This exploratory clinical trial tests low-dose naltrexone (LDN) for the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). A remote trial approach is used, with eligibility open to the entire U.S.

Start Date01 Apr 2026

Sponsor / Collaborator

The University of Alabama at Birmingham

NCT05382091

/ Not yet recruitingPhase 2

A Phase II Multi-Center Safety Study Examining the Use of the O'Neil Long Acting Naltrexone Implant (OLANI) in Opioid Dependent Persons Receiving Repeat Dosing

This study will examine the safety and efficacy of the O'Neil Long Acting Naltrexone Implant (OLANI) in persons with opioid dependency who are seeking relapse-prevention treatment. All participants will be treated in an open label manner. No randomization will occur. The OLANI is a long-acting biodegradable form of naltrexone which is implanted in the abdominal region. It is hypothesized that the OLANI will produce blood levels sufficient to block the effects of opioids for an extended period allowing patients to engage in psychosocial treatment and recovery over the long term. After the initial set of implants, participants will be offered 3 sets of single implants 13 weeks, each with an acceptable window of 12-16 weeks after the previous dose.

Start Date15 Jan 2026

Sponsor / Collaborator

Go Medical Industries Pty Ltd.

[+5]

NCT07224009

/ Not yet recruitingPhase 2IIT

Phase II Clinical Trial Evaluating the Safety and Efficacy of Low Dose Naltrexone (LDN) for the Management of Fatigue in Prostate Cancer Patients on Androgen Deprivation Therapy (ADT)

The study is being done to see if a small daily dose of naltrexone (LDN, 3 mg pill) can help reduce tiredness (fatigue) in men with prostate cancer. All men in this study are being treated with hormone therapy (also called androgen deprivation therapy, or ADT). Some may also be taking newer hormone medicines such as apalutamide, daralutamide, enzalutamide, or abiraterone.

Start Date01 Jan 2026

Sponsor / Collaborator

The University of Arkansas

100 Clinical Results associated with Naltrexone Hydrochloride

100 Translational Medicine associated with Naltrexone Hydrochloride

100 Patents (Medical) associated with Naltrexone Hydrochloride

3,578

Literatures (Medical) associated with Naltrexone Hydrochloride

31 Dec 2025·JOURNAL OF DERMATOLOGICAL TREATMENT

Hailey-Hailey disease successfully treated with naloxone: 2 case reports and Review of the literature on efficacy of opioid receptor antagonist in Hailey-Hailey disease patients

Review

Author: Chengrang Li ; Zhimin Duan ; Fang Fang ; Beilei Xu ; Jianbing Wu ; Hao Song ; Junyou Zheng ; Nan Sheng

BACKGROUND:

Hailey-Hailey disease (HHD), a genetic blistering disease, is caused by a mutation in a calcium transporter protein in the Golgi apparatus encoded by the ATP2C1 gene. Clinically, HHD is characterized by flaccid vesicles, blisters, erosions, fissures, and maceration mainly in intertriginous regions. Some patients remain refractory to conventional treatments. Previously, a series of reports have confirmed naltrexone as an effective option for those patients. However, in China, naltrexone is unavailable in some hospitals and unaffordable for some patients.

OBJECTIVE:

To confirm naloxone as a treatment option for HHD, and assess the efficacy rate and safety of naltrexone for patients with HHD.

METHODS:

Two patients with biopsy-proven HHD received naloxone (2 mg/d, via intravenous infusion). We followed up with the two patients, assessing the change of skin lesions and obtaining photographs. We searched the PubMed databases using the keywords 'Hailey-Hailey disease' or 'benign familial pemphigus', and 'naltrexone' or 'naloxone', and reviewed English publications of reports and analyzed the efficacy and safety of naltrexone.

RESULTS:

Two patients prescribed naloxone showed completely remission in two weeks without any adverse reactions. The total remission rate of naltrexone for HHD is approximately 80%, without severe adverse effects.

CONCLUSION:

Naltrexone is effective and safe in the treatment of HHD. Naloxone, an analog of naltrexone, can also effectively and safely treat HHD, potentially offering a new therapeutic option for patients with refractory HHD.

01 Dec 2025·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Intramolecular hydrogen-bonding motifs in the 14-oxymorphinan opioids: An experimental and computational study

Article

Author: Pevzner, Alexander ; Yeffet, Dina ; Parvari, Galit ; Elias, Shlomi ; Zafrani, Yossi ; Eichen, Yoav ; Columbus, Ishay ; Lifshin-Karton, Naama ; Saphier, Sigal ; Cohen, Yoram

Increasing the molecular rigidity of bioactive compounds by intramolecular hydrogen bonds (IMHB) may affect both pharmacodynamics (PD) and pharmacokinetics (PK) by an increase in molecular recognition, lipophilicity and membrane permeability. Recently, in our study on opioids lipophilicity, we suggested two types of IMHBs, i.e., O-H⋯N and N⁺-H^…O, which may exist in 14-oxymorphinan structures and may explain some trends and even apparent anomalies in their pharmacologically relevant molecular properties. In the present study we show, both experimentally and computationally, that these IMHBs indeed exist in the three FDA-approved opioid antagonists, Naloxone, Naltrexone and Nalmefene, as well as in their 3-O- and 14-O-methylated derivatives. Since the charged form of these morphinans is the biologically active species, we propose that the charge-assisted IMHB (CAHB) N⁺-H^…O, which is herein studied for the first time, plays an important role in the bioactivity of this subfamily of opioids.

01 Dec 2025·JOURNAL OF PAIN AND SYMPTOM MANAGEMENT

Low Dose Naltrexone for Refractory Cancer Pain: Case Series of Initial Safety and Effectiveness

Article

Author: Chung, Matthew ; Malik, Aila ; Ye, Alice

CONTEXT:

Low dose naltrexone (LDN) has been utilized off-label for chronic non-cancer pain; its benefits in treating cancer-related pain remain unclear.

OBJECTIVES:

We describe the safety and effectiveness of LDN therapy from initiation to the first two follow-up visits in treating refractory cancer-pain.

METHODS:

Medical charts of cancer patients seen in the Pain Management Center who were prescribed LDN between 2022 and 2023 were reviewed. They were classified as "responders" if they attributed improvement in their primary pain complaints to LDN therapy.

RESULTS:

Among the 20 cancer patients who were prescribed LDN, the most common cancer diagnosis was breast cancer (45%). There were 10 patients with cancer burden-related pain and 10 patients with therapy-related pain. Positive response rates of 80% (16/20), and 76.9% (10/13) were recorded at the first and second follow-up visits, respectively which occurred at a mean (SD) of 65.9 (53.3), and 104.8 (60.4) days following LDN initiation, respectively. The most common maximum titration dose of naltrexone was 3.0 mg daily (n = 9) (range 1.5-4.5 mg daily). Therapy-related neuropathy accounted for seven cases with a 71% positive response rate in this subset at the first follow-up. Minor adverse events were noted in two patients (insomnia, GI upset) at the first follow-up; these did not require discontinuation of LDN. The discontinuation rate by the second follow-up was 15% (3/20) (two with inadequate pain relief, one with diarrhea).

CONCLUSION:

Early follow-up indicates potential benefits for patients with refractory cancer pain with LDN being well-tolerated, with a low incidence of adverse events.

217

News (Medical) associated with Naltrexone Hydrochloride

30 Jan 2026

·www.globenewswire.com

Scilex Holding Company Announces $20 Million Strategic Investment in Quantum Scan Holdings, Inc., Targeting Trillion-Dollar Preventive Diagnosis and Prognosis Markets

PALO ALTO, Calif., Jan. 30, 2026 (GLOBE NEWSWIRE) -- Scilex Holding Company (“Scilex” or the “Company”) (Nasdaq: SCLX), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain and neurodegenerative and cardiometabolic disease, today announced that it has made a $20 million strategic investment in Quantum Scan Holdings, Inc. (“Quantum Scan”), a breakthrough medical technology company, targeting trillion-dollar market of preventive diagnosis and prognosis of human diseases and illness. The investment is intended to support Quantum Scan’s ongoing efforts to identify, develop, and deploy innovative medical technologies, including advanced diagnostic platforms, integrated analytics, and scalable healthcare solutions designed to improve accessibility and efficiency across clinical and non-traditional care settings. Scilex believes this strategic investment is synergistic with its large investment in Datavault AI (Nasdaq: DVLT) (“Datavault”). Mustaq Patel, Chief Executive Officer of Quantum Scan, stated: “We are grateful to Scilex for their strategic investment and confidence in our team and vision. The need for continued innovation in medical technologies has never been greater. This capital enables Quantum Scan to accelerate its focus on forward-looking healthcare solutions and to invest in technologies that we believe can deliver long-term value and meaningful impact across the healthcare ecosystem.” Henry Ji, Ph.D., Chairman and Chief Executive Officer of Scilex Holding Company, commented: “Quantum Scan is led by an experienced team with a clear focus on innovation, revenue-generation, disciplined execution, and potential large long-term value creation. We believe this investment complements Scilex’s strategic priorities and provides an opportunity to support the development of innovative medical technology platforms aligned with our broader commitment to advancing healthcare solutions.” For more information on Scilex Holding Company, refer to www.scilexholding.com For more information on Semnur Pharmaceuticals, Inc., refer to www.semnurpharma.com For more information on ZTlido® including Full Prescribing Information, refer to www.ztlido.com. For more information on ELYXYB®, including Full Prescribing Information, refer to www.elyxyb.com. For more information on Gloperba®, including Full Prescribing Information, refer to www.gloperba.com. https://www.facebook.com/scilex.pharm https://www-linkedin-com.sutd.idm.oclc.org/company/scilex-holding-company/ info@scilexholding.com About Scilex Holding Company Scilex is an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain and neurodegenerative and cardiometabolic disease. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with acute and chronic pain and is dedicated to advancing and improving patient outcomes. Scilex’s commercial products include: (i) ZTlido® (lidocaine topical system) 1.8%, a prescription lidocaine topical product approved by the U.S. Food and Drug Administration (the “FDA”) for the relief of neuropathic pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain; (ii) ELYXYB®, a potential first-line treatment and the only FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults; and (iii) Gloperba®, the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults. In addition, Scilex has three product candidates: (i) SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXA” or “SP-102”), which is owned by Semnur (a majority owned subsidiary of Scilex) and is a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, for which Scilex has completed a Phase 3 study and was granted Fast Track status from the FDA in 2017; (ii) SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a next-generation, triple-strength formulation of ZTlido, for the treatment of acute pain and for which Scilex has recently completed a Phase 2 trial in acute low back pain. SP-103 has been granted Fast Track status from the FDA in low back pain; and (iii) SP-104 (4.5 mg, low-dose naltrexone hydrochloride delayed-release capsules) (“SP-104”), a novel low-dose delayed-release naltrexone hydrochloride being developed for the treatment of fibromyalgia. Scilex is headquartered in Palo Alto, California. About Quantum Scan Holdings, Inc. Quantum Scan Holdings, Inc. is a medical technology and innovation company focused on the development and investment in advanced healthcare technologies. Quantum Scan’s activities include medical platforms, diagnostics, analytics, and related innovations aimed at enhancing healthcare delivery, accessibility, and clinical insight. Forward-Looking Statements This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts and may be accompanied by words that convey projected future events or outcomes, such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” or variations of such words or by expressions of similar meaning. These forward-looking statements include, but are not limited to, statements regarding future events, Quantum Scan’s prospects, plans and goals, Scilex’s intellectual property goals and processes, future opportunities for Scilex and its subsidiaries, the future business strategies, long-term objectives and commercialization plans of Scilex and its subsidiaries, the current and prospective product candidates, planned clinical trials and preclinical activities and potential product approvals, as well as the potential for market acceptance of any approved products and the related market opportunity of Scilex and its subsidiaries, statements regarding SP-102, if approved by the FDA, Scilex’s potential to attract new capital and avoid the effects of negative debt leverage and other statements that are not historical facts. These statements are based on management’s current expectations and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on, by any investor as a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Scilex. These statements are subject to a number of risks and uncertainties regarding Scilex’s business, Quantum Scan’s business and Datavault’s business, and actual results may differ materially. These risks and uncertainties include, but are not limited to, general economic, political and business conditions; the ability of Scilex and its subsidiaries to develop and successfully market products; the ability of Scilex and its subsidiaries to grow and manage growth profitably and retain its key employees; the risk that the potential product candidates that Scilex develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Scilex’s product candidates; the risk that Scilex’s product candidates may not be beneficial to patients or successfully commercialized; the risk that Scilex has overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe these therapies; risks that the prior results of the clinical trials may not be replicated; regulatory and intellectual property risks; the risk of failure to realize the anticipated benefits of the transactions contemplated with Datavault and Quantum Scan and other risks and uncertainties indicated from time to time and other risks set forth in Scilex’s filings with the SEC. There may be additional risks that Scilex presently does not know or that Scilex currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements provide Scilex’s expectations, plans or forecasts of future events and views as of the date of the communication. Scilex anticipates that subsequent events and developments will cause such assessments to change. However, while Scilex may elect to update these forward-looking statements at some point in the future, Scilex specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Scilex’s assessments as of any date subsequent to the date of this communication. Accordingly, investors are cautioned not to place undue reliance on these forward-looking statements. Contacts: Investors and MediaScilex Holding Company 960 San Antonio RoadPalo Alto, CA 94303Office: (650) 516-4310 Email: investorrelations@scilexholding.com Website: www.scilexholding.com SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc., a majority-owned subsidiary of Scilex Holding Company. A proprietary name review by the FDA is planned. ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex Holding Company. Gloperba® is the subject of an exclusive, transferable license to use the registered trademark by Scilex Holding Company. ELYXYB® is a registered trademark owned by Scilex Holding Company. Scilex Bio™ is a trademark owned by Scilex Holding Company, Inc. All other trademarks are the property of their respective owners. © 2026 Scilex Holding Company All Rights Reserved.

Drug ApprovalFast TrackPhase 3Phase 2

14 Jan 2026

·www.biocorrx.com

BioCorRx, Inc. Announces Initiation of Clinical Study by Majority-Owned Subsidiary BioCorRx Pharmaceuticals, Inc. Evaluating Long-Acting Naltrexone Implant With or Without Bupropion

Clinical Study Evaluating a Long-Acting Naltrexone Implant Under the FDA's 505(b)(2) Pathway ANAHEIM, CA - January 14, 2026 (NEWMEDIAWIRE) - BioCorRx Inc. (OTCID: BICX) (the "Company"), a developer and provider of innovative treatment programs for substance abuse and related disorders, today announced that its majority-owned subsidiary, BioCorRx Pharmaceuticals, Inc., has initiated a Phase 1 clinical study evaluating BICX104, an investigational long-acting subcutaneous naltrexone implant, administered with or without bupropion, compared to the FDA-approved extended-release naltrexone injection Vivitrol®. The study: Safety and Pharmacokinetics Study of BICX104 With or Without Bupropion Compared to Vivitrol (ClinicalTrials.gov Identifier: NCT07269873) is now underway following completion of required institutional review requirements. The trial is designed to generate pharmacokinetic and tolerability data to support the continued development of BICX104 under the FDA's 505(b)(2) regulatory pathway. "This study is intended to support the continued development of BICX104 by generating pharmacokinetic and tolerability data," said Lourdes Felix, CEO, BioCorRx Inc. "The data generated will help inform subsequent development activities as we advance this investigational long-acting formulation." The clinical trial will enroll participants into four sequential cohorts and evaluate BICX104 administered alone and in combination with bupropion. BICX104 is designed to provide sustained plasma concentrations of naltrexone for approximately three months following a minimally invasive subcutaneous implantation procedure. Participants will complete an 84-day treatment period, followed by an 84-day follow-up period and a 28-day post-treatment observation phase. Study assessments include pharmacokinetic sampling, monitoring of adverse events, laboratory evaluations, vital signs, and other tolerability measures. Outcomes from the investigational arms will be compared to those from participants receiving Vivitrol®, an approved extended-release naltrexone product. About BioCorRx Inc. BioCorRx Inc. (OTCID: BICX) is an addiction treatment solutions company offering a unique approach to the treatment of substance use and other related disorders. Beat Addiction Recovery is a substance use disorder recovery program that typically includes BioCorRx's proprietary Cognitive Behavioral Therapy (CBT) modules along with peer support via mobile app along with medication prescribed by an independent treating physician under their discretion. The UnCraveRx® Weight Loss Program is also a medication-assisted weight loss program that includes access to concierge on-demand wellness specialists: nutritionists, fitness experts, and personal support from behavioral experts, please visit www.uncraverx.com for more information on UnCraveRx®. BioCorRx also operates through its subsidiary, BioCorRx Pharmaceuticals Inc., which focuses on pharmaceutical commercialization and development, including LUCEMYRA® (lofexidine) - an FDA-approved medication indicated to mitigate opioid withdrawal symptoms in adults - and the development of BICX104, an investigational implantable naltrexone pellet program. For more information on BICX and its subsidiary pipeline, please visit www.BioCorRx.com. About BICX104 Research reported in this publication was supported by the National Institute On Drug Abuse of the National Institutes of Health under Award Number U01DA059994. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. About MUD Research has shown that methamphetamine is a highly addictive stimulant and one of the most misused stimulant drugs in the world. Some of the side effects of MUD are severe dental problems, memory loss, aggression, psychotic behavior, and damage to the cardiovascular system. In 2022 the National Survey on Drug Use and Health reported that more than 16.6 million people used methamphetamine at least once during their lifetime. About OUD OUD is a chronic disorder, with serious potential consequences including disability, relapses, and death. Opioids, used medically for pain relief, have analgesic and central nervous system depressant effects as well as the potential to cause euphoria with an overpowering desire to use opioids despite the consequences. OUD can involve misuse of prescribed opioid medications, use of diverted opioid medications or illicitly obtained heroin. OUD is typically a chronic and relapsing illness, that is associated with significantly increased rates of morbidity and mortality. About Obesity It is estimated that 1 billion people worldwide are obese. In 2024 the World Health Organization reported that one in eight people live with obesity and stressed the importance and need to curb the obesity epidemic with new interventions. It is estimated that by 2035 the global obesity crisis could rise to over 4 billion people. Affecting healthcare costs upwards of $4 trillion with obesity-related conditions including; stroke, heart disease, cancer, and type 2 diabetes. About LUCEMYRA® (lofexidine) LUCEMYRA® (lofexidine), an oral tablet, is a central alpha 2-adrenergic agonist that reduces the release of norepinephrine to suppress the neurochemical surge that produces opioid withdrawal. It is indicated for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults. In clinical trials, LUCEMYRA® reduced the severity of withdrawal symptoms compared to placebo, as reported by patients experiencing opioid withdrawal. LUCEMYRA® is administered A orally for up to 14 days, with dosing guided by symptoms. LUCEMYRA® should be discontinued with gradual dose reduction over two to four days. The most common adverse reactions are orthostatic hypotension, bradycardia, hypotension, dizziness, somnolence, sedation, and dry mouth. Forward-Looking Statements This press release contains forward-looking statements. These forward-looking statements generally are identified by the words "believe," "project," "estimate," "become," "plan," "will," and similar expressions. These forward-looking statements involve known and unknown. risks as well as uncertainties. Although the Company believes that its expectations are based on reasonable assumptions, the actual results that the Company may achieve may differ materially from any forward-looking statements, which reflect the opinions of the management of the Company only as of the date hereof. Important Safety Information What is LUCEMYRA? LUCEMYRA is a non-opioid prescription medicine used in adults to help with the symptoms of opioid withdrawal that may happen when you stop taking an opioid suddenly. LUCEMYRA will not completely prevent the symptoms of opioid withdrawal and is not a treatment for opioid use disorder. Important Safety Information LUCEMYRA can cause serious side effects, including low blood pressure, slow heart rate, and fainting. Watch for symptoms of low blood pressure or heart rate, including dizziness, lightheadedness, or feeling faint at rest or when quickly standing up; if you experience these symptoms, call your healthcare provider right away and do not take your next dose of LUCEMYRA until you have talked to your healthcare provider. Avoid becoming dehydrated or overheated and be careful not to stand up too suddenly from lying or sitting, as these may increase your risk of low blood pressure and fainting. When your treatment is complete, you will need to stop taking LUCEMYRA gradually, or your blood pressure could increase. After a period of not using opioid drugs, you can become more sensitive to the effects of opioids if you start using them again. This may increase your risk of overdose and death. Before taking LUCEMYRA, tell your healthcare provider about all your medical conditions, including if you have low blood pressure, slow heart rate, any heart problems including history of heart attack or a condition called long QT syndrome, liver or kidney problems, or if you drink alcohol. Tell your healthcare provider if you are pregnant, plan on becoming pregnant, or are breastfeeding; it is not known if LUCEMYRA can harm your unborn baby or whether LUCEMYRA passes into your breast milk. Especially tell your healthcare provider if you take benzodiazepines, barbiturates, tranquilizers, or sleeping pills, as taking these with LUCEMYRA can cause serious side effects. The most common side effects of LUCEMYRA include low blood pressure or symptoms of low blood pressure such as lightheadedness, slow heart rate, dizziness, sleepiness, and dry mouth. To report SUSPECTED ADVERSE REACTIONS or product complaints, contact BioCorRx Pharmaceuticals Inc. at 1-833-LUCEMYRA. You may also report SUSPECTED ADVERSE REACTIONS to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Click here to see full Prescribing Information. IBioCorRx Inc. info@BioCorRx.com 714-462-4880 Investor Relations: Crescendo Communications, LLC 212- 671-1020 x304 bicx@crescendo-ir.com Released January 14, 2026

Phase 1Clinical Result

09 Jan 2026

·www.drugs.com

Benefit of Retention on MOUD Treatment Lasts for at Least Four Years

FRIDAY, Jan. 9, 2026 -- The benefit of retention on medication for opioid use disorder (MOUD) on overall survival persists through about four to five years of treatment, according to a study published online Jan. 8 in Addiction . Corey J. Hayes, Pharm.D., Ph.D., M.P.H., from the University of Arkansas for Medical Sciences in Little Rock, and colleagues estimated how the risk for all-cause mortality changes with the duration of MOUD in a retrospective cohort study using electronic health record data from the U.S. Veterans Healthcare Administration. The duration of MOUD was measured in days; discontinuation was defined as a gap exceeding 28 days in any MOUD coverage. The sample included 19,666 buprenorphine initiators, 8,675 methadone initiators, and 4,007 extended-release naltrexone initiators. The researchers observed 26,841 discontinuations during approximately 226,000 person-years of time at risk for discontinuation or pre-discontinuation death (118.9 discontinuations per 1,000 person-years). There were 3,251 deaths during a total of about 106,000 person-years of post-discontinuation follow-up (3.1 deaths per 1,000 person-years). The largest marginal gain in probability of six-year survival from an additional year on MOUD occurred around two years compared with six months on MOUD. Relative to six-month MOUD retention, statistically significant gains continued through about four to five years of MOUD retention. After four to five years, there was no statistically significant marginal gain from one additional year of MOUD. "Patients and providers will value these gains differently and our work can help guide discussions on how to optimally choose duration of therapy based on expected survival while accommodating individual values," the authors write. Abstract/Full Text

Clinical Result

100 Deals associated with Naltrexone Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D02095	Naltrexone Hydrochloride	N07BB04	DB00704

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Opium Dependence	China	Shenzhen Sciencare Medical Industries Co., Ltd.	25 Jun 2024
Heroin Dependence	Australia	Generic Health Pty Ltd.	31 Aug 2007
Alcoholism	United States	Teva Women's Health, Inc.	20 Nov 1984
Opioid-Related Disorders	United States	Teva Women's Health, Inc.	20 Nov 1984

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Alcohol Use Disorder	Phase 3	China	Shenzhen Sciencare Medical Industries Co., Ltd.	04 Feb 2026
Unspecified drug dependence	Phase 3	United States	Alkermes, Inc.	01 May 2010
Crohn Disease	Phase 2	United States	Hershey Medical Center	01 Sep 2006
Inflammation	Phase 2	United States	Hershey Medical Center	01 Sep 2006
COVID-19	Phase 1	United States	Statera Biopharma, Inc.	05 Dec 2021
Inflammatory Bowel Diseases	Preclinical	China	Shenzhen Sciencare Medical Industries Co., Ltd.	27 Sep 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04791969 (CTgov)	Phase 2	-	60	Ecological Momentary Intervention+Naltrexone Hydrochloride (Naltrexone With Ecological Momentary Intervention)	zmryiorses = ztdsbeynmb cjijtzudvz (xjiyfpcocz, obvdkeycrb - gawghcrswz) View more	-	27 Oct 2025
				Placebo (Placebo With Ecological Momentary Intervention)	zmryiorses = ftvtohacjb cjijtzudvz (xjiyfpcocz, uleqmxkuvp - uzddjznkjq) View more
NCT05073679 (ONPED, CTgov)	Phase 2/3	Binge-Eating Disorder \| Bulimia Nervosa \| Atypical anorexia nervosa ... View more	9	Naltrexone Hydrochloride (Intervention)	dsscojeojy(xymsyzuror) = cjbnsdltxw umpmlcvjlq (gexwbsblgz, 2.016184515) View more	-	19 Aug 2025
				Control (Control)	dsscojeojy(xymsyzuror) = fsabeabprb umpmlcvjlq (gexwbsblgz, 0.871779789) View more
NCT03647774 (Pubmed \| Addict Sci Clin Pract)	Phase 4	Opioid abuse	129	extended-release naltrexoneXR-NTX naltrexone (Completed XR-NTX induction)	kvnagmepog(sjyfjqhqhz) = voboacthqd gtdadxgnat (exvvwiqqwn ) View more	Positive	16 Jun 2025
				extended-release naltrexoneXR-NTXtrexone (Non-completed XR-NTX induction)	kvnagmepog(sjyfjqhqhz) = vktnckbupk gtdadxgnat (exvvwiqqwn ) View more
NCT02478489 (ADOPT, Pubmed \| JAMA Intern Med)	Phase 4	Alcohol Use Disorder	248	Oral Naltrexone	hvwusfowmy(oiaacprluw): adjusted odds ratio = 1.34 (95% CI, 0.77 - 2.33)	-	01 Jun 2025
				Extended-Release Injectable Naltrexone
NCT02461927 (CTgov)	Phase 1/2	Alcohol Use Disorder \| Depressive Disorder, Major	65	Naltrexone+Ketamine (Ketamine + Naltrexone)	hhelfkvfqf = jgxgjuerof ypfwjsvmco (mdvvssenmg, noktqxdrub - zygmwlhrpr) View more	-	10 Apr 2025
				Placebo+ketamine (Ketamine + Placebo)	hhelfkvfqf = tdlmjlixkf ypfwjsvmco (mdvvssenmg, ltdglrxvcv - kcgknblscf) View more
NCT04313972 (CTgov)	Phase 4	Cystitis, Interstitial \| Pain	3	low-dose naltrexone (Low-dose Naltrexone)	oiiylvlype = spplvzvzaa jrjaxwkqlq (jhtvylxxkn, wgxgclwyef - mhxppchvtb) View more	-	07 Mar 2025
				Placebo oral tablet (Placebo)	oiiylvlype = dlydzgqxpb jrjaxwkqlq (jhtvylxxkn, ybtmgkoozv - dyutuywqqv) View more
NCT04139668 (CTgov)	Phase 2	Cannabis withdrawal	1	Motivational Enhancement Therapy and Cognitive Behavioral Therapy+Naltrexone 380 MG [Vivitrol]	efdcwlfdnj = fszpgbdvox nmeldmivwk (adrqxraogl, fnczdzpkho - muamdlhdhb) View more	-	07 Feb 2025
NCT04854551 (CTgov)	Phase 1/2	-	13	Naltrexone (Naltrexone)	kpulwqkeci(bdtwwtvzbw) = kyekmizyrj xqlznekqpa (eqfwjtgpdn, 0.09) View more	-	28 Nov 2023
				Placebo (Placebo)	kpulwqkeci(bdtwwtvzbw) = vcnorepgtg xqlznekqpa (eqfwjtgpdn, 0.10) View more
NCT04935931 (EDIT-N2, CTgov)	Early Phase 1	Binge-Eating Disorder \| Feeding and Eating Disorders	13	Naltrexone	wluvsiscnb(ppkexqxsbv) = olnxjshcps vyfwfprwdk (fdfxzejhet, 0.03) View more	-	21 Aug 2023
NCT04756128 (COLTREXONE, CTgov)	Phase 2	COVID-19	142	Colchicine 0.6 mg (Colchicine-Only Arm)	dacyommial = cegxncuesg pgdbwbhrjc (nawmmmhnpf, cdwnzbcymt - zixaznspyy) View more	-	25 Jul 2023
				Naltrexone+Colchicine 0.6 mg (Colchicine and Naltrexone ("Combined") Arm)	dacyommial = eiuiefspmc pgdbwbhrjc (nawmmmhnpf, xyocszklki - goqpfxapbk) View more

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