{"id":"valnoctamide","rwe":[{"pmid":"41764707","year":"2026","title":"Antiseizure Medications that Did Not Reach the Epilepsy Market: An Assessment of Factors Contributing to Their Failed Clinical Development Over the Last Three Decades.","finding":"","journal":"Drugs","studyType":"Clinical Study"},{"pmid":"35461339","year":"2022","title":"Existing and emerging pharmacological approaches to the treatment of mania: A critical overview.","finding":"","journal":"Translational psychiatry","studyType":"Clinical Study"},{"pmid":"33256172","year":"2020","title":"Valproic Acid and Its Amidic Derivatives as New Antivirals against Alphaherpesviruses.","finding":"","journal":"Viruses","studyType":"Clinical Study"},{"pmid":"31708430","year":"2019","title":"Novel treatment approaches and pediatric research networks in status epilepticus.","finding":"","journal":"Epilepsy & behavior : E&B","studyType":"Clinical Study"},{"pmid":"31132386","year":"2019","title":"Amidic derivatives of valproic acid, valpromide and valnoctamide, inhibit HSV-1 infection in oligodendrocytes.","finding":"","journal":"Antiviral research","studyType":"Clinical Study"}],"tags":[{"label":"valnoctamide","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"N05CM13","category":"atc"},{"label":"Active","category":"status"}],"phase":"phase_3","safety":{},"trials":[],"aliases":[],"patents":[],"pricing":[],"allNames":"nirvanil","offLabel":[],"synonyms":["valnoctamide","nirvanil","valmethamide"],"timeline":[],"brandName":"Nirvanil","ecosystem":[],"mechanism":{"modality":"Small Molecule","drugClass":"valnoctamide","explanation":"Imagine your nervous system as a busy highway with many cars (neurotransmitters) constantly moving. Nirvanil is like a traffic cop that helps slow down the traffic, making it easier for you to relax and fall asleep. This is a simplified explanation of how Nirvanil works, but the actual mechanism is more complex and not fully understood.","oneSentence":"Nirvanil works by interacting with the body's nervous system to produce a sedative effect.","technicalDetail":"Valnoctamide is a small molecule that modulates the activity of neurotransmitters in the central nervous system, leading to sedative and hypnotic effects. The exact molecular mechanisms underlying its action are not well-characterized, but it is thought to interact with GABA receptors and other targets to produce its therapeutic effects."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/2802","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=VALNOCTAMIDE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=VALNOCTAMIDE","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T02:45:40.670411","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T08:42:01.549946+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"competitors":[{"drugName":"scopolamine","drugSlug":"scopolamine","fdaApproval":"1979-12-31","genericCount":7,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"propiomazine","drugSlug":"propiomazine","fdaApproval":"1960-12-05","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"triclofos","drugSlug":"triclofos","fdaApproval":"","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"ethchlorvynol","drugSlug":"ethchlorvynol","fdaApproval":"1961-05-10","genericCount":1,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"dexmedetomidine","drugSlug":"dexmedetomidine","fdaApproval":"1999-12-17","patentExpiry":"Jun 26, 2039","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"suvorexant","drugSlug":"suvorexant","fdaApproval":"2014-08-13","patentExpiry":"Nov 20, 2029","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"lemborexant","drugSlug":"lemborexant","fdaApproval":"2019-12-20","patentExpiry":"Sep 20, 2031","patentStatus":"Patent protected","relationship":"same-class"}],"genericName":"valnoctamide","indications":{"approved":[],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"scopolamine","brandName":"scopolamine","genericName":"scopolamine","approvalYear":"1979","relationship":"same-class"},{"drugId":"propiomazine","brandName":"propiomazine","genericName":"propiomazine","approvalYear":"1960","relationship":"same-class"},{"drugId":"triclofos","brandName":"triclofos","genericName":"triclofos","approvalYear":"","relationship":"same-class"},{"drugId":"ethchlorvynol","brandName":"ethchlorvynol","genericName":"ethchlorvynol","approvalYear":"1961","relationship":"same-class"},{"drugId":"dexmedetomidine","brandName":"dexmedetomidine","genericName":"dexmedetomidine","approvalYear":"1999","relationship":"same-class"},{"drugId":"suvorexant","brandName":"suvorexant","genericName":"suvorexant","approvalYear":"2014","relationship":"same-class"},{"drugId":"lemborexant","brandName":"lemborexant","genericName":"lemborexant","approvalYear":"2019","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT00140179","phase":"PHASE3","title":"Valnoctamide in Mania","status":"COMPLETED","sponsor":"Beersheva Mental Health Center","startDate":"2004-09","conditions":["Mania","Schizoaffective Disorder, Manic Type"],"enrollment":80,"completionDate":"2008-05"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"crossReferences":{"UNII":"3O25NRX9YG","CHEBI":"CHEBI:134767","INN_ID":"1065","UMLSCUI":"C0077995","ChEMBL_ID":"CHEMBL1075733","KEGG_DRUG":"D02717","DRUGBANK_ID":"DB13099","PUBCHEM_CID":"20140","MESH_SUPPLEMENTAL_RECORD_UI":"C045179"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[],"publicationCount":74,"therapeuticAreas":["Neuroscience"],"atcClassification":{"source":"DrugCentral","atcCode":"N05CM13","allCodes":["N05CM13"]},"biosimilarFilings":[],"recentPublications":[{"date":"2026 Mar 1","pmid":"41764707","title":"Antiseizure Medications that Did Not Reach the Epilepsy Market: An Assessment of Factors Contributing to Their Failed Clinical Development Over the Last Three Decades.","journal":"Drugs"},{"date":"2022 Apr 23","pmid":"35461339","title":"Existing and emerging pharmacological approaches to the treatment of mania: A critical overview.","journal":"Translational psychiatry"},{"date":"2020 Nov 26","pmid":"33256172","title":"Valproic Acid and Its Amidic Derivatives as New Antivirals against Alphaherpesviruses.","journal":"Viruses"},{"date":"2019 Dec","pmid":"31708430","title":"Novel treatment approaches and pediatric research networks in status epilepticus.","journal":"Epilepsy & behavior : E&B"},{"date":"2019 Aug","pmid":"31132386","title":"Amidic derivatives of valproic acid, valpromide and valnoctamide, inhibit HSV-1 infection in oligodendrocytes.","journal":"Antiviral research"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","companyName":"","companyId":"","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Nirvanil is a small molecule. It is also known by the synonyms AXIQUEL, MCN-X-181, NSC-32363, NSC-34092, VALNOCTAMIDA, and VALNOCTAMIDE.","enrichmentLevel":5,"visitCount":0,"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T08:42:01.549946+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}