{"id":"ambenonium","rwe":[],"tags":[{"label":"Cholinesterase Inhibitor","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Acetylcholinesterase","category":"target"},{"label":"ACHE","category":"gene"},{"label":"N07AA30","category":"atc"},{"label":"Off-Patent","category":"patent"},{"label":"Active","category":"status"},{"label":"Myasthenia gravis","category":"indication"},{"label":"Sanofi Aventis Us","category":"company"},{"label":"Approved 1950s","category":"decade"},{"label":"Cholinergic Agents","category":"pharmacology"},{"label":"Cholinesterase Inhibitors","category":"pharmacology"},{"label":"Enzyme Inhibitors","category":"pharmacology"},{"label":"Neurotransmitter Agents","category":"pharmacology"},{"label":"Parasympathomimetics","category":"pharmacology"},{"label":"Peripheral Nervous System Agents","category":"pharmacology"}],"phase":"marketed","safety":{"drugInteractions":[{"url":"/drug/betamethasone","drug":"betamethasone","action":"Monitor closely","effect":"May interact with Ambenonium Chloride, Betamethasone","source":"DrugCentral","drugSlug":"betamethasone"},{"url":"/drug/cortisone","drug":"cortisone","action":"Monitor closely","effect":"May interact with Ambenonium Chloride, Cortisone","source":"DrugCentral","drugSlug":"cortisone"},{"url":"/drug/desoxycortone","drug":"desoxycortone","action":"Monitor closely","effect":"May interact with Ambenonium Chloride, Desoxycorticosterone","source":"DrugCentral","drugSlug":"desoxycortone"},{"url":"/drug/dexamethasone","drug":"dexamethasone","action":"Monitor closely","effect":"May interact with Ambenonium Chloride, Dexamethasone","source":"DrugCentral","drugSlug":"dexamethasone"},{"url":"/drug/fludrocortisone","drug":"fludrocortisone","action":"Monitor closely","effect":"May interact with Ambenonium Chloride, Fludrocortisone","source":"DrugCentral","drugSlug":"fludrocortisone"},{"url":"/drug/hydrocortisone","drug":"hydrocortisone","action":"Monitor closely","effect":"May interact with Ambenonium Chloride, Hydrocortisone","source":"DrugCentral","drugSlug":"hydrocortisone"},{"url":"/drug/methylprednisolone","drug":"methylprednisolone","action":"Monitor closely","effect":"May interact with Ambenonium Chloride, Methylprednisolone","source":"DrugCentral","drugSlug":"methylprednisolone"},{"url":"/drug/paramethasone","drug":"paramethasone","action":"Monitor closely","effect":"May interact with Ambenonium Chloride, Paramethasone","source":"DrugCentral","drugSlug":"paramethasone"},{"url":"/drug/prednisolone","drug":"prednisolone","action":"Monitor closely","effect":"May interact with Ambenonium Chloride, Prednisolone","source":"DrugCentral","drugSlug":"prednisolone"},{"url":"/drug/prednisone","drug":"prednisone","action":"Monitor closely","effect":"May interact with Ambenonium Chloride, Prednisone","source":"DrugCentral","drugSlug":"prednisone"},{"url":"/drug/tetracosactide","drug":"tetracosactide","action":"Monitor closely","effect":"May interact with Ambenonium Chloride, Cosyntropin","source":"DrugCentral","drugSlug":"tetracosactide"},{"url":"/drug/triamcinolone","drug":"triamcinolone","action":"Monitor closely","effect":"May interact with Ambenonium Chloride, Triamcinolone","source":"DrugCentral","drugSlug":"triamcinolone"}],"commonSideEffects":[],"contraindications":["Asthma","Gastrointestinal obstruction","Parkinsonism","Urinary tract obstruction"]},"trials":[],"aliases":[],"company":"Sanofi","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=AMBENONIUM","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:30:03.031417+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Ambenonium","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T03:30:10.770265+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada 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chloride","mytelase"],"timeline":[{"date":"1956-05-01","type":"positive","source":"DrugCentral","milestone":"FDA approval (Sanofi Aventis Us)"}],"aiSummary":"Mytelase (Ambenonium) is a small molecule cholinesterase inhibitor developed by Sanofi Aventis US, targeting acetylcholinesterase to treat Myasthenia gravis. It was FDA approved in 1956 and remains off-patent with no active Orange Book patents. Mytelase works by inhibiting the breakdown of acetylcholine, a neurotransmitter that facilitates muscle contraction. As a result, it increases the concentration of acetylcholine in the synaptic cleft, leading to improved muscle strength and function in patients with Myasthenia gravis. Despite being off-patent, Mytelase is still commercially available.","brandName":"Mytelase","ecosystem":[{"indication":"Myasthenia gravis","otherDrugs":[{"name":"azathioprine","slug":"azathioprine","company":"Prometheus Labs"},{"name":"efgartigimod alfa","slug":"efgartigimod-alfa","company":"Argenx Bv"},{"name":"neostigmine","slug":"neostigmine","company":"Eclat Pharms Llc"},{"name":"pyridostigmine","slug":"pyridostigmine","company":"Valeant Pharms Llc"}],"globalPrevalence":621600}],"mechanism":{"target":"Acetylcholinesterase","novelty":"Follow-on","targets":[{"gene":"ACHE","source":"DrugCentral","target":"Acetylcholinesterase","protein":"Acetylcholinesterase"}],"moaClass":"Cholinesterase Inhibitors","modality":"Small Molecule","drugClass":"Cholinesterase Inhibitor","explanation":"","oneSentence":"","technicalDetail":"Mytelase inhibits acetylcholinesterase, the enzyme responsible for hydrolyzing acetylcholine into choline and acetic acid, thereby increasing the concentration of acetylcholine in the synaptic cleft and enhancing neuromuscular transmission."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Ambenonium_chloride","title":"Ambenonium chloride","extract":"Ambenonium is a cholinesterase inhibitor used in the management of myasthenia gravis."},"commercial":{"launchDate":"1956","_launchSource":"DrugCentral (FDA 1956-05-01, SANOFI AVENTIS US)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/146","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=AMBENONIUM","fields":["publications"],"source":"PubMed/NCBI"},{"id":3,"url":"https://en.wikipedia.org/wiki/Ambenonium_chloride","fields":["history","overview"],"source":"Wikipedia"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange 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patents","relatedDrugs":[{"drugId":"neostigmine","brandName":"neostigmine","genericName":"neostigmine","approvalYear":"2013","relationship":"same-class"},{"drugId":"pyridostigmine","brandName":"pyridostigmine","genericName":"pyridostigmine","approvalYear":"1955","relationship":"same-class"}],"trialDetails":[],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"_patentsChecked":true,"crossReferences":{"NUI":"N0000020242","MMSL":"2011","NDDF":"001706","UNII":"L16PUN799N","VUID":"4022236","CHEBI":"CHEBI:2627","VANDF":"4018246","INN_ID":"552","RXNORM":"468764","UMLSCUI":"C0002412","chemblId":"CHEMBL1200541","ChEMBL_ID":"CHEMBL1652","KEGG_DRUG":"D01001","DRUGBANK_ID":"DB01122","PUBCHEM_CID":"2131","SNOMEDCT_US":"36537006","SECONDARY_CAS_RN":"115-79-7","MESH_DESCRIPTOR_UI":"D000549"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"1956-","companyName":"Sanofi","relationship":"Original Developer"}],"publicationCount":85,"therapeuticAreas":["Neuroscience"],"atcClassification":{"source":"DrugCentral","atcCode":"N07AA30","allCodes":["N07AA30"]},"biosimilarFilings":[],"originalDeveloper":"Sanofi Aventis Us","recentPublications":[],"companionDiagnostics":[],"genericManufacturers":0,"_genericFilersChecked":true,"genericManufacturerList":[],"status":"approved","companyName":"Sanofi","companyId":"sanofi","modality":"Small molecule","firstApprovalDate":"1956","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health 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