drugset
Drugs / Naltrexone
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Naltrexone

also known as Vivitrol · XRNTX · Revia · NTX · Naltrexone hydrochloride · LDN · Extended-Release Naltrexone · Naltrexone HCl · +20 more

Small molecule targets TLR4 via inhibition

Developed for
alcohol dependence · opiate dependence · obesity disorder · alcohol-related disorders · substance-related disorder · major depressive disorder · binge eating disorder · cocaine dependence
+88 more · nicotine dependence · alcohol abuse · heroin dependence · methamphetamine dependence · bipolar disorder · COVID-19 · depressive disorder · migraine disorder · schizophrenia · attention deficit-hyperactivity disorder · chronic pain syndrome · fibromyalgia · pathological gambling · schizoaffective disorder · substance abuse · cannabis dependence · eating disorder · osteoarthritis · stereotypic movement disorder · anorexia nervosa · atopic eczema · breast cancer · bulimia nervosa · Crohn disease · melanoma · myalgic encephalomeyelitis/chronic fatigue syndrome · obsessive-compulsive disorder · opioid abuse · psoriatic arthritis · type 2 diabetes mellitus · vulvodynia · alcohol-induced disorders · alcoholic liver disease · amphetamine abuse · borderline personality disorder · brain injury · Charcot-Marie-Tooth disease · Charcot-Marie-Tooth disease type 1A · cirrhosis of liver · cocaine abuse · complex regional pain syndrome · complex regional pain syndrome type 1 · complex regional pain syndrome type 2 · corneal ulcer · dermatitis · diabetic polyneuropathy · drug dependence · dry eye syndrome · endometriosis · frontal fibrosing alopecia · headache disorder · hypoglycemia · impulse control disorder · interstitial cystitis · kidney cancer · lichen planopilaris · long COVID-19 · malignant glioma · metastatic prostate carcinoma · morbid obesity · multiple sclerosis · neurological pain disorder · neuropathy, painful · persian gulf syndrome · pervasive developmental disorder · post-traumatic stress disorder · post-viral disorder · prostate cancer · psoriasis · radiculopathy · schizophreniform disorder · spinal cord injury · tuberculosis · type 1 diabetes mellitus · ulcerative colitis · alcohol-induced mental disorder · dissociative disorder · eosinophilic granulomatosis with polyangiitis · fibrotic liver disease · kleptomania · metabolic dysfunction-associated steatotic liver disease · microscopic polyangiitis · polyarteritis nodosa · psychiatric disorder · pyromania · sexual disorder · Takayasu arteritis · trichotillomania
Investigated by
National Institute on Drug Abuse (NIDA) · National Institute on Alcohol Abuse and Alcoholism (NIAAA) · Yale University · Alkermes, Inc. · New York State Psychiatric Institute · Orexigen Therapeutics, Inc
+232 more · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · University of Pennsylvania · Pfizer · Allodynic Therapeutics, Inc · Stanford University · University of California, Los Angeles · Columbia University · Medical University of South Carolina · University of Minnesota · AgelessRx · Bausch Health Americas, Inc. · Brown University · Johns Hopkins University · NYU Langone Health · Shenzhen Sciencare Medical Industries Co., Ltd. · The Emmes Company, LLC · The University of Texas Health Science Center, Houston · University of California, San Francisco · University of Oslo · Alza Corporation · Brigham and Women's Hospital · Centre for Addiction and Mental Health · Friends Research Institute, Inc. · Go Medical Industries Pty Ltd · Massachusetts General Hospital · National Institute of Mental Health (NIMH) · Research Foundation for Mental Hygiene, Inc. · State University of New York - Upstate Medical University · UConn Health · US Department of Veterans Affairs · University of Alabama at Birmingham · University of Texas Southwestern Medical Center · VA Office of Research and Development · Akyso Therapeutics, LLC · Bankole Johnson · Boston Medical Center · Cephalon · Children's Mercy Hospital Kansas City · Clinilabs, Inc. · Elite Laboratories, Inc · Haukeland University Hospital · Indiana University · Institute of Liver and Biliary Sciences, India · Marta Peciña, MD PhD · Mayo Clinic · Mclean Hospital · Milton S. Hershey Medical Center · National Health and Medical Research Council, Australia · National Institutes of Health (NIH) · Oregon Health and Science University · Oslo University Hospital · Seoul National University Hospital · St. Joseph's Healthcare Hamilton · The Hospital of Vestfold · The Research Council of Norway · United States Department of Defense · University of Chicago · University of Colorado, Denver · University of Kansas Medical Center · University of North Carolina, Chapel Hill · University of Sydney · VA Boston Healthcare System · VA Connecticut Healthcare System · Academic Medical Center - University of Amsterdam · Albert Einstein Healthcare Network · Alberta Health services · Aliri Bioanalysis · American Diabetes Association · American Fibromyalgia Syndrome Association · American Psychological Foundation · American Society for Metabolic and Bariatric Surgery · Annette C. Toledano MD · Ardena · Asan Medical Center · all 238 on the full record

Regulatory milestones approvals, filings & regulatory actions · 8 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed alcohol dependence 3 milestones
Filed Other VIVITROL alcohol dependence 2008-05-22

“New drug application for VIVITROL submitted in Russia.” alkermes.com ↗
Filed UK (MHRA) VIVITROL alcohol dependence 2007-04-02

“submitted a Marketing Authorization Application (MAA) for VIVITROL® (naltrexone for extended-release injectable suspension) to regulatory authorities in the United Kingdom...” alkermes.com ↗
Filed US (FDA) Vivitrex alcohol dependence 2005-03-31

“today announced that the Company has submitted a New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for marketing approval of Vivitrex(R)” alkermes.com ↗

“On March 31, 2005, Alkermes submitted a New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for marketing approval of Vivitrex” alkermes.com ↗
Filed opiate dependence 1 milestone
Filed US (FDA) VIVITROL opiate dependence 2010-04-13

“The Advisory Committee's recommendation, while not binding, will be considered by the FDA in its review of the supplemental New Drug Application (sNDA) that Alkermes has...” alkermes.com ↗

“submitted a supplemental New Drug Application (sNDA) for VIVITROL® (naltrexone for extended-release injectable suspension) to the U.S. Food and Drug Administration (FDA)” alkermes.com ↗

“The company recently submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the treatment of opioid dependence.” alkermes.com ↗

“The sNDA for VIVITROL for the treatment of opioid dependence was submitted in April 2010.” alkermes.com ↗
Approved Indication not stated 4 milestones
Approved EU (EMA) Mysimba — 2015-03-26 europa.eu ↗
Label expansion US (FDA) VIVITROL — 2010-10-12 fda.gov ↗
Label expansion US (FDA) REVIA — 1994-12-30 fda.gov ↗
Approved US (FDA) REVIA — 1984-11-20 fda.gov ↗

Trials 316 · started per year

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EU approved 2015
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 09 trials · 1 missed
Phase 0 NCT04553263 Jun 2023 → Jan 2025 attention deficit-hyperactivity disorder, cognitive disorder, substance abuse University of California, Los Angeles Withdrawn No outcome recorded
Phase 0 NCT05509257 Sep 2022 → Sep 2026 overdue anorexia nervosa, binge eating disorder, bulimia nervosa Children's Mercy Hospital Kansas City Recruiting No outcome recorded
Phase 0 NCT05007561 Nov 2021 → Mar 2026 — San Diego State University Completed No outcome recorded
Phase 0 NCT04977674 Sep 2021 → Feb 2023 major depressive disorder King's College London Completed No outcome recorded
Phase 0 NCT04935931 Jul 2021 → Jun 2022 binge eating disorder Children's Mercy Hospital Kansas City Completed No outcome recorded
Phase 0 NCT04562779 Jan 2021 → Jan 2022 alcohol dependence Denver Health and Hospital Authority Completed Missed primary
Phase 0 NCT03447743 Sep 2019 → Mar 2022 opiate dependence Michele Staton Completed No outcome recorded
Phase 0 NCT03766893 Sep → Dec 2018 opiate dependence Lifespan Completed No outcome recorded
Phase 0 NCT00667771 Apr 2008 → Dec 2010 alcohol dependence National Institute on Alcohol Abuse and Alcoholism (NIAAA) Completed No outcome recorded
Phase 138 trials · 2 met primary
Phase 1 NCT07224087 Oct 2026 → Dec 2027 expected obesity disorder Medical University of South Carolina Not yet recruiting No outcome recorded
Phase 1 NCT07064564 Jul 2026 → Oct 2029 expected opiate dependence Akyso Therapeutics, LLC Active not recruiting No outcome recorded
Phase 1 NCT06374290 Jul → Dec 2024 — The University of Texas Health Science Center, Houston Terminated No outcome recorded Stop: Enrollment
Phase 1 NCT06216132 Jun 2024 → Apr 2025 substance-related disorder Akyso Therapeutics, LLC Completed No outcome recorded
Phase 1 NCT05968690 Sep 2023 → Sep 2026 overdue melanoma Sarah Weiss Recruiting No outcome recorded
Phase 1 NCT05919017 Jun → Dec 2023 — Shenzhen Sciencare Medical Industries Co., Ltd. Unknown No outcome recorded
Phase 1 NCT04828694 Jun 2022 → Feb 2023 opiate dependence BioCorRx Inc Completed No outcome recorded
Phase 1 NCT05304364 Mar → Oct 2022 substance-related disorder Delpor, Inc. Completed No outcome recorded
Phase 1 NCT04708327 Dec 2021 → Jun 2022 COVID-19 Cytocom, Inc. Unknown No outcome recorded
Phase 1 NCT04958876 Oct → Dec 2021 — Scilex Pharmaceuticals, Inc. Completed No outcome recorded
Phase 1/215 trials · 2 missed
Phase 1/2 NCT07398404 Sep 2026 → Dec 2030 expected obesity disorder Medical University of South Carolina Not yet recruiting No outcome recorded
Phase 1/2 NCT04854551 May 2021 → Apr 2022 alcohol-related disorders University of Colorado, Denver Completed No outcome recorded
Phase 1/2 NCT03447782 Jul 2018 → Nov 2020 headache disorder Boston Children's Hospital Completed No outcome recorded
Phase 1/2 NCT03278886 Jul → Dec 2018 HIV infectious disease, alcohol-related disorders Boston Medical Center Completed No outcome recorded
Phase 1/2 NCT02885311 Jan 2017 → Oct 2018 alcohol abuse, alcohol dependence Northwell Health Completed No outcome recorded
Phase 1/2 NCT02696512 Mar 2016 → Mar 2017 brain injury International Brain Research Foundation Unknown No outcome recorded
Phase 1/2 NCT02461927 Jan 2015 → Oct 2023 alcohol dependence, major depressive disorder VA Office of Research and Development Completed Missed primary
Phase 1/2 NCT02088177 Oct 2014 → Mar 2016 cannabis dependence New York State Psychiatric Institute Completed No outcome recorded
Phase 1/2 NCT01982643 Nov 2013 → Feb 2015 methamphetamine dependence Walter Ling Completed No outcome recorded
Phase 1/2 NCT01895036 Feb 2011 → Sep 2013 opiate dependence New York State Psychiatric Institute Completed No outcome recorded
Phase 295 trials · 2 met primary · 12 missed
Phase 2 NCT05382091 Jan 2027 → Jul 2029 expected opiate dependence Go Medical Industries Pty Ltd Not yet recruiting No outcome recorded
Phase 2 NCT07862400 Jan → Jul 2027 expected vulvodynia University of Florida Not yet recruiting No outcome recorded
Phase 2 NCT07285473 Nov 2026 → Apr 2028 expected myalgic encephalomeyelitis/chronic fatigue syndrome University of Alabama at Birmingham Not yet recruiting No outcome recorded
Phase 2 NCT07249554 Nov 2026 → Jul 2028 expected alcohol-related disorders Johns Hopkins University Not yet recruiting No outcome recorded
Phase 2 NCT07224009 Aug 2026 → Jan 2029 expected metastatic prostate carcinoma University of Arkansas Recruiting No outcome recorded
Phase 2 NCT06622239 Jun 2026 → Feb 2027 expected — Seoul National University Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07132177 Nov 2025 → Apr 2026 alcohol abuse Brigham and Women's Hospital Completed No outcome recorded
Phase 2 NCT06723561 Feb 2025 → Jun 2026 overdue neurological pain disorder, spinal cord injury Medical College of Wisconsin Active not recruiting No outcome recorded
Phase 2 NCT05685225 Jan → Dec 2025 migraine disorder Allodynic Therapeutics, Inc Withdrawn No outcome recorded Stop: Enrollment
Phase 2 NCT05940324 Feb 2024 → Nov 2028 expected obsessive-compulsive disorder Stanford University Recruiting No outcome recorded
Phase 2/316 trials · 2 met primary
Phase 2/3 NCT06633900 Apr 2025 → Apr 2027 expected — University of California, San Francisco Recruiting No outcome recorded
Phase 2/3 NCT07092618 Dec 2024 → Aug 2025 overdue — AgelessRx Recruiting No outcome recorded
Phase 2/3 NCT05073679 Apr 2022 → May 2024 anorexia nervosa, bulimia nervosa, impulse control disorder Rosemary Claire Roden Terminated No outcome recorded Stop: Enrollment
Phase 2/3 NCT04605081 Jan 2022 → May 2027 expected eating disorder, obesity disorder Yale University Active not recruiting No outcome recorded
Phase 2/3 NCT04662801 Aug 2021 → Sep 2022 obesity disorder Yale University Completed No outcome recorded
Phase 2/3 NCT04599478 Jun 2021 → Dec 2025 overdue eating disorder, obesity disorder Yale University Active not recruiting No outcome recorded
Phase 2/3 NCT03946111 Aug 2019 → Dec 2024 binge eating disorder, obesity disorder Yale University Completed No outcome recorded
Phase 2/3 NCT03539900 Apr 2018 → Apr 2022 binge eating disorder Yale University Completed Mixed
Phase 2/3 NCT03047005 Aug 2017 → Dec 2021 binge eating disorder, obesity disorder Yale University Completed Mixed
Phase 2/3 NCT03185143 Jun 2017 → May 2018 migraine disorder Allodynic Therapeutics, Inc Completed No outcome recorded
Phase 345 trials · 10 met primary · 3 missed
Phase 3 NCT07433413 Mar 2026 → Apr 2027 expected alcohol-related disorders Shenzhen Sciencare Medical Industries Co., Ltd. Not yet recruiting No outcome recorded
Phase 3 NCT07475546 Jul 2025 → Apr 2026 overdue — AgelessRx Active not recruiting No outcome recorded
Phase 3 NCT05827159 Aug 2024 → Dec 2027 expected alcohol-related disorders Yale University Recruiting No outcome recorded
Phase 3 NCT06233799 Jul 2024 → Oct 2026 expected amphetamine abuse, methamphetamine dependence National Institute on Drug Abuse (NIDA) Active not recruiting No outcome recorded
Phase 3 NCT05157698 Jan 2022 → May 2026 obesity disorder Yale University Completed No outcome recorded
Phase 3 NCT05092841 Sep 2021 → Mar 2024 Charcot-Marie-Tooth disease type 1A Tasly GeneNet Pharmaceuticals Co., Ltd Completed No outcome recorded
Phase 3 NCT04762758 Mar 2021 → Apr 2024 Charcot-Marie-Tooth disease Pharnext S.C.A. Unknown No outcome recorded
Phase 3 NCT03970330 Jan 2020 → Jun 2021 endometriosis Milton S. Hershey Medical Center Terminated Missed primary Stop: Business
Phase 3 NCT03232346 Aug 2017 → Jun 2021 opiate dependence New York State Psychiatric Institute Completed No outcome recorded
Phase 3 NCT03479086 Jun 2017 → Nov 2020 alcohol dependence South West Sydney Local Health District Unknown No outcome recorded
Phase 471 trials · 3 met primary · 6 missed
Phase 4 NCT07832084 Nov 2026 → Apr 2027 expected obesity disorder Jing Luo Not yet recruiting No outcome recorded
Phase 4 NCT07213466 Jan 2026 → Feb 2028 expected bipolar I disorder, bipolar II disorder, obesity disorder, schizoaffective disorder Mayo Clinic Recruiting No outcome recorded
Phase 4 NCT06620562 Jun 2025 → Jun 2028 expected morbid obesity Laval University Recruiting No outcome recorded
Phase 4 NCT06605703 Sep 2024 → Feb 2026 obesity disorder WW International Inc Completed No outcome recorded
Phase 4 NCT06809166 Jul 2024 → Jan 2026 overdue obesity disorder The Royal's Institute of Mental Health Research Recruiting No outcome recorded
Phase 4 NCT06426303 May 2024 → Dec 2028 expected alcohol-related disorders Oregon Health and Science University Recruiting No outcome recorded
Phase 4 NCT06306157 Jan 2024 → Aug 2026 overdue complex regional pain syndrome type 1, complex regional pain syndrome type 2 Hospital for Special Surgery, New York Enrolling by invitation No outcome recorded
Phase 4 NCT05919797 Jun 2023 → Jun 2027 expected obesity disorder Columbia University Recruiting No outcome recorded
Phase 4 NCT05537935 Apr 2023 → Jun 2027 expected HIV infectious disease, neuropathy, painful Emory University Recruiting No outcome recorded
Phase 4 NCT04739995 Jun 2022 → Oct 2024 — Fundació Sant Joan de Déu Unknown No outcome recorded
Phase not applicable27 trials · 1 met primary · 2 missed
— NCT07641283 Jun 2026 → Dec 2027 expected stereotypic movement disorder Seoul National University Hospital Not yet recruiting No outcome recorded
— NCT06175507 Dec 2023 → Mar 2025 alcoholic liver disease Institute of Liver and Biliary Sciences, India Unknown No outcome recorded
— NCT05053503 May 2022 → Apr 2025 opiate dependence, substance withdrawal syndrome Spark Biomedical, Inc. Completed No outcome recorded
— NCT05924893 Jan 2021 → Jun 2022 corneal ulcer Minia University Completed No outcome recorded
— NCT04391764 Dec 2020 → Oct 2022 cirrhosis of liver Institute of Liver and Biliary Sciences, India Completed No outcome recorded
— NCT03581630 Jul 2017 → Jul 2018 breast cancer, obesity disorder Gangnam Severance Hospital Completed No outcome recorded
— NCT02818036 Aug 2016 → Jun 2018 — Tristen Inagaki Completed Mixed
— NCT02965768 Jan 2016 → Aug 2022 myalgic encephalomeyelitis/chronic fatigue syndrome University of Alabama at Birmingham Withdrawn No outcome recorded
— NCT02502162 Jun 2015 → Jul 2027 expected complex regional pain syndrome Stanford University Recruiting No outcome recorded
— NCT02317744 Dec 2014 → Sep 2016 binge eating disorder Yale University Completed Missed primary
Comparator or background therapy113 trials
Phase 0 NCT04166071 Comparator Dec 2021 → Sep 2026 overdue — University of California, Los Angeles Enrolling by invitation No outcome recorded
Phase 0 NCT01175512 Comparator Jul 2010 → Dec 2011 opiate dependence University of California, San Francisco Completed No outcome recorded
Phase 1 NCT07269873 Comparator Mar → Dec 2026 expected — BioCorRx Pharmaceuticals Inc Recruiting No outcome recorded
Phase 1 NCT05620940 Comparator Sep 2024 → Dec 2025 overdue alcohol dependence, multiple sclerosis, opiate dependence Inventage Lab., Inc. Recruiting No outcome recorded
Phase 1 NCT05002946 Comparator Jan → Apr 2022 — Scilex Pharmaceuticals, Inc. Completed No outcome recorded
Show all 113 trials opens the full record — a long page

News releases announcing trial results or a regulatory action · 40

DateIssuerRelease
2025-11-04 Currax Pharmaceuticals Results Currax Announces ObesityWeek® Data Showing that CONTRAVE® Helps Curb Cravings and Offers Marked Effectiveness in Certain Populations with Obesity curraxpharma.com ↗
Data to be presented by Dr. Robert F. Kushner, Professor Emeritus of Endocrinology, Metabolism and Molecular Medicine at Northwestern Feinberg School of Medicine, Chicago, show that treatment with CONTRAVE led to improved craving control throughout treatment when compared to placebo.
2025-03-20 Currax Pharmaceuticals Regulatory Currax Secures Reliable and Consistent Supply of CONTRAVE®/MYSIMBA with FDA Approval for Second Manufacturing Site curraxpharma.com ↗
the U.S. Food & Drug Administration (FDA) has approved a second manufacturing site for CONTRAVE, also marketed as MYSIMBA® in the European Union and European Economic Area.
2025-03-11 Currax Pharmaceuticals Results Currax Pharmaceuticals: Peer-Reviewed Study in Obesity Pillars Further Substantiates Cardiovascular Safety Profile of CONTRAVE®/MYSIMBA® curraxpharma.com ↗
The findings further substantiate the cardiovascular safety profile of CONTRAVE/MYSIMBA, aligning with previous clinical and observational studies.
2024-08-27 Currax Pharmaceuticals Results Currax Pharmaceuticals: CONTRAVE®/MYSIMBA® Demonstrates Positive Cardiovascular Safety in a Large, Real-World Evidence Study curraxpharma.com ↗
The results showed there is no evidence of excess cardiovascular risk and no statistically significant difference in major adverse cardiovascular events (MACE) between CONTRAVE®/MYSIMBA® and the comparator group.
2024-07-24 Currax Pharmaceuticals Regulatory New Facility Assures Continuity of Supply of Anti-Obesity Treatment CONTRAVE®/MYSIMBA® Amidst GLP-1 Supply Issues curraxpharma.com ↗
Currax Pharmaceuticals LLC (“Currax”) today announced the approval of additional manufacturing site for CONTRAVE®/MYSIMBA® in the European Union (EU) and European Union Economic Areas (EEA).
2023-10-19 Currax Pharmaceuticals Results Currax Pharmaceuticals: CONTRAVE®/MYSIMBA® demonstrates no increased risk in major adverse cardiac events in a large, long-term real-world evidence study curraxpharma.com ↗
Researchers found no evidence of excess cardiovascular risk and no statistically significant difference in MACE between the CONTRAVE®/MYSIMBA® group and the comparator group.
2023-03-23 Scilex Pharmaceuticals, Inc. Results Scilex, a Sorrento Company, Highlights Safety Data From Phase 1 Trial of SP-104, a Proprietary Low Dose Naltrexone for Fibromyalgia gcs-web.com ↗
Phase 1 clinical trial data showed that SP-104 treated healthy volunteers and had lower rates of adverse events, as compared with immediate release naltrexone -treated volunteers.
2021-06-30 Alkermes, Inc. Results Alkermes Presented New Data Analysis on Healthcare Resource Use Among Veterans With Alcohol Dependence alkermes.com ↗
In the study, VIVITROL treatment for alcohol dependence was associated with decreases in inpatient care and increases in outpatient care during the one-year period following initiation of treatment with VIVITROL, compared to the one-year period before VIVITROL treatment initiation.
2017-11-14 Alkermes, Inc. Results VIVITROL® and Value of Medication-Assisted Treatment for Opioid Dependence Featured in Study Sponsored by National Institute on Drug Abuse alkermes.com ↗
Results from a National Institute on Drug Abuse (NIDA)-funded study, were published in The Lancet today, comparing extended-release naltrexone (VIVITROL®) and buprenorphine-naloxone, two options for opioid dependence.
2017-10-18 Alkermes, Inc. Results New Study Comparing Effectiveness of Extended-Release Naltrexone to Buprenorphine-Naloxone for Opioid Dependence Published in JAMA Psychiatry alkermes.com ↗
Ten patients discontinued treatment due to adverse events: four in the extended-release naltrexone group and six in the buprenorphine-naloxone group.
2016-08-19 Pfizer Regulatory FDA Approves TROXYCA® ER (oxycodone hydrochloride and naltrexone hydrochloride) Extended-Release Capsules CII with Abuse-Deterrent Properties for the Management of Pain pfizer.com ↗
the U.S. Food and Drug Administration (FDA) has approved TROXYCA ® ER (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules
2016-06-08 Pfizer Regulatory Pfizer Announces FDA Advisory Committees’ Recommend ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride) Extended-Release Capsules for Approval pfizer.com ↗
The Committees recommended the inclusion of abuse-deterrent labeling for intranasal (11 to 4) and intravenous (9 to 6) routes of abuse.

All press releases naming this drug 67 releases

DateIssuerRelease

Evidence & citations 33 cited values

Every value below carries the sentence it was read from. 462 sources stand behind the page.

FieldValueCited text
Known as naltrexone “Naltrexone, an orally semisynthetic opiate antagonist, is FDA-approved for the treatment of heroin/alcohol addiction, and low-dose naltrexone (LDN) has been observed to improve...” PMID 35001215 ↗ Jan 2022
414

“Battery of medications provided through a 12-week schedule including: Minocycline, Lamotrigine, Flumazenil, Modafinil, Bromocriptine, Donepezil, Methylphenidate, Methyl B12,...” NCT02696512 ↗

“Combination of (RS)-baclofen, naltrexone hydrochloride and D-sorbitol, termed PXT3003, improved myelination in the Pmp22 transgenic co-culture cellular model, and moderately...” PMID 25491744 ↗ Dec 2014

“Participants categorized as not experiencing early weight loss at the end of the first month of treatment will continue BWL plus a weight loss medication (Naltrexone Bupropion)...” NCT04662801 ↗

“A PHASE 1, OPEN-LABEL, EXPLORATORY, FIXED-SEQUENCE, PHARMACOKINETIC SINGLE ASCENDING DOSE STUDY OF IVL3004 VERSUS VIVITROL® (NALTREXONE) LONG-ACTING INJECTABLE (LAI) AND...” NCT05620940 ↗

“An Open-Label Study Assessing the Safety and Efficacy of Naltrexone Sustained Release (SR) in Combination With Bupropion Sustained Release (SR) in Overweight and Obese,...” NCT00563563 ↗

“The purpose of this study is to determine if the opioid agonist effects of doses of 4/1 mg, 8/2 mg, and 16/4 mg of buprenorphine/naloxone can be completely blocked by 50 mg of...” NCT00733720 ↗

“ALO-02 capsules, intended to deter abuse, contain pellets of extended-release oxycodone hydrochloride (HCl), an opioid agonist, surrounding sequestered naltrexone HCl, an...” PMID 25724154 ↗ Apr 2015

“CONTRAVE® will be titrated up to a therapeutic dose (Naltrexone 32mg/Bupropion 360mg) over a 4-week period as per clinical guidelines, and what is typical in the LEAF clinic.” NCT06809166 ↗

“Injectable naltrexone will be used, at a dose of 4cc (380mg of naltrexone), administered by intramuscular injection to the buttocks (alternating sides monthly).” NCT04408313 ↗

“Naltrexone 50 mg will be taken orally every 12 hours, from the evening of Day 00 (13 hours prior to IMP application), until the evening of the patch removal.” NCT03975010 ↗

Show 404 more sources
Known as Depot naltrexone “addition of a monthly injection of depot naltrexone to treatment as usual (TAU) will significantly improve outcome” NCT00781898 ↗
Known as Extended-Release Naltrexone “The opioid antagonist extended-release naltrexone (XR-NTX) in the treatment of opioid use disorder (OUD) is effective in terms of safety, abstinence from opioid use and...” PMID 35850782 ↗ Jul 2022
10

“We estimated the feasibility and effectiveness of extended-release naltrexone (XR-NTX) as relapse prevention among opioid-dependent male adults leaving a large urban jail.” PMID 25703440 ↗ Apr 2015

“Extended-release naltrexone (XR-NTX), an approved treatment for opioid or alcohol dependence, is a once-monthly injectable formulation of naltrexone.” PMID 24674234 ↗ Mar 2014

“Extended-release naltrexone (XR-NTX, Vivitrol; Alkermes Inc.) is an injectable monthly sustained-release mu opioid receptor antagonist.” PMID 25602580 ↗ Jan 2015

“XR-NTX (Extended-Release Naltrexone) doses of 380mg (Weeks 0, 3 and 6) via intramuscular (IM) injections in the gluteus.” NCT05262270 ↗

“One dose of intramuscular injection of 380mg extended-release naltrexone.” NCT01822132 ↗

“extended-release naltrexone (XR-NTX, Vivitrol®; Alkermes Inc.)” PMID 27282118 ↗ Jun 2016

“Extended Release Naltrexone for Opioid-Dependent Youth” NCT01843023 ↗

“Extended-Release Naltrexone (Vivitrol®)” NCT02032433 ↗

“Vivitrol (Extended Release Naltrexone)” NCT04094584 ↗

“XR-NTX (Extended-Release Naltrexone)” NCT01893827 ↗
Known as LDN “The goal of this pilot clinical trial is to find out how well low dose naltrexone works for people with pain due to spinal cord injury. The main questions it aims to answer...” NCT06723561 ↗
11

“Naltrexone, an orally semisynthetic opiate antagonist, is FDA-approved for the treatment of heroin/alcohol addiction, and low-dose naltrexone (LDN) has been observed to improve...” PMID 35001215 ↗ Jan 2022

“Low dose naltrexone(LDN) is an attractive emergent therapy with analgesic, anti-pruritic and anti-inflammatory properties for various dermatological disorders including psoriasis.” NCT04250792 ↗

“The investigators will compare the use of daily low dose naltrexone (LDN) (4.5 mg) compared with placebo in subjects that have symptomatic inflammatory bowel disease (IBD).” NCT01810185 ↗

“PURPOSE: Low-dose naltrexone (LDN) is commonly used to control pain and other symptoms, especially in patients with autoimmune diseases, but with limited evidence.” PMID 37045708 ↗ Apr 2023

“The investigators are testing treatment with low-dose naltrexone (LDN) for symptom relief of complex regional pain syndrome (CRPS).” NCT02502162 ↗

“This study will examine the effects of low-dose naltrexone (LDN) on children with autistic spectrum disorders.” NCT00318162 ↗

“Low-dose naltrexone (LDN) has demonstrated improvement of symptoms in conditions associated with IC/PBS.” NCT04313972 ↗

“Low Dose Naltrexone (LDN), naltrexone at a much lower dose” NCT05537935 ↗

“naltrexone hydrochloride, (Low-Dose Naltrexone, or LDN)” NCT01174914 ↗

“Low Dose Naltrexone (LDN)” NCT01650350 ↗

Show 1 more source
Known as Low dose naltrexone “Low dose naltrexone(LDN) is an attractive emergent therapy with analgesic, anti-pruritic and anti-inflammatory properties for various dermatological disorders including psoriasis.” NCT04250792 ↗
5

“The investigators will compare the use of daily low dose naltrexone (LDN) (4.5 mg) compared with placebo in subjects that have symptomatic inflammatory bowel disease (IBD).” NCT01810185 ↗

“Low-dose naltrexone (LDN) has demonstrated improvement of symptoms in conditions associated with IC/PBS.” NCT04313972 ↗

“Low Dose Naltrexone (LDN), naltrexone at a much lower dose” NCT05537935 ↗

“naltrexone hydrochloride, (Low-Dose Naltrexone, or LDN)” NCT01174914 ↗

“Low-dose Naltrexone” NCT02965768 ↗
Known as Low dose Naltrexone (LDN) “Low dose Naltrexone (LDN)” NCT04604704 ↗
Known as Medisorb naltrexone “This was a Phase 3, multi-center extension of Alkermes' Study ALK21-003EXT (NCT01218971) to further assess the long-term safety of repeat monthly doses of Medisorb® naltrexone...” NCT00156923 ↗
3

“ALK21-003EXT: An Extension of Study ALK21-003 (NCT01218958) to Test the Long-term Safety of Medisorb® Naltrexone (VIVITROL®)” NCT01218971 ↗

“ALK21-006: Long-Term Study of Medisorb® Naltrexone (VIVITROL®)” NCT01218997 ↗

“Medisorb® naltrexone (VIVITROL®)” NCT01218984 ↗
Known as naltrexone chlorhydrate “A pill of naltrexone chlorhydrate 50mg, associated to yellow liquid paraffin pills simulating borage seed and fish oil.” NCT01211769 ↗
Known as Naltrexone for extended-release injectable suspension “Naltrexone for extended-release injectable suspension” NCT01218984 ↗
Known as Naltrexone HCl “Naltrexone hydrochloride (HCl) 8 mg/Bupropion hydrochloride (HCl) 90 mg extended release (ER) combination tablets, orally, one tablet, in the morning, daily, for 1 week,...” NCT03581630 ↗
9

“ALO-02 capsules, intended to deter abuse, contain pellets of extended-release oxycodone hydrochloride (HCl), an opioid agonist, surrounding sequestered naltrexone HCl, an...” PMID 25724154 ↗ Apr 2015

“Participants will receive daily weight loss medication, Contrave, at a dose of 360 mg (Naltrexone HCl 32mg, Bupropion HCl 360mg).” NCT04553263 ↗

“Oxycodone hydrochloride (HCl) 20 mg IV and naltrexone HCl 2.4 mg IV administered simultaneously x 1 dose IV push over 4 min.” NCT01825447 ↗

“The drug being tested in this study is naltrexone HCl and bupropion HCl Extended- Release fixed dose combination (NB) .” NCT02745912 ↗

“oxycodone HCl and naltrexone HCl extended-release capsules” NCT01428583 ↗

“Naltrexone HCl 8 mg/bupropion HCl 90 mg tablets” NCT02616315 ↗

“Naltrexone HCL, 4.5 mg, Once a day.” NCT02502162 ↗

“Naltrexone HCl 50 MG Oral Tablet” NCT04547985 ↗

“Drug: Naltrexone-HCl” NCT00663117 ↗
Known as Naltrexone hydrochloride “Naltrexone hydrochloride was administered approximately 12 hours and 1 hour prior to and 12 hours after each dose of fentanyl to minimize the occurrence of unacceptable adverse...” NCT01780233 ↗
14

“Combination of (RS)-baclofen, naltrexone hydrochloride and D-sorbitol, termed PXT3003, improved myelination in the Pmp22 transgenic co-culture cellular model, and moderately...” PMID 25491744 ↗ Dec 2014

“Safety and tolerability of ALO-02 (oxycodone hydrochloride and sequestered naltrexone hydrochloride) extended-release capsules in older patients: a pooled analysis of two...” PMID 31456431 ↗ Sep 2019

“NB medication will combine BUPROPION HYDROCHLORIDE (360 mg/day) and NALTREXONE HYDROCHLORIDE (32 mg/day). Taken daily in pill form.” NCT03539900 ↗

“Evaluate the Efficacy and Safety of Naltrexone Hydrochloride Implant in Patients With Alcohol Use Disorder” NCT07433413 ↗

“The drug being tested in this study is called naltrexone hydrochloride/bupropion hydrochloride (NB).” NCT02616315 ↗

“one tablet of 50mg Naltrexone hydrochloride (ReVia®. Toronto, ON: Teva Canada Limited; 2015)” NCT04276259 ↗

“Naltrexone Hydrochloride, 50 mg., intermittent with ecological momentary assessment (EMA)” NCT04791969 ↗

“Naltrexone hydrochloride is a generic, FDA-approved since 1998 drug, an opioid antagonist” NCT01174914 ↗

“NALTREXONE HYDROCHLORIDE 4,5 mg, coated oral tablets, 1xd. for 4 months” NCT05955313 ↗

“morphine sulfate and naltrexone hydrochloride (EMBEDA)” NCT01179191 ↗

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Known as Naltrexone hydrochloride (HCl) “Naltrexone hydrochloride (HCl) 8 mg/Bupropion hydrochloride (HCl) 90 mg extended release (ER) combination tablets, orally, one tablet, in the morning, daily, for 1 week,...” NCT03581630 ↗
Known as Naltrexone Hydrochloride ER “Effect of Naltrexone Hydrochloride ER and Bupropion Hydrochloride ER Combination (Contrave®/Mysimba®) on Major Adverse Cardiovascular Events (MACE)” NCT06098079 ↗
Known as Naltrexone Low-Dose “Naltrexone Low-Dose (3mg) once daily at bedtime for 9 months” NCT01174914 ↗
Known as Naltrexone SR “Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)” NCT01764386 ↗
2

“Naltrexone SR 32 mg/ bupropion SR 360 mg/ day” NCT00456521 ↗

“Naltrexone SR 32 mg/bupropion SR 360 mg/ day” NCT00474630 ↗
Known as naltrexone sustained-release “naltrexone sustained-release (SR, 32 mg/day), combined with bupropion SR (360 mg/day) plus BMOD” PMID 20559296 ↗ Jun 2010
Known as naltrexone sustained-release (SR) “OBJECTIVE: This study assessed the effects of 32 mg naltrexone sustained release (SR)/360 mg bupropion SR (NB) on body weight in adults with obesity, with comprehensive...” PMID 28026920 ↗ Dec 2016
1

“combined naltrexone sustained-release (SR) (32 mg/day) plus bupropion SR (360 mg/day) (NB32) or placebo” PMID 23408728 ↗ May 2013
Known as Naltrexone/ ReVia “Naltrexone/ ReVia” NCT00614328 ↗
Known as Nemexin “Naltrexone (Nemexin) oral tablet 50 mg daily for 2 days, Naltrexone (Nemexin) oral tablet 100 mg daily for 5 days” NCT03854942 ↗
Known as NTX “Additionally, CBD seems to be a particularly promising candidate for enhancing the effects of established medication, specifically Naltrexone (NTX), an opioid-antagonist, which...” NCT06845124 ↗
15

“This is a randomized, double blind placebo-controlled trial to examine the role of Relapse Prevention (RP) and Contingency Management (CMP) combined with Naltrexone (NTX) for...” NCT00218569 ↗

“This is a double-blind placebo-controlled study to evaluate the effect of Naltrexone (NTX) and counseling on highly active antiretroviral treatment (HAART) medication adherence” NCT01227044 ↗

“While currently approved medications, such as naltrexone (NTX), reduce craving and relapse risk to a certain extent, new approaches are needed to complement these pharmaca.” PMID 35410938 ↗ Apr 2022

“In the present study, 24 overweight women with a diagnosis of schizophrenia or schizoaffective disorder were randomized to placebo or naltrexone (NTX) 25 mg/d for 8 weeks.” PMID 25102328 ↗ Oct 2014

“A randomized, double-blind, parallel-group double-dummy study evaluated two medications, bupropion (BUP) and naltrexone (NTX), in treatment-seeking cigarette smokers” PMID 27213949 ↗ Jun 2016

“The opiate antagonist naltrexone (Ntx) has demonstrated efficacy in the treatment of alcohol dependence and as a component of treatment to reduce heavy drinking.” PMID 18796184 ↗ Sep 2008

“Consented adults (age 18-65) were randomized to (1) IV ketamine (KET) 0.5 mg/kg over 40 min, (2) IM naltrexone (NTX) 380 mg once, or (3) linkage alone (LA).” PMID 36419181 ↗ Nov 2022

“antagonist maintenance with naltrexone (NTX), which may be an optimal longer-term strategy for this population, requires prior opioid detoxification” NCT02543944 ↗

“the efficacy of the opioid antagonist naltrexone (NTX) as a tobacco dependence treatment remains unresolved.” NCT00270231 ↗

“Naltrexone (NTX) is a nonspecific pure opioid antagonist with a high affinity for the µ-opioid receptor.” NCT03810495 ↗

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Known as O/NTX “efficacy of NMT may be improved by using extended-release naltrexone (XR/NTX) instead of oral naltrexone (O/NTX)” NCT01389167 ↗
1

“Oral Naltrexone (O-NTX)” NCT01893827 ↗
Known as Oral Naltrexone “Oral Naltrexone (O-NTX)” NCT01893827 ↗
Known as PO-NTX “Oral naltrexone (PO-NTX)” NCT02478489 ↗
Known as Revia “This study will compare cognitive behavioral therapy with a time-limited motivational enhancement therapy to which naltrexone (Revia) or placebo medication is added.” NCT00000456 ↗
17

“Although naltrexone (Revia) has been approved for the treatment of alcohol dependence, few pharmacotherapy studies have been undertaken with early problem drinkers.” NCT00000455 ↗

“It is available in the United States (US) as 2 formulations; a once daily oral formulation (Revia) and a once monthly intramuscular injection (Vivitrol).” NCT03810495 ↗

“This study will evaluate the effectiveness of the medication naltrexone (Revia) for treating alcoholism.” NCT00000438 ↗

“one tablet of 50mg Naltrexone hydrochloride (ReVia®. Toronto, ON: Teva Canada Limited; 2015)” NCT04276259 ↗

“Naltrexone (Revia, Vivitrol) is recognized as having the potential for hepatotoxicity.” PMID 23036218 ↗ Nov 2012

“Naltrexone hydrochloride (ReVia®. Toronto, ON: Teva Canada Limited; 2015)” NCT04322526 ↗

“naltrexone (Revia)” NCT00006206 ↗

“naltrexone (Revia)” NCT00000452 ↗

“naltrexone (Revia)” NCT00000447 ↗

“naltrexone (Revia)” NCT00006204 ↗

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Known as sustained-release naltrexone “Sustained-release naltrexone is a treatment option that works by blocking the euphoric and overdose effects of opioids.” PMID 40342086 ↗ May 2025