliases":[],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=TEGASEROD","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:26:05.110338+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:26:11.956837+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=TEGASEROD","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:26:12.631078+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Serotonin 4 (5-HT4) receptor partial agonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:26:13.183797+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1516474/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:26:13.084385+00:00"}},"allNames":"zelnorm","offLabel":[],"synonyms":["tegaserod maleate","tegaserod","HTF 919","zelnorm"],"timeline":[{"date":"2002-07-24","type":"positive","source":"DrugCentral","milestone":"FDA approval"}],"aiSummary":"Zelnorm (tegaserod) is a serotonin-4 receptor agonist, a small molecule modality developed to target the 5-hydroxytryptamine receptor 2B. It was originally developed and is now owned by Alfasigma. Zelnorm was FDA-approved in 2002 for the treatment of chronic idiopathic constipation and irritable bowel syndrome characterized by constipation. The drug is off-patent, with no active Orange Book patents, and currently has no generic manufacturers. Key safety considerations include its relatively short half-life of 11 hours and low bioavailability of 11%.","approvals":[{"date":"2002-07-24","orphan":false,"company":"","regulator":"FDA"}],"brandName":"Zelnorm","ecosystem":[{"indication":"Chronic idiopathic constipation","otherDrugs":[{"name":"lactitol","slug":"lactitol","company":"Braintree Labs"},{"name":"linaclotide","slug":"linaclotide","company":"Forest Labs Llc"},{"name":"lubiprostone","slug":"lubiprostone","company":"Sucampo Pharma Llc"},{"name":"plecanatide","slug":"plecanatide","company":"Synergy Pharms Inc"}],"globalPrevalence":1120000000},{"indication":"Irritable bowel syndrome characterized by constipation","otherDrugs":[{"name":"linaclotide","slug":"linaclotide","company":"Forest Labs Llc"},{"name":"lubiprostone","slug":"lubiprostone","company":"Sucampo Pharma Llc"},{"name":"tenapanor","slug":"tenapanor","company":"Ardelyx Inc"}],"globalPrevalence":null}],"mechanism":{"target":"5-hydroxytryptamine receptor 2B","novelty":"Follow-on","targets":[{"gene":"HTR2B","source":"DrugCentral","target":"5-hydroxytryptamine receptor 2B","protein":"5-hydroxytryptamine receptor 2B"},{"gene":"HTR4","source":"DrugCentral","target":"5-hydroxytryptamine receptor 4","protein":"5-hydroxytryptamine receptor 4"},{"gene":"HTR3A","source":"DrugCentral","target":"5-hydroxytryptamine receptor 3A","protein":"5-hydroxytryptamine receptor 3A"},{"gene":"HTR1A","source":"DrugCentral","target":"5-hydroxytryptamine receptor 1A","protein":"5-hydroxytryptamine receptor 1A"},{"gene":"HTR1D","source":"DrugCentral","target":"5-hydroxytryptamine receptor 1D","protein":"5-hydroxytryptamine receptor 1D"}],"moaClass":"Serotonin 4 Receptor Agonists","modality":"Small Molecule","drugClass":"Serotonin-4 Receptor Agonist","explanation":"","oneSentence":"","technicalDetail":"Tegaserod acts as a selective agonist of the 5-HT4 receptor, a subtype of serotonin receptor, which plays a key role in regulating gastrointestinal motility and secretion."},"commercial":{"launchDate":"2002","_launchSource":"DrugCentral (FDA 2002-07-24, )"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/2579","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=TEGASEROD","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=TEGASEROD","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":"2026-03-30T15:49:00.777980","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:26:14.968023+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"glycerol","drugSlug":"glycerol","fdaApproval":"1982-05-06","patentExpiry":"Sep 22, 2030","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"lubiprostone","drugSlug":"lubiprostone","fdaApproval":"2006-01-31","patentExpiry":"Oct 25, 2027","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"linaclotide","drugSlug":"linaclotide","fdaApproval":"2012-08-30","patentExpiry":"Oct 30, 2031","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"prucalopride","drugSlug":"prucalopride","fdaApproval":"2018-12-14","genericCount":17,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"plecanatide","drugSlug":"plecanatide","fdaApproval":"2017-01-19","patentExpiry":"Sep 15, 2031","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"tenapanor","drugSlug":"tenapanor","fdaApproval":"2019-09-12","patentExpiry":"Nov 26, 2042","patentStatus":"Patent protected","relationship":"same-class"}],"genericName":"tegaserod","indications":{"approved":[{"name":"Chronic idiopathic constipation","source":"DrugCentral","snomedId":82934008,"regulator":"FDA","eligibility":null,"usPrevalence":null,"globalPrevalence":1120000000,"prevalenceMethod":"curated","prevalenceSource":"Am J Gastroenterol, 2011 (PMID:21606976)"},{"name":"Irritable bowel syndrome characterized by constipation","source":"DrugCentral","snomedId":440630006,"regulator":"FDA","eligibility":{"age":"adult women less than 65 years of age","sex":"women","sex limitation":"men not established"}}],"offLabel":[],"pipeline":[]},"currentOwner":"Alfasigma","drugCategory":"active","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"glycerol","brandName":"glycerol","genericName":"glycerol","approvalYear":"1982","relationship":"same-class"},{"drugId":"lubiprostone","brandName":"lubiprostone","genericName":"lubiprostone","approvalYear":"2006","relationship":"same-class"},{"drugId":"linaclotide","brandName":"linaclotide","genericName":"linaclotide","approvalYear":"2012","relationship":"same-class"},{"drugId":"prucalopride","brandName":"prucalopride","genericName":"prucalopride","approvalYear":"2018","relationship":"same-class"},{"drugId":"plecanatide","brandName":"plecanatide","genericName":"plecanatide","approvalYear":"2017","relationship":"same-class"},{"drugId":"tenapanor","brandName":"tenapanor","genericName":"tenapanor","approvalYear":"2019","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT00232089","phase":"PHASE3","title":"Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia","status":"COMPLETED","sponsor":"Novartis","startDate":"2004-05","conditions":["Dyspepsia"],"enrollment":1296,"completionDate":"2006-06"},{"nctId":"NCT00348634","phase":"PHASE4","title":"Effect of Tegaserod on Orocecal Transit in Elderly Chronic Constipation Patients","status":"TERMINATED","sponsor":"Novartis","startDate":"2006-07","conditions":["Chronic Constipation"],"enrollment":60,"completionDate":"2007-04"},{"nctId":"NCT00277550","phase":"PHASE4","title":"The Effects of Tegaserod vs. Placebo on Whole Gut Transit Time in Patients With Chronic Constipation and Dyspepsia","status":"WITHDRAWN","sponsor":"Novartis","startDate":"","conditions":["Constipation and Dyspepsia"],"enrollment":0,"completionDate":""},{"nctId":"NCT00171522","phase":"PHASE4","title":"Preference of Tegaserod vs. PEG 3350 in Patients With Constipation","status":"COMPLETED","sponsor":"Novartis","startDate":"2005-05","conditions":["Constipation"],"enrollment":52,"completionDate":"2005-09"},{"nctId":"NCT00693732","phase":"PHASE4","title":"Validation of Surrogate Measures in Irritable Bowel Syndrome (IBS)","status":"COMPLETED","sponsor":"National University Hospital, Singapore","startDate":"2009-02","conditions":["Irritable Bowel Syndrome"],"enrollment":30,"completionDate":"2012-01"},{"nctId":"NCT00153140","phase":"PHASE4","title":"Polyethyleneglycol3350 vs Tegaserod in Treatment of Patients With Chronic Constipation","status":"COMPLETED","sponsor":"Braintree Laboratories","startDate":"2004-07","conditions":["Constipation"],"enrollment":239,"completionDate":""},{"nctId":"NCT00390975","phase":"PHASE4","title":"Effect of Tegaserod on Gastric Emptying in Patients With Diabetic Gastroparesis","status":"TERMINATED","sponsor":"Novartis","startDate":"2007-01","conditions":["Gastroparesis","Diabetes"],"enrollment":40,"completionDate":"2007-03"},{"nctId":"NCT00399659","phase":"PHASE3","title":"Safety and Efficacy of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain.","status":"TERMINATED","sponsor":"Novartis","startDate":"2006-11","conditions":["Opioid-induced Constipation"],"enrollment":360,"completionDate":"2007-04"},{"nctId":"NCT00414024","phase":"PHASE3","title":"Safety and Efficacy of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain.","status":"TERMINATED","sponsor":"Novartis","startDate":"2007-02","conditions":["Opioid-induced Constipation"],"enrollment":11,"completionDate":"2007-05"},{"nctId":"NCT00142974","phase":"PHASE2","title":"Assessment of the Effect of Tegaserod (2 mg Tid and 6 mg Tid) on Dyspeptic Symptoms in Diabetic Patients With Symptoms of Diabetic Gastropathy","status":"TERMINATED","sponsor":"Novartis","startDate":"2004-05","conditions":["Diabetic Gastropathy"],"enrollment":120,"completionDate":"2005-04"},{"nctId":"NCT00365820","phase":"PHASE2,PHASE3","title":"Efficacy and Safety of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain","status":"TERMINATED","sponsor":"Novartis","startDate":"2006-07","conditions":["Constipation"],"enrollment":670,"completionDate":"2007-04"},{"nctId":"NCT00171431","phase":"PHASE3","title":"The Effect of Tegaserod on Patterns of Flow in the Small Bowel of Patients With Irritable Bowel Syndrome (IBS)","status":"TERMINATED","sponsor":"Novartis Pharmaceuticals","startDate":"2004-11","conditions":["Constipation Predominant","Irritable Bowel Syndrome (IBS-C)"],"enrollment":20,"completionDate":"2006-05"},{"nctId":"NCT00563758","phase":"NA","title":"A Randomized, Double-blind, Placebo-controlled Multicenter Study to Assess the Efficacy, Safety and Tolerability of Tegaserod 2 mg Bid vs Placebo in Patients With Chronic Constipation","status":"TERMINATED","sponsor":"Hospital Authority, Hong Kong","startDate":"2004-12","conditions":["Constipation","Chronic Disease"],"enrollment":250,"completionDate":"2006-02"},{"nctId":"NCT00511771","phase":"","title":"A Treatment Investigational New Drug (tIND) Program of Tegaserod in Women With Irritable Bowel Syndrome With Constipation or With Chronic Idiopathic Constipation","status":"NO_LONGER_AVAILABLE","sponsor":"Novartis","startDate":"","conditions":["Irritable Bowel Syndrome With Constipation","Chronic Idiopathic Constipation"],"enrollment":0,"completionDate":""},{"nctId":"NCT00149851","phase":"PHASE2","title":"A Study to Assess the Efficacy, Safety and Tolerability of Tegaserod Alone and in Combination With Omeprazole Given Orally in Patients With Symptoms of Symptomatic Gastroesophageal Reflux Disease (sGERD)","status":"COMPLETED","sponsor":"Novartis","startDate":"2004-01","conditions":["Symptomatic Gastroespohageal Reflux Disease"],"enrollment":832,"completionDate":"2005-06"},{"nctId":"NCT00563615","phase":"NA","title":"Study of Effect of Tegaserod on Small and Large Bowel Transit by Scintigraphic Method","status":"UNKNOWN","sponsor":"Hospital Authority, Hong Kong","startDate":"2004-11","conditions":["Constipation"],"enrollment":60,"completionDate":"2006-10"},{"nctId":"NCT00149877","phase":"PHASE4","title":"Efficacy, Safety and Tolerability of Tegaserod in Patients With Chronic Constipation","status":"COMPLETED","sponsor":"Novartis","startDate":"2004-04","conditions":["Chronic Constipation"],"enrollment":250,"completionDate":"2006-02"},{"nctId":"NCT00141089","phase":"PHASE3","title":"Assessment of Efficacy and Safety of Tegaserod in Male Patients With Chronic Constipation.","status":"COMPLETED","sponsor":"Novartis","startDate":"2004-03","conditions":["Chronic Constipation"],"enrollment":1026,"completionDate":"2005-02"},{"nctId":"NCT00232024","phase":"PHASE3","title":"Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia","status":"COMPLETED","sponsor":"Novartis","startDate":"2004-01","conditions":["Dyspepsia"],"enrollment":1296,"completionDate":"2006-05"},{"nctId":"NCT00232037","phase":"PHASE3","title":"Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia","status":"COMPLETED","sponsor":"Novartis","startDate":"2004-09","conditions":["Dyspepsia"],"enrollment":359,"completionDate":"2006-08"},{"nctId":"NCT00232102","phase":"PHASE3","title":"Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia","status":"COMPLETED","sponsor":"Novartis","startDate":"2004-09","conditions":["Dyspepsia"],"enrollment":423,"completionDate":"2006-08"},{"nctId":"NCT00171470","phase":"PHASE3","title":"The Role of Tegaserod Therapy in the Management of Dyspeptic Symptoms in Female Patients on Proton Pump Inhibitors for the Treatment of Heartburn.","status":"COMPLETED","sponsor":"Novartis","startDate":"2005-04","conditions":["Dyspepsia"],"enrollment":60,"completionDate":"2006-08"},{"nctId":"NCT00139568","phase":"PHASE3","title":"An Evaluation of the Efficacy and Safety of Tegaserod 6 mg Bid Given Orally to Chinese Patients With Chronic Constipation","status":"COMPLETED","sponsor":"Novartis","startDate":"2005-02","conditions":["Constipation"],"enrollment":600,"completionDate":"2005-10"},{"nctId":"NCT00142987","phase":"PHASE4","title":"Efficacy of Tegaserod in Relieving the Symptoms of Female Patients With Irritable Bowel Syndrome (IBS), Excluding Those With Predominant Diarrhea IBS","status":"COMPLETED","sponsor":"Novartis","startDate":"2004-04","conditions":["IBS-C and IBS With Mixed Bowel Habits"],"enrollment":664,"completionDate":"2005-06"},{"nctId":"NCT00171483","phase":"PHASE3","title":"Assessment of the Role of Tegaserod Therapy in the Management of Gastroesophageal Reflux Disease (GERD) Symptoms in Patients With Incomplete Response to Proton Pump Inhibitors (PPIs).","status":"COMPLETED","sponsor":"Novartis","startDate":"2004-01","conditions":["Gastroesophageal Reflux Disease (GERD)"],"enrollment":30,"completionDate":"2005-04"},{"nctId":"NCT00171418","phase":"PHASE3","title":"Assessment of the Effects of Tegaserod in the Management of Gastroesophageal Reflux Disease (GERD) in Patients With Incomplete Response to Proton Pump Inhibitors (PPIs).","status":"COMPLETED","sponsor":"Novartis","startDate":"2003-06","conditions":["Gastroesophageal Reflux Disease (GERD)"],"enrollment":54,"completionDate":"2005-02"},{"nctId":"NCT00171457","phase":"PHASE3","title":"The Effects of Tegaserod on Mechanical Sensitivity of the Esophagus and Stomach in Patients With Heartburn and Dyspepsia.","status":"COMPLETED","sponsor":"Novartis","startDate":"2005-04","conditions":["Heartburn","Dyspepsia"],"enrollment":24,"completionDate":"2006-09"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Oral","formulation":"Tablet","formulations":[{"form":"TABLET","route":"ORAL","productName":"ZELNORM"},{"form":"TABLET","route":"ORAL","productName":"Zelnorm"}]},"_patentsChecked":true,"crossReferences":{"NUI":"N0000148771","MMSL":"16842","NDDF":"009658","UNII":"458VC51857","VUID":"4021352","CHEBI":"CHEBI:51043","VANDF":"4021352","INN_ID":"7606","RXNORM":"139778","UMLSCUI":"C0537147","chemblId":"CHEMBL1516474","ChEMBL_ID":"CHEMBL76370","KEGG_DRUG":"D02730","DRUGBANK_ID":"DB01079","PUBCHEM_CID":"135409453","SNOMEDCT_US":"386035006","IUPHAR_LIGAND_ID":"226","SECONDARY_CAS_RN":"189188-57-6","MESH_SUPPLEMENTAL_RECORD_UI":"C105050"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"present","companyName":"Alfasigma","relationship":"Current Owner"}],"pharmacokinetics":{"source":"DrugCentral","halfLife":"11.0 hours","clearance":"18.0 mL/min/kg","bioavailability":"11%","fractionUnbound":"0.02%","volumeOfDistribution":"5.3 L/kg"},"publicationCount":467,"therapeuticAreas":["Metabolic"],"atcClassification":{"source":"DrugCentral","atcCode":"A06AX06","allCodes":["A06AX06"]},"biosimilarFilings":[],"recentPublications":[],"companionDiagnostics":[],"genericManufacturers":0,"_genericFilersChecked":true,"genericManufacturerList":[],"status":"withdrawn","companyName":"Alfasigma","companyId":"","modality":"Small molecule","firstApprovalDate":"2002","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2002-07-24T00:00:00.000Z","mah":"","brand_name_local":null,"application_number":""},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"EU","regulator":"EMA","status":"refused","approval_date":null,"mah":null,"brand_name_local":"Zelnorm","application_number":"EMEA/H/C/000621"},{"country_code":"GB","regulator":"MHRA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Zelnorm","application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:26:14.968023+00:00","fieldsConflicting":2,"overallConfidence":0.8},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}