TheraRadar
Data updated: Jul 17, 2026

NALTREXONE · Teva

Generic · see VIVITROL
CNS Approved 2006-04-13

NALTREXONE is FDA-approved to treat 2 conditions (same as VIVITROL).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
20
Years on Market

Details

Status
Prescription
First Approved
2006-04-13
Routes
INTRAMUSCULAR
Dosage Forms
FOR SUSPENSION, EXTENDED RELEASE

Companies

Teva
Active Ingredient: NALTREXONE

NALTREXONE Approval History

2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2023 to 2023
Jul 2023 ORIGINAL
Update
FDA Letter

What NALTREXONE Treats

2 indications

NALTREXONE is approved for 2 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Alcohol Dependence
  • Opioid Dependence

Same approved indications as VIVITROL (same active ingredient).

Source: FDA Label

Teva's other novel FDA approvals

Other CDER-designated drugs from the same sponsor (2016–2025).

AJOVY
2018
FREMANEZUMAB-VFRM
1 designation
AUSTEDO
2017
DEUTETRABENAZINE
1 designation
CINQAIR
2016
RESLIZUMAB
1 designation
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Clinical Trial Registry

79 trials
Trial Sponsor ID Phase Status Title
NCT04678895 D20145 Ph 2 recruiting Low-Dose Naltrexone for the Treatment of Painful Diabetic Neuropathy
NCT07224009 299392 Ph 2 not yet recruiting Low Dose Naltrexone (LDN) for Management of Fatigue in Prostate Cancer Patients on Androgen Deprivation Therapy (ADT)
NCT05458609 results posted H-52091 Ph 3 completed Lemborexant Augmentation of Naltrexone for Alcohol Craving and Sleep
NCT07475546 ALRx011 Ph 3 active not recruiting Combination Gerotherapeutic Interventions for Healthspan Improvement
NCT07433413 AUD SK2007-NQT-301 Ph 3 not yet recruiting Evaluate the Efficacy and Safety of Naltrexone Hydrochloride Implant in Patients With Alcohol Use Disorder
NCT04276259 RAISE STUDY19050307 1R01MH122548-01 Ph 4 completed Rapid Antidepressant Improvement Secondary to Excitatory Brain Responses
NCT05968690 092302 Pro2023001214, NCI-2023-06872 Ph 1 recruiting Naltrexone and Propranolol Combined With Immunotherapy
NCT07092618 ALRx009 Ph 2, Ph 3 recruiting Effectiveness of Alternative Therapies in Maintaining Weight Loss Achieved by GLP-1 Medications Post-Cessation
NCT02330419 SayWhen results posted 1DP5OD019809 1DP5OD019809 Ph 2 completed Better Than Study: Targeting Heavy Alcohol Use With Naltrexone Among Men Who Have Sex With Men (MSM)
NCT01950520 results posted 130200 13-DK-0200 Ph 2 completed Study of Human Non-Shivering Thermogenesis and Basal Metabolic Rate
NCT06622239 NiNsSIB AYM-NiNsSIB Ph 2 not yet recruiting Trial to Evaluate the Effects of Naltrexone in Nonsuicidal Self-injury
NCT06426303 ABSTAIN 25536 Ph 4 recruiting Sex Differences in Trauma, Inflammation and Brain Function and the Implications for Treatment Efficacy in Alcohol Use Disorder
NCT04450316 results posted 57305 Ph 2 terminated Low-dose Naltrexone for Bladder Pain Syndrome
NCT04854551 results posted 21-2886 Ph 1, Ph 2 completed Opioid Modulation and Neural Reward Activation in Healthy Adults
NCT02885311 results posted 15-0743 R34AA024589 Ph 1, Ph 2 completed Collaborative Care for Alcohol Use Disorders in the Patient-centered Medical Home
NCT04249882 results posted 19-001735 R21AA027180 Ph 2 completed A Novel Human Lab Model for Screening AUD Medications
NCT04756128 COLTREXONE results posted X2103400 Ph 2 completed Impact of Colchicine and Low-dose Naltrexone on COVID-19
NCT04325802 DERM-2019-28471 Ph 2 withdrawn Treatment of Chronic Itch in Atopic Dermatitis With Opioid Antagonist Naltrexone
NCT00775229 results posted 0806M36061 Ph 2 completed Naltrexone in the Treatment of Trichotillomania
NCT02268448 DERM-2006-15390 Ph 1 completed Treatment of Chronic Itch in Atopic Dermatitis (Eczema): Nerve Function
NCT04604704 ALRx004 Ph 2 completed Pilot Study Into LDN and NAD+ for Treatment of Patients With Post-COVID-19 Syndrome
NCT02324725 814234 Ph 4 completed Biomarkers of Injectable Extended Release Naltrexone Treatment
NCT03660475 results posted DDES001/18-110-0002 Ph 2 completed Effect of Topical Naltrexone Ophthalmic Solution on the Signs and Symptoms of Dry Eye in Diabetic Subjects
NCT03970330 results posted Study00011187 Ph 3 terminated Low-Dose Naltrexone in Combination With Standard Treatment in Women With Endometriosis
NCT04604678 ALRx003 Ph 2 withdrawn Pilot Study Into the Use of Metformin and LDN for Patients With COVID-19
NCT01625611 results posted 1011007710 R01AA021818-01A1, U54AA027989 Ph 1 completed Kappa-PET Imaging and Naltrexone in Alcohol Drinking Behaviors
NCT02537197 REB15-2025 Ph 1 completed The Effect of Regular Naltrexone Dosing on Disordered Gamblers
NCT01650350 results posted BrUOG 275 Ph 2 terminated Low Dose Naltrexone for Metastatic Melanoma, Castrate Resistant Prostate Cancer and Renal Cancer
NCT03113409 results posted #7456 Ph 2, Ph 3 terminated Buprenorphine as Adjunct to Outpatient Induction Onto Vivitrol
NCT04365985 SINK COVID-19 results posted 2020-097 Ph 2 terminated Study of Immunomodulation Using Naltrexone and Ketamine for COVID-19
NCT02137252 results posted 14-056 R01CA150226 Ph 2 terminated Naltrexone RCT for Treatment-Emergent Fatigue in Patients Receiving Radiation Therapy for Breast Cancer
NCT02736474 results posted MZhao-005 Ph 4 completed Naltrexone and Bupropion Combination on Obese,Smoking Patients With Schizophrenia
NCT04154033 DERM-2019-27870 Ph 2 withdrawn Treatment of Chronic Itch in Atopic Dermatitis With Topical Naltrexone
NCT03008590 LDN-VA results posted NURB-008-16S Ph 2 completed Low Dose Naltrexone for Chronic Pain From Arthritis
NCT02322047 PaN results posted W81XWH-14-1-0025 Ph 2 completed Prazosin and Naltrexone (PaN) Study for Veterans With Alcohol Use Disorders
NCT03851731 Naltrexone-Ph1a-001 Ph 1 completed Evaluation of Intranasal Naltrexone and Naloxone
NCT00568958 results posted 0706002743 R01AA016621, NIH grant AA016621-01 Ph 4 completed Naltrexone for Heavy Drinking in Young Adults
NCT01053078 Naltrexone results posted 0903M60907 R01DK062440, 7-09-DCS-02 Ph 1, Ph 2 completed Naltrexone and Hypoglycemia in Type 1 Diabetes
NCT04115020 2019P001799 Ph 2 withdrawn Low Dose Naltrexone for Chronic Pain in Osteoarthritis and Inflammatory Arthritis
NCT03854942 10-002 Ph 1 terminated Study of the Opioid Modulation of the Effect of Alcohol on the Dopaminergic Reward System
NCT03132571 NBC results posted 1606017928 Ph 2 terminated Naltrexone-Bupropion Versus Placebo-Bupropion for Weight Loss in Schizophrenia
NCT02026011 results posted NTX-AA R01AA021744 Ph 2 completed Naltrexone for Individuals of East Asian Descent
NCT01227044 DAWN results posted 0909005730 1R01AA018923 Ph 2, Ph 3 completed Reducing Heavy Drinking to Optimize HIV/AIDS Treatment and Prevention
NCT01856712 results posted 2012-0702 Ph 3 completed Oral vs. Injectable Naltrexone for Hospitalized Veterans With Alcohol Dependence
NCT02696434 results posted ALK6428-A302 Ph 3 completed Evaluating Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL
NCT02842073 results posted 16-1370 TTSA018P1 Ph 2 completed An Open Label Trial of Bupropion and Naltrexone for Binge Drinking
NCT02593474 #7146 U54DA037842 Ph 1 completed Medication-Assisted Treatment for Youth With Substance Use Disorders
NCT00743145 results posted IRB# 5693 DA19239 Ph 2 completed Effects of Low-dose Naltrexone in Combination With a Range of Smoked Marijuana
NCT00715117 LDN-Ped results posted PSU-IRB-27793 Ph 2 completed The Efficacy of Low Dose Naltrexone Therapy in Children With Crohn's Disease
NCT01625091 WHATIF results posted 86-2012-N U01AA020797-01 Ph 3 completed Clinical Trial to Reduce Drinking in Women With HIV

Showing 50 of 79 trials

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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

NALTREXONE FDA Label Details

Indications & Usage

NALTREXONE is FDA-approved to treat 2 conditions — same approved indications as VIVITROL.

Looking for the branded version?

VIVITROL

Full clinical data, patents, trials, and competitive landscape for naltrexone.

See VIVITROL

Data Sources

FDA Approval: ANDA213195 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.