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Lucemyra

(Lofexidine)

ApprovedSmall molecule

BBioCorRx Pharmaceuticals Inc

Lofexidine is used to reduce withdrawal symptoms when people are stopping opioid use, helping make the process more tolerable and increasing the chances of successfully quitting.[2] Lucemyra is currently approved and in use across 7 indications[4].[1]

Lucemyra is one of 108 small molecule programs targeting Opioid Dependence. It is currently in Approved.

7

Indications

24

Total Trials

3

Active Trials

107

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Opioid DependenceActive, not recruiting

Drug DependenceActive, not recruiting

Heroin DependenceApproved

Opioid Use DisorderApproved

Liver FailureApproved

Cocaine DependenceApproved

BuprenorphineRecruiting

Opioid DependenceApproved

Active, not recruiting

Drug DependenceApproved

Active, not recruiting

Heroin DependenceApproved

Approved

Opioid Use DisorderApproved

Approved

Liver FailureApproved

Approved

Cocaine DependenceApproved

Approved

BuprenorphinePhase 2

Recruiting

Competition

Competitive Landscape

48 competitors in Opioid Use Disorder

#DrugCompanyPhaseTrials

Suboxone

Sovaldi

Dolophine

HHikma Pharmaceuticals LLC

Cabenuva

Oxycontin

Dilaudid

RRhodes Pharmaceuticals, L.P.

Lucemyra

BBioCorRx Pharmaceuticals Inc

MS Contin

HHikma Pharmaceuticals LLC

Narcan

Duragesic

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 2Recruiting

Opioid Withdrawal

NCT05027919

Phase 2Recruiting

Opioid Use Disorder

NCT05511909

Clinical

Trials by Indication[1]

Opioid Withdrawal4 trials

Assessing a Clinically-meaningful Opioid Withdrawal Phenotype

Recruiting·UUniversity of Maryland, Baltimore·Phase 2·NCT05027919·60 enrolled

Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment

Completed·NNew York State Psychiatric Institute·Phase 2·NCT04056182·20 enrolled

Evaluation of Lofexidine for Treatment of Opioid Withdrawal - 7

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 1·NCT00000358

Show 1 more trial

Evaluation of Lofexidine for Treatment of Opioid Withdrawal - 3

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 1·NCT00000354

Withdrawal3 trials

Evaluation of Lofexidine for Treatment of Opiate Withdrawal - 10

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 1·NCT00000345

Lofexidine for Opiate Withdrawal - 1

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 3·NCT00032942·66 enrolled

Effect of Lofexidine and Oral THC on Marijuana Withdrawal and Relapse

Completed·NNew York State Psychiatric Institute·Phase 2·NCT00373503·8 enrolled

Effectiveness3 trials

Randomized, Double-Blind, Placebo-Controlled Pilot Study on the Safety and Effectiveness of LUCEMYRA During an Opioid Taper in Treatment of Withdrawal

Terminated·UUSWM, LLC (dba US WorldMeds)·Phase 2·NCT04070157·4 enrolled

Effectiveness of Lofexidine to Prevent Stress-Related Opiate Relapse During Naltrexone Treatment - 1

Completed·YYale University·Phase 2·NCT00142909·86 enrolled

Effectiveness of Naltrexone and Lofexidine in Treating Detoxified Heroin Addicts - 1

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 1·NCT00218530

Opioid Use Disorder2 trials

Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder

Completed·SSpark Biomedical, Inc.·N/A·NCT05053503·108 enrolled

Evaluating a Mechanistically-Supported Pharmacotherapy to Treat Opioid Withdrawal

Recruiting·JJohns Hopkins University·Phase 2·NCT05511909·100 enrolled

Opioid Use1 trial

Impact of Lofexidine on Stress, Craving and Opioid Use

Completed·MMedical University of South Carolina·Phase 2·NCT03718065·112 enrolled

9 more indications

Treatment1 trial

An Innovative Intervention for OUD Treatment

Completed·JJohns Hopkins University·Phase 2/3·NCT04325659·46 enrolled

Prevention1 trial

Treatment of Withdrawal Symptoms and Prevention of Relapse in Patients With Tramadol Abuse

Completed·ZZagazig University·Phase 4·NCT05569031·52 enrolled

Buprenorphine1 trial

Lofexidine Combined With Buprenorphine for Reducing Symptoms of PTSD and OU Relapse in Veterans

Recruiting·PPharmacotherapies for Alcohol and Substance Use Disorders Alliance·Phase 2·NCT04360681·120 enrolled

MPA1 trial

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

Completed·UUSWM, LLC (dba US WorldMeds)·Phase 1·NCT04188730·16 enrolled

Lumbar Spine Surgery1 trial

Lofexidine for Adults Undergoing Lumbar Spine Surgery

Completed·MMayo Clinic·Phase 4·NCT04126083·6 enrolled

Interaction1 trial

Interactions Between Intravenous (IV) Cocaine and Lofexidine

Terminated·NNational Institute on Drug Abuse (NIDA)·Phase 1·NCT01148992·16 enrolled

Tics1 trial

Lofexidine Pharmacokinetics in the Presence of Paroxetine in Healthy Volunteers

Completed·UUSWM, LLC (dba US WorldMeds)·Phase 1·NCT02681198·24 enrolled

Cannabis1 trial

Combined Pharmacotherapy for Cannabis Dependency

Completed·NNew York State Psychiatric Institute·Phase 2/3·NCT01020019·156 enrolled

Unspecified3 trials

Open-Label, Safety Study of Lofexidine

Completed·UUSWM, LLC (dba US WorldMeds)·Phase 3·NCT02363998·286 enrolled

Lofexidine for Inpatient Opiate Detox

Completed·UUS Department of Veterans Affairs·Phase 3·NCT00235729·264 enrolled

Lofexidine for Inpatient Opiate Detox in Singapore

Completed·IInstitute of Mental Health, Singapore·Phase 4·NCT01675648·112 enrolled

Regulatory

FDA Approval Timeline[5]

May 16, 2018

LUCEMYRA

NDA NDA209229

Sources

References

[1]
ClinicalTrials.gov — 24 trial records for Lofexidine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Lucemyra drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Lofexidine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Lofexidine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA209229). U.S. Food & Drug Administration.
[6]
SEC EDGAR — BioCorRx Pharmaceuticals Inc company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Adrenergic Receptor Alpha-2 Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: BBioCorRx Pharmaceuticals Inc

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