{"id":"niaprazine","rwe":[{"pmid":"40698961","year":"2025","title":"[Niaprazine in adult and elderly sleep disorders: results of an observational study on perceived efficacy and tolerability.].","finding":"","journal":"Rivista di psichiatria","studyType":"Clinical Study"},{"pmid":"40160009","year":"2025","title":"Sleep-related painful erection: the first case in a child.","finding":"","journal":"Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine","studyType":"Clinical Study"},{"pmid":"39996644","year":"2025","title":"Development and Characterization of Niaprazine-Loaded Xanthan Gum-Based Gel for Oral Administration.","finding":"","journal":"Gels (Basel, Switzerland)","studyType":"Clinical Study"},{"pmid":"39335600","year":"2024","title":"Unveiling Niaprazine's Potential: Behavioral Insights into a Re-Emerging Anxiolytic Agent.","finding":"","journal":"Biomedicines","studyType":"Clinical Study"},{"pmid":"37544550","year":"2023","title":"Dexmedetomidine at Home for Intractable Dystonia and Insomnia in Children With Special Needs: A Case Series.","finding":"","journal":"Journal of pain and symptom management","studyType":"Clinical Study"}],"tags":[{"label":"niaprazine","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"N05CM16","category":"atc"},{"label":"Active","category":"status"}],"phase":"phase_2","safety":{},"trials":[],"aliases":[],"patents":[],"pricing":[],"allNames":"nopron","offLabel":[],"synonyms":["niaprazine trihydrochloride","niaprazine","nopron"],"timeline":[],"approvals":[],"brandName":"Nopron","ecosystem":[],"mechanism":{"modality":"Small Molecule","drugClass":"niaprazine","explanation":"While the exact details of how Nopron works are unclear, it is believed to affect the way the brain processes information and regulates emotions. This may help to alleviate symptoms of certain conditions, although more research is needed to confirm its effectiveness. It is not a well-understood medication, and its potential benefits and risks are not yet fully understood.","oneSentence":"Nopron is thought to work by interacting with certain receptors in the brain.","technicalDetail":"Nopron is a niaprazine, a class of compounds that may interact with serotonin receptors, dopamine receptors, or other neurotransmitter systems in the brain, although the specific mechanisms are not well-characterized."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1908","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=NIAPRAZINE","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T12:56:28.583607","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":"niaprazine","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":[],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"crossReferences":{"NDDF":"005813","UNII":"R2H3YN6E3L","CHEBI":"CHEBI:135505","INN_ID":"2817","RXNORM":"31722","UMLSCUI":"C0068673","ChEMBL_ID":"CHEMBL2105141","KEGG_DRUG":"D07333","DRUGBANK_ID":"DB13687","PUBCHEM_CID":"71919","SNOMEDCT_US":"713432007","SECONDARY_CAS_RN":"34426-53-4","MESH_SUPPLEMENTAL_RECORD_UI":"C021062"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[],"publicationCount":25,"therapeuticAreas":["Neuroscience"],"atcClassification":{"source":"DrugCentral","atcCode":"N05CM16","allCodes":["N05CM16"]},"biosimilarFilings":[],"recentPublications":[{"date":"2025 Jul-Aug","pmid":"40698961","title":"[Niaprazine in adult and elderly sleep disorders: results of an observational study on perceived efficacy and tolerability.].","journal":"Rivista di psichiatria"},{"date":"2025 Aug 1","pmid":"40160009","title":"Sleep-related painful erection: the first case in a child.","journal":"Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine"},{"date":"2025 Feb 1","pmid":"39996644","title":"Development and Characterization of Niaprazine-Loaded Xanthan Gum-Based Gel for Oral Administration.","journal":"Gels (Basel, Switzerland)"},{"date":"2024 Sep 12","pmid":"39335600","title":"Unveiling Niaprazine's Potential: Behavioral Insights into a Re-Emerging Anxiolytic Agent.","journal":"Biomedicines"},{"date":"2023 Dec","pmid":"37544550","title":"Dexmedetomidine at Home for Intractable Dystonia and Insomnia in Children With Special Needs: A Case Series.","journal":"Journal of pain and symptom management"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","companyName":"","companyId":"","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Nopron is a small molecule with the synonyms 1709 CERM, 1709-CERM, 1709CERM, J10.716F, NIAPRAZINA, and NIAPRAZINE.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":false,"score":1}}