{"id":"opipramol","rwe":[],"tags":[{"label":"opipramol","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Sigma non-opioid intracellular receptor 1","category":"target"},{"label":"SIGMAR1","category":"gene"},{"label":"EBP","category":"gene"},{"label":"CACNA1B","category":"gene"},{"label":"N06AA05","category":"atc"},{"label":"Active","category":"status"},{"label":"Depressive disorder","category":"indication"},{"label":"Adrenergic Agents","category":"pharmacology"},{"label":"Adrenergic Uptake Inhibitors","category":"pharmacology"},{"label":"Antidepressive Agents","category":"pharmacology"},{"label":"Antidepressive Agents, Tricyclic","category":"pharmacology"},{"label":"Central Nervous System Agents","category":"pharmacology"},{"label":"Membrane Transport Modulators","category":"pharmacology"},{"label":"Neurotransmitter Agents","category":"pharmacology"},{"label":"Neurotransmitter Uptake Inhibitors","category":"pharmacology"},{"label":"Psychotropic Drugs","category":"pharmacology"}],"phase":"phase_3","safety":{"safetySignals":[{"llr":201.238,"date":"","count":132,"signal":"General physical health deterioration","source":"DrugCentral FAERS","actionTaken":"Reported 132 times (LLR=201)"},{"llr":87.179,"date":"","count":15,"signal":"Abnormal palmar/plantar creases","source":"DrugCentral FAERS","actionTaken":"Reported 15 times (LLR=87)"},{"llr":73.308,"date":"","count":36,"signal":"Product prescribing error","source":"DrugCentral FAERS","actionTaken":"Reported 36 times (LLR=73)"},{"llr":48.581,"date":"","count":15,"signal":"Dysmorphism","source":"DrugCentral FAERS","actionTaken":"Reported 15 times (LLR=49)"},{"llr":47.453,"date":"","count":16,"signal":"Product monitoring error","source":"DrugCentral FAERS","actionTaken":"Reported 16 times (LLR=47)"},{"llr":40.18,"date":"","count":7,"signal":"Hypoparathyroidism secondary","source":"DrugCentral FAERS","actionTaken":"Reported 7 times (LLR=40)"},{"llr":39.722,"date":"","count":33,"signal":"Foetal exposure during pregnancy","source":"DrugCentral FAERS","actionTaken":"Reported 33 times (LLR=40)"},{"llr":39.11,"date":"","count":7,"signal":"VACTERL syndrome","source":"DrugCentral FAERS","actionTaken":"Reported 7 times (LLR=39)"},{"llr":37.862,"date":"","count":6,"signal":"CADASIL","source":"DrugCentral FAERS","actionTaken":"Reported 6 times (LLR=38)"},{"llr":36.798,"date":"","count":71,"signal":"Fall","source":"DrugCentral FAERS","actionTaken":"Reported 71 times (LLR=37)"},{"llr":36.308,"date":"","count":7,"signal":"Hemivertebra","source":"DrugCentral FAERS","actionTaken":"Reported 7 times (LLR=36)"},{"llr":35.645,"date":"","count":8,"signal":"Transposition of the great vessels","source":"DrugCentral FAERS","actionTaken":"Reported 8 times (LLR=36)"},{"llr":35.382,"date":"","count":6,"signal":"Hanging","source":"DrugCentral FAERS","actionTaken":"Reported 6 times (LLR=35)"},{"llr":34.348,"date":"","count":28,"signal":"Delirium","source":"DrugCentral FAERS","actionTaken":"Reported 28 times (LLR=34)"},{"llr":33.805,"date":"","count":6,"signal":"Visual evoked potentials abnormal","source":"DrugCentral FAERS","actionTaken":"Reported 6 times (LLR=34)"}],"commonSideEffects":[{"effect":"General physical health deterioration","drugRate":"LLR 201","severity":"common"},{"effect":"Abnormal palmar/plantar creases","drugRate":"LLR 87","severity":"common"},{"effect":"Product prescribing error","drugRate":"LLR 73","severity":"common"},{"effect":"Dysmorphism","drugRate":"LLR 49","severity":"common"},{"effect":"Product monitoring error","drugRate":"LLR 47","severity":"common"},{"effect":"Hypoparathyroidism secondary","drugRate":"LLR 40","severity":"common"},{"effect":"Foetal exposure during pregnancy","drugRate":"LLR 40","severity":"common"},{"effect":"VACTERL syndrome","drugRate":"LLR 39","severity":"common"},{"effect":"CADASIL","drugRate":"LLR 38","severity":"common"},{"effect":"Fall","drugRate":"LLR 37","severity":"common"},{"effect":"Hemivertebra","drugRate":"LLR 36","severity":"common"},{"effect":"Transposition of the great vessels","drugRate":"LLR 36","severity":"common"},{"effect":"Hanging","drugRate":"LLR 35","severity":"common"},{"effect":"Delirium","drugRate":"LLR 34","severity":"common"},{"effect":"Visual evoked potentials abnormal","drugRate":"LLR 34","severity":"common"}]},"trials":[],"aliases":[],"patents":[],"pricing":[],"allNames":"opramidol","offLabel":[],"synonyms":["opipramol dihydrochloride","opipramol","opramidol"],"timeline":[],"approvals":[],"brandName":"Opramidol","ecosystem":[{"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":{"target":"Sigma non-opioid intracellular receptor 1","targets":[{"gene":"SIGMAR1","source":"DrugCentral","target":"Sigma non-opioid intracellular receptor 1","protein":"Sigma non-opioid intracellular receptor 1"},{"gene":"EBP","source":"DrugCentral","target":"3-beta-hydroxysteroid-Delta(8),Delta(7)-isomerase","protein":"3-beta-hydroxysteroid-Delta(8),Delta(7)-isomerase"},{"gene":"CACNA1B","source":"DrugCentral","target":"Voltage-dependent N-type calcium channel subunit alpha-1B","protein":"Voltage-dependent N-type calcium channel subunit alpha-1B"}],"modality":"Small Molecule","drugClass":"opipramol","explanation":"Imagine your brain has a complex system of messengers that help you feel happy or sad. Opipramol helps to calm down the messengers that make you feel sad, which can help to improve your mood and reduce symptoms of depression.","oneSentence":"Opipramol works by binding to the sigma non-opioid intracellular receptor 1, which helps to regulate mood and emotional responses.","technicalDetail":"Opipramol exerts its effects by selectively binding to the sigma-1 receptor, a subtype of the sigma receptor family, which is involved in the regulation of intracellular signaling pathways and has been implicated in the pathophysiology of depression."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1993","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=OPIPRAMOL","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=OPIPRAMOL","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T15:08:32.166943","biosimilars":[],"competitors":[{"drugName":"desipramine","drugSlug":"desipramine","fdaApproval":"1964-11-20","genericCount":8,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"imipramine","drugSlug":"imipramine","fdaApproval":"1959-04-16","genericCount":3,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"clomipramine","drugSlug":"clomipramine","fdaApproval":"1989-12-29","genericCount":19,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"trimipramine","drugSlug":"trimipramine","fdaApproval":"1979-06-12","genericCount":3,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"amitriptyline","drugSlug":"amitriptyline","fdaApproval":"1961-04-07","genericCount":33,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"nortriptyline","drugSlug":"nortriptyline","fdaApproval":"1964-11-06","genericCount":9,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"protriptyline","drugSlug":"protriptyline","fdaApproval":"1967-09-27","genericCount":4,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"doxepin","drugSlug":"doxepin","fdaApproval":"1969-09-23","patentExpiry":"Sep 7, 2030","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"amoxapine","drugSlug":"amoxapine","fdaApproval":"1980-09-22","genericCount":3,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"maprotiline","drugSlug":"maprotiline","fdaApproval":"1980-12-01","genericCount":4,"patentStatus":"Off-patent — generic available","relationship":"same-class"}],"genericName":"opipramol","indications":{"approved":[{"name":"Depressive disorder","source":"DrugCentral","snomedId":35489007,"regulator":"FDA","usPrevalence":21000000,"globalPrevalence":280000000,"prevalenceMethod":"curated","prevalenceSource":"WHO, 2023"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"desipramine","brandName":"desipramine","genericName":"desipramine","approvalYear":"1964","relationship":"same-class"},{"drugId":"imipramine","brandName":"imipramine","genericName":"imipramine","approvalYear":"1959","relationship":"same-class"},{"drugId":"clomipramine","brandName":"clomipramine","genericName":"clomipramine","approvalYear":"1989","relationship":"same-class"},{"drugId":"trimipramine","brandName":"trimipramine","genericName":"trimipramine","approvalYear":"1979","relationship":"same-class"},{"drugId":"amitriptyline","brandName":"amitriptyline","genericName":"amitriptyline","approvalYear":"1961","relationship":"same-class"},{"drugId":"nortriptyline","brandName":"nortriptyline","genericName":"nortriptyline","approvalYear":"1964","relationship":"same-class"},{"drugId":"protriptyline","brandName":"protriptyline","genericName":"protriptyline","approvalYear":"1967","relationship":"same-class"},{"drugId":"doxepin","brandName":"doxepin","genericName":"doxepin","approvalYear":"1969","relationship":"same-class"},{"drugId":"amoxapine","brandName":"amoxapine","genericName":"amoxapine","approvalYear":"1980","relationship":"same-class"},{"drugId":"maprotiline","brandName":"maprotiline","genericName":"maprotiline","approvalYear":"1980","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT03083405","phase":"","title":"Selected Disorders and Sleep Bruxism","status":"ENROLLING_BY_INVITATION","sponsor":"Wroclaw Medical University","startDate":"2017-04-20","conditions":["Sleep Bruxism","Hypertension","Thyroid Dysfunction","Mental Status Change","Sleep Apnea","Sleep Disorders","Cardiovascular Risk Factor","Cardiovascular Diseases","Temporomandibular Disorder"],"enrollment":100,"completionDate":"2026-12"},{"nctId":"NCT02374567","phase":"PHASE3","title":"Pharmacovigilance in Gerontopsychiatric Patients","status":"TERMINATED","sponsor":"Hannover Medical School","startDate":"2015-01","conditions":["Dementia","Depression","Schizophrenia","Psychosomatic Disorders","Anxiety Disorders"],"enrollment":407,"completionDate":"2017-06-28"},{"nctId":"NCT03065998","phase":"EARLY_PHASE1","title":"Double Blind Placebo Control Opipramol-Baclofen Treatment for Addiction","status":"UNKNOWN","sponsor":"Ministry of Health, Israel","startDate":"2017-03","conditions":["Drug Abuse"],"enrollment":140,"completionDate":"2019-01"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"crossReferences":{"NUI":"N0000167254","NDDF":"004149","UNII":"D23ZXO613C","CHEBI":"CHEBI:94614","INN_ID":"1838","RXNORM":"7674","UMLSCUI":"C0029105","ChEMBL_ID":"CHEMBL370753","KEGG_DRUG":"D08297","DRUGBANK_ID":"DB12930","PUBCHEM_CID":"9417","SNOMEDCT_US":"1156223004","IUPHAR_LIGAND_ID":"11247","MESH_DESCRIPTOR_UI":"D009888"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[],"publicationCount":0,"therapeuticAreas":["Neuroscience"],"atcClassification":{"source":"DrugCentral","atcCode":"N06AA05","allCodes":["N06AA05"]},"biosimilarFilings":[],"recentPublications":[],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","companyName":"","companyId":"","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Opramidol, also known as Opipramol, is a small molecule drug that targets the sigma non-opioid intracellular receptor 1. It belongs to the opipramol class and is used to treat depressive disorder. The commercial status of Opipramol is unclear, but it is not FDA-approved. As a result, its availability and safety profile may vary. Further research is needed to fully understand its pharmacological properties.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}