{"id":"methsuximide","rwe":[],"tags":[{"label":"Anti-epileptic Agent","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Voltage-gated T-type calcium channel","category":"target"},{"label":"CACNA1G","category":"gene"},{"label":"CACNA1H","category":"gene"},{"label":"CACNA1I","category":"gene"},{"label":"N03AD03","category":"atc"},{"label":"Oral","category":"route"},{"label":"Capsule","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Mature","category":"status"},{"label":"Absence seizure","category":"indication"},{"label":"Epilepsy","category":"indication"},{"label":"Parke Davis","category":"company"},{"label":"Approved 1950s","category":"decade"},{"label":"Anticonvulsants","category":"pharmacology"},{"label":"Central Nervous System Agents","category":"pharmacology"}],"phase":"marketed","safety":{"commonSideEffects":[{"effect":"Nausea or vomiting","drugRate":"reported","severity":"unknown"},{"effect":"Drowsiness","drugRate":"reported","severity":"unknown"},{"effect":"Ataxia or dizziness","drugRate":"reported","severity":"unknown"},{"effect":"Diarrhea","drugRate":"reported","severity":"unknown"},{"effect":"Weight loss","drugRate":"reported","severity":"unknown"},{"effect":"Epigastric and abdominal pain","drugRate":"reported","severity":"unknown"},{"effect":"Constipation","drugRate":"reported","severity":"unknown"},{"effect":"Leukopenia","drugRate":"reported","severity":"unknown"},{"effect":"Monocytosis","drugRate":"reported","severity":"unknown"},{"effect":"Pancytopenia with or without bone marrow suppression","drugRate":"reported","severity":"unknown"},{"effect":"Eosinophilia","drugRate":"reported","severity":"unknown"},{"effect":"Headache","drugRate":"reported","severity":"unknown"},{"effect":"Blurred vision","drugRate":"reported","severity":"unknown"},{"effect":"Photophobia","drugRate":"reported","severity":"unknown"},{"effect":"Hiccups","drugRate":"reported","severity":"unknown"},{"effect":"Insomnia","drugRate":"reported","severity":"unknown"},{"effect":"Confusion","drugRate":"reported","severity":"unknown"},{"effect":"Instability","drugRate":"reported","severity":"unknown"},{"effect":"Mental slowness","drugRate":"reported","severity":"unknown"},{"effect":"Depression","drugRate":"reported","severity":"unknown"},{"effect":"Hypochondriacal behavior","drugRate":"reported","severity":"unknown"},{"effect":"Aggressiveness","drugRate":"reported","severity":"unknown"},{"effect":"Psychosis","drugRate":"reported","severity":"unknown"},{"effect":"Suicidal behavior","drugRate":"reported","severity":"unknown"},{"effect":"Auditory hallucinations","drugRate":"reported","severity":"unknown"},{"effect":"Proteinuria","drugRate":"reported","severity":"unknown"},{"effect":"Microscopic hematuria","drugRate":"reported","severity":"unknown"},{"effect":"Hyperemia","drugRate":"reported","severity":"unknown"},{"effect":"Periorbital edema","drugRate":"reported","severity":"unknown"},{"effect":"Urticaria","drugRate":"reported","severity":"unknown"}],"contraindications":["Acute intermittent porphyria","Aggressive behavior","Depressive disorder","Disease of liver","Kidney disease","Neutropenic disorder","Suicidal thoughts","Systemic lupus erythematosus"],"specialPopulations":{"Pregnancy":"Reports suggest an association between the use of anticonvulsant drugs by women with epilepsy and an elevated incidence of birth defects in children born to these women. Data are more extensive with respect to phenytoin and phenobarbital, but these are also the most commonly prescribed anticonvulsants; less systematic or anecdotal reports suggest possible similar association with the use of all known anticonvulsant drugs.The reports suggesting an elevated incidence of birth d","Paediatric use":"See DOSAGE AND ADMINISTRATION."}},"trials":[],"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_fixedAt":"2026-03-30T17:35:29.440226","allNames":"celontin","offLabel":[],"synonyms":["mesuximid","methsuximide","celontin","mesuximide","mesuximidum","methsuximid","racemic methsuximide","(+/-)-Mesuximide"],"timeline":[{"date":"1957-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from PARKE DAVIS to Parke Davis"},{"date":"1957-02-08","type":"positive","source":"DrugCentral","milestone":"FDA approval (Parke Davis)"},{"date":"2023-05-01","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 1 manufacturer approved"}],"aiSummary":"Celontin (METHSUXIMIDE) is a small molecule anti-epileptic agent developed by Parke Davis, targeting voltage-gated T-type calcium channels. It was FDA-approved in 1957 for the treatment of absence seizures and epilepsy. As an off-patent medication, Celontin is available as a generic product. Key considerations for its use include its mechanism of action and potential side effects. Celontin's commercial status allows for generic competition.","approvals":[{"date":"1957-02-08","orphan":false,"company":"PARKE DAVIS","regulator":"FDA"}],"brandName":"Celontin","ecosystem":[{"indication":"Absence seizure","otherDrugs":[{"name":"acetazolamide","slug":"acetazolamide","company":"Teva Branded Pharm"},{"name":"clonazepam","slug":"clonazepam","company":"Roche"},{"name":"ethosuximide","slug":"ethosuximide","company":"Parke Davis"},{"name":"lorazepam","slug":"lorazepam","company":"Valeant Intl"}],"globalPrevalence":null},{"indication":"Epilepsy","otherDrugs":[{"name":"amobarbital","slug":"amobarbital","company":""},{"name":"carbamazepine","slug":"carbamazepine","company":"Novartis"},{"name":"diazepam","slug":"diazepam","company":"Roche"},{"name":"felbamate","slug":"felbamate","company":"Meda Pharms"}],"globalPrevalence":50000000}],"mechanism":{"target":"Voltage-gated T-type calcium channel","novelty":"Follow-on","targets":[{"gene":"CACNA1G","source":"DrugCentral","target":"Voltage-gated T-type calcium channel","protein":"Voltage-dependent T-type calcium channel subunit alpha-1G","isPrimary":true,"activityType":"","activityValue":null},{"gene":"CACNA1H","source":"DrugCentral","target":"Voltage-gated T-type calcium channel","protein":"Voltage-dependent T-type calcium channel subunit alpha-1H"},{"gene":"CACNA1I","source":"DrugCentral","target":"Voltage-gated T-type calcium channel","protein":"Voltage-dependent T-type calcium channel subunit alpha-1I"}],"modality":"Small Molecule","drugClass":"Anti-epileptic Agent","explanation":"Think of your brain as a city with many doors. These doors, called channels, control what comes in and out. Celontin blocks one type of door, called T-type calcium channels, which helps to reduce the abnormal electrical activity that can cause seizures.","oneSentence":"Celontin works by blocking the activity of voltage-gated T-type calcium channels in the brain.","technicalDetail":"Celontin (METHSUXIMIDE) acts as a selective blocker of the T-type calcium channel, specifically targeting the alpha1G subunit, which is involved in the regulation of neuronal excitability and seizure susceptibility."},"commercial":{"launchDate":"1957","_launchSource":"DrugCentral (FDA 1957-02-08, PARKE DAVIS)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1758","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=METHSUXIMIDE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=METHSUXIMIDE","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":"2026-03-30T12:39:01.286191","biosimilars":[],"competitors":[{"drugName":"ethosuximide","drugSlug":"ethosuximide","fdaApproval":"1960-11-02","genericCount":9,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"phensuximide","drugSlug":"phensuximide","fdaApproval":"","patentStatus":"Unknown","relationship":"same-class"}],"genericName":"methsuximide","indications":{"approved":[{"name":"Absence seizure","source":"DrugCentral","snomedId":79631006,"regulator":"FDA","eligibility":"patients with absence (petit mal) seizures refractory to other drugs"},{"name":"Epilepsy","source":"DrugCentral","snomedId":84757009,"regulator":"FDA","usPrevalence":3400000,"globalPrevalence":50000000,"prevalenceMethod":"curated","prevalenceSource":"WHO, 2023"}],"offLabel":[{"name":"Epilepsy characterized by intractable complex partial seizures","source":"DrugCentral","drugName":"METHSUXIMIDE","evidenceCount":1,"evidenceLevel":"emerging"}],"pipeline":[]},"_fixedFields":["primaryTarget"],"currentOwner":"Parke Davis","drugCategory":"mature","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"ethosuximide","brandName":"ethosuximide","genericName":"ethosuximide","approvalYear":"1960","relationship":"same-class"},{"drugId":"phensuximide","brandName":"phensuximide","genericName":"phensuximide","approvalYear":"","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT03196466","phase":"","title":"Population Pharmacokinetics of Antiepileptic in Pediatrics","status":"COMPLETED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2017-06-19","conditions":["Epilepsy"],"enrollment":753,"completionDate":"2023-06-15"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Oral","formulation":"Capsule","formulations":[{"form":"CAPSULE","route":"ORAL","productName":"Methsuximide"},{"form":"CAPSULE","route":"ORAL","productName":"Celontin"}]},"_patentsChecked":true,"crossReferences":{"NUI":"N0000146950","MMSL":"105","NDDF":"001630","UNII":"0G76K8X6C0","VUID":"4018637","CHEBI":"CHEBI:6846","VANDF":"4018637","INN_ID":"582","RXNORM":"225235","UMLSCUI":"C0109002","ChEMBL_ID":"CHEMBL697","KEGG_DRUG":"D00404","DRUGBANK_ID":"DB05246","PUBCHEM_CID":"6476","SNOMEDCT_US":"386187007","IUPHAR_LIGAND_ID":"7228","MESH_SUPPLEMENTAL_RECORD_UI":"C100286"},"formularyStatus":[],"originalProduct":{"form":"CAPSULE","route":"ORAL","company":"Parke-Davis Div of Pfizer Inc","brandName":"Celontin","isOriginal":true,"marketingStatus":"NDA"},"_enricherVersion":"v2","_offLabelChecked":true,"developmentCodes":[],"ownershipHistory":[{"period":"1957-","companyName":"Parke Davis","relationship":"Original Developer"}],"publicationCount":89,"therapeuticAreas":["Neuroscience"],"atcClassification":{"source":"DrugCentral","atcCode":"N03AD03","allCodes":["N03AD03"]},"biosimilarFilings":[],"originalDeveloper":"Parke Davis","recentPublications":[],"companionDiagnostics":[],"genericManufacturers":1,"_genericFilersChecked":true,"genericManufacturerList":["Novitium Pharma"],"status":"approved","companyName":"Parke Davis","companyId":"pfizer","modality":"Small molecule","firstApprovalDate":"1957","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1957-02-08T00:00:00.000Z","mah":"PARKE DAVIS","brand_name_local":null,"application_number":""},{"country_code":"CA","regulator":"Health Canada","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},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}