{"id":"fenoldopam","rwe":[{"pmid":"41717482","year":"2025","title":"Ramulus mori (Sangzhi) alkaloids improve intestinal oxidative damage and inflammation in DHEA-induced polycystic ovary syndrome rats via gut microbiota and metabolite modulation.","finding":"","journal":"Frontiers in pharmacology","studyType":"Clinical Study"},{"pmid":"41716311","year":"2026","title":"Correction: Ramulus mori (Sangzhi) alkaloids improve intestinal oxidative damage and inflammation in DHEA-induced polycystic ovary syndrome rats via gut microbiota and metabolite modulation.","finding":"","journal":"Frontiers in pharmacology","studyType":"Clinical Study"},{"pmid":"41207628","year":"2025","title":"Non-catalytic UBL2 domain directs deubiquitinase USP11 toward K48-linked polyubiquitin chains.","finding":"","journal":"The Journal of biological chemistry","studyType":"Clinical Study"},{"pmid":"41122654","year":"2025","title":"Case Report: Bevacizumab-induced renal-limited TMA and FSGS-like lesions in a kidney transplant recipient.","finding":"","journal":"Frontiers in oncology","studyType":"Clinical Study"},{"pmid":"40587063","year":"2025","title":"Integrative genetic analysis of shared genetic architecture of stroke and coronary artery disease: implications for pharmacist-led precision medicine.","finding":"","journal":"International journal of clinical pharmacy","studyType":"Clinical Study"}],"tags":[{"label":"Dopaminergic Agonist","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"D(1A) dopamine receptor","category":"target"},{"label":"DRD1","category":"gene"},{"label":"DRD5","category":"gene"},{"label":"DRD4","category":"gene"},{"label":"C01CA19","category":"atc"},{"label":"Intravenous","category":"route"},{"label":"Injection","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Mature","category":"status"},{"label":"Hypertensive urgency","category":"indication"},{"label":"Malignant essential hypertension","category":"indication"},{"label":"Hospira","category":"company"},{"label":"Approved 1990s","category":"decade"},{"label":"Antihypertensive Agents","category":"pharmacology"},{"label":"Cardiovascular Agents","category":"pharmacology"},{"label":"Dopamine Agents","category":"pharmacology"},{"label":"Dopamine Agonists","category":"pharmacology"},{"label":"Neurotransmitter Agents","category":"pharmacology"},{"label":"Vasodilator Agents","category":"pharmacology"}],"phase":"marketed","safety":{"commonSideEffects":[],"contraindications":["Open-angle glaucoma"],"specialPopulations":{"Pregnancy":"There are insufficient data regarding CORLOPAM use in pregnancy to evaluate for drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal studies, there was no evidence of teratogenicity or fetotoxicity when fenoldopam was orally administered to rats and rabbits during organogenesis. There are adverse effects on maternal and fetal outcomes associated with severe hypertension. The estimated background risk for major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is to 4% and 15 to 20%, respectively. Disease-associated maternal and/or embryo/fetal risk Severe hypertension can result in maternal stroke, pulmonary edema, myocardial ischemia or death of the mother or fetus. Data. Animal Data Oral reproduction studies have been performed in rats and rabbits at doses of 12.5 to 200 mg/kg/day and 6.25 to 25 mg/kg/day, respectively, administered during the period of organogenesis. Studies have revealed maternal toxicity at the highest doses tested but no evidence of harm to the fetus due to fenoldopam.","Geriatric use":"Clinical studies of fenoldopam did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should start at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.","Paediatric use":"Safety and effectiveness of fenoldopam have been established in the age groups age 1 month (at least kg or full term) to 12 years old requiring blood pressure reduction. The adverse event profile in pediatric patients is similar to that seen in adults. The pharmacokinetics of fenoldopam are independent of age when corrected for body weight. The long-term effects of fenoldopam on growth and development have not been studied."}},"trials":[],"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=FENOLDOPAM","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:40:57.835151+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Fenoldopam","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T00:41:06.279495+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:41:04.318073+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=FENOLDOPAM","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:41:05.166112+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1256646/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:41:05.879031+00:00"}},"allNames":"corlopam","offLabel":[],"synonyms":["fenoldopam hydrobromide","fenoldopam","fenoldopam mesylate","corlopam","fenoldopam mesilate"],"timeline":[{"date":"1997-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from HOSPIRA to Hospira"},{"date":"1997-09-23","type":"positive","source":"DrugCentral","milestone":"FDA approval (Hospira)"},{"date":"2003-12-01","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 1 manufacturer approved"}],"aiSummary":"Corlopam (FENOLDOPAM) is a small molecule dopaminergic agonist that targets the D(1A) dopamine receptor. It was originally developed by Hospira and is currently owned by the same company. Corlopam is FDA-approved for the treatment of hypertensive urgency and malignant essential hypertension. The drug is off-patent, with multiple generic manufacturers available. Key safety considerations include its short half-life and low bioavailability.","approvals":[{"date":"1997-09-23","orphan":false,"company":"HOSPIRA","regulator":"FDA"}],"brandName":"Corlopam","ecosystem":[{"indication":"Hypertensive urgency","otherDrugs":[{"name":"chlorothiazide","slug":"chlorothiazide","company":"Oak Pharms Akorn"},{"name":"diazoxide","slug":"diazoxide","company":""},{"name":"hydrochlorothiazide","slug":"hydrochlorothiazide","company":""},{"name":"losartan","slug":"losartan","company":"Merck Sharp Dohme"}],"globalPrevalence":null},{"indication":"Malignant essential hypertension","otherDrugs":[{"name":"nitroprusside","slug":"nitroprusside","company":"Roche"}],"globalPrevalence":1280000000}],"mechanism":{"target":"D(1A) dopamine receptor","novelty":"Follow-on","targets":[{"gene":"DRD1","source":"DrugCentral","target":"D(1A) dopamine receptor","protein":"D(1A) dopamine receptor"},{"gene":"DRD5","source":"DrugCentral","target":"D(1B) dopamine receptor","protein":"D(1B) dopamine receptor"},{"gene":"DRD4","source":"DrugCentral","target":"D(4) dopamine receptor","protein":"D(4) dopamine receptor"},{"gene":"DRD2","source":"DrugCentral","target":"D(2) dopamine receptor","protein":"D(2) dopamine receptor"},{"gene":"GFER","source":"DrugCentral","target":"FAD-linked sulfhydryl oxidase ALR","protein":"FAD-linked sulfhydryl oxidase ALR"},{"gene":"KDM4E","source":"DrugCentral","target":"Lysine-specific demethylase 4E","protein":"Lysine-specific demethylase 4E"},{"gene":"ADRA1A","source":"DrugCentral","target":"Adrenergic receptor alpha-1","protein":"Alpha-1A adrenergic receptor"},{"gene":"ADRA1B","source":"DrugCentral","target":"Adrenergic receptor alpha-1","protein":"Alpha-1B adrenergic receptor"},{"gene":"ADRA1D","source":"DrugCentral","target":"Adrenergic receptor alpha-1","protein":"Alpha-1D adrenergic receptor"}],"moaClass":"Dopamine Agonists","modality":"Small Molecule","drugClass":"Dopaminergic Agonist","explanation":"","oneSentence":"","technicalDetail":"Corlopam acts as a selective agonist at the D(1A) dopamine receptor subtype, which is involved in the regulation of blood pressure through its effects on renal and mesenteric vascular beds."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Fenoldopam","title":"Fenoldopam","extract":"Fenoldopam, sold under the brand name Corlopam, is a drug and synthetic benzazepine derivative which acts as a selective D1 receptor partial agonist. Fenoldopam is used as an antihypertensive agent. It was approved by the US Food and Drug Administration (FDA) in September 1997."},"commercial":{"launchDate":"1997","_launchSource":"DrugCentral (FDA 1997-09-23, HOSPIRA)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1153","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=FENOLDOPAM","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=FENOLDOPAM","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Fenoldopam","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":"2026-03-30T11:15:15.085340","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:41:07.616207+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"isoprenaline","drugSlug":"isoprenaline","fdaApproval":"1956-03-09","relationship":"same-class"},{"drugName":"norepinephrine","drugSlug":"norepinephrine","fdaApproval":"1950-07-13","patentExpiry":"Mar 8, 2041","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"dopamine","drugSlug":"dopamine","fdaApproval":"1974-02-25","genericCount":9,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"phenylephrine","drugSlug":"phenylephrine","fdaApproval":"1952-01-21","patentExpiry":"Sep 26, 2036","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"dobutamine","drugSlug":"dobutamine","fdaApproval":"1978-07-18","genericCount":10,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"metaraminol","drugSlug":"metaraminol","fdaApproval":"1954-09-29","genericCount":5,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"methoxamine","drugSlug":"methoxamine","fdaApproval":"","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"mephentermine","drugSlug":"mephentermine","fdaApproval":"1951-12-29","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"midodrine","drugSlug":"midodrine","fdaApproval":"1996-09-06","genericCount":14,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"arbutamine","drugSlug":"arbutamine","fdaApproval":"1997-09-12","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"epinephrine","drugSlug":"epinephrine","fdaApproval":"1948-11-19","patentExpiry":"Oct 20, 2036","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"ephedrine","drugSlug":"ephedrine","fdaApproval":"","patentExpiry":"May 16, 2040","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"droxidopa","drugSlug":"droxidopa","fdaApproval":"2014-02-18","genericCount":16,"patentStatus":"Off-patent — generic available","relationship":"same-class"}],"genericName":"fenoldopam","indications":{"approved":[{"name":"Hypertensive urgency","source":"DrugCentral","snomedId":443482000,"regulator":"FDA"},{"name":"Malignant essential hypertension","source":"DrugCentral","snomedId":78975002,"regulator":"FDA","usPrevalence":119900000,"globalPrevalence":1280000000,"prevalenceMethod":"curated","prevalenceSource":"WHO, 2023"}],"offLabel":[],"pipeline":[]},"currentOwner":"Hospira","drugCategory":"mature","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"isoprenaline","brandName":"isoprenaline","genericName":"isoprenaline","approvalYear":"1956","relationship":"same-class"},{"drugId":"norepinephrine","brandName":"norepinephrine","genericName":"norepinephrine","approvalYear":"1950","relationship":"same-class"},{"drugId":"dopamine","brandName":"dopamine","genericName":"dopamine","approvalYear":"1974","relationship":"same-class"},{"drugId":"phenylephrine","brandName":"phenylephrine","genericName":"phenylephrine","approvalYear":"1952","relationship":"same-class"},{"drugId":"dobutamine","brandName":"dobutamine","genericName":"dobutamine","approvalYear":"1978","relationship":"same-class"},{"drugId":"metaraminol","brandName":"metaraminol","genericName":"metaraminol","approvalYear":"1954","relationship":"same-class"},{"drugId":"methoxamine","brandName":"methoxamine","genericName":"methoxamine","approvalYear":"","relationship":"same-class"},{"drugId":"mephentermine","brandName":"mephentermine","genericName":"mephentermine","approvalYear":"1951","relationship":"same-class"},{"drugId":"midodrine","brandName":"midodrine","genericName":"midodrine","approvalYear":"1996","relationship":"same-class"},{"drugId":"arbutamine","brandName":"arbutamine","genericName":"arbutamine","approvalYear":"1997","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT02620761","phase":"PHASE2,PHASE3","title":"Fenoldopam to Prevent Renal Dysfunction in Indomethacin Treated Preterm Infants","status":"TERMINATED","sponsor":"Medical College of Wisconsin","startDate":"2019-02-06","conditions":["Patent Ductus Arteriosus (PDA)","Acute Kidney Injury (AKI)"],"enrollment":1,"completionDate":"2020-01-31"},{"nctId":"NCT00743106","phase":"NA","title":"The Effect of Fenoldopam in Solitary Partial Nephrectomy Surgery","status":"TERMINATED","sponsor":"The Cleveland Clinic","startDate":"2002-09","conditions":["Partial Nephrectomy"],"enrollment":90,"completionDate":"2010-02"},{"nctId":"NCT00557219","phase":"PHASE3","title":"Fenoldopam and Ketanserin for Acute Kidney Failure Prevention After Cardiac Surgery","status":"TERMINATED","sponsor":"Medical University of Gdansk","startDate":"2008-04","conditions":["Acute Renal Failure"],"enrollment":60,"completionDate":"2015-04"},{"nctId":"NCT01073189","phase":"PHASE4","title":"Intra-Renal Therapy of Diuretic Unresponsive Acute Kidney Injury","status":"WITHDRAWN","sponsor":"Southeast Renal Research Institute","startDate":"2010-04","conditions":["Kidney Failures, Acute"],"enrollment":0,"completionDate":"2011-01"},{"nctId":"NCT00286403","phase":"PHASE2,PHASE3","title":"Vasodilators and Anti-Oxidant Therapy in Early ATN","status":"WITHDRAWN","sponsor":"Southeast Renal Research Institute","startDate":"2008-08","conditions":["Acute Renal Failure"],"enrollment":0,"completionDate":"2008-10"},{"nctId":"NCT00621790","phase":"PHASE3","title":"Fenoldopam and Acute Renal Failure","status":"COMPLETED","sponsor":"Università Vita-Salute San Raffaele","startDate":"2008-02","conditions":["Acute Renal Failure"],"enrollment":667,"completionDate":"2013-06"},{"nctId":"NCT00122018","phase":"PHASE2","title":"An Investigation of N-acetylcysteine and Fenoldopam as Renal Protection Agents for Cardiac Surgery","status":"COMPLETED","sponsor":"Linda F. Barr, M.D.","startDate":"2002-05","conditions":["Kidney Failure, Acute","Kidney Failure, Chronic","Cardiac Surgical Procedures"],"enrollment":80,"completionDate":"2006-03"},{"nctId":"NCT00592150","phase":"PHASE1","title":"Effect of Gene Variants on Dopamine Receptor Natriuretic Responses","status":"UNKNOWN","sponsor":"University of Virginia","startDate":"2007-06","conditions":["Hypertension"],"enrollment":44,"completionDate":"2013-06"},{"nctId":"NCT01690832","phase":"PHASE4","title":"Fenoldopam for Prevention of Acute Kidney Injury","status":"UNKNOWN","sponsor":"University of Roma La Sapienza","startDate":"2012-09","conditions":["Coronary Artery Disease"],"enrollment":100,"completionDate":"2014-12"},{"nctId":"NCT00982527","phase":"PHASE3","title":"Fenoldopam in Pediatric Cardiac Surgery","status":"COMPLETED","sponsor":"Bambino Gesù Hospital and Research Institute","startDate":"2009-09","conditions":["Kidney Failure, Acute"],"enrollment":80,"completionDate":"2010-11"},{"nctId":"NCT01324245","phase":"NA","title":"Intervention Study to Compare the Natriuretic Effects of Enalapril on Low and High Salt Diet","status":"COMPLETED","sponsor":"Georgetown University","startDate":"2002-11","conditions":["Salt-sensitive Hypertension"],"enrollment":45,"completionDate":"2006-05"},{"nctId":"NCT00747331","phase":"PHASE4","title":"Fenoldopam and Splanchnic Perfusion During Cardiopulmonary Bypass","status":"COMPLETED","sponsor":"IRCCS Policlinico S. Donato","startDate":"2008-09","conditions":["Cardiac Complications","Cardiopulmonary Bypass"],"enrollment":80,"completionDate":"2009-04"},{"nctId":"NCT00467181","phase":"PHASE2","title":"A Pilot Study to Investigate Fenoldopam Usage in the Prevention of Postoperative Renal Dysfunction in Patients at a High Risk for Renal Impairment During Cariopulmonary Bypass for Cardiac Surgery","status":"COMPLETED","sponsor":"Summa Health System","startDate":"2005-01","conditions":["Cardiac Surgery With Cardiopulmonary Bypass"],"enrollment":30,"completionDate":"2006-04"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Intravenous","formulation":"Injection","formulations":[{"form":"INJECTION, SOLUTION","route":"INTRAVENOUS","productName":"Corlopam"}]},"_patentsChecked":true,"crossReferences":{"NUI":"N0000148574","MMSL":"11504","NDDF":"007356","UNII":"INU8H2KAWG","VUID":"4021120","CHEBI":"CHEBI:5002","VANDF":"4021120","INN_ID":"4673","RXNORM":"155091","UMLSCUI":"C0060180","chemblId":"CHEMBL1256646","ChEMBL_ID":"CHEMBL588","KEGG_DRUG":"D00613","DRUGBANK_ID":"DB00800","PUBCHEM_CID":"3341","SNOMEDCT_US":"108590002","IUPHAR_LIGAND_ID":"939","SECONDARY_CAS_RN":"67287-54-1","MESH_DESCRIPTOR_UI":"D018818"},"formularyStatus":[],"originalProduct":{"form":"INJECTION, SOLUTION","route":"INTRAVENOUS","company":"Hospira, Inc.","brandName":"Corlopam","isOriginal":true,"marketingStatus":"NDA"},"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"1997-","companyName":"Pfizer","relationship":"Original Developer"}],"pharmacokinetics":{"source":"DrugCentral","halfLife":"1.0 hours","clearance":"41.5 mL/min/kg","bioavailability":"6%","fractionUnbound":"0.12%","volumeOfDistribution":"0.5 L/kg"},"publicationCount":770,"therapeuticAreas":["Cardiovascular"],"atcClassification":{"source":"DrugCentral","atcCode":"C01CA19","allCodes":["C01CA19"]},"biosimilarFilings":[],"originalDeveloper":"Hospira","recentPublications":[{"date":"2025","pmid":"41717482","title":"Ramulus mori (Sangzhi) alkaloids improve intestinal oxidative damage and inflammation in DHEA-induced polycystic ovary syndrome rats via gut microbiota and metabolite modulation.","journal":"Frontiers in pharmacology"},{"date":"2026","pmid":"41716311","title":"Correction: Ramulus mori (Sangzhi) alkaloids improve intestinal oxidative damage and inflammation in DHEA-induced polycystic ovary syndrome rats via gut microbiota and metabolite modulation.","journal":"Frontiers in pharmacology"},{"date":"2025 Dec","pmid":"41207628","title":"Non-catalytic UBL2 domain directs deubiquitinase USP11 toward K48-linked polyubiquitin chains.","journal":"The Journal of biological chemistry"},{"date":"2025","pmid":"41122654","title":"Case Report: Bevacizumab-induced renal-limited TMA and FSGS-like lesions in a kidney transplant recipient.","journal":"Frontiers in oncology"},{"date":"2025 Oct","pmid":"40587063","title":"Integrative genetic analysis of shared genetic architecture of stroke and coronary artery disease: implications for pharmacist-led precision medicine.","journal":"International journal of clinical pharmacy"}],"companionDiagnostics":[],"genericManufacturers":4,"_genericFilersChecked":true,"genericManufacturerList":["Hikma","Luitpold","Sandoz","Teva Parenteral"],"status":"approved","companyName":"Hospira","companyId":"pfizer","modality":"Small molecule","firstApprovalDate":"1997","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":"1997-09-23T00:00:00.000Z","mah":"HOSPIRA","brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":"1997-09-23T00:00:00.000Z","mah":"HOSPIRA","brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":"1997-09-23T00:00:00.000Z","mah":"HOSPIRA","brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":"1997-09-23T00:00:00.000Z","mah":"HOSPIRA","brand_name_local":null,"application_number":null},{"country_code":"SA","regulator":"SFDA","status":"likely_approved","approval_date":"1997-09-23T00:00:00.000Z","mah":"HOSPIRA","brand_name_local":null,"application_number":null},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1997-09-23T00:00:00.000Z","mah":"HOSPIRA","brand_name_local":null,"application_number":""},{"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":"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},{"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}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:41:07.616207+00:00","fieldsConflicting":2,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}