{"id":"clotiazepam","rwe":[{"pmid":"41869242","year":"2026","title":"Efficacy of Clotiazepam for Respiratory Dyskinesia in a Patient With Parkinsonism: A Case Report.","finding":"","journal":"Cureus","studyType":"Clinical Study"},{"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":"33630483","year":"2006","title":"Clotiazepam.","finding":"","journal":"","studyType":"Clinical Study"},{"pmid":"35085176","year":"2022","title":"Jumping stump phenomenon: a case report.","finding":"","journal":"Prosthetics and orthotics international","studyType":"Clinical Study"},{"pmid":"34437050","year":"2021","title":"Serotonin Syndrome Triggered by Increasing the Dose of Quetiapine.","finding":"","journal":"Clinical practice and cases in emergency medicine","studyType":"Clinical Study"}],"tags":[{"label":"clotiazepam","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"N05BA21","category":"atc"},{"label":"Active","category":"status"}],"phase":"phase_2","safety":{"safetySignals":[{"llr":69.578,"date":"","count":37,"signal":"Coma","source":"DrugCentral FAERS","actionTaken":"Reported 37 times (LLR=70)"},{"llr":50.861,"date":"","count":8,"signal":"Eczema eyelids","source":"DrugCentral FAERS","actionTaken":"Reported 8 times (LLR=51)"},{"llr":48.555,"date":"","count":28,"signal":"Suicide attempt","source":"DrugCentral FAERS","actionTaken":"Reported 28 times (LLR=49)"},{"llr":38.881,"date":"","count":14,"signal":"Miosis","source":"DrugCentral FAERS","actionTaken":"Reported 14 times (LLR=39)"},{"llr":35.394,"date":"","count":9,"signal":"Analgesic drug level increased","source":"DrugCentral FAERS","actionTaken":"Reported 9 times (LLR=35)"},{"llr":35.032,"date":"","count":15,"signal":"Inappropriate antidiuretic hormone secretion","source":"DrugCentral FAERS","actionTaken":"Reported 15 times (LLR=35)"},{"llr":33.873,"date":"","count":9,"signal":"Cross sensitivity reaction","source":"DrugCentral FAERS","actionTaken":"Reported 9 times (LLR=34)"},{"llr":32.274,"date":"","count":20,"signal":"Hepatic function abnormal","source":"DrugCentral FAERS","actionTaken":"Reported 20 times (LLR=32)"},{"llr":32.052,"date":"","count":34,"signal":"Somnolence","source":"DrugCentral FAERS","actionTaken":"Reported 34 times (LLR=32)"},{"llr":31.655,"date":"","count":42,"signal":"Toxicity to various agents","source":"DrugCentral FAERS","actionTaken":"Reported 42 times (LLR=32)"},{"llr":29.649,"date":"","count":13,"signal":"Poisoning","source":"DrugCentral FAERS","actionTaken":"Reported 13 times (LLR=30)"}],"commonSideEffects":[{"effect":"Coma","drugRate":"LLR 70","severity":"common"},{"effect":"Eczema eyelids","drugRate":"LLR 51","severity":"common"},{"effect":"Suicide attempt","drugRate":"LLR 49","severity":"common"},{"effect":"Miosis","drugRate":"LLR 39","severity":"common"},{"effect":"Analgesic drug level increased","drugRate":"LLR 35","severity":"common"},{"effect":"Inappropriate antidiuretic hormone secretion","drugRate":"LLR 35","severity":"common"},{"effect":"Cross sensitivity reaction","drugRate":"LLR 34","severity":"common"},{"effect":"Hepatic function abnormal","drugRate":"LLR 32","severity":"common"},{"effect":"Somnolence","drugRate":"LLR 32","severity":"common"},{"effect":"Toxicity to various agents","drugRate":"LLR 32","severity":"common"},{"effect":"Poisoning","drugRate":"LLR 30","severity":"common"}]},"trials":[],"aliases":[],"patents":[],"pricing":[],"allNames":["clotiazepam"],"offLabel":[],"synonyms":["clotiazepam"],"timeline":[],"approvals":[],"ecosystem":[],"mechanism":{"modality":"Small Molecule","drugClass":"clotiazepam","explanation":"Imagine your brain is a busy city with many different streets and intersections. Neurotransmitters are like the traffic signals that help different parts of the brain communicate with each other. Clotiazepam may help regulate the flow of traffic by adjusting the signals that control the flow of neurotransmitters.","oneSentence":"Clotiazepam is thought to work by modulating the activity of neurotransmitters in the brain.","technicalDetail":"Clotiazepam is a benzodiazepine receptor agonist, which means it binds to specific receptors in the brain that are involved in regulating anxiety, sleep, and other functions."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/718","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=CLOTIAZEPAM","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=CLOTIAZEPAM","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T10:13:54.698110","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T11:03:40.120165+00:00","fieldsConflicting":0,"overallConfidence":0.95},"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 available","relationship":"same-class"},{"drugName":"halazepam","drugSlug":"halazepam","fdaApproval":"1981-09-24","patentStatus":"Unknown","relationship":"same-class"}],"genericName":"clotiazepam","indications":{"approved":[],"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":[{"nctId":"NCT04440423","phase":"PHASE1","title":"Bioavailability of Clotiazepam 5 mg With Regards to Reference Product","status":"COMPLETED","sponsor":"Laboratorios Andromaco S.A.","startDate":"2020-03-11","conditions":["Bioequivalence"],"enrollment":26,"completionDate":"2020-03-28"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"crossReferences":{"NDDF":"005796","UNII":"ZCN055599V","CHEBI":"CHEBI:31425","INN_ID":"3496","RXNORM":"2622","UMLSCUI":"C0009073","ChEMBL_ID":"CHEMBL1697737","KEGG_DRUG":"D01328","DRUGBANK_ID":"DB01559","PUBCHEM_CID":"2811","SNOMEDCT_US":"698256004","MESH_SUPPLEMENTAL_RECORD_UI":"C084599"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[],"publicationCount":66,"therapeuticAreas":["Neuroscience"],"atcClassification":{"source":"DrugCentral","atcCode":"N05BA21","allCodes":["N05BA21"]},"biosimilarFilings":[],"recentPublications":[{"date":"2026 Feb","pmid":"41869242","title":"Efficacy of Clotiazepam for Respiratory Dyskinesia in a Patient With Parkinsonism: A Case Report.","journal":"Cureus"},{"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":"33630483","title":"Clotiazepam.","journal":""},{"date":"2022 Apr 1","pmid":"35085176","title":"Jumping stump phenomenon: a case report.","journal":"Prosthetics and orthotics international"},{"date":"2021 Aug","pmid":"34437050","title":"Serotonin Syndrome Triggered by Increasing the Dose of Quetiapine.","journal":"Clinical practice and cases in emergency medicine"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","brandName":"CLOTIAZEPAM","companyName":"","companyId":"","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Clotiazepam is a small molecule drug in the clotiazepam class, but its target and exact mechanism of action are unknown. It is not FDA-approved for any indications. The commercial status of clotiazepam is unclear, and it may be patented or off-patent. Clotiazepam's pharmacokinetic properties, such as half-life and bioavailability, are also unknown. As a result, key safety considerations and generic manufacturers are also unclear.","enrichmentLevel":5,"visitCount":0,"trialStats":{"total":1,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T11:03:40.120165+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":false,"safety":true,"trials":true,"score":3}}