{"id":"ethyl-loflazepate","rwe":[{"pmid":"38867823","year":"2023","title":"Clinical practice for unspecified anxiety disorder in primary care.","finding":"","journal":"PCN reports : psychiatry and clinical neurosciences","studyType":"Clinical Study"},{"pmid":"33630478","year":"2006","title":"Ethyl Loflazepate.","finding":"","journal":"","studyType":"Clinical Study"},{"pmid":"35941665","year":"2022","title":"Ethyl loflazepate as a treatment for patients with idiopathic and psychogenic taste disorder.","finding":"","journal":"BioPsychoSocial medicine","studyType":"Clinical Study"},{"pmid":"35885868","year":"2022","title":"Trends and Geographic Variabilities in Benzodiazepines Prescription in Primary Care to Older Adults: A 3-Year Population-Based Ecological Study in Portugal.","finding":"","journal":"Healthcare (Basel, Switzerland)","studyType":"Clinical Study"},{"pmid":"35343929","year":"2022","title":"Transfer of Ethyl Loflazepate Into Cord Blood, Breast Milk, and Infant's Serum: A Case Report.","finding":"","journal":"Journal of clinical psychopharmacology","studyType":"Clinical Study"}],"tags":[{"label":"ethyl loflazepate","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"N05BA18","category":"atc"},{"label":"Active","category":"status"},{"label":"Anxiety","category":"indication"},{"label":"Depressive disorder","category":"indication"},{"label":"Anti-Anxiety Agents","category":"pharmacology"},{"label":"Central Nervous System Agents","category":"pharmacology"},{"label":"Central Nervous System Depressants","category":"pharmacology"},{"label":"Psychotropic Drugs","category":"pharmacology"},{"label":"Tranquilizing Agents","category":"pharmacology"}],"phase":"phase_2","safety":{"safetySignals":[{"llr":70.431,"date":"","count":29,"signal":"Altered state of consciousness","source":"DrugCentral FAERS","actionTaken":"Reported 29 times (LLR=70)"},{"llr":41.517,"date":"","count":15,"signal":"Parkinsonism","source":"DrugCentral FAERS","actionTaken":"Reported 15 times (LLR=42)"},{"llr":41.081,"date":"","count":12,"signal":"Tongue oedema","source":"DrugCentral FAERS","actionTaken":"Reported 12 times (LLR=41)"},{"llr":39.87,"date":"","count":26,"signal":"Intentional overdose","source":"DrugCentral FAERS","actionTaken":"Reported 26 times (LLR=40)"},{"llr":39.156,"date":"","count":24,"signal":"Suicide attempt","source":"DrugCentral FAERS","actionTaken":"Reported 24 times (LLR=39)"},{"llr":34.989,"date":"","count":15,"signal":"Neuroleptic malignant syndrome","source":"DrugCentral FAERS","actionTaken":"Reported 15 times (LLR=35)"},{"llr":34.169,"date":"","count":18,"signal":"Irritability","source":"DrugCentral FAERS","actionTaken":"Reported 18 times (LLR=34)"},{"llr":31.206,"date":"","count":8,"signal":"Mallory-Weiss syndrome","source":"DrugCentral FAERS","actionTaken":"Reported 8 times (LLR=31)"},{"llr":29.754,"date":"","count":21,"signal":"Rhabdomyolysis","source":"DrugCentral FAERS","actionTaken":"Reported 21 times (LLR=30)"},{"llr":29.693,"date":"","count":28,"signal":"Overdose","source":"DrugCentral FAERS","actionTaken":"Reported 28 times (LLR=30)"},{"llr":28.03,"date":"","count":18,"signal":"Hepatic function abnormal","source":"DrugCentral FAERS","actionTaken":"Reported 18 times (LLR=28)"},{"llr":26.587,"date":"","count":6,"signal":"Pressure of speech","source":"DrugCentral FAERS","actionTaken":"Reported 6 times (LLR=27)"}],"commonSideEffects":[{"effect":"Altered state of consciousness","drugRate":"LLR 70","severity":"common"},{"effect":"Parkinsonism","drugRate":"LLR 42","severity":"common"},{"effect":"Tongue oedema","drugRate":"LLR 41","severity":"common"},{"effect":"Suicide attempt","drugRate":"LLR 39","severity":"common"},{"effect":"Neuroleptic malignant syndrome","drugRate":"LLR 35","severity":"common"},{"effect":"Irritability","drugRate":"LLR 34","severity":"common"},{"effect":"Mallory-Weiss syndrome","drugRate":"LLR 31","severity":"common"},{"effect":"Rhabdomyolysis","drugRate":"LLR 30","severity":"common"},{"effect":"Overdose","drugRate":"LLR 30","severity":"common"},{"effect":"Hepatic function abnormal","drugRate":"LLR 28","severity":"common"},{"effect":"Pressure of speech","drugRate":"LLR 27","severity":"common"}],"contraindications":["Angle-closure glaucoma","Myasthenia gravis"]},"trials":[],"aliases":[],"patents":[],"pricing":[],"allNames":"meilax","offLabel":[],"synonyms":["ethyl flucozepate","CM 6912","ethyl loflazepate","meilax","victan","CM6912","CM-6912"],"timeline":[],"approvals":[],"brandName":"Meilax","ecosystem":[{"indication":"Anxiety","otherDrugs":[{"name":"alprazolam","slug":"alprazolam","company":"Pharmacia And Upjohn"},{"name":"chlordiazepoxide","slug":"chlordiazepoxide","company":"Valeant Pharm Intl"},{"name":"chlormezanone","slug":"chlormezanone","company":""},{"name":"clorazepate","slug":"clorazepate","company":"Recordati Rare"}],"globalPrevalence":301000000},{"indication":"Depressive disorder","otherDrugs":[{"name":"amitriptyline","slug":"amitriptyline","company":"Astrazeneca"},{"name":"amoxapine","slug":"amoxapine","company":"Lederle"},{"name":"bupropion","slug":"bupropion","company":"Glaxosmithkline"},{"name":"citalopram","slug":"citalopram","company":"Forest Labs"}],"globalPrevalence":280000000}],"mechanism":{"modality":"Small Molecule","drugClass":"ethyl loflazepate","explanation":"Imagine your brain is like a busy city with lots of people talking and moving around. GABA is like a traffic cop that helps to slow down the traffic and keep everything calm. Meilax helps the traffic cop to do its job more effectively, which can help to reduce feelings of anxiety and stress.","oneSentence":"Meilax works by enhancing the activity of a neurotransmitter called gamma-aminobutyric acid (GABA), which helps to calm the brain and reduce anxiety.","technicalDetail":"Meilax acts as a partial agonist at the GABA_A receptor, which is a type of receptor that is responsible for the inhibitory effects of GABA in the brain. By enhancing the activity of GABA, Meilax can help to reduce the excitability of neurons and promote a sense of calm and relaxation."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Ethyl_loflazepate","title":"Ethyl loflazepate","extract":"Ethyl loflazepate is a drug which is a benzodiazepine derivative. It possesses anxiolytic, anticonvulsant, sedative and skeletal muscle relaxant properties. In animal studies it was found to have low toxicity, although in rats evidence of pulmonary phospholipidosis occurred with pulmonary foam cells developing with long-term use of very high doses. Its elimination half-life is 51–103 hours. Its mechanism of action is similar to other benzodiazepines. Ethyl loflazepate also produces an active metabolite which is stronger than the parent compound. Ethyl loflazepate was designed to be a prodrug for descarboxyloflazepate, its active metabolite. It is the active metabolite which is responsible for most of the pharmacological effects rather than ethyl loflazepate. The main metabolites of ethyl loflazepate are descarbethoxyloflazepate, loflazepate and 3-hydroxydescarbethoxyloflazepate. Accumulation of the active metabolites of ethyl loflazepate are not affected by those with kidney failure or impairment. The symptoms of an overdose of ethyl loflazepate include sleepiness, agitation and ataxia. Hypotonia may also occur in severe cases. These symptoms occur much more frequently and severely in children. Death from therapeutic maintenance doses of ethyl loflazepate taken for 2 – 3 weeks has been reported in 3 elderly patients. The cause of death was asphyxia due to benzodiazepine toxicity. High doses of the antidepressant fluvoxamine may potentiate the adverse effects of ethyl loflazep"},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1092","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ETHYL LOFLAZEPATE","fields":["publications"],"source":"PubMed/NCBI"},{"id":3,"url":"https://en.wikipedia.org/wiki/Ethyl_loflazepate","fields":["history","overview"],"source":"Wikipedia"}],"_enrichedAt":"2026-03-30T11:16:39.864244","biosimilars":[],"competitors":[{"drugName":"diazepam","drugSlug":"diazepam","fdaApproval":"1963-11-15","patentExpiry":"Oct 16, 2032","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"chlordiazepoxide","drugSlug":"chlordiazepoxide","fdaApproval":"1960-02-24","genericCount":1,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"oxazepam","drugSlug":"oxazepam","fdaApproval":"1965-06-04","genericCount":12,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"clorazepate","drugSlug":"clorazepate","fdaApproval":"1972-06-23","genericCount":19,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"lorazepam","drugSlug":"lorazepam","fdaApproval":"1977-09-30","patentExpiry":"Jan 8, 2034","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"clobazam","drugSlug":"clobazam","fdaApproval":"2011-10-21","patentExpiry":"Sep 5, 2039","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"prazepam","drugSlug":"prazepam","fdaApproval":"","genericCount":1,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"alprazolam","drugSlug":"alprazolam","fdaApproval":"1981-10-16","genericCount":24,"patentStatus":"Off-patent — generic 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2023"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"diazepam","brandName":"diazepam","genericName":"diazepam","approvalYear":"1963","relationship":"same-class"},{"drugId":"chlordiazepoxide","brandName":"chlordiazepoxide","genericName":"chlordiazepoxide","approvalYear":"1960","relationship":"same-class"},{"drugId":"oxazepam","brandName":"oxazepam","genericName":"oxazepam","approvalYear":"1965","relationship":"same-class"},{"drugId":"clorazepate","brandName":"clorazepate","genericName":"clorazepate","approvalYear":"1972","relationship":"same-class"},{"drugId":"lorazepam","brandName":"lorazepam","genericName":"lorazepam","approvalYear":"1977","relationship":"same-class"},{"drugId":"clobazam","brandName":"clobazam","genericName":"clobazam","approvalYear":"2011","relationship":"same-class"},{"drugId":"prazepam","brandName":"prazepam","genericName":"prazepam","approvalYear":"","relationship":"same-class"},{"drugId":"alprazolam","brandName":"alprazolam","genericName":"alprazolam","approvalYear":"1981","relationship":"same-class"},{"drugId":"halazepam","brandName":"halazepam","genericName":"halazepam","approvalYear":"1981","relationship":"same-class"}],"trialDetails":[],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"crossReferences":{"NDDF":"005857","UNII":"VJB5FW9W9J","CHEBI":"CHEBI:31573","INN_ID":"4837","RXNORM":"24524","UMLSCUI":"C0059772","ChEMBL_ID":"CHEMBL1213460","KEGG_DRUG":"D01293","DRUGBANK_ID":"DB01545","PUBCHEM_CID":"3299","SNOMEDCT_US":"769093001","SECONDARY_CAS_RN":"71735-10-9","MESH_SUPPLEMENTAL_RECORD_UI":"C029617"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[],"publicationCount":47,"therapeuticAreas":["Neuroscience"],"atcClassification":{"source":"DrugCentral","atcCode":"N05BA18","allCodes":["N05BA18"]},"biosimilarFilings":[],"recentPublications":[{"date":"2023 Sep","pmid":"38867823","title":"Clinical practice for unspecified anxiety disorder in primary care.","journal":"PCN reports : psychiatry and clinical neurosciences"},{"date":"2006","pmid":"33630478","title":"Ethyl Loflazepate.","journal":""},{"date":"2022 Aug 8","pmid":"35941665","title":"Ethyl loflazepate as a treatment for patients with idiopathic and psychogenic taste disorder.","journal":"BioPsychoSocial medicine"},{"date":"2022 Jul 19","pmid":"35885868","title":"Trends and Geographic Variabilities in Benzodiazepines Prescription in Primary Care to Older Adults: A 3-Year Population-Based Ecological Study in Portugal.","journal":"Healthcare (Basel, Switzerland)"},{"date":"2022 Jul-Aug 01","pmid":"35343929","title":"Transfer of Ethyl Loflazepate Into Cord Blood, Breast Milk, and Infant's Serum: A Case Report.","journal":"Journal of clinical psychopharmacology"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","companyName":"","companyId":"","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Meilax, also known as ethyl loflazepate, is a small molecule drug in the benzodiazepine class. It is used to treat anxiety and depressive disorders. The commercial status of Meilax is currently unknown, and it is not clear if it is patented or available as a generic medication. Further research is needed to determine its key safety considerations and pharmacokinetic properties.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":false,"score":3}}