ReVia

(Naltrexone)

ApprovedSmall molecule

Naltrexone is used to treat alcohol and opioid addiction by reducing cravings and blocking the pleasurable effects of these substances. It can also be used to help with weight management in some cases.[2] ReVia is currently approved and in use across 70 indications[4].[1]

ReVia is one of 1245 small molecule programs targeting HIV infection. It is currently in Approved.

Indications

225

Total Trials

Active Trials

1,244

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

HIV InfectionApproved

Cirrhosis of LiverActive, not recruiting

Pervasive Developmental DisorderApproved

Methamphetamine DependenceActive, not recruiting

Nicotine DependenceApproved

Depressive DisorderApproved

Gambling BehaviourApproved

Migraine DisorderApproved

Binge EatingApproved

Mental or Behavioural DisorderApproved

HIV InfectionApproved

Approved

Cirrhosis of LiverPreclinical

Active, not recruiting

Pervasive Developmental DisorderApproved

Approved

Methamphetamine DependencePhase 2

Active, not recruiting

Nicotine DependenceApproved

Approved

Depressive DisorderApproved

Approved

Gambling BehaviourApproved

Approved

Migraine DisorderApproved

Approved

Binge EatingApproved

Approved

Mental or Behavioural DisorderApproved

Approved

Showing 10 of 67 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

ReVia

Teva

Approved

2 2

Tecentriq

Roche

Preclinical

36 3

Prolia

Amgen

Preclinical

14 4

Gemzar

GGynecologic Oncology Group

Preclinical

22 5

DATROWAY

Daiichi Sankyo

Preclinical

4 6

Megace

Bristol-Myers Squibb

Preclinical

4 7

MS Contin

Merck & Co.

Preclinical

2 8

Zolymbus

AbbVie

Preclinical

1 9

Lupron

EEastern Cooperative Oncology Group

Preclinical

5 10

Methylthioninium Chloride

PProvepharm SAS

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 1Not yet recruiting

MPA

NCT07269873

Q2 2027

Phase 1Recruiting

Eating Disorder

NCT05509257

Q1 2028

Phase 3Recruiting

Alcohol Use Disorder

NCT05827159

Q3 2028

Phase 2Recruiting

Alcohol Dependence

NCT06845124

Clinical

Trials by Indication[1]

Alcohol Dependence19 trials

Modafinil and Naltrexone to Reduce Cocaine and Alcohol Dependence

Completed·KKyle Kampman·Phase 2·NCT00142818·164 enrolled

Pharmacotherapy for Alcohol Dependence in Convicted Drinking Drivers

Terminated·CCentre for Addiction and Mental Health·Phase 4·NCT01638377·2 enrolled

Naltrexone in Two Models of Psychosocial Treatments for Cocaine and Alcohol Dependence

Completed·UUniversity of Pennsylvania·Phase 3·NCT00167232·164 enrolled

Show 16 more trials

Naltrexone in Two Models of Psychosocial Treatments for Cocaine and Alcohol Dependence - 1

Completed·UUniversity of Pennsylvania·Phase 3·NCT00218660·164 enrolled

Naltrexone for Bipolar Disorder and Alcohol Dependence

Completed·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT00223275·50 enrolled

An Exploratory Study of Naltrexone Plus Aripiprazole for Alcohol Dependence

Completed·MMedical University of South Carolina·Phase 2·NCT00667875·65 enrolled

Effectiveness of Gabapentin When Used With Naltrexone to Treat Alcohol Dependence Compared to Placebo and Naltrexone Alone

Completed·MMedical University of South Carolina·Phase 3·NCT00183196·150 enrolled

Trial for the Treatment of Alcohol Dependence

Unknown status·UUniversity of Sydney·Phase 4·NCT00120601·200 enrolled

Drug Therapy for Alcohol Dependence in Alaska Natives (Naltrexone/Sertraline)

Completed·YYale University·Phase 2·NCT00000451·198 enrolled

Oral vs. Injectable Naltrexone for Hospitalized Veterans With Alcohol Dependence

Completed·UUniversity of Wisconsin, Madison·Phase 3·NCT01856712·54 enrolled

Combined Treatment for Cocaine-Alcohol Dependence - 1

Completed·TThe University of Texas Health Science Center, Houston·Phase 2·NCT00218569·87 enrolled

Pharmacogenetic Response to Naltrexone For Alcohol Dependence

Completed·DDavid Oslin·Phase 4·NCT00831272·221 enrolled

A Trial to Investigate the Effects of Cannabidiol Plus Naltrexone on Alcohol Craving in Patients With Alcohol Dependence

Recruiting·—·Phase 2·NCT06845124·150 enrolled

Extended-release Naltrexone for Alcohol Dependence in Primary Care

Completed·NNYU Langone Health·Phase 4·NCT00620750·72 enrolled

Injectable Versus Oral Naltrexone Treatment of Alcohol Dependence In Serious Mental Illness (SMI)

Completed·SState University of New York - Upstate Medical University·Phase 4·NCT00453804·15 enrolled

Sertraline for Alcohol Dependence and Depression

Completed·UUniversity of Pennsylvania·Phase 4·NCT00004554·171 enrolled

Sertraline and Naltrexone for Alcohol Dependence

Completed·NNational Institute on Alcohol Abuse and Alcoholism (NIAAA)·Phase 2·NCT00000440·124 enrolled

Long-Acting Injectable Naltrexone Treatment of Alcohol Dependence in Primary Care vs. in Specialized Chemical Dependence Treatment: A Pilot Trial

Terminated·SState University of New York - Upstate Medical University·Phase 4·NCT00461890·20 enrolled

Naltrexone Treatment of Alcohol Dependence

Completed·NNational Institute on Alcohol Abuse and Alcoholism (NIAAA)·Phase 4·NCT00000452·240 enrolled

Treatment13 trials

Naltrexone in the Treatment of Pyromania

Withdrawn·UUniversity of Minnesota·Phase 2·NCT00467454

The Effects of Treatment With Naltrexone in Alcohol and Cannabis-dependent Patients

Unknown status·TTel-Aviv Sourasky Medical Center·N/A·NCT01560013·24 enrolled

RCT for Gambling and Naltrexone, Using Use Eye-tracking Analysis to Predict Treatment Response

Unknown status·UUniversity of Sao Paulo·Phase 2·NCT04738773·40 enrolled

Show 10 more trials

Understanding Treatment Response With Naltrexone Among White Alcoholics

Completed·UUniversity of Pennsylvania·Phase 4·NCT00817089·24 enrolled

Alcohol Disorder hOsPital Treatment Trial

Completed·—·Phase 4·NCT02478489·248 enrolled

Extended-Release vs. Oral Naltrexone Alcohol Treatment in Primary Care

Completed·NNYU Langone Health·Phase 4·NCT01893827·237 enrolled

Drug Treatment for Depressed Alcoholics (Naltrexone/Fluoxetine)

Completed·NNational Institute on Alcohol Abuse and Alcoholism (NIAAA)·Phase 4·NCT00006204·106 enrolled

Post-Treatment Effects of Naltrexone

Completed·IIndiana University·Phase 4·NCT00006449·160 enrolled

Extended-Release Naltrexone Opioid Treatment at Jail Re-Entry

Completed·NNYU Langone Health·Phase 4·NCT01999946·217 enrolled

Addiction Treatment in Russia: Oral vs. Naltrexone Implant

Completed·UUniversity of Pennsylvania·Phase 2/3·NCT00218426·306 enrolled

Behavior and Naltrexone Treatment for Alcoholics

Completed·NNational Institute on Alcohol Abuse and Alcoholism (NIAAA)·Phase 4·NCT00000449·160 enrolled

Efficacy of Naltrexone Treatment as Augmentation to SSRI in OCD Patients

Completed·SSheba Medical Center·N/A·NCT00234689

Naltrexone Treatment for Alcoholic Women

Completed·YYale University·Phase 4·NCT00000448·160 enrolled

Alcohol7 trials

Study of the Opioid Modulation of the Effect of Alcohol on the Dopaminergic Reward System

Terminated·RRWTH Aachen University·Phase 1·NCT03854942·43 enrolled

Combination of Disulfiram Plus Naltrexone to Treat Both Cocaine- and Alcohol-dependent Individuals - 1

Completed·UUniversity of Pennsylvania·Phase 2·NCT00142844·208 enrolled

Lemborexant Augmentation of Naltrexone for Alcohol Craving and Sleep

Completed·—·Phase 3·NCT05458609·8 enrolled

Show 4 more trials

Sweet Preference and Alcohol Craving

Completed·UUniversity of North Carolina, Chapel Hill·Phase 2·NCT01296646·80 enrolled

Pharmacotherapy for HIV Infected Patients With Alcohol Problems

Withdrawn·VVA Connecticut Healthcare System·Phase 4·NCT00854230

Naltrexone Effects on Alcohol Intake

Completed·UUniversity of California, San Francisco·N/A·NCT00254670

Naltrexone as Adjunct in Alcoholic Cocaine Dependent Patients - 4

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00000307

Opioid6 trials

Dopamine and Opioid Receptor Antagonists Reduce Cue-induced Reward Responding and Reward Impulsivity

Completed·UUniversity of Zurich·N/A·NCT02557984·121 enrolled

Opioid Modulation and Neural Reward Activation in Healthy Adults

Completed·UUniversity of Colorado, Denver·Phase 1/2·NCT04854551·13 enrolled

An fMRI Study of Opioid-related Changes in Neural Activity

Completed·TTristen Inagaki·N/A·NCT02818036·82 enrolled

Show 3 more trials

Extended Release Naltrexone for Opioid-Dependent Youth

Completed·FFriends Research Institute, Inc.·Phase 4·NCT01843023·288 enrolled

Evaluation of the O'Neil Long Acting Naltrexone Implant in Opioid Dependent Persons

Not yet recruiting·GGo Medical Industries Pty Ltd·Phase 2·NCT05382091·250 enrolled

Improved Strategies for Outpatient Opioid Detoxification

Completed·NNew York State Psychiatric Institute·Phase 1·NCT01377610·150 enrolled

Opioid Dependence6 trials

Neurobiology of Opioid Dependence: 4 - 4

Withdrawn·YYale University·Phase 2·NCT00000195

Low Dose Naltrexone-buprenorphine Transfer to Vivitrol Injection in Opioid Dependence

Completed·PPaolo Mannelli·Phase 2·NCT01690546·38 enrolled

Neurobiology of Opioid Dependence: 5 - 5

Withdrawn·YYale University·Phase 2·NCT00000196

Show 3 more trials

Naltrexone vs Buprenorphine-Naloxone for Opioid Dependence in Norway

Completed·UUniversity of Oslo·Phase 3·NCT01717963·166 enrolled

Improving Treatment Outcomes for Prescription Opioid Dependence

Completed·UUniversity of Arkansas·Phase 2/3·NCT02543944·117 enrolled

Memantine and Naltrexone Treatment for Opioid Dependence

Completed·NNew York State Psychiatric Institute·Phase 2·NCT00125515·81 enrolled

96 more indications

Alcoholism6 trials

Validation of a Test System for Development of Medications for Alcoholism

Completed·TTechnische Universität Dresden·Phase 3·NCT02652585·46 enrolled

Research on Individualized Treatment for Alcoholism

Completed·IIndiana University School of Medicine·Phase 2·NCT00523133·185 enrolled

Medication Development in Alcoholism: Acamprosate Versus Naltrexone

Completed·TThe Scripps Research Institute·Phase 2·NCT00656630·68 enrolled

Show 3 more trials

Behavioral Therapy Plus Naltrexone for Alcoholism

Completed·MMedical University of South Carolina·Phase 4·NCT00000456·160 enrolled

Naltrexone Treatment for Alcoholism

Completed·JJohns Hopkins University·Phase 4·NCT00000438·192 enrolled

Genetic and Brain Mechanisms of Naltrexone's Treatment Efficacy for Alcoholism

Completed·MMedical University of South Carolina·Phase 4·NCT00920829·358 enrolled

COVID-194 trials

Study of Immunomodulation Using Naltrexone and Ketamine for COVID-19

Terminated·CCorewell Health East·Phase 2·NCT04365985·70 enrolled

Impact of Colchicine and Low-dose Naltrexone on COVID-19

Completed·HHealthPartners Institute·Phase 2·NCT04756128·142 enrolled

Pilot Study Into LDN and NAD+ for Treatment of Patients With Post-COVID-19 Syndrome

Completed·AAgelessRx·Phase 2·NCT04604704·36 enrolled

Show 1 more trial

Pilot Study Into the Use of Metformin and LDN for Patients With COVID-19

Withdrawn·AAgelessRx·Phase 2·NCT04604678

Buprenorphine4 trials

Comparison of Buprenorphine/Naloxone With Naltrexone in Opioid Dependent Adolescents

Withdrawn·SState University of New York at Buffalo·Phase 4·NCT01015066

Nalrexone Facilitated Discontinuation of Buprenorphine

Completed·NNew York State Psychiatric Institute·Phase 1/2·NCT01895036·6 enrolled

Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment

Completed·NNYU Langone Health·Phase 4·NCT02032433·570 enrolled

Show 1 more trial

The Effect of Buprenorphine Delivered by Buprenorphine Transdermal System (BTDS) at Doses up to 80 Micrograms/Hour (mcg/hr) and Naltrexone on Electrocardiogram (ECG) Intervals in Healthy Volunteers

Completed·PPurdue Pharma LP·Phase 1·NCT01999114·328 enrolled

Oral4 trials

Pharmacokinetic Evaluation of Intranasal, Intramuscular, and Oral Naltrexone in Healthy Volunteers

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 1·NCT02750748·14 enrolled

Behavioral Naltrexone Therapy for Promoting Adherence to Oral Naltrexone vs Extended Release Injectable Depot Naltrexone

Completed·NNew York State Psychiatric Institute·Phase 3·NCT00577408·60 enrolled

Naltrexone and Behavioral Drug and HIV Risk Reduction Counseling in Russia

Completed·YYale University·Phase 3·NCT01389167·320 enrolled

Show 1 more trial

Adherence to HIV Therapy in Heroin Addicts: Oral vs XR-NTX

Completed·UUniversity of Pennsylvania·Phase 2·NCT01101815·200 enrolled

Prevention4 trials

Reducing Heavy Drinking to Optimize HIV/AIDS Treatment and Prevention

Completed·YYale University·Phase 2/3·NCT01227044·51 enrolled

Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist

Completed·MMassachusetts General Hospital·Phase 4·NCT01673594·37 enrolled

Naltrexone for Relapse Prevention

Completed·UUConn Health·Phase 4·NCT00000442·57 enrolled

Show 1 more trial

Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail

Completed·NNYU Langone Health·Phase 3·NCT01180647·48 enrolled

Effectiveness4 trials

Effectiveness Study Low-Dose Naltrexone Versus ARV's for HIV+

Completed·TThe Ojai Foundation·Phase 2·NCT01174914·171 enrolled

Effectiveness of Naltrexone Versus Placebo to Reduce Craving for Alcohol With Evaluation of Genetic Variability.

Completed·MMedical University of South Carolina·Phase 4·NCT00366626·83 enrolled

Comparing Treatments for HIV-Infected Opioid Users in an Integrated Care Effectiveness Study (CHOICES) Scale-Up

Completed·OOregon Health and Science University·Phase 2/3·NCT03275350·114 enrolled

Show 1 more trial

Comparing Treatments for HIV-Infected Opioid and Alcohol Users in an Integrated Care Effectiveness Study

Completed·OOregon Health and Science University·Phase 3·NCT01908062·51 enrolled

Alcohol Use Disorder4 trials

Sex Differences in Trauma, Inflammation and Brain Function and the Implications for Treatment Efficacy in Alcohol Use Disorder

Recruiting·MMilky Kohno·Phase 4·NCT06426303·100 enrolled

Emergency Department-Initiated Medications for Alcohol Use Disorder

Recruiting·YYale University·Phase 3·NCT05827159·240 enrolled

Inpatient Single Dose Interventions for Alcohol Use Disorder

Completed·—·Phase 1·NCT04562779·44 enrolled

Show 1 more trial

Naltrexone for Medication Compliance Among HIV-infected Men With Alcohol Use Disorder

Completed·FFred Hutchinson Cancer Center·Phase 4·NCT01377168·159 enrolled

Atopic Dermatitis3 trials

Treatment of Chronic Itch in Atopic Dermatitis With Topical Naltrexone

Withdrawn·UUniversity of Minnesota·Phase 2·NCT04154033

Treatment of Chronic Itch in Atopic Dermatitis (Eczema): Nerve Function

Completed·UUniversity of Minnesota·Phase 1·NCT02268448·8 enrolled

Treatment of Chronic Itch in Atopic Dermatitis With Opioid Antagonist Naltrexone

Withdrawn·UUniversity of Minnesota·Phase 2·NCT04325802

Alcohol Use Disorders3 trials

Prazosin and Naltrexone (PaN) Study for Veterans With Alcohol Use Disorders

Completed·SSeattle Institute for Biomedical and Clinical Research·Phase 2·NCT02322047·31 enrolled

Treatment Strategy for Alcohol Use Disorders in Veterans With TBI

Completed·VVA Office of Research and Development·Phase 3·NCT01342549·62 enrolled

Collaborative Care for Alcohol Use Disorders in the Patient-centered Medical Home

Completed·NNorthwell Health·Phase 1/2·NCT02885311·27 enrolled

Schizophrenia3 trials

Naltrexone-Bupropion Versus Placebo-Bupropion for Weight Loss in Schizophrenia

Terminated·YYale University·Phase 2·NCT03132571·5 enrolled

Naltrexone and Bupropion Combination on Obese,Smoking Patients With Schizophrenia

Completed·SShanghai Mental Health Center·Phase 4·NCT02736474·22 enrolled

Pilot Trial of Naltrexone for Obesity in Women With Schizophrenia

Completed·YYale University·N/A·NCT00793780·24 enrolled

Breast Cancer2 trials

Naltrexone RCT for Treatment-Emergent Fatigue in Patients Receiving Radiation Therapy for Breast Cancer

Terminated·—·Phase 2·NCT02137252·3 enrolled

Phase II of Naltrexone in Hormone-Refractory Metastatic Breast Cancer

Terminated·MMasonic Cancer Center, University of Minnesota·Phase 2·NCT00379197·13 enrolled

Double-blind2 trials

Double-Blind Naltrexone in Kleptomania

Completed·UUniversity of Minnesota·Phase 2·NCT00332579·25 enrolled

Double-Blind Naltrexone in Compulsive Sexual Behavior

Completed·UUniversity of Minnesota·Phase 2·NCT00467558·7 enrolled

Depression2 trials

Low-Dose Naltrexone (LDN) for Depression Relapse and Recurrence

Completed·MMassachusetts General Hospital·Phase 2·NCT01874951·12 enrolled

Naltrexone & SSRI in Alcoholics With Depression/PTSD

Completed·YYale University·Phase 3·NCT00338962·88 enrolled

Medication2 trials

Medication and Counseling for Controlled Drinking

Unknown status·RResearch Foundation for Mental Hygiene, Inc.·Phase 3·NCT01115894·200 enrolled

Medication and Counseling for Controlled Drinking (Project SMART)

Completed·NNational Institute on Alcohol Abuse and Alcoholism (NIAAA)·Phase 3·NCT00444418·200 enrolled

Borderline personality disorder2 trials

Naltrexone in Borderline Personality Disorder

Terminated·—·Phase 3·NCT00124839·48 enrolled

Naltrexone in the Treatment of Dissociative Symptoms in Patients With Borderline Personality Disorder

Completed·—·Phase 2·NCT01133301·30 enrolled

MPR2 trials

Combination Gerotherapeutic Interventions for Healthspan Improvement

Active, not recruiting·AAgelessRx·Phase 3·NCT07475546·30 enrolled

COMBINE (Acamprosate/Naltrexone)

Completed·UUniversity of North Carolina, Chapel Hill·Phase 3·NCT00006206·1,375 enrolled

Smoking Cessation2 trials

Naltrexone for At-Risk and Problem Drinking in Smoking Cessation Treatment

Completed·—·Phase 2·NCT00938886·150 enrolled

Efficacy of Naltrexone in Women's Smoking Cessation

Completed·UUniversity of Chicago·Phase 2·NCT00271024·333 enrolled

Opioid Use Disorder2 trials

Evaluating Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL

Completed·AAlkermes, Inc.·Phase 3·NCT02696434·101 enrolled

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

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

Drug Abuse2 trials

HIV Risk Reduction and Drug Abuse Treatment in Malaysia

Completed·YYale University·Phase 2·NCT00383045·180 enrolled

HIV Risk Reduction and Drug Abuse Treatment in Iran

Withdrawn·YYale University·Phase 2·NCT00398008

MPA2 trials

The Impact of the Opiate Antagonist Naltrexone on the Emotional Valence of Dreams

Completed·UUniversity of Bern·Phase 4·NCT02792140·32 enrolled

Safety and PK Study of BICX104 With or Without Bupropion Compared to Vivitrol

Not yet recruiting·BBioCorRx Pharmaceuticals Inc·Phase 1·NCT07269873·30 enrolled

Opioids2 trials

Opioids and Social Support Enhanced Extinction Effects

Enrolling by invitation·UUniversity of California, Los Angeles·Phase 1·NCT04166071·60 enrolled

Neuropharmacological Basis of Social Connection: The Role of Opioids

Completed·UUniversity of California, Los Angeles·N/A·NCT01672723·34 enrolled

Pathological Gambling2 trials

Naltrexone in the Treatment of Concurrent Alcohol Dependence and Pathological Gambling

Completed·CCentre for Addiction and Mental Health·N/A·NCT00326807·50 enrolled

Investigation of Naltrexone for Pathological Gambling

Completed·YYale University·Phase 2·NCT01057862·9 enrolled

Attention Deficit Hyperactivity Disorder2 trials

An Open-Label Study of Naltrexone in Adults With Attention Deficit Hyperactivity Disorder.

Completed·MMassachusetts General Hospital·Phase 4·NCT01873729·3 enrolled

A Double-Blind Comparison of Naltrexone and Placebo in Adults With Attention Deficit Hyperactivity Disorder

Terminated·MMassachusetts General Hospital·Phase 4·NCT01721330·3 enrolled

Maintenance Therapy2 trials

Medication Maintenance Therapy in Community Pharmacy Settings

Completed·LLifespan·Phase 1·NCT03766893·11 enrolled

Medication Maintenance Therapy in Community Pharmacy Settings

Unknown status·LLifespan·Phase 2/3·NCT04139213·250 enrolled

Pilot Study2 trials

In Hospital IM Naltrexone: A Pilot Study

Withdrawn·UUniversity of Colorado, Denver·Phase 4·NCT05087771

Pilot Study of Depot NTX in Homeless Veterans

Terminated·UUS Department of Veterans Affairs·Phase 4·NCT01155869·7 enrolled

Substance Abuse1 trial

Substance Abuse Pre-Treatment Screening Study

Recruiting·TThe University of Texas Health Science Center, Houston··NCT00439049·7,500 enrolled

Age1 trial

Naltrexone and Adrenergic Agents to Reduce Heroin Use in Heroin Addicts

Completed·—·Phase 2·NCT00142948·301 enrolled

Cigarette Smoker1 trial

Naltrexone and Varenicline: Weight Gain and Tolerability in Cigarette Smokers

Completed·YYale University·Phase 1/2·NCT00502216·40 enrolled

Adult1 trial

Naltrexone for Heavy Drinking in Young Adults

Completed·YYale University·Phase 4·NCT00568958·140 enrolled

Alcohol Use1 trial

Treating Alcohol Use In Older Adults With Depression

Completed·UUS Department of Veterans Affairs·Phase 4·NCT00018824·74 enrolled

Alcohol Drinking1 trial

Kappa-PET Imaging and Naltrexone in Alcohol Drinking Behaviors

Completed·YYale University·Phase 1·NCT01625611·59 enrolled

Trichotillomania1 trial

Naltrexone in the Treatment of Trichotillomania

Completed·UUniversity of Chicago·Phase 2·NCT00775229·51 enrolled

Marijuana1 trial

Effects of Low-dose Naltrexone in Combination With a Range of Smoked Marijuana

Completed·NNew York State Psychiatric Institute·Phase 2·NCT00743145·23 enrolled

Post-Traumatic Stress Disorder1 trial

Treatment for Alcoholism and Post-Traumatic Stress Disorder (Naltrexone)

Completed·UUniversity of Pennsylvania·Phase 4·NCT00006489·165 enrolled

Osteoarthritis1 trial

Low Dose Naltrexone for Chronic Pain in Osteoarthritis and Inflammatory Arthritis

Withdrawn·—·Phase 2·NCT04115020

Alcohol Misuse1 trial

Endophenotype for Alcohol Misuse in Healthy Minority Populations

Completed·UUniversity of Pennsylvania·Phase 4·NCT00256451·43 enrolled

Chronic pain1 trial

Low Dose Naltrexone for Chronic Pain From Arthritis

Completed·VVA Office of Research and Development·Phase 2·NCT03008590·29 enrolled

Metastatic Melanoma1 trial

Low Dose Naltrexone for Metastatic Melanoma, Castrate Resistant Prostate Cancer and Renal Cancer

Terminated·—·Phase 2·NCT01650350·7 enrolled

Attention1 trial

An Investigation of the Effects of Opioid Receptor Blockade on Changes in Self-esteem and Social Attention

Completed·MMcGill University·N/A·NCT04757506·35 enrolled

Smokers1 trial

Targeted Interventions for Weight-Concerned Smokers

Completed·YYale University·Phase 2·NCT00105482·172 enrolled

Treatment Resistant Depression1 trial

Double-Blind Trial of Ketamine Therapy Plus or Minus Naltrexone in Treatment Resistant Depression (TRD)

Completed·SStanford University·Phase 1·NCT02911597·16 enrolled

Smoking1 trial

The Effect of Naltrexone and Varenicline on Alcohol-Mediated Smoking Lapse

Completed·YYale University·Phase 2·NCT00773422·30 enrolled

Prostate Cancer1 trial

Low Dose Naltrexone (LDN) for Management of Fatigue in Prostate Cancer Patients on Androgen Deprivation Therapy (ADT)

Not yet recruiting·UUniversity of Arkansas·Phase 2·NCT07224009·60 enrolled

Dry Eye1 trial

Effect of Topical Naltrexone Ophthalmic Solution on the Signs and Symptoms of Dry Eye in Diabetic Subjects

Completed·SSassani, Joseph S., MD, MHA·Phase 2·NCT03660475·60 enrolled

Cognition1 trial

Control of Cognition (Naltrexone, Methylphenidate, and ADHD Study (NMAS))

Completed·UUniversity of Michigan·Phase 4·NCT01993108·23 enrolled

Fasting Conditions1 trial

Exploratory Bioavailability of Fentanyl Sublingual Spray Under Fasting Conditions

Completed·IINSYS Therapeutics Inc·N/A·NCT02138396·12 enrolled

Cocaine Dependence1 trial

Naltrexone in Treatment of Cocaine Dependence - 5

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00015080

Experimental1 trial

Role of the Endogenous Opioid System Underlying Modulation of Experimental Pain

Withdrawn·UUniversity of Florida·N/A·NCT01327326

Eating Disorder1 trial

Naltrexone Neuroimaging in Teens With Eating Disorders

Recruiting·—·Phase 1·NCT05509257·60 enrolled

Randomized1 trial

A Randomized Placebo-Controlled, Crossover-Design Study of the Effects of Low Dose Naltrexone

Completed·UUniversity of California, San Francisco·Phase 3·NCT00501696·80 enrolled

Crohn's Disease1 trial

The Efficacy of Low Dose Naltrexone Therapy in Children With Crohn's Disease

Completed·MMilton S. Hershey Medical Center·Phase 2·NCT00715117·14 enrolled

Weight Gain1 trial

Naltrexone for Antipsychotic-Induced Weight Gain

Completed·YYale University·N/A·NCT01866098·144 enrolled

Cardiovascular1 trial

Effect of Heroin Use on Immune Activation and Cardiovascular Risk in HIV

Completed·MMetroHealth Medical Center··NCT03976258·190 enrolled

Ketamine1 trial

Glutamate and Opioid Mechanisms of Antidepressant Response to Ketamine

Completed·KKing's College London·Phase 1·NCT04977674·27 enrolled

Fentanyl1 trial

Pharmacokinetic Characterization of the Active, Separated System With PK Controller (Fentanyl Iontophoretic Transdermal System, 40 Mcg Fentanyl Per Activation).

Completed·IIncline Therapeutics, Inc.·Phase 1·NCT01750060·54 enrolled

Gulf War Illness1 trial

Trial of Naltrexone and Dextromethorphan for Gulf War Illness

Completed·—·Phase 2·NCT02206490·60 enrolled

Completed·PPain Therapeutics·Phase 1·NCT02165930·17 enrolled

Adolescent1 trial

Science-Based Treatment for Opioid-Dependent Adolescents

Unknown status·—·Phase 2·NCT00182572·80 enrolled

Diabetic Neuropathy1 trial

Low-Dose Naltrexone for the Treatment of Painful Diabetic Neuropathy

Recruiting·—·Phase 2·NCT04678895·35 enrolled

Gambling Disorder1 trial

Drug Treatment for Pathologic Gambling Disorder

Completed·UUniversity of Chicago·Phase 3·NCT00053677·83 enrolled

Stress Response1 trial

The Comparison of Stress Response to Rapid Opioid Detoxification Applying Different Methods of Opioid Antagonism

Completed·VVilnius University·N/A·NCT02362256·60 enrolled

Type 1 Diabetes1 trial

Naltrexone and Hypoglycemia in Type 1 Diabetes

Completed·UUniversity of Minnesota·Phase 1/2·NCT01053078·29 enrolled

Self-injurious behavior1 trial

Evaluation of Naltrexone as a Treatment for Self-injurious Behavior

Withdrawn·—·Phase 4·NCT02726035

Methadone1 trial

Addition of Naltrexone to Methadone Taper

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00135759·174 enrolled

Endometriosis1 trial

Low-Dose Naltrexone in Combination With Standard Treatment in Women With Endometriosis

Terminated·MMilton S. Hershey Medical Center·Phase 3·NCT03970330·9 enrolled

Parkinson's Disease1 trial

Naltrexone for Impulse Control Disorders in Parkinson's Disease

Completed·UUniversity of Pennsylvania·Phase 4·NCT01052831·50 enrolled

ALK1 trial

ALK21-006: Long-Term Study of Medisorb® Naltrexone (VIVITROL®)

Completed·AAlkermes, Inc.·Phase 3·NCT01218997·436 enrolled

Autism1 trial

Participant(s) With Autism and High Pain Tolerance Treated With High Dose Naltrexone

Completed·SState University of New York - Upstate Medical University··NCT05100563·1 enrolled

Tics1 trial

iSTEP-N 101b: Pharmacokinetics and Safety Study of Low- and High-Dose Naltrexone Implants vs Monthly Vivitrol in Healthy Volunteers

Not yet recruiting·AAkyso Therapeutics, LLC·Phase 1·NCT07064564·33 enrolled

Cannabis Use Disorder1 trial

Vivitrol Treatment for Cannabis Use Disorder

Terminated·CCentre for Addiction and Mental Health·Phase 2·NCT04139668·1 enrolled

Methamphetamine Use1 trial

Risky Decision Making in Methamphetamine Users: The Role of Opioid Blockade

Completed·OOregon Health and Science University·N/A·NCT01822132·76 enrolled

Immunodeficiency1 trial

Naltrexone for Opioid Dependent Released Human Immunodeficiency Virus Positive (HIV+) Criminal Justice Populations

Completed·YYale University·Phase 1/2·NCT01246401·151 enrolled

Drug1 trial

Feasibility Study of Extended-release Naltrexone (Vivitrol) in Drug Court Settings

Completed·—·Phase 4·NCT02978417·14 enrolled

Relapse1 trial

Opioid Relapse & HIV Risk: 48 Versus 24 Weeks of Injectable Extended Release Naltrexone

Completed·UUniversity of Pennsylvania·Phase 2/3·NCT01882361·77 enrolled

Outcome1 trial

Outcomes of Opioid Addicted Prisoners With Extended-Release Injectable Naltrexone

Completed·UUniversity of Pennsylvania·Phase 2/3·NCT02617628·146 enrolled

ALS1 trial

Targeted Naltrexone to Support Individuals Participating in Dry January

Recruiting·—·Phase 2·NCT07132177·20 enrolled

Function1 trial

To Evaluate the Influence of the A118G Polymorphism in the mu Opioid Receptor Gene (OPRM1) on Effects of GSK1521498 and Naltrexone on Physiological and Behavioural Markers of Brain Function in Healthy Social Drinkers

Completed· GSK logo

GSK·Phase 1·NCT01738867·56 enrolled

Opioid Addiction1 trial

Long Acting Naltrexone for Opioid Addiction: Focus on Sustained Abstinence and Recovery

Completed·LLars Tanum·Phase 4·NCT03647774·317 enrolled

Nicotine Dependence1 trial

Behavioral/Drug Therapy for Alcohol-Nicotine Dependence (Naltrexone/Nicotine Patch)

Completed·TThe University of Texas Health Science Center, Houston·Phase 4·NCT00000447·200 enrolled

Intravenous1 trial

Pharmacokinetic Study of Fentanyl 400 µg Sublingual Spray, Actiq® 400 µg Transmucosally, and Fentanyl Citrate Injection 100 µg Intravenously (iv)

Completed·IINSYS Therapeutics Inc·Phase 1·NCT01780233·40 enrolled

ART1 trial

Pharmacokinetic Study of Vivitrol in Healthy Participants

Completed·GGo Medical Industries Pty Ltd·Phase 1·NCT04716881·9 enrolled

ESS1 trial

Study of Naltrexone-Induced Blockade of Antidepressant Effects

Completed·MMarta Peciña, MD PhD·Phase 4·NCT04322526·25 enrolled

Prolonged Grief Disorder1 trial

Naltrexone for Prolonged Grief Disorder

Terminated·TTexas Tech University·Phase 4·NCT06140420·7 enrolled

Craving1 trial

Naltrexone, Craving, and Drinking

Completed·—·Phase 4·NCT00006203·180 enrolled

Maintenance Treatment1 trial

Naltrexone Maintenance Treatment of Alcoholism

Completed·TThe Scripps Research Institute·Phase 4·NCT00000450·159 enrolled

Cocaine Use Disorder1 trial

Extended-Release Naltrexone and Monthly Extended-Release Buprenorphine for Cocaine Use Disorder (CURB-2)

Completed·UUniversity of Texas Southwestern Medical Center·Phase 2·NCT05262270·427 enrolled

Ondansetron1 trial

Combined Pharmacotherapies for Alcoholism (Naltrexone/Ondansetron)

Completed·NNational Institute on Alcohol Abuse and Alcoholism (NIAAA)·Phase 2·NCT00027079·360 enrolled

Neuroimaging1 trial

Naltrexone Neuroimaging

Completed·—·Phase 1·NCT04935931·13 enrolled

Methamphetamine1 trial

Study of Naltrexone for Methamphetamine Addiction

Completed·—·Phase 2·NCT00984360·22 enrolled

Biomarkers1 trial

Biomarkers of Injectable Extended Release Naltrexone Treatment

Completed·UUniversity of Pennsylvania·Phase 4·NCT02324725·32 enrolled

MRI1 trial

Depot Naltrexone Mechanism of Action in Heroin Dependent Patients Using fMRI and SPECT

Completed·—·Phase 4·NCT01471145·40 enrolled

Clinical Trial1 trial

Clinical Trial to Reduce Drinking in Women With HIV

Completed·UUniversity of Florida·Phase 3·NCT01625091·194 enrolled

Weight loss1 trial

Effectiveness of Alternative Therapies in Maintaining Weight Loss Achieved by GLP-1 Medications Post-Cessation

Recruiting·AAgelessRx·Phase 2/3·NCT07092618·150 enrolled

Unspecified10 trials

Naltrexone Augmentation of Nicotine Patch Therapy - 1

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 3·NCT00218153·200 enrolled

Evaluation of Intranasal Naltrexone and Naloxone

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 1·NCT03851731·12 enrolled

Effects of Naltrexone on Nicotine Reinforcement

Completed·UUniversity of Pennsylvania·Phase 2·NCT00270231·64 enrolled

Show 7 more trials

Augmenting Zyprexa With Naltrexone to Ameliorate Metabolic Side-Effects

Completed·MMclean Hospital·Phase 1·NCT00567034·30 enrolled

Study to Evaluate the Safety of SP-104

Completed·SScilex Pharmaceuticals, Inc.·Phase 1·NCT04958876·52 enrolled

The Effect of Regular Naltrexone Dosing on Disordered Gamblers

Completed·UUniversity of Calgary·Phase 1·NCT02537197·35 enrolled

Use of Naltrexone in a Clinical Setting

Completed·NNational Institute on Alcohol Abuse and Alcoholism (NIAAA)·Phase 4·NCT00000445·300 enrolled

The O'Neil Long Acting Naltrexone Implant (OLANI) Pharmacokinetic (PK)/Safety Study in Healthy Volunteers

Completed·GGo Medical Industries Pty Ltd·Phase 1·NCT03810495·20 enrolled

Exploring the PK of Different Doses of Naltrexone in Patients With AUD

Unknown status·SShenzhen Sciencare Medical Industries Co., Ltd.·Phase 1·NCT05919017·60 enrolled

Naltrexone for Early Problem Drinkers

Completed·UUConn Health·Phase 4·NCT00000455·160 enrolled

Regulatory

FDA Approval Timeline[5]

Nov 20, 1984

REVIA

NDA NDA018932

Apr 13, 2006

VIVITROL

NDA NDA021897

Sources

References

[1]
ClinicalTrials.gov — 225 trial records for Naltrexone. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — ReVia drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Naltrexone compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Naltrexone. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021897). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for ReVia. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Teva company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Opioid Receptors; Mu/kappa/delta Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Teva

Patent Landscape[6]

Patent Cliff

Oct 15, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7919499Oct 15, 2029

ReVia

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q1 2028

Q3 2028

Trials by Indication[1]

Alcohol Dependence19 trials

Treatment13 trials

Alcohol7 trials

Opioid6 trials

Opioid Dependence6 trials

Alcoholism6 trials

COVID-194 trials

Buprenorphine4 trials

Oral4 trials

Prevention4 trials

Effectiveness4 trials

Alcohol Use Disorder4 trials

Atopic Dermatitis3 trials

Alcohol Use Disorders3 trials

Schizophrenia3 trials

Breast Cancer2 trials

Double-blind2 trials

Depression2 trials

Medication2 trials

Borderline personality disorder2 trials

MPR2 trials

Smoking Cessation2 trials

Opioid Use Disorder2 trials

Drug Abuse2 trials

MPA2 trials

Opioids2 trials

Pathological Gambling2 trials

Attention Deficit Hyperactivity Disorder2 trials

Maintenance Therapy2 trials

Pilot Study2 trials

Substance Abuse1 trial

Age1 trial

Cigarette Smoker1 trial

Adult1 trial

Alcohol Use1 trial

Alcohol Drinking1 trial

Trichotillomania1 trial

Marijuana1 trial

Post-Traumatic Stress Disorder1 trial

Osteoarthritis1 trial

Alcohol Misuse1 trial

Chronic pain1 trial

Metastatic Melanoma1 trial

Attention1 trial

Smokers1 trial

Treatment Resistant Depression1 trial

Smoking1 trial

Prostate Cancer1 trial

Dry Eye1 trial

Cognition1 trial

Fasting Conditions1 trial

Cocaine Dependence1 trial

Experimental1 trial

Eating Disorder1 trial

Randomized1 trial

Crohn's Disease1 trial

Weight Gain1 trial

Cardiovascular1 trial

Ketamine1 trial

Fentanyl1 trial

Gulf War Illness1 trial

Infusion1 trial

Cirrhosis1 trial

Oxycodone1 trial

Adolescent1 trial

Diabetic Neuropathy1 trial

Gambling Disorder1 trial

Stress Response1 trial

Type 1 Diabetes1 trial

Self-injurious behavior1 trial

Methadone1 trial