{"id":"chlormezanone","rwe":[{"pmid":"39216838","year":"2024","title":"Pharmacological chaperones restore proteostasis of epilepsy-associated GABA(A) receptor variants.","finding":"","journal":"Pharmacological research","studyType":"Clinical Study"},{"pmid":"37013328","year":"2022","title":"Hepatocellular and dermatological outcomes of chlormezanone.","finding":"","journal":"JPMA. The Journal of the Pakistan Medical Association","studyType":"Clinical Study"},{"pmid":"33260625","year":"2020","title":"Chemistry of Substituted Thiazinanes and Their Derivatives.","finding":"","journal":"Molecules (Basel, Switzerland)","studyType":"Clinical Study"},{"pmid":"29352387","year":"2018","title":"Current Perspectives on Erythema Multiforme.","finding":"","journal":"Clinical reviews in allergy & immunology","studyType":"Clinical Study"},{"pmid":"29188475","year":"2018","title":"Current Perspectives on Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis.","finding":"","journal":"Clinical reviews in allergy & immunology","studyType":"Clinical Study"}],"tags":[{"label":"chlormezanone","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"M03BB02","category":"atc"},{"label":"Off-Patent","category":"patent"},{"label":"Active","category":"status"},{"label":"Anxiety","category":"indication"},{"label":"Approved 1960s","category":"decade"},{"label":"Anti-Anxiety Agents","category":"pharmacology"},{"label":"Central Nervous System Agents","category":"pharmacology"},{"label":"Central Nervous System Depressants","category":"pharmacology"},{"label":"Muscle Relaxants, Central","category":"pharmacology"},{"label":"Neuromuscular Agents","category":"pharmacology"},{"label":"Peripheral Nervous System Agents","category":"pharmacology"},{"label":"Psychotropic Drugs","category":"pharmacology"},{"label":"Tranquilizing Agents","category":"pharmacology"}],"phase":"marketed","safety":{"safetySignals":[{"llr":829.275,"date":"","count":162,"signal":"Temperature regulation disorder","source":"DrugCentral FAERS","actionTaken":"Reported 162 times (LLR=829)"},{"llr":730.759,"date":"","count":161,"signal":"Food allergy","source":"DrugCentral FAERS","actionTaken":"Reported 161 times (LLR=731)"},{"llr":700.883,"date":"","count":159,"signal":"Coeliac disease","source":"DrugCentral FAERS","actionTaken":"Reported 159 times (LLR=701)"},{"llr":625.887,"date":"","count":162,"signal":"Immunodeficiency","source":"DrugCentral FAERS","actionTaken":"Reported 162 times (LLR=626)"},{"llr":537.139,"date":"","count":160,"signal":"Bursitis","source":"DrugCentral FAERS","actionTaken":"Reported 160 times (LLR=537)"},{"llr":483.719,"date":"","count":163,"signal":"Rash erythematous","source":"DrugCentral FAERS","actionTaken":"Reported 163 times (LLR=484)"},{"llr":444.278,"date":"","count":162,"signal":"Fluid retention","source":"DrugCentral FAERS","actionTaken":"Reported 162 times (LLR=444)"},{"llr":397.256,"date":"","count":162,"signal":"Upper respiratory tract infection","source":"DrugCentral FAERS","actionTaken":"Reported 162 times (LLR=397)"},{"llr":329.968,"date":"","count":164,"signal":"Hyperhidrosis","source":"DrugCentral FAERS","actionTaken":"Reported 164 times (LLR=330)"},{"llr":329.878,"date":"","count":161,"signal":"Asthma","source":"DrugCentral FAERS","actionTaken":"Reported 161 times (LLR=330)"},{"llr":276.035,"date":"","count":163,"signal":"Hepatic enzyme increased","source":"DrugCentral FAERS","actionTaken":"Reported 163 times (LLR=276)"},{"llr":275.863,"date":"","count":165,"signal":"Erythema","source":"DrugCentral FAERS","actionTaken":"Reported 165 times (LLR=276)"},{"llr":224.329,"date":"","count":165,"signal":"Hypersensitivity","source":"DrugCentral FAERS","actionTaken":"Reported 165 times (LLR=224)"},{"llr":215.365,"date":"","count":150,"signal":"Rheumatoid arthritis","source":"DrugCentral FAERS","actionTaken":"Reported 150 times (LLR=215)"},{"llr":214.421,"date":"","count":162,"signal":"Back pain","source":"DrugCentral FAERS","actionTaken":"Reported 162 times (LLR=214)"}],"commonSideEffects":[]},"trials":[],"aliases":[],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=CHLORMEZANONE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:20:17.962660+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:20:23.560553+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=CHLORMEZANONE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:20:23.896231+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1200714/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:20:24.672688+00:00"}},"allNames":"phenarol","offLabel":[],"synonyms":["clormezanone","chlormezanone","chlormethazanone","chlormethazone","dichloromezanone","phenarol","dl-Chlormezanone"],"timeline":[{"date":"1960-05-20","type":"positive","source":"DrugCentral","milestone":"FDA approval"}],"aiSummary":"Phenarol, also known as chlormezanone, is a small molecule drug in the chlormezanone class. It was originally developed and is currently owned by a company, but the exact details are not specified. Phenarol is FDA-approved for the treatment of anxiety and was approved in 1960. It has a high bioavailability of 99% but lacks generic manufacturers due to its off-patent status. As an off-patent medication, Phenarol is no longer protected by active patents.","approvals":[{"date":"1960-05-20","orphan":false,"company":"","regulator":"FDA"}],"brandName":"Phenarol","ecosystem":[{"indication":"Anxiety","otherDrugs":[{"name":"alprazolam","slug":"alprazolam","company":"Pharmacia And Upjohn"},{"name":"chlordiazepoxide","slug":"chlordiazepoxide","company":"Valeant Pharm Intl"},{"name":"clorazepate","slug":"clorazepate","company":"Recordati Rare"},{"name":"diazepam","slug":"diazepam","company":"Roche"}],"globalPrevalence":301000000}],"mechanism":{"novelty":"Follow-on","modality":"Small Molecule","drugClass":"chlormezanone","explanation":"","oneSentence":"","technicalDetail":"Phenarol acts as a GABA_A receptor agonist, enhancing the inhibitory effects of gamma-aminobutyric acid (GABA) on neuronal activity, which results in a sedative and anxiolytic effect."},"commercial":{"launchDate":"1960","_launchSource":"DrugCentral (FDA 1960-05-20, )"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/603","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=CHLORMEZANONE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=CHLORMEZANONE","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":"2026-03-30T09:34:26.143201","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:20:26.325479+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"chlorzoxazone","drugSlug":"chlorzoxazone","fdaApproval":"1958-08-15","genericCount":21,"patentStatus":"Off-patent — generic available","relationship":"same-class"}],"genericName":"chlormezanone","indications":{"approved":[{"name":"Anxiety","source":"DrugCentral","snomedId":48694002,"regulator":"FDA","usPrevalence":40000000,"globalPrevalence":301000000,"prevalenceMethod":"curated","prevalenceSource":"WHO, 2022"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"chlorzoxazone","brandName":"chlorzoxazone","genericName":"chlorzoxazone","approvalYear":"1958","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT02582736","phase":"","title":"Antipsychotics and Risk of Hyperglycemic Emergencies","status":"COMPLETED","sponsor":"Canadian Network for Observational Drug Effect Studies, CNODES","startDate":"2012-04","conditions":["Psychotic Disorders","Schizophrenia","Schizoaffective Disorder","Bipolar Disorder","Diabetes Mellitus, Type 2"],"enrollment":725489,"completionDate":"2012-12"},{"nctId":"NCT01450865","phase":"PHASE1","title":"Effect of the Kv7-channel Opener Flupirtine on the Excitability of Human Peripheral Myelinated Axons in Vivo","status":"COMPLETED","sponsor":"Ludwig-Maximilians - University of Munich","startDate":"2009-10","conditions":["Axonal Change, Neuronal","Pain"],"enrollment":20,"completionDate":"2010-08"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"_patentsChecked":true,"crossReferences":{"NUI":"N0000146590","MMSL":"4413","NDDF":"001447","UNII":"GP568V9G19","VUID":"4018260","CHEBI":"CHEBI:3619","VANDF":"4018260","INN_ID":"782","RXNORM":"2373","UMLSCUI":"C0008223","chemblId":"CHEMBL1200714","ChEMBL_ID":"CHEMBL1200714","KEGG_DRUG":"D00268","DRUGBANK_ID":"DB01178","PUBCHEM_CID":"2717","SNOMEDCT_US":"387400008","IUPHAR_LIGAND_ID":"7323","MESH_DESCRIPTOR_UI":"D002720"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[],"pharmacokinetics":{"source":"DrugCentral","bioavailability":"99%"},"publicationCount":139,"therapeuticAreas":["Neuroscience"],"atcClassification":{"source":"DrugCentral","atcCode":"M03BB02","allCodes":["M03BB02","M03BB52","M03BB72"]},"biosimilarFilings":[],"recentPublications":[{"date":"2024 Oct","pmid":"39216838","title":"Pharmacological chaperones restore proteostasis of epilepsy-associated GABA(A) receptor variants.","journal":"Pharmacological research"},{"date":"2022 Nov","pmid":"37013328","title":"Hepatocellular and dermatological outcomes of chlormezanone.","journal":"JPMA. The Journal of the Pakistan Medical Association"},{"date":"2020 Nov 28","pmid":"33260625","title":"Chemistry of Substituted Thiazinanes and Their Derivatives.","journal":"Molecules (Basel, Switzerland)"},{"date":"2018 Feb","pmid":"29352387","title":"Current Perspectives on Erythema Multiforme.","journal":"Clinical reviews in allergy & immunology"},{"date":"2018 Feb","pmid":"29188475","title":"Current Perspectives on Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis.","journal":"Clinical reviews in allergy & immunology"}],"companionDiagnostics":[],"genericManufacturers":0,"_genericFilersChecked":true,"genericManufacturerList":[],"status":"withdrawn","companyName":"","companyId":"","modality":"Small molecule","firstApprovalDate":"1960","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1960-05-20T00:00:00.000Z","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":"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":0,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:20:26.325479+00:00","fieldsConflicting":2,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}