Data updated: May 26, 2026
VIVITROL (naltrexone)
Trial Activity: Declining 8 active trials
CNS
Approved 2006-04-13
VIVITROL is indicated for the treatment of Alcohol Dependence; Opioid Dependence.
Source: FDA Label • ALKERMES
How VIVITROL Works
Naltrexone functions as an opioid antagonist with a high affinity for the mu opioid receptor. It binds to these receptors but possesses little to no opioid agonist activity, meaning it does not activate the receptors. By occupying these biological targets, the medication blocks the effects of opioid substances.
Development Insights
New York State Psychiatric Institute conducting 8 trials (9%)
100 indications explored (Broad Platform)
→ opioid dependence (6 trials)
→ alcohol dependence (6 trials)
→ alcohol use disorder (5 trials)
2
Indications
--
Phase 3 Trials
2
Priority Reviews
20
Years on Market
Details
- Status
- Prescription
- First Approved
- 2006-04-13
- Patent Cliff
- 2029
- Routes
- INTRAMUSCULAR
- Dosage Forms
- FOR SUSPENSION, EXTENDED RELEASE
VIVITROL Approval History
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
28 FDA actions from 2006 to 2025 · 1 indication expansions
Jun 2019 SUPPL
Update
Dec 2016 SUPPL
Mfg
Dec 2016 SUPPL
Mfg
May 2016 SUPPL Priority
Mfg
Jan 2016 SUPPL Priority
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Jan 2015 SUPPL Priority
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Aug 2014 SUPPL Priority
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Apr 2014 SUPPL Priority
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Feb 2014 SUPPL Priority
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Jan 2014 SUPPL Priority
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Mar 2013 SUPPL Priority
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Aug 2010 SUPPL
Mfg
What VIVITROL Treats
2 indicationsVIVITROL is approved for 2 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Alcohol Dependence
- Opioid Dependence
Source: FDA Label
VIVITROL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
1
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
5
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
1
Same indication, different mechanism — what else might this patient receive?
Unlock 3 more competitors across all three rings.
Upgrade to Pro Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to VIVITROL
3 of 4FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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Clinical Trial Registry
87 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 |
| NCT04454411 results posted | 843403 | Ph 2 | terminated | Brain Mechanisms of Pharmacotherapy in Opioid Use Disorder |
| 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 |
| NCT01587196 fMRI CURE results posted | 813953 | Ph 2 | completed | CURE Addiction Center of Excellence: Brain Mechanisms of Relapse and Recovery |
| 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 | 57305 | Ph 2 | suspended | 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 |
| NCT04828694 | BioCorRx-21-01a UG3DA047925 | Ph 1 | completed | Pharmacokinetic and Safety Study of Naltrexone Release From Subcutaneous BICX104 Pellets Compared to Vivitrol Injections |
| 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 |
| NCT03232346 results posted | 7522 1R21DA042243 | Ph 3 | completed | A Strategy to Improve Success of Treatment Discontinuation in Buprenorphine Responders |
| 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 |
Showing 50 of 87 trials
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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.
VIVITROL FDA Label Details
Indications & Usage
FDA Label (PDF)VIVITROL is indicated for the treatment of Alcohol Dependence; Opioid Dependence.
View full patent landscape →
1 OB patents · 1 families ·
25 international docs across 10 countries
VIVITROL Patents & Exclusivity
Latest Patent: Oct 2029
Patents (1 active)
US7919499
Expires Oct 15, 2029
Source: FDA Orange Book
Pro Intelligence Preview
Deep insights for VIVITROL
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2029
- • 2 active patents
Trial Analysis
- • 89 total trials
- • Stage: Declining
Competitive Landscape
- • 4 similar drugs
- • Same target/indication analysis
Unlock Full Intelligence
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment