{"id":"levomethadone","rwe":[{"pmid":"41517339","year":"2025","title":"Levomethadone Selectively Reduces Emotional Impulsivity in ASRS-Positive ADHD-OUD Patients, Independent of Dose Escalation.","finding":"","journal":"Journal of clinical medicine","studyType":"Clinical Study"},{"pmid":"41482038","year":"2026","title":"A comparison of short-term analgesic effects of xylazine alone or combined with levomethadone or ketamine in calves after hot-iron disbudding.","finding":"","journal":"Journal of dairy science","studyType":"Clinical Study"},{"pmid":"41330407","year":"2025","title":"[Opioid substitution therapy for opioid use disorder and legal framework in Germany].","finding":"","journal":"Fortschritte der Neurologie-Psychiatrie","studyType":"Clinical Study"},{"pmid":"39924451","year":"2025","title":"Relative risks of adverse effects across different opioid agonist treatments-A systematic review and meta-analysis.","finding":"","journal":"Addiction (Abingdon, England)","studyType":"Clinical Study"},{"pmid":"39910803","year":"2026","title":"Switching to levomethadone improves methadone-induced hyperhidrosis: A case report.","finding":"","journal":"Journal of addictive diseases","studyType":"Clinical Study"}],"tags":[{"label":"levomethadone","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"N07BC05","category":"atc"},{"label":"Active","category":"status"},{"label":"Opioid dependence","category":"indication"}],"phase":"phase_2","safety":{"safetySignals":[{"llr":213.998,"date":"","count":63,"signal":"Aggression","source":"DrugCentral FAERS","actionTaken":"Reported 63 times (LLR=214)"},{"llr":194.733,"date":"","count":75,"signal":"Drug abuse","source":"DrugCentral FAERS","actionTaken":"Reported 75 times (LLR=195)"},{"llr":173.378,"date":"","count":33,"signal":"Logorrhoea","source":"DrugCentral FAERS","actionTaken":"Reported 33 times (LLR=173)"},{"llr":133.531,"date":"","count":20,"signal":"Patient uncooperative","source":"DrugCentral FAERS","actionTaken":"Reported 20 times (LLR=134)"},{"llr":131.485,"date":"","count":42,"signal":"Restlessness","source":"DrugCentral FAERS","actionTaken":"Reported 42 times (LLR=131)"},{"llr":117.109,"date":"","count":42,"signal":"Dysarthria","source":"DrugCentral FAERS","actionTaken":"Reported 42 times (LLR=117)"},{"llr":113.209,"date":"","count":27,"signal":"Bradyphrenia","source":"DrugCentral FAERS","actionTaken":"Reported 27 times (LLR=113)"},{"llr":101.184,"date":"","count":25,"signal":"Substance abuse","source":"DrugCentral FAERS","actionTaken":"Reported 25 times (LLR=101)"},{"llr":98.517,"date":"","count":23,"signal":"Bradykinesia","source":"DrugCentral FAERS","actionTaken":"Reported 23 times (LLR=99)"},{"llr":88.343,"date":"","count":30,"signal":"Abnormal behaviour","source":"DrugCentral FAERS","actionTaken":"Reported 30 times (LLR=88)"},{"llr":86.898,"date":"","count":30,"signal":"Drug dependence","source":"DrugCentral FAERS","actionTaken":"Reported 30 times (LLR=87)"}],"commonSideEffects":[{"effect":"Aggression","drugRate":"LLR 214","severity":"common"},{"effect":"Drug abuse","drugRate":"LLR 195","severity":"common"},{"effect":"Logorrhoea","drugRate":"LLR 173","severity":"common"},{"effect":"Patient uncooperative","drugRate":"LLR 134","severity":"common"},{"effect":"Restlessness","drugRate":"LLR 131","severity":"common"},{"effect":"Dysarthria","drugRate":"LLR 117","severity":"common"},{"effect":"Bradyphrenia","drugRate":"LLR 113","severity":"common"},{"effect":"Substance abuse","drugRate":"LLR 101","severity":"common"},{"effect":"Bradykinesia","drugRate":"LLR 99","severity":"common"},{"effect":"Abnormal behaviour","drugRate":"LLR 88","severity":"common"},{"effect":"Drug dependence","drugRate":"LLR 87","severity":"common"}]},"trials":[],"aliases":[],"patents":[],"pricing":[],"allNames":["levomethadone","levomethadone hydrochloride","levomethadone HCl"],"offLabel":[],"synonyms":["levomethadone","levomethadone hydrochloride","levomethadone HCl"],"timeline":[],"approvals":[],"ecosystem":[{"indication":"Opioid dependence","otherDrugs":[{"name":"buprenorphine","slug":"buprenorphine","company":"Reckitt Benckiser"},{"name":"levomethadyl acetate","slug":"levomethadyl-acetate","company":"Roxane"},{"name":"naloxone","slug":"naloxone","company":"Adapt"}],"globalPrevalence":null}],"mechanism":{"modality":"Small Molecule","drugClass":"levomethadone","explanation":"Imagine your brain has special locks for opioids, and LEVOMETHADONE has a key that fits into those locks. When it binds, it helps reduce the discomfort and urge to use opioids, making it easier to manage withdrawal symptoms and stay on track with treatment.","oneSentence":"LEVOMETHADONE works by binding to opioid receptors in the brain, reducing withdrawal symptoms and cravings.","technicalDetail":"LEVOMETHADONE exerts its effects by selectively binding to mu-opioid receptors, activating the G-protein coupled receptor pathway, and modulating the release of neurotransmitters involved in reward and pain processing."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4586","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=LEVOMETHADONE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=LEVOMETHADONE","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T12:19:49.692632","biosimilars":[],"competitors":[{"drugName":"buprenorphine","drugSlug":"buprenorphine","fdaApproval":"1981-12-29","patentExpiry":"Sep 5, 2031","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"methadone","drugSlug":"methadone","fdaApproval":"1947-08-13","genericCount":13,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"levomethadyl acetate","drugSlug":"levomethadyl-acetate","fdaApproval":"1993-07-09","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"lofexidine","drugSlug":"lofexidine","fdaApproval":"2018-05-16","genericCount":3,"patentStatus":"Off-patent — generic available","relationship":"same-class"}],"genericName":"levomethadone","indications":{"approved":[{"name":"Opioid dependence","source":"DrugCentral","snomedId":75544000,"regulator":"FDA"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"buprenorphine","brandName":"buprenorphine","genericName":"buprenorphine","approvalYear":"1981","relationship":"same-class"},{"drugId":"methadone","brandName":"methadone","genericName":"methadone","approvalYear":"1947","relationship":"same-class"},{"drugId":"levomethadyl-acetate","brandName":"levomethadyl acetate","genericName":"levomethadyl acetate","approvalYear":"1993","relationship":"same-class"},{"drugId":"lofexidine","brandName":"lofexidine","genericName":"lofexidine","approvalYear":"2018","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT04254731","phase":"PHASE4","title":"Effects of Switching From Racemic Methadone to R-methadone on QTc Intervals","status":"ACTIVE_NOT_RECRUITING","sponsor":"Oslo University Hospital","startDate":"2015-05-07","conditions":["Adverse Drug Effect","Drug Effect","Heart Arrhythmia"],"enrollment":10,"completionDate":"2024-07-30"},{"nctId":"NCT03685162","phase":"","title":"Observational Study to Evaluate Levomethadone Safety and Effectiveness in Subjects Under Opioid Maintenance Treatment","status":"COMPLETED","sponsor":"L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.","startDate":"2018-02-27","conditions":["Opioid Addiction"],"enrollment":103,"completionDate":"2023-02-16"},{"nctId":"NCT05251376","phase":"PHASE1","title":"Study of LYN-014 in Individuals With Opioid Use Disorder Who Are Stable on Methadone Therapy","status":"WITHDRAWN","sponsor":"Lyndra Inc.","startDate":"2022-02-28","conditions":["Opioid Use Disorder, Moderate"],"enrollment":0,"completionDate":"2022-12-19"},{"nctId":"NCT01722435","phase":"","title":"Completion of OST - a Prospective Study","status":"COMPLETED","sponsor":"Universitätsklinikum Hamburg-Eppendorf","startDate":"2011-07","conditions":["Opioid Dependence"],"enrollment":78,"completionDate":"2014-02"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"crossReferences":{"NDDF":"007175","UNII":"6Y75Z4E8NS","CHEBI":"CHEBI:136003","INN_ID":"5002","RXNORM":"236913","UMLSCUI":"C0772241","ChEMBL_ID":"CHEMBL159659","KEGG_DRUG":"D08121","DRUGBANK_ID":"DB13515","PUBCHEM_CID":"22267","SNOMEDCT_US":"1156227003","SECONDARY_CAS_RN":"5967-73-7"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[],"publicationCount":93,"therapeuticAreas":["Pain"],"atcClassification":{"source":"DrugCentral","atcCode":"N07BC05","allCodes":["N07BC05"]},"biosimilarFilings":[],"recentPublications":[{"date":"2025 Dec 23","pmid":"41517339","title":"Levomethadone Selectively Reduces Emotional Impulsivity in ASRS-Positive ADHD-OUD Patients, Independent of Dose Escalation.","journal":"Journal of clinical medicine"},{"date":"2026 Mar","pmid":"41482038","title":"A comparison of short-term analgesic effects of xylazine alone or combined with levomethadone or ketamine in calves after hot-iron disbudding.","journal":"Journal of dairy science"},{"date":"2025 Dec","pmid":"41330407","title":"[Opioid substitution therapy for opioid use disorder and legal framework in Germany].","journal":"Fortschritte der Neurologie-Psychiatrie"},{"date":"2025 Jun","pmid":"39924451","title":"Relative risks of adverse effects across different opioid agonist treatments-A systematic review and meta-analysis.","journal":"Addiction (Abingdon, England)"},{"date":"2026 Jan-Mar","pmid":"39910803","title":"Switching to levomethadone improves methadone-induced hyperhidrosis: A case report.","journal":"Journal of addictive diseases"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","brandName":"LEVOMETHADONE","companyName":"","companyId":"","modality":"Small molecule","firstApprovalDate":"","aiSummary":"LEVOMETHADONE is a small molecule drug in the levomethadone class, originally developed and currently owned by an unknown entity. It is approved for the treatment of opioid dependence. The commercial status of LEVOMETHADONE is unclear, with unknown patent status and generic manufacturers. LEVOMETHADONE works by interacting with opioid receptors in the brain to reduce withdrawal symptoms and cravings. Key safety considerations include unknown half-life and bioavailability.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}