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Last Updated: February 11, 2025

CLINICAL TRIALS PROFILE FOR NALTREXONE


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All Clinical Trials for Naltrexone

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000195 ↗ Neurobiology of Opioid Dependence: 4 - 4 Withdrawn National Institute on Drug Abuse (NIDA) Phase 2 1993-01-01 The purpose of this study is to determine the effect of chronic naltrexone pre-treatment on the response to yohimbine in healthy volunteers.
NCT00000195 ↗ Neurobiology of Opioid Dependence: 4 - 4 Withdrawn Yale University Phase 2 1993-01-01 The purpose of this study is to determine the effect of chronic naltrexone pre-treatment on the response to yohimbine in healthy volunteers.
NCT00000196 ↗ Neurobiology of Opioid Dependence: 5 - 5 Withdrawn National Institute on Drug Abuse (NIDA) Phase 2 1993-01-01 The purpose of this study is to determine the effect of acute naltrexone pretreatment on the response to yohimbine in healthy volunteers.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Naltrexone

Condition Name

Condition Name for Naltrexone
Intervention Trials
Alcoholism 55
Alcohol Dependence 50
Obesity 28
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Condition MeSH

Condition MeSH for Naltrexone
Intervention Trials
Alcoholism 124
Opioid-Related Disorders 97
Disease 50
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Clinical Trial Locations for Naltrexone

Trials by Country

Trials by Country for Naltrexone
Location Trials
United States 816
Canada 15
Germany 13
China 12
Russian Federation 11
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Trials by US State

Trials by US State for Naltrexone
Location Trials
New York 69
Connecticut 58
California 54
Pennsylvania 53
Texas 38
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Clinical Trial Progress for Naltrexone

Clinical Trial Phase

Clinical Trial Phase for Naltrexone
Clinical Trial Phase Trials
Phase 4 104
Phase 3 62
Phase 2/Phase 3 36
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Clinical Trial Status

Clinical Trial Status for Naltrexone
Clinical Trial Phase Trials
Completed 303
Recruiting 58
Not yet recruiting 47
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Clinical Trial Sponsors for Naltrexone

Sponsor Name

Sponsor Name for Naltrexone
Sponsor Trials
National Institute on Drug Abuse (NIDA) 96
National Institute on Alcohol Abuse and Alcoholism (NIAAA) 61
Yale University 39
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Sponsor Type

Sponsor Type for Naltrexone
Sponsor Trials
Other 523
NIH 180
Industry 133
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Naltrexone: Clinical Trials, Market Analysis, and Projections

Introduction

Naltrexone, a drug initially developed in the 1960s to treat opioid addiction, has been gaining attention for its potential in treating a variety of conditions beyond its licensed use. This article delves into the current clinical trials, market analysis, and future projections for naltrexone.

Clinical Trials: Exploring New Uses for Naltrexone

Long COVID and Myalgic Encephalomyelitis (ME)

Clinical trials are underway to investigate the efficacy of Low-Dose Naltrexone (LDN) in treating Long COVID and ME. A significant trial in Australia, conducted by scientists from Griffith University’s National Centre for Neuroimmunology and Emerging Diseases (NCNED), is recruiting 100 patients with Long COVID. This double-blinded, randomized controlled trial (RCT) will track symptoms such as cognitive function, pain, sleep, and fatigue over three months, comparing the results with a placebo group and healthy individuals. Initial data is expected by early 2025, with the next phase to include patients with ME[1].

Another RCT in Canada is focusing on reducing fatigue in Long COVID patients with ME/CFS-like symptoms, using doses titrated from 1mg to 4.5mg daily. These trials aim to formalize decades of patient experiences with LDN and provide robust evidence for its efficacy in these conditions[1].

Other Ongoing Trials

In addition to Long COVID and ME, other clinical trials are investigating LDN's effects on various conditions. For example, a Spanish study is examining LDN's impact on female patients with fibromyalgia, and a Harvard University study is looking at how ME/CFS patients respond to LDN and/or Mestinon, a drug used to treat myasthenia gravis[1].

Mechanism of Action and Safety Profile

Naltrexone, when used in low doses, has been observed to regulate immune cells and reduce inflammation. It works by modulating the immune system and increasing the release of endorphins, which help moderate the immune response. This mechanism makes LDN a promising candidate for treating autoimmune and inflammatory diseases[1][3].

Despite its versatile use, LDN's safety profile remains strong, with few side effects reported at low doses. This safety profile is crucial for its potential use in chronic conditions where long-term treatment is necessary.

Market Analysis

Current Market Size and Growth

The global naltrexone market, along with buprenorphine, is significant and growing. In 2023, the naltrexone and buprenorphine market was valued at approximately USD 3.56 billion and is projected to grow at a CAGR of 12.41% from 2024 to 2030, reaching USD 9.56 billion by 2035[2][5].

Drivers of Market Growth

Several factors are driving the growth of the naltrexone market:

  • Increasing Prevalence of Substance Use Disorders: The global opioid crisis and rising alcohol dependence are key drivers. Government initiatives and increasing awareness of opioid use disorder (OUD) treatment are boosting market demand[2][5].
  • Advancements in Treatment Options: Innovations such as extended-release naltrexone (XR-naltrexone) and combination therapies are enhancing treatment outcomes and efficiency. The SWIFT study, for example, showed that rapid initiation of XR-naltrexone can significantly increase treatment initiation rates[4][5].
  • Telemedicine and Digital Health: The adoption of telemedicine and digital health solutions is making treatment more accessible, especially in underserved areas[2].

Regional Market Dynamics

  • North America: This region is expected to contribute significantly to the global market, driven by the high prevalence of opioid addiction and strong government support for OUD treatment. The U.S. has seen a growing adoption of medication-assisted treatment (MAT)[2][5].
  • Asia-Pacific: This is the fastest-growing market due to rising opioid addiction cases and expanding healthcare access. Governments in the region are increasing awareness and access to medications like naltrexone and buprenorphine[2].
  • Europe: The market in Europe is influenced by healthcare reforms, research advancements, and patient-focused initiatives. The prevalence of OUD is increasing due to an aging population and changing lifestyles[5].

Market Projections

Future Growth

The naltrexone market is expected to continue its robust growth due to several factors:

  • Increasing Incidence of Autoimmune Diseases: The rise in autoimmune conditions, such as multiple sclerosis and rheumatoid arthritis, is driving the need for treatments like naltrexone[3].
  • Expanding Government Initiatives: Governments are increasingly focusing on addiction treatment and public health programs, which supports the growth of the naltrexone market[2][5].
  • Innovations in Drug Formulations: Developments in extended-release formulations and combination therapies are expected to enhance treatment outcomes and drive market growth[5].

Competitive Landscape

The market is competitive, with several players engaging in mergers and acquisitions to strengthen their market position. For instance, Purdue Pharma's acquisition of a novel buprenorphine transdermal system highlights the industry's interest in expanding treatment portfolios[5].

Key Takeaways

  • Clinical Trials: Ongoing trials are investigating LDN's efficacy in treating Long COVID, ME, and other conditions, building on patient experiences and prior research.
  • Market Growth: The naltrexone market is growing significantly due to the increasing prevalence of substance use disorders, advancements in treatment options, and government initiatives.
  • Regional Dynamics: North America, Asia-Pacific, and Europe are key regions driving market growth, each with unique factors influencing their respective markets.
  • Future Projections: The market is expected to continue growing, driven by the rise in autoimmune diseases, expanding government initiatives, and innovations in drug formulations.

FAQs

What is Low-Dose Naltrexone (LDN)?

LDN refers to the use of naltrexone at doses significantly lower than those used for opioid addiction treatment. It has been used off-label for conditions like chronic pain, multiple sclerosis, and ME.

What are the current clinical trials on LDN focusing on?

Current trials are primarily focusing on the efficacy of LDN in treating Long COVID and ME, as well as other conditions like fibromyalgia.

How is the naltrexone market expected to grow?

The naltrexone market is projected to grow at a CAGR of around 12.41% from 2024 to 2030, driven by increasing substance use disorders, advancements in treatment options, and government initiatives.

What regions are driving the growth of the naltrexone market?

North America, Asia-Pacific, and Europe are the key regions driving market growth, with the Asia-Pacific region being the fastest-growing due to rising opioid addiction cases and expanding healthcare access.

What are the main drivers of the naltrexone market growth?

The main drivers include the increasing prevalence of substance use disorders, advancements in treatment options like extended-release naltrexone, and government initiatives to combat the opioid crisis.

How does naltrexone work in treating autoimmune diseases?

Naltrexone works by modulating the immune system, reducing inflammation, and increasing the release of endorphins, which help moderate the immune response.

Sources

  1. Clinical trials explore how Low-Dose Naltrexone could help people with Long COVID - The Sick Times
  2. Naltrexone and Buprenorphine Market Size & Share 2025-2035 - MetaTech Insights
  3. Naltrexone Market Size, Share and Growth Report, 2034 - Transparency Market Research
  4. Rapid Initiation of Injection Naltrexone for Opioid Use Disorder - JAMA Network Open
  5. Naltrexone And Buprenorphine Market Size Report, 2030 - Grand View Research

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