{"id":"lofexidine","rwe":[{"pmid":"41671014","year":"2026","title":"Medications for Opioid Use Disorder, Opioid Withdrawal, and Opioid Overdose: A Review.","finding":"","journal":"JAMA","studyType":"Clinical Study"},{"pmid":"41075537","year":"2025","title":"Fixed-proportion mixtures with the α2-adrenergic agonist clonidine or lofexidine do not alter fentanyl self-administration in non-opioid-dependent male and female rats.","finding":"","journal":"The Journal of pharmacology and experimental therapeutics","studyType":"Clinical Study"},{"pmid":"40840120","year":"2025","title":"Effects of Δ(9)-tetrahydrocannabinol (THC), cannabidiol (CBD), and THC:CBD mixtures on behavioral and physiological signs of morphine withdrawal in rhesus monkeys.","finding":"","journal":"The Journal of pharmacology and experimental therapeutics","studyType":"Clinical Study"},{"pmid":"40672361","year":"2025","title":"Dexmedetomidine potently and reversibly regulates stress-mediated behaviors.","finding":"","journal":"Frontiers in pharmacology","studyType":"Clinical Study"},{"pmid":"30000984","year":"2006","title":"Lofexidine.","finding":"","journal":"","studyType":"Clinical Study"}],"tags":[{"label":"lofexidine","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Alpha-2A adrenergic receptor","category":"target"},{"label":"ADRA2A","category":"gene"},{"label":"ADRA2B","category":"gene"},{"label":"ADRA2C","category":"gene"},{"label":"N07BC04","category":"atc"},{"label":"Oral","category":"route"},{"label":"Tablet","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Active","category":"status"},{"label":"Opioid withdrawal","category":"indication"},{"label":"Biocorrx Pharms","category":"company"},{"label":"Approved 2010s","category":"decade"},{"label":"Adrenergic Agents","category":"pharmacology"},{"label":"Adrenergic Agonists","category":"pharmacology"},{"label":"Adrenergic alpha-2 Receptor Agonists","category":"pharmacology"},{"label":"Adrenergic alpha-Agonists","category":"pharmacology"},{"label":"Antihypertensive Agents","category":"pharmacology"},{"label":"Cardiovascular Agents","category":"pharmacology"},{"label":"Central Nervous System Agents","category":"pharmacology"},{"label":"Narcotic Antagonists","category":"pharmacology"},{"label":"Neurotransmitter Agents","category":"pharmacology"},{"label":"Peripheral Nervous System Agents","category":"pharmacology"},{"label":"Sensory System Agents","category":"pharmacology"}],"phase":"marketed","safety":{"commonSideEffects":[{"effect":"Orthostatic hypotension","drugRate":"25%","severity":"common"},{"effect":"Bradycardia","drugRate":"25%","severity":"common"},{"effect":"Dizziness","drugRate":"20%","severity":"common"},{"effect":"Somnolence","drugRate":"15%","severity":"common"},{"effect":"Sedation","drugRate":"12%","severity":"common"},{"effect":"Dry mouth","drugRate":"10%","severity":"common"},{"effect":"Insomnia","drugRate":"15%","severity":"common"},{"effect":"Diarrhea","drugRate":"reported","severity":"unknown"},{"effect":"Anxiety","drugRate":"reported","severity":"unknown"},{"effect":"Chills","drugRate":"reported","severity":"unknown"},{"effect":"Hyperhidrosis","drugRate":"reported","severity":"unknown"},{"effect":"Extremity pain","drugRate":"reported","severity":"unknown"},{"effect":"Syncope","drugRate":"0.9%","severity":"mild"},{"effect":"Tinnitus","drugRate":"3.2%","severity":"mild"},{"effect":"Elevations in blood pressure above normal values (>= 140 mmHg systolic)","drugRate":"39.7%","severity":"serious"},{"effect":"Elevations in blood pressure above normal values (>= 170 mmHg systolic)","drugRate":"8.6%","severity":"serious"},{"effect":"QT prolongation","drugRate":"reported","severity":"unknown"},{"effect":"Torsades de pointes","drugRate":"reported","severity":"unknown"},{"effect":"Cardiac arrest","drugRate":"reported","severity":"unknown"}],"specialPopulations":{"Lactation":"There is no information regarding the presence of LUCEMYRA or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. Caution should be exercised when LUCEMYRA is administered to nursing woman.The developmental and health benefits should be considered along with the mothers clinical need for LUCEMYRA and any other potential adverse effects on breastfed children from LUCEMYRA or from the underlying maternal condition.","Pregnancy":"The safety of LUCEMYRA in pregnant women has not been established. In animal reproduction studies, oral administration of lofexidine during organogenesis to pregnant rats and rabbits caused reduction in fetal weights, increases in fetal resorptions, and litter loss at exposures below that in humans. When oral lofexidine was administered from the beginning of organogenesis through lactation, increased stillbirths and litter loss were noted along with decreased viability and lactation indices. The offspring exhibited delays in sexual maturation, auditory startle, and surface righting. These effects occurred at exposures below that in humans.","Geriatric use":"No studies have been performed to characterize the pharmacokinetics of LUCEMYRA or to establish its safety and effectiveness in geriatric patients. Caution should be exercised when LUCEMYRA is administered to patients over 65 years of age. Dosing adjustments similar to those recommended in patients with renal impairment should be considered [see Dosage and Administration (2.3), Use in Specific Populations (8.7)].","Paediatric use":"The safety and effectiveness of LUCEMYRA have not been established in pediatric patients.","Renal impairment":"Dosing adjustments similar to those recommended in patients with renal impairment should be considered [see Dosage and Administration (2.3), Use in Specific Populations (8.7)]."}},"trials":[],"aliases":[],"company":"Biocorrx Pharms","patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-12-18","unitCost":"$12.8727/EA","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$4,699","description":"LOFEXIDINE 0.18 MG TABLET","retrievedDate":"2026-04-07"}],"allNames":"lucemyra","offLabel":[],"synonyms":["lofexidine hydrochloride","lofexidine","(+/-)-Lofexidine","lofexidine HCl","lofexadine"],"timeline":[{"date":"2018-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from US WORLDMEDS LLC to Biocorrx Pharms"},{"date":"2018-05-16","type":"positive","source":"DrugCentral","milestone":"FDA approval (Us Worldmeds Llc)"},{"date":"2024-08-20","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 1 manufacturer approved"}],"aiSummary":"Lucemyra (lofexidine) is a small molecule drug that targets the alpha-2A adrenergic receptor to treat opioid withdrawal. It was originally developed by US WorldMeds LLC and is now owned by Biocorrx Pharmaceuticals. Lucemyra was FDA-approved in 2018 for the management of opioid withdrawal symptoms. The drug has a half-life of 12 hours and high bioavailability of 90%. It is now off-patent with multiple generic manufacturers.","approvals":[{"date":"2018-05-16","orphan":false,"company":"US WORLDMEDS LLC","regulator":"FDA"}],"brandName":"Lucemyra","ecosystem":[{"indication":"Opioid withdrawal","otherDrugs":[{"name":"methadone","slug":"methadone","company":"Roxane"}],"globalPrevalence":null}],"mechanism":{"target":"Alpha-2A adrenergic receptor","novelty":"Follow-on","targets":[{"gene":"ADRA2A","source":"DrugCentral","target":"Alpha-2A adrenergic receptor","protein":"Alpha-2A adrenergic receptor"},{"gene":"ADRA2B","source":"DrugCentral","target":"Alpha-2B adrenergic receptor","protein":"Alpha-2B adrenergic receptor"},{"gene":"ADRA2C","source":"DrugCentral","target":"Alpha-2C adrenergic receptor","protein":"Alpha-2C adrenergic receptor"},{"gene":"HTR1A","source":"DrugCentral","target":"5-hydroxytryptamine receptor 1A","protein":"5-hydroxytryptamine receptor 1A"}],"modality":"Small Molecule","drugClass":"lofexidine","explanation":"Lofexidine is central alpha-2 adrenergic agonist that binds to receptors on adrenergic neurons. This reduces the release of norepinephrine and decreases sympathetic tone.","oneSentence":"Lucemyra works by activating the alpha-2A adrenergic receptor to reduce the release of norepinephrine, a neurotransmitter involved in withdrawal symptoms.","technicalDetail":"Lucemyra acts as an agonist at the alpha-2A adrenergic receptor, which is a subtype of adrenergic receptor that inhibits the release of norepinephrine, a neurotransmitter involved in the sympathetic nervous system's response to stress and withdrawal."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Lofexidine","title":"Lofexidine","extract":"Lofexidine, sold as a generic by Indoco, MSN, Novitium, Ani Pharma, Regcon, etc; and under the brand name Lucemyra; is a medication historically used to treat high blood pressure; today, it is more commonly used to help with the physical symptoms of opioid withdrawal. It is taken by mouth. It is an α2A-adrenergic receptor agonist. It was initially approved for use by the Food and Drug Administration in the United States in 2018, considering it to be a first-in-class medication. Subsequent generic approvals by the FDA started August 21, 2024 with Indoco Remedies with Competitive Generic Therapy (CGT) designation, which provided Indoco with a 180-day exclusivity period from the date of the product’s first commercial launch in the United States. Following this exclusivity period multiple generics were approved by other manufacturers: MSN February 24, 2025, NOVITIUM PHARMA October 22, 2025, Regcon Holdings. The FDA approval of multiple generic sources of Lofexidine has resulted in the widespread availability of FDA approved cheaper alternative to the branded medication with significant cost savings to patients. The normal out-of-pocket price of Lucemyra is $1,144.96 per 36, 0.18mg tablets. As of the 12th of December 2025 at one representative pharmacy, a branded Lucemyra 3 day supply costs $756, whereas the generic versions costs $142, an 81% discount. Due to widespread inter-generic competition the price/unit of generic lofexidine itself is under steady downward pressure and thi","wiki_society_and_culture":"==Society and culture==\nBritannia Pharmaceuticals has licensed lofexidine to be sold by US WorldMeds for sale in North America.  In the United Kingdom, the hydrochloride form, lofexidine HCl, has been licensed and sold since 1992 for opioid withdrawal relief in tablet form as BritLofex by Britannia Pharmaceuticals. The Lucemyra official prescription drug promotion website currently (December 2025) advertises that \"LUCEMYRA is the only FDA-approved, non-opioid medicine proven to help with symptoms of opioid withdrawal\". However, this prescription drug promotion is obsolete, and thus potentially inaccurate and misleading because of the FDA approval of multiple generic versions of lofexidine since August 2024 that provide significant cost savings to patients."},"commercial":{"launchDate":"2018","_launchSource":"DrugCentral (FDA 2018-05-16, US WORLDMEDS LLC)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1593","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=LOFEXIDINE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=LOFEXIDINE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Lofexidine","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T14:08:37.110562","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"}],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"genericName":"lofexidine","indications":{"approved":[{"name":"Opioid withdrawal","source":"DrugCentral","snomedId":87132004,"regulator":"FDA","eligibility":"adults"}],"offLabel":[],"pipeline":[]},"currentOwner":"Biocorrx Pharms","drugCategory":"active","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","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"}],"trialDetails":[{"nctId":"NCT05995535","phase":"PHASE2","title":"Pregabalin Plus Lofexidine for the Outpatient Treatment of Opioid Withdrawal","status":"RECRUITING","sponsor":"University of Pennsylvania","startDate":"2024-01-01","conditions":["Opiate Withdrawal Syndrome","Opioid Use"],"enrollment":150,"completionDate":"2026-08-31"},{"nctId":"NCT04325659","phase":"PHASE2,PHASE3","title":"An Innovative Intervention for OUD Treatment","status":"COMPLETED","sponsor":"Johns Hopkins University","startDate":"2020-11-15","conditions":["Opioid-Related Disorders","Opioid Dependence","Opioid Addiction","Opioid Withdrawal"],"enrollment":46,"completionDate":"2026-01-01"},{"nctId":"NCT05712707","phase":"PHASE1,PHASE2","title":"Sublingual Dexmedetomidine for Treating Opioid Withdrawal","status":"ACTIVE_NOT_RECRUITING","sponsor":"New York State Psychiatric Institute","startDate":"2023-02-28","conditions":["Opioid Use Disorder","Opioid Withdrawal"],"enrollment":160,"completionDate":"2026-08-31"},{"nctId":"NCT05511909","phase":"PHASE2","title":"Evaluating Buspirone to Treat Opioid Withdrawal","status":"ACTIVE_NOT_RECRUITING","sponsor":"Johns Hopkins University","startDate":"2022-12-15","conditions":["Opioid Use Disorder","Opioid Withdrawal","Opioid Craving","Anxiety"],"enrollment":100,"completionDate":"2027-03-31"},{"nctId":"NCT06047834","phase":"PHASE2","title":"Pharmacokinetic and Safety Study of Oral Lofexidine in Neonates Experiencing Opioid Withdrawal Due to Intrauterine Exposure to Opioids","status":"ACTIVE_NOT_RECRUITING","sponsor":"BioCorRx Pharmaceuticals Inc","startDate":"2023-10-02","conditions":["Opioid Withdrawal (Disorder)"],"enrollment":24,"completionDate":"2026-10"},{"nctId":"NCT05027919","phase":"PHASE2","title":"Assessing a Clinically-meaningful Opioid Withdrawal Phenotype","status":"RECRUITING","sponsor":"University of Maryland, Baltimore","startDate":"2021-12-01","conditions":["Opioid Withdrawal","Opioid Use Disorder","Opioid Craving"],"enrollment":60,"completionDate":"2027-02-28"},{"nctId":"NCT06711640","phase":"PHASE1","title":"A Pharmacokinetic, Safety, and Tolerability Study of LUCEMYRA in the Treatment of Opioid Withdrawal Management in Adolescent Subjects","status":"WITHDRAWN","sponsor":"USWM, LLC (dba US WorldMeds)","startDate":"2025-06","conditions":["Opioid Withdrawal (Disorder)","Opioid Use Disorder"],"enrollment":0,"completionDate":"2026-02"},{"nctId":"NCT05053503","phase":"NA","title":"Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder","status":"COMPLETED","sponsor":"Spark Biomedical, Inc.","startDate":"2022-05-27","conditions":["Opioid-use Disorder","Opioid Withdrawal"],"enrollment":108,"completionDate":"2025-04-04"},{"nctId":"NCT04360681","phase":"PHASE2","title":"Lofexidine Combined With Buprenorphine for Reducing Symptoms of PTSD and OU Relapse in Veterans","status":"RECRUITING","sponsor":"Pharmacotherapies for Alcohol and Substance Use Disorders Alliance","startDate":"2021-03-09","conditions":["Post Traumatic Stress Disorder","Opioid-use Disorder"],"enrollment":120,"completionDate":"2025-12-31"},{"nctId":"NCT03718065","phase":"PHASE2","title":"Impact of Lofexidine on Stress, Craving and Opioid Use","status":"COMPLETED","sponsor":"Medical University of South Carolina","startDate":"2019-06-26","conditions":["Opioid-use Disorder","Opiate Dependence"],"enrollment":112,"completionDate":"2024-01-30"},{"nctId":"NCT04070157","phase":"PHASE2","title":"Randomized, Double-Blind, Placebo-Controlled Pilot Study on the Safety and Effectiveness of LUCEMYRA During an Opioid Taper in Treatment of Withdrawal","status":"TERMINATED","sponsor":"USWM, LLC (dba US WorldMeds)","startDate":"2019-08-02","conditions":["Opioid Withdrawal (Disorder)"],"enrollment":4,"completionDate":"2019-11-27"},{"nctId":"NCT04218240","phase":"PHASE2","title":"Combining Pregabalin (LYRICA®) With Lofexidine (LUCEMYRATM) to Treat OPIOID Withdrawal","status":"COMPLETED","sponsor":"University of Pennsylvania","startDate":"2020-12-17","conditions":["Opioid Withdrawal"],"enrollment":90,"completionDate":"2023-08-31"},{"nctId":"NCT05569031","phase":"PHASE4","title":"Treatment of Withdrawal Symptoms and Prevention of Relapse in Patients With Tramadol Abuse","status":"COMPLETED","sponsor":"Zagazig University","startDate":"2019-01-01","conditions":["Opiate Withdrawal Syndrome"],"enrollment":52,"completionDate":"2022-06-15"},{"nctId":"NCT04188730","phase":"PHASE1","title":"A Study Evaluating the Relative Bioavailability of Lofexidine Granules for Reconstitution Compared to LUCEMYRA (Lofexidine) Tablets and the Effect of Food on the Bioavailability of the Lofexidine Granules for Reconstitution","status":"COMPLETED","sponsor":"USWM, LLC (dba US WorldMeds)","startDate":"2021-02-16","conditions":["Normal Healthy Volunteers"],"enrollment":16,"completionDate":"2021-03-26"},{"nctId":"NCT01863186","phase":"PHASE3","title":"Efficacy, Safety and Dose-Response Study Followed by Open-Label Study of Lofexidine Treatment of Opioid Withdrawal","status":"COMPLETED","sponsor":"USWM, LLC (dba US WorldMeds)","isPivotal":true,"startDate":"2013-06","conditions":["Opioid Dependence","Acute Opioid Withdrawal Syndrome"],"enrollment":603,"completionDate":"2014-12"},{"nctId":"NCT02363998","phase":"PHASE3","title":"Open-Label, Safety Study of Lofexidine","status":"COMPLETED","sponsor":"USWM, LLC (dba US WorldMeds)","startDate":"2015-02","conditions":["Opioid Withdrawal"],"enrollment":286,"completionDate":"2015-10"},{"nctId":"NCT04126083","phase":"PHASE4","title":"Lofexidine for Adults Undergoing Lumbar Spine Surgery","status":"COMPLETED","sponsor":"Mayo Clinic","startDate":"2019-09-01","conditions":["Opioid Withdrawal"],"enrollment":6,"completionDate":"2021-04-15"},{"nctId":"NCT04056182","phase":"PHASE2","title":"Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment","status":"COMPLETED","sponsor":"New York State Psychiatric Institute","startDate":"2019-09-01","conditions":["Opioid-use Disorder"],"enrollment":20,"completionDate":"2021-01-29"},{"nctId":"NCT01020019","phase":"PHASE2,PHASE3","title":"Combined Pharmacotherapy for Cannabis Dependency","status":"COMPLETED","sponsor":"New York State Psychiatric Institute","startDate":"2010-01","conditions":["Cannabis Dependence","Marijuana Dependence"],"enrollment":156,"completionDate":"2014-09"},{"nctId":"NCT01820442","phase":"PHASE1","title":"Pharmacokinetic & Pharmacodynamic Interaction of Lofexidine and Buprenorphine in Buprenorphine Maintained Patients","status":"COMPLETED","sponsor":"USWM, LLC (dba US WorldMeds)","startDate":"2013-03","conditions":["Opioid Dependence","Buprenorphine Withdrawal Syndrome"],"enrollment":30,"completionDate":"2013-09"},{"nctId":"NCT02681198","phase":"PHASE1","title":"Lofexidine Pharmacokinetics in the Presence of Paroxetine in Healthy Volunteers","status":"COMPLETED","sponsor":"USWM, LLC (dba US WorldMeds)","startDate":"2016-01","conditions":["Healthy"],"enrollment":24,"completionDate":"2016-03"},{"nctId":"NCT01558934","phase":"PHASE1","title":"Pilot Study of Lofexidine and Methadone Pharmacodynamic Interaction in Methadone Maintained Patients","status":"COMPLETED","sponsor":"USWM, LLC (dba US WorldMeds)","startDate":"2012-02","conditions":["Opioid Dependence","Methadone Withdrawal Syndrome"],"enrollment":6,"completionDate":"2012-04"},{"nctId":"NCT02318836","phase":"PHASE1","title":"Single-Dose Pharmacokinetics and Safety of Oral Lofexidine in Hepatically-Impaired Subjects","status":"COMPLETED","sponsor":"USWM, LLC (dba US WorldMeds)","startDate":"2014-06","conditions":["Liver Failure"],"enrollment":24,"completionDate":"2014-10"},{"nctId":"NCT01437306","phase":"PHASE1","title":"Lofexidine Food Effect Study in Healthy Volunteers","status":"COMPLETED","sponsor":"USWM, LLC (dba US WorldMeds)","startDate":"2011-10","conditions":["Healthy"],"enrollment":13,"completionDate":"2011-10"},{"nctId":"NCT02801357","phase":"PHASE1","title":"Study to Evaluate the Exposures of Lofexidine and Its Major Metabolites in Subjects Seeking Buprenorphine Dose Reduction","status":"COMPLETED","sponsor":"USWM, LLC (dba US WorldMeds)","startDate":"2016-06","conditions":["Substance Withdrawal Syndrome","Opiate Addiction","Opiate Dependence"],"enrollment":10,"completionDate":"2016-08"},{"nctId":"NCT02446002","phase":"PHASE1","title":"Assessment of the Effect of Naltrexone on Lofexidine Single Dose Pharmacokinetics in Healthy Subjects","status":"COMPLETED","sponsor":"USWM, LLC (dba US WorldMeds)","startDate":"2015-05","conditions":["Healthy"],"enrollment":25,"completionDate":"2015-06"},{"nctId":"NCT02313103","phase":"PHASE1","title":"Single-dose Pharmacokinetics and Safety of Oral Lofexidine in Renally-Impaired Subjects","status":"COMPLETED","sponsor":"USWM, LLC (dba US WorldMeds)","startDate":"2014-11","conditions":["Renally Impaired Subjects"],"enrollment":16,"completionDate":"2015-02"},{"nctId":"NCT01629446","phase":"PHASE1","title":"Lofexidine Mass Balance in Volunteers","status":"COMPLETED","sponsor":"USWM, LLC (dba US WorldMeds)","startDate":"2012-05","conditions":["Normal Healthy Volunteers"],"enrollment":6,"completionDate":"2012-06"},{"nctId":"NCT01310296","phase":"PHASE1","title":"Lofexidine ADME & Mass Balance in Volunteers","status":"COMPLETED","sponsor":"USWM, LLC (dba US WorldMeds)","startDate":"2011-07","conditions":["Normal Healthy Volunteers Will be Treated With Lofexidine to Understand the Absolute Bioavailability and Mass Balance Recovery of the Product"],"enrollment":12,"completionDate":"2011-08"},{"nctId":"NCT01650649","phase":"PHASE1","title":"Main Study of Lofexidine and Methadone Pharmacodynamic Interaction in Methadone Maintained Patients","status":"COMPLETED","sponsor":"USWM, LLC (dba US WorldMeds)","startDate":"2012-07","conditions":["Opioid Dependence","Methadone Withdrawal Syndrome"],"enrollment":27,"completionDate":"2012-12"},{"nctId":"NCT00000345","phase":"PHASE1","title":"Evaluation of Lofexidine for Treatment of Opiate Withdrawal - 10","status":"COMPLETED","sponsor":"National Institute on Drug Abuse (NIDA)","startDate":"1996-04","conditions":["Opioid-Related Disorders"],"enrollment":0,"completionDate":""},{"nctId":"NCT00032942","phase":"PHASE3","title":"Lofexidine for Opiate Withdrawal - 1","status":"COMPLETED","sponsor":"National Institute on Drug Abuse (NIDA)","startDate":"2001-04","conditions":["Opioid-Related Disorders"],"enrollment":66,"completionDate":""},{"nctId":"NCT00000358","phase":"PHASE1","title":"Evaluation of Lofexidine for Treatment of Opioid Withdrawal - 7","status":"COMPLETED","sponsor":"National Institute on Drug Abuse (NIDA)","startDate":"","conditions":["Opioid-Related Disorders","Substance-Related Disorders"],"enrollment":0,"completionDate":""},{"nctId":"NCT00218530","phase":"PHASE1","title":"Effectiveness of Naltrexone and Lofexidine in Treating Detoxified Heroin Addicts - 1","status":"COMPLETED","sponsor":"National Institute on Drug Abuse (NIDA)","startDate":"2003-03","conditions":["Heroin Dependence"],"enrollment":0,"completionDate":"2004-09"},{"nctId":"NCT00000354","phase":"PHASE1","title":"Evaluation of Lofexidine for Treatment of Opioid Withdrawal - 3","status":"COMPLETED","sponsor":"National Institute on Drug Abuse (NIDA)","startDate":"1996-07","conditions":["Opioid-Related Disorders","Substance-Related Disorders"],"enrollment":0,"completionDate":"1997-12"},{"nctId":"NCT01148992","phase":"PHASE1","title":"Interactions Between Intravenous (IV) Cocaine and Lofexidine","status":"TERMINATED","sponsor":"National Institute on Drug Abuse (NIDA)","startDate":"2010-08","conditions":["Cocaine Related Disorders"],"enrollment":16,"completionDate":"2011-03"},{"nctId":"NCT01675648","phase":"PHASE4","title":"Lofexidine for Inpatient Opiate Detox in Singapore","status":"COMPLETED","sponsor":"Institute of Mental Health, Singapore","startDate":"2012-08","conditions":["Opiate Dependent Patients Who Are Undergoing Inpatient Detoxification in Singapore"],"enrollment":112,"completionDate":"2015-07"},{"nctId":"NCT00142909","phase":"PHASE2","title":"Effectiveness of Lofexidine to Prevent Stress-Related Opiate Relapse During Naltrexone Treatment - 1","status":"COMPLETED","sponsor":"Yale University","startDate":"2005-02","conditions":["Opioid-Related Disorders"],"enrollment":86,"completionDate":"2009-01"},{"nctId":"NCT00373503","phase":"PHASE2","title":"Effect of Lofexidine and Oral THC on Marijuana Withdrawal and Relapse","status":"COMPLETED","sponsor":"New York State Psychiatric Institute","startDate":"2005-08","conditions":["Marijuana Dependence"],"enrollment":8,"completionDate":"2008-09"},{"nctId":"NCT00235729","phase":"PHASE3","title":"Lofexidine for Inpatient Opiate Detox","status":"COMPLETED","sponsor":"US Department of Veterans Affairs","isPivotal":true,"startDate":"2006-06","conditions":["Opiate Addiction"],"enrollment":264,"completionDate":"2007-10"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"pivotalTrials":["NCT01863186","NCT00235729"],"administration":{"route":"Oral","formulation":"Tablet","formulations":[{"form":"TABLET, FILM COATED","route":"ORAL","productName":"Lucemyra"}]},"_patentsChecked":true,"crossReferences":{"NUI":"N0000171822","MMSL":"34252","NDDF":"004132","UNII":"UI82K0T627","VUID":"4025252","CHEBI":"CHEBI:51368","VANDF":"4025251","INN_ID":"3766","RXNORM":"235853","UMLSCUI":"C0065152","ChEMBL_ID":"CHEMBL1788132","KEGG_DRUG":"D04765","DRUGBANK_ID":"DB04948","PUBCHEM_CID":"30668","SNOMEDCT_US":"349934008","IUPHAR_LIGAND_ID":"9868","SECONDARY_CAS_RN":"21498-08-8","MESH_SUPPLEMENTAL_RECORD_UI":"C025655"},"formularyStatus":[],"originalProduct":{"form":"TABLET, FILM COATED","route":"ORAL","company":"US WorldMeds, LLC","brandName":"Lucemyra","isOriginal":true,"marketingStatus":"NDA"},"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"2018-","companyName":"Us Worldmeds Llc","relationship":"Original Developer"},{"period":"present","companyName":"Biocorrx Pharms","relationship":"Current Owner"}],"pharmacokinetics":{"source":"FDA label","halfLife":"12 hours","bioavailability":"90%"},"publicationCount":230,"therapeuticAreas":["Neuroscience"],"atcClassification":{"source":"DrugCentral","atcCode":"N07BC04","allCodes":["N07BC04"]},"biosimilarFilings":[],"originalDeveloper":"Us Worldmeds Llc","recentPublications":[{"date":"2026 Mar 17","pmid":"41671014","title":"Medications for Opioid Use Disorder, Opioid Withdrawal, and Opioid Overdose: A Review.","journal":"JAMA"},{"date":"2025 Oct","pmid":"41075537","title":"Fixed-proportion mixtures with the α2-adrenergic agonist clonidine or lofexidine do not alter fentanyl self-administration in non-opioid-dependent male and female rats.","journal":"The Journal of pharmacology and experimental therapeutics"},{"date":"2025 Sep","pmid":"40840120","title":"Effects of Δ(9)-tetrahydrocannabinol (THC), cannabidiol (CBD), and THC:CBD mixtures on behavioral and physiological signs of morphine withdrawal in rhesus monkeys.","journal":"The Journal of pharmacology and experimental therapeutics"},{"date":"2025","pmid":"40672361","title":"Dexmedetomidine potently and reversibly regulates stress-mediated behaviors.","journal":"Frontiers in pharmacology"},{"date":"2006","pmid":"30000984","title":"Lofexidine.","journal":""}],"companionDiagnostics":[],"genericManufacturers":3,"_genericFilersChecked":true,"genericManufacturerList":["Msn","Novitium Pharma","Regcon Holdings"],"status":"approved","companyName":"Biocorrx Pharms","companyId":"biocorrx-pharms","modality":"Small molecule","firstApprovalDate":"2018","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2018-05-16T00:00:00.000Z","mah":"US WORLDMEDS LLC","brand_name_local":null,"application_number":""},{"country_code":"CA","regulator":"Health Canada","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":5,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}