{"id":"ethionamide","rwe":[{"pmid":"41898460","year":"2026","title":"Real-World Assessment of the Xpert MTB/XDR for Detecting Isoniazid and Second-Line Drug Resistance Among TB Patients.","finding":"","journal":"International journal of molecular sciences","studyType":"Clinical Study"},{"pmid":"41856489","year":"2026","title":"Prevalence and resistance spectrum of ahpC mutations in isoniazid-resistant Mycobacterium tuberculosis isolates.","finding":"","journal":"Microbiology spectrum","studyType":"Clinical Study"},{"pmid":"41838347","year":"2026","title":"Interaction of a porphyrinic cage with ethionamide: a spectroscopic and computational study.","finding":"","journal":"Photochemical & photobiological sciences : Official journal of the European Photochemistry Association and the European Society for Photobiology","studyType":"Clinical Study"},{"pmid":"41809859","year":"2026","title":"Multicentre field evaluation of Xpert MTB/XDR in sub-Saharan Africa.","finding":"","journal":"ERJ open research","studyType":"Clinical Study"},{"pmid":"41754383","year":"2026","title":"Effectiveness and Safety of Bedaquiline-Containing Modified Shorter Regimens for Multidrug- or Rifampicin-Resistant Tuberculosis: A Single-Arm Meta-Analysis.","finding":"","journal":"Pathogens (Basel, Switzerland)","studyType":"Clinical Study"}],"tags":[{"label":"Antimycobacterial","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"J04AD03","category":"atc"},{"label":"Oral","category":"route"},{"label":"Tablet","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Active","category":"status"},{"label":"Acute tuberculosis","category":"indication"},{"label":"Pulmonary Mycobacterium avium complex infection","category":"indication"},{"label":"Pulmonary tuberculosis","category":"indication"},{"label":"Wyeth Pharms","category":"company"},{"label":"Approved 1960s","category":"decade"},{"label":"Anti-Bacterial Agents","category":"pharmacology"},{"label":"Anti-Infective Agents","category":"pharmacology"},{"label":"Antimetabolites","category":"pharmacology"},{"label":"Antitubercular Agents","category":"pharmacology"},{"label":"Fatty Acid Synthesis Inhibitors","category":"pharmacology"},{"label":"Hypolipidemic Agents","category":"pharmacology"}],"phase":"marketed","safety":{"safetySignals":[{"llr":408.401,"date":"","count":120,"signal":"Drug resistance","source":"DrugCentral FAERS","actionTaken":"Reported 120 times (LLR=408)"},{"llr":140.33,"date":"","count":64,"signal":"Electrocardiogram QT prolonged","source":"DrugCentral FAERS","actionTaken":"Reported 64 times (LLR=140)"},{"llr":111.202,"date":"","count":48,"signal":"Drug reaction with eosinophilia and systemic symptoms","source":"DrugCentral FAERS","actionTaken":"Reported 48 times (LLR=111)"},{"llr":90.108,"date":"","count":60,"signal":"Neuropathy peripheral","source":"DrugCentral FAERS","actionTaken":"Reported 60 times (LLR=90)"},{"llr":74.165,"date":"","count":26,"signal":"Pathogen resistance","source":"DrugCentral FAERS","actionTaken":"Reported 26 times (LLR=74)"},{"llr":73.805,"date":"","count":13,"signal":"Tuberculoma of central nervous system","source":"DrugCentral FAERS","actionTaken":"Reported 13 times (LLR=74)"},{"llr":63.856,"date":"","count":75,"signal":"Anaemia","source":"DrugCentral FAERS","actionTaken":"Reported 75 times (LLR=64)"},{"llr":58.595,"date":"","count":10,"signal":"Urinary tract inflammation","source":"DrugCentral FAERS","actionTaken":"Reported 10 times (LLR=59)"},{"llr":51.735,"date":"","count":22,"signal":"Deafness","source":"DrugCentral FAERS","actionTaken":"Reported 22 times (LLR=52)"},{"llr":49.812,"date":"","count":83,"signal":"Vomiting","source":"DrugCentral FAERS","actionTaken":"Reported 83 times (LLR=50)"},{"llr":48.385,"date":"","count":11,"signal":"Neuropsychiatric symptoms","source":"DrugCentral FAERS","actionTaken":"Reported 11 times (LLR=48)"},{"llr":48.327,"date":"","count":16,"signal":"Multiple-drug resistance","source":"DrugCentral FAERS","actionTaken":"Reported 16 times (LLR=48)"},{"llr":47.979,"date":"","count":28,"signal":"Drug-induced liver injury","source":"DrugCentral FAERS","actionTaken":"Reported 28 times (LLR=48)"},{"llr":46.216,"date":"","count":26,"signal":"Hypothyroidism","source":"DrugCentral FAERS","actionTaken":"Reported 26 times (LLR=46)"},{"llr":43.56,"date":"","count":16,"signal":"Hepatitis cholestatic","source":"DrugCentral FAERS","actionTaken":"Reported 16 times (LLR=44)"}],"commonSideEffects":[],"contraindications":["Alcoholism","Diabetes mellitus","Disease of liver","Hepatic failure","Hypothyroidism"],"specialPopulations":{"Paediatric use":"At present, the drug should not be used in pediatric patients under 12 years of age except when the organisms are definitely resistant to primary therapy and systemic dissemination of the disease, or other life-threatening complications of tuberculosis, is judged to be imminent."}},"trials":[],"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=ETHIONAMIDE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:22:26.358489+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Ethionamide","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T03:22:35.129506+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:22:33.714536+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ETHIONAMIDE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:22:34.550429+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Enoyl-[acyl-carrier-protein] reductase inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:22:35.129127+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1441/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:22:35.024995+00:00"}},"allNames":"trecator","offLabel":[],"synonyms":["ethioniamide","amidazine","ethionamide"],"timeline":[{"date":"1965-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from WYETH PHARMS INC to Wyeth Pharms"},{"date":"1965-04-30","type":"positive","source":"DrugCentral","milestone":"FDA approval (Wyeth Pharms Inc)"}],"aiSummary":"Trecator (ETHIONAMIDE) is a small molecule antimycobacterial drug originally developed by WYETH PHARMS INC and currently owned by Wyeth Pharms. It was FDA approved in 1965 for the treatment of acute tuberculosis, pulmonary Mycobacterium avium complex infection, and pulmonary tuberculosis. Trecator is off-patent and has no active Orange Book patents, indicating it is available as a generic medication. However, there are currently no generic manufacturers listed. As an off-patent medication, its commercial status is subject to change.","approvals":[{"date":"1965-04-30","orphan":false,"company":"WYETH PHARMS INC","regulator":"FDA"}],"brandName":"Trecator","ecosystem":[{"indication":"Acute tuberculosis","otherDrugs":[{"name":"aminosalicylic acid","slug":"aminosalicylic-acid","company":"Consolidated Midland"},{"name":"capreomycin","slug":"capreomycin","company":"Akorn"},{"name":"cycloserine","slug":"cycloserine","company":"Purdue Gmp"},{"name":"ethambutol","slug":"ethambutol","company":"Sti Pharma Llc"}],"globalPrevalence":1280000},{"indication":"Pulmonary Mycobacterium avium complex infection","otherDrugs":[{"name":"azithromycin","slug":"azithromycin","company":""},{"name":"clarithromycin","slug":"clarithromycin","company":"Abbvie"},{"name":"rifabutin","slug":"rifabutin","company":"Pharmacia And Upjohn"}],"globalPrevalence":null},{"indication":"Pulmonary tuberculosis","otherDrugs":[{"name":"aminosalicylic acid","slug":"aminosalicylic-acid","company":"Consolidated Midland"},{"name":"bedaquiline","slug":"bedaquiline","company":"Janssen Therap"},{"name":"capreomycin","slug":"capreomycin","company":"Akorn"},{"name":"cycloserine","slug":"cycloserine","company":"Purdue Gmp"}],"globalPrevalence":1280000}],"mechanism":{"novelty":"Follow-on","modality":"Small Molecule","drugClass":"Antimycobacterial","explanation":"","oneSentence":"","technicalDetail":"Trecator (ETHIONAMIDE) exerts its antimycobacterial effects by inhibiting the enzyme enoyl-ACP reductase, which is involved in the synthesis of mycolic acid through the fatty acid synthase I pathway."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Ethionamide","title":"Ethionamide","extract":"Ethionamide is an antibiotic used to treat tuberculosis. Specifically it is used, along with other antituberculosis medications, to treat active multidrug-resistant tuberculosis. It is no longer recommended for leprosy. It is taken by mouth."},"commercial":{"launchDate":"1965","_launchSource":"DrugCentral (FDA 1965-04-30, WYETH PHARMS INC)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1083","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=ETHIONAMIDE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ETHIONAMIDE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Ethionamide","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":"2026-03-30T11:07:51.472666","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:22:37.055381+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"isoniazid","drugSlug":"isoniazid","fdaApproval":"1952-09-29","genericCount":26,"patentStatus":"Off-patent — generic available","relationship":"same-target"}],"genericName":"ethionamide","indications":{"approved":[{"name":"Acute tuberculosis","source":"DrugCentral","snomedId":25629007,"regulator":"FDA","eligibility":{"resistance":"M. tuberculosis resistant to isoniazid or rifampin","intolerance":"intolerance on the part of the patient to other drugs","companion drugs":"suitable companion drug or drugs, the choice being based on the results of susceptibility tests"},"prevalenceClass":"1-5 / 10 000","globalPrevalence":1280000,"prevalenceMethod":"orphanet","prevalenceSource":"Orphanet (European Medicines Agency 2018[INST])"},{"name":"Pulmonary Mycobacterium avium complex infection","source":"DrugCentral","snomedId":186342000,"regulator":"FDA","eligibility":null},{"name":"Pulmonary tuberculosis","source":"DrugCentral","snomedId":154283005,"regulator":"FDA","eligibility":{"resistance":"resistant to isoniazid or rifampin","susceptibility":"susceptible to ethionamide","companion drugs":"at least one drug to which the M. tuberculosis isolate is known to be susceptible (if resistant to both isoniazid and rifampin, yet susceptible to ethionamide, at least two other drugs)"},"usPrevalence":null,"globalPrevalence":1280000,"prevalenceMethod":"curated","prevalenceSource":"Orphanet (European Medicines Agency 2018[INST])"}],"offLabel":[{"name":"Atypical mycobacterial infection","source":"DrugCentral","drugName":"ETHIONAMIDE","evidenceCount":116,"evidenceLevel":"strong"},{"name":"Leprosy","source":"DrugCentral","drugName":"ETHIONAMIDE","evidenceCount":81,"evidenceLevel":"strong"},{"name":"Tuberculosis of meninges","source":"DrugCentral","drugName":"ETHIONAMIDE","evidenceCount":39,"evidenceLevel":"moderate"}],"pipeline":[]},"currentOwner":"Wyeth Pharms","drugCategory":"active","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"isoniazid","brandName":"isoniazid","genericName":"isoniazid","approvalYear":"1952","relationship":"same-target"}],"trialDetails":[{"nctId":"NCT07350174","phase":"PHASE2","title":"Phase 2a Trial of Alpibectir Plus Ethionamide for Tuberculosis Meningitis","status":"NOT_YET_RECRUITING","sponsor":"BioVersys AG","startDate":"2026-03-30","conditions":["Tuberculosis Meningitis"],"enrollment":64,"completionDate":"2028-10-30"},{"nctId":"NCT00042289","phase":"","title":"Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2003-06-09","conditions":["HIV Infections"],"enrollment":1578,"completionDate":"2020-09-30"},{"nctId":"NCT05807399","phase":"PHASE2","title":"PanACEA - STEP2C -01","status":"RECRUITING","sponsor":"Michael Hoelscher","startDate":"2023-04-14","conditions":["Pulmonary Tuberculosis","Other Specified Pulmonary Tuberculosis"],"enrollment":390,"completionDate":"2027-12-30"},{"nctId":"NCT05473195","phase":"PHASE2","title":"A Phase 2 Trial to Evaluate the EBA, Safety and Tolerability of Eto Alone and in Combination With BVL-GSK098","status":"COMPLETED","sponsor":"TASK Applied Science","startDate":"2022-12-06","conditions":["Rifampicin- and Isoniazid-Susceptible Pulmonary Tuberculosis (TB)"],"enrollment":105,"completionDate":"2024-04-16"},{"nctId":"NCT05175794","phase":"","title":"Triage Test for All Oral DR-TB Regimen (TRiAD Study)","status":"COMPLETED","sponsor":"Centre for the AIDS Programme of Research in South Africa","startDate":"2022-05-26","conditions":["Drug Resistant Tuberculosis","MDR-TB","XDR-TB","Tuberculosis"],"enrollment":786,"completionDate":"2025-06-01"},{"nctId":"NCT06748937","phase":"PHASE2","title":"A Study of the Early Effects, Safety, and Acceptability of Oral Alpibectir in Combination With Ethionamide","status":"RECRUITING","sponsor":"TASK Applied Science","startDate":"2025-03-03","conditions":["Tuberculosis"],"enrollment":60,"completionDate":"2026-03-30"},{"nctId":"NCT02365623","phase":"PHASE2","title":"An Exploratory Study of TMC207 in Japanese Participants With Pulmonary Multi-Drug Resistant Tuberculosis (MDR-TB)","status":"COMPLETED","sponsor":"Janssen Pharmaceutical K.K.","startDate":"2015-02-18","conditions":["Tuberculosis, Multidrug-Resistant"],"enrollment":6,"completionDate":"2018-11-08"},{"nctId":"NCT04567368","phase":"","title":"TB-CAPT MTB/XDR Study","status":"ACTIVE_NOT_RECRUITING","sponsor":"Foundation for Innovative New Diagnostics, Switzerland","startDate":"2021-05-14","conditions":["Tuberculosis","Resistance Bacterial","Diagnoses Disease"],"enrollment":753,"completionDate":"2024-12-30"},{"nctId":"NCT05315661","phase":"PHASE1","title":"The Safety and The Efficacy Evaluation of ET-STEM in Patients With Frontotemporal Dementia","status":"ACTIVE_NOT_RECRUITING","sponsor":"Samsung Medical Center","startDate":"2022-07-06","conditions":["Frontotemporal Dementia"],"enrollment":12,"completionDate":"2026-12-31"},{"nctId":"NCT05258877","phase":"","title":"Pharmacokinetics of Ethionamide and Ethionamide Sulfoxide in Patients Established on Treatment for Tuberculosis.","status":"COMPLETED","sponsor":"BioVersys AG","startDate":"2022-06-10","conditions":["Tuberculosis, Pulmonary"],"enrollment":30,"completionDate":"2023-09-30"},{"nctId":"NCT03237182","phase":"PHASE4","title":"The Individualized M(X) Drug-resistant TB Treatment Strategy Study","status":"TERMINATED","sponsor":"Centre for the AIDS Programme of Research in South Africa","startDate":"2017-06-14","conditions":["Tuberculosis, Multidrug-Resistant"],"enrollment":205,"completionDate":"2022-12-19"},{"nctId":"NCT00000796","phase":"NA","title":"A Prospective Study of Multidrug Resistance and a Pilot Study of the Safety of and Clinical and Microbiologic Response to Levofloxacin in Combination With Other Antimycobacterial Drugs for Treatment of Multidrug-Resistant Pulmonary Tuberculosis (MDRTB) in HIV-Infected Patients.","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"","conditions":["HIV Infections","Tuberculosis"],"enrollment":525,"completionDate":"1998-10"},{"nctId":"NCT02454205","phase":"PHASE2,PHASE3","title":"An Open-label RCT to Evaluate a New Treatment Regimen for Patients With Multi-drug Resistant Tuberculosis","status":"COMPLETED","sponsor":"University of Cape Town","startDate":"2015-11-12","conditions":["Tuberculosis","Multidrug Resistant Tuberculosis","Extensively-drug Resistant Tuberculosis"],"enrollment":154,"completionDate":"2021-08-30"},{"nctId":"NCT02099240","phase":"EARLY_PHASE1","title":"Patients Response to Early Switch To Oral:Osteomyelitis Study","status":"TERMINATED","sponsor":"Julio Ramirez","startDate":"2014-03-06","conditions":["Osteomyelitis"],"enrollment":11,"completionDate":"2018-11-07"},{"nctId":"NCT03625739","phase":"","title":"Population Pharmacokinetics of Anti-tuberculosis Drugs in Children With Tuberculosis","status":"RECRUITING","sponsor":"Beijing Children's Hospital","startDate":"2018-07-01","conditions":["Tuberculosis"],"enrollment":800,"completionDate":"2026-12-31"},{"nctId":"NCT02975570","phase":"PHASE3","title":"Efficacy and Tolerability of Delamanid, Linezolid, Pyrazinamide and Levofloxacin","status":"WITHDRAWN","sponsor":"Boston University","startDate":"2017-08","conditions":["Tuberculosis Multi Drug Resistant Active"],"enrollment":0,"completionDate":"2022-08"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Oral","formulation":"Tablet","formulations":[{"form":"TABLET, FILM COATED","route":"ORAL","productName":"Trecator"}]},"_patentsChecked":true,"crossReferences":{"NUI":"N0000146400","MMSL":"4700","NDDF":"002851","UNII":"OAY8ORS3CQ","VUID":"4018059","CHEBI":"CHEBI:4885","VANDF":"4018059","INN_ID":"867","RXNORM":"4127","UMLSCUI":"C0015021","chemblId":"CHEMBL1441","ChEMBL_ID":"CHEMBL1441","KEGG_DRUG":"D00591","DRUGBANK_ID":"DB00609","PDB_CHEM_ID":"1JA","PUBCHEM_CID":"2761171","SNOMEDCT_US":"32800009","MESH_DESCRIPTOR_UI":"D005000"},"formularyStatus":[],"originalProduct":{"form":"TABLET, FILM COATED","route":"ORAL","company":"Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.","brandName":"Trecator","isOriginal":true,"marketingStatus":"NDA"},"_enricherVersion":"v2","_offLabelChecked":true,"developmentCodes":[],"ownershipHistory":[{"period":"1965-","companyName":"Pfizer","relationship":"Original Developer"},{"period":"present","companyName":"Pfizer","relationship":"Current Owner"}],"pharmacokinetics":{"source":"DrugCentral","bioavailability":"80%"},"publicationCount":1152,"therapeuticAreas":["Infectious Disease"],"atcClassification":{"source":"DrugCentral","atcCode":"J04AD03","allCodes":["J04AD03"]},"biosimilarFilings":[],"originalDeveloper":"Wyeth Pharms Inc","recentPublications":[{"date":"2026 Mar 12","pmid":"41898460","title":"Real-World Assessment of the Xpert MTB/XDR for Detecting Isoniazid and Second-Line Drug Resistance Among TB Patients.","journal":"International journal of molecular sciences"},{"date":"2026 Mar 19","pmid":"41856489","title":"Prevalence and resistance spectrum of ahpC mutations in isoniazid-resistant Mycobacterium tuberculosis isolates.","journal":"Microbiology spectrum"},{"date":"2026 Mar 16","pmid":"41838347","title":"Interaction of a porphyrinic cage with ethionamide: a spectroscopic and computational study.","journal":"Photochemical & photobiological sciences : Official journal of the European Photochemistry Association and the European Society for Photobiology"},{"date":"2026 Mar","pmid":"41809859","title":"Multicentre field evaluation of Xpert MTB/XDR in sub-Saharan Africa.","journal":"ERJ open research"},{"date":"2026 Jan 25","pmid":"41754383","title":"Effectiveness and Safety of Bedaquiline-Containing Modified Shorter Regimens for Multidrug- or Rifampicin-Resistant Tuberculosis: A Single-Arm Meta-Analysis.","journal":"Pathogens (Basel, Switzerland)"}],"companionDiagnostics":[],"genericManufacturers":0,"_genericFilersChecked":true,"genericManufacturerList":[],"status":"approved","companyName":"Wyeth Pharms","companyId":"pfizer","modality":"Small molecule","firstApprovalDate":"1965","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1965-04-30T00:00:00.000Z","mah":"WYETH PHARMS INC","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":"BR","regulator":"ANVISA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"MX","regulator":"COFEPRIS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AR","regulator":"ANMAT","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TR","regulator":"TITCK","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IN","regulator":"CDSCO","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TH","regulator":"FDA-TH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"MY","regulator":"NPRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"PH","regulator":"FDA-PH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"CO","regulator":"INVIMA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"ZA","regulator":"SAHPRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TW","regulator":"TFDA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"HK","regulator":"DH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"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},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":1,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:22:37.055381+00:00","fieldsConflicting":2,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}