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Last Updated: April 28, 2025

CLINICAL TRIALS PROFILE FOR METHYLENE BLUE


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505(b)(2) Clinical Trials for Methylene Blue

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT00214877 ↗ Methylene Blue for Cognitive Dysfunction in Bipolar Disorder Completed Stanley Medical Research Institute Phase 3 2003-11-01 While many bipolar patients treated with mood stabilizing medications experience improvement in their symptoms, some continue to have ongoing difficulties with concentration and memory. The purpose of this study is to look at whether these symptoms can be improved by adding the compound methylene blue to the treatment plan of patients who are already taking lamotrigine. Methylene blue is an available 'over the counter medication' in Canada. It has been studied in the long-term treatment of mood symptoms in bipolar disorder. Several clinical studies done in bipolar disorder report that methylene blue has had positive effects on both cognition and mood. It is important to do further research in this area as we know that, for patients who continue to have ongoing cognitive difficulties, there is no recognized standard of care for bipolar patients who experience these type of deficits.
OTC NCT00214877 ↗ Methylene Blue for Cognitive Dysfunction in Bipolar Disorder Completed Nova Scotia Health Authority Phase 3 2003-11-01 While many bipolar patients treated with mood stabilizing medications experience improvement in their symptoms, some continue to have ongoing difficulties with concentration and memory. The purpose of this study is to look at whether these symptoms can be improved by adding the compound methylene blue to the treatment plan of patients who are already taking lamotrigine. Methylene blue is an available 'over the counter medication' in Canada. It has been studied in the long-term treatment of mood symptoms in bipolar disorder. Several clinical studies done in bipolar disorder report that methylene blue has had positive effects on both cognition and mood. It is important to do further research in this area as we know that, for patients who continue to have ongoing cognitive difficulties, there is no recognized standard of care for bipolar patients who experience these type of deficits.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Methylene Blue

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00070317 ↗ Lymph Node Mapping and Sentinel Lymph Node Identification in Patients With Stage IB1 Cervical Cancer Terminated National Cancer Institute (NCI) N/A 2004-06-01 This clinical trial is studying how well lymph node mapping and sentinel lymph node identification work in finding lymph node metastases in patients with stage IB1 cervical cancer. Diagnostic procedures, such as lymph node mapping and sentinel lymph node identification, performed before and during surgery, may improve the ability to detect lymph node metastases in patients who have cervical cancer.
NCT00070317 ↗ Lymph Node Mapping and Sentinel Lymph Node Identification in Patients With Stage IB1 Cervical Cancer Terminated Gynecologic Oncology Group N/A 2004-06-01 This clinical trial is studying how well lymph node mapping and sentinel lymph node identification work in finding lymph node metastases in patients with stage IB1 cervical cancer. Diagnostic procedures, such as lymph node mapping and sentinel lymph node identification, performed before and during surgery, may improve the ability to detect lymph node metastases in patients who have cervical cancer.
NCT00131599 ↗ Thymidylate Synthase Polymorphisms as a Predictor of Toxicity to 5-Fluorouracil Based Chemotherapy in Stage III Colon Cancer Unknown status AHS Cancer Control Alberta 2002-08-01 Cancer of the colon and rectum are the third most common cancers in Canadian males and females. The initial therapy of colorectal cancer is surgery to remove the cancer and nearby lymph glands. If the cancer has spread to the lymph glands there is a high chance that the cancer will come back. To reduce the risk of the cancer recurring, patients are treated with an anticancer drug 5-fluorouracil (5FU) in combination with a vitamin leucovorin (LV). This study will determine if a simple blood test can predict which patients are at risk for developing side effects from this chemotherapy. In addition, participants of this study will be followed to determine if this same blood test will predict which patients will have their cancer relapse.
NCT00159510 ↗ Studies of Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome Terminated Helse Nord Phase 1 2004-04-01 Nitric oxide (NO) plays a pivotal role in maintenance of normal vascular tone. However, in sepsis the excessive production of NO results in myocardial depression, vasoplegia, and cytotoxic effects, thus promoting shock and multiple organ dysfunction. A recently completed study from our group showed advantageous cardiovascular effects of continuously infused methylene blue (MB), an inhibitor of NO pathway, in human septic shock. In another investigation, we have found that the combination of inhaled NO and continuously infused MB attenuates endotoxin-induced acute lung injury (ALI) in sheep. Our intention is, in a new study, to test the hypothesis that the combination of MB and NO (MB+NO) improves both cardiovascular and pulmonary functions as well as clinical outcome in patients with septic shock and ALI. Forty mechanically ventilated patients diagnosed with hyperdynamic septic shock and ALI, will be randomized to groups receiving 1. Conventional treatment (control group)(n =10); 2. MB infusion in addition to conventional treatment (n=10); 3. Inhaled NO in addition to conventional treatment (n=10); 4. MB infusion combined with inhaled NO (MB+NO) in addition to conventional treatment (n=10).
NCT00159510 ↗ Studies of Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome Terminated Northern State Medical University Phase 1 2004-04-01 Nitric oxide (NO) plays a pivotal role in maintenance of normal vascular tone. However, in sepsis the excessive production of NO results in myocardial depression, vasoplegia, and cytotoxic effects, thus promoting shock and multiple organ dysfunction. A recently completed study from our group showed advantageous cardiovascular effects of continuously infused methylene blue (MB), an inhibitor of NO pathway, in human septic shock. In another investigation, we have found that the combination of inhaled NO and continuously infused MB attenuates endotoxin-induced acute lung injury (ALI) in sheep. Our intention is, in a new study, to test the hypothesis that the combination of MB and NO (MB+NO) improves both cardiovascular and pulmonary functions as well as clinical outcome in patients with septic shock and ALI. Forty mechanically ventilated patients diagnosed with hyperdynamic septic shock and ALI, will be randomized to groups receiving 1. Conventional treatment (control group)(n =10); 2. MB infusion in addition to conventional treatment (n=10); 3. Inhaled NO in addition to conventional treatment (n=10); 4. MB infusion combined with inhaled NO (MB+NO) in addition to conventional treatment (n=10).
NCT00187005 ↗ Total Therapy Study XIV for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia Terminated St. Jude Children's Research Hospital Phase 3 1998-07-01 The main purpose of this study is to find out if radiation to the central nervous system (CNS) can be safely omitted with early intensification of chemotherapy and chemotherapy given directly to the CNS. Another purpose is to find out if survival of children with ALL can be improved with risk-directed therapy given on this protocol.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Methylene Blue

Condition Name

Condition Name for Methylene Blue
Intervention Trials
Septic Shock 6
Prostate Cancer 4
Malaria 4
Covid-19 4
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Condition MeSH

Condition MeSH for Methylene Blue
Intervention Trials
Shock 8
COVID-19 8
Malaria 7
Shock, Septic 7
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Clinical Trial Locations for Methylene Blue

Trials by Country

Trials by Country for Methylene Blue
Location Trials
United States 112
China 27
Canada 10
Brazil 7
Burkina Faso 5
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Trials by US State

Trials by US State for Methylene Blue
Location Trials
Pennsylvania 7
Texas 7
New York 7
Maryland 6
California 5
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Clinical Trial Progress for Methylene Blue

Clinical Trial Phase

Clinical Trial Phase for Methylene Blue
Clinical Trial Phase Trials
Phase 4 11
Phase 3 10
Phase 2/Phase 3 7
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Clinical Trial Status

Clinical Trial Status for Methylene Blue
Clinical Trial Phase Trials
Completed 59
Recruiting 17
Unknown status 12
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Clinical Trial Sponsors for Methylene Blue

Sponsor Name

Sponsor Name for Methylene Blue
Sponsor Trials
National Cancer Institute (NCI) 7
Heidelberg University 7
Isofol Medical AB 3
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Sponsor Type

Sponsor Type for Methylene Blue
Sponsor Trials
Other 160
Industry 22
NIH 9
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Methylene Blue: Clinical Trials, Market Analysis, and Projections

Introduction

Methylene Blue, a versatile compound with a long history of medical and industrial use, is undergoing significant scrutiny in various clinical trials and market analyses. This article will delve into the current state of clinical trials involving Methylene Blue, its market analysis, and projections for the future.

Clinical Trials Update

Alzheimer's Disease and Dementia

Methylene Blue, under the name Hydromethylthionine mesylate (HMTM) or LMTX, has been a focus of research for its potential in treating Alzheimer's disease and other forms of dementia. TauRx Therapeutics Ltd has been conducting trials to evaluate its efficacy. A Phase 2/3 monotherapy trial initiated in January 2018 aimed to enroll 180 patients with all-cause dementia and Alzheimer's disease. However, the trial failed to meet its primary endpoints, including 18F-FDG-PET imaging and safety assessments[1].

Despite this setback, some biomarker results presented at the 2023 Alzheimer's Association International Conference (AAIC) in Amsterdam showed promising trends. For instance, plasma neurofilament light levels increased in the Methylene Blue control group but not in the treated group, suggesting potential neuroprotective effects[1].

Septic Shock

Methylene Blue is also being investigated for its use in treating refractory septic shock. A multicenter, randomized, placebo-controlled trial is underway to assess its efficacy in improving arterial pressure and reducing the need for vasopressors. The trial involves administering a bolus of 2 mg/kg Methylene Blue followed by a continuous infusion of 0.5 mg/kg/h for 48 hours. The primary outcome is the total dose of vasopressor required in the first 48 hours, with secondary outcomes including other hemodynamic parameters and organ function indexes[3].

SARS-CoV-2

In the context of the COVID-19 pandemic, Methylene Blue was evaluated in a Phase 2, randomized, placebo-controlled, single-blind clinical trial for its efficacy in treating SARS-CoV-2-infected patients. The study found no significant difference in virus clearance or reduction in viral load between the Methylene Blue and placebo groups, indicating that Methylene Blue did not offer superior efficacy over the placebo in this setting[4].

Market Analysis

Current Market Size and Growth

The global Methylene Blue market is experiencing steady growth. As of 2023, the market size was valued at approximately USD 7.66 billion. It is projected to grow at a Compound Annual Growth Rate (CAGR) of 5.2% from 2024 to 2030, reaching nearly USD 10.93 billion by 2030[5].

Market Segments and Applications

Methylene Blue has diverse applications across various industries, including pharmaceutical, textile, biological, chemical, and aquaculture. The pharmaceutical segment is expected to dominate the market, driven by its use in treating conditions such as acquired methemoglobinemia and its potential in neurodegenerative diseases[5].

Regional Insights

North America is anticipated to lead the Methylene Blue market, driven by high demand for antiseptics and the presence of advanced research and development facilities in countries like the United States and Canada. The Asia-Pacific region, particularly countries like India, China, and Japan, is also expected to contribute significantly to the market growth due to the presence of major manufacturers and key players[5].

Market Projections

Growth Drivers

The Methylene Blue market is expected to be driven by several factors, including an increasing global population, rising health conditions, and extensive use in medical research and testing. Its versatility in applications such as medical tests, bacterial identification, and as a redox indicator further supports market growth[5].

Challenges and Restraints

Despite the positive outlook, the market faces challenges such as undesirable side effects of Methylene Blue, including nausea, excessive sweating, headache, and confusion. Additionally, the synthesis of methemoglobin from Methylene Blue can be a significant restraint[5].

Key Takeaways

  • Clinical Trials: Methylene Blue is being evaluated in various clinical trials for Alzheimer's disease, septic shock, and SARS-CoV-2, with mixed results.
  • Market Size and Growth: The global Methylene Blue market is projected to grow from USD 7.66 billion in 2023 to nearly USD 10.93 billion by 2030 at a CAGR of 5.2%.
  • Market Segments: The pharmaceutical segment is expected to dominate the market, with North America leading in terms of regional demand.
  • Growth Drivers: Increasing global population, rising health conditions, and extensive use in medical research are key drivers.
  • Challenges: Undesirable side effects and the synthesis of methemoglobin are significant restraints.

FAQs

What is the current market size of Methylene Blue?

The global Methylene Blue market was valued at approximately USD 7.66 billion in 2023[5].

What is the projected growth rate of the Methylene Blue market from 2024 to 2030?

The Methylene Blue market is expected to grow at a CAGR of 5.2% from 2024 to 2030[5].

What are the primary applications of Methylene Blue?

Methylene Blue is used in various applications including pharmaceutical, textile, biological, chemical, and aquaculture. It is also used in medical tests, bacterial identification, and as a redox indicator[5].

Which region is expected to lead the Methylene Blue market?

North America is anticipated to lead the Methylene Blue market, driven by high demand and advanced research facilities[5].

What are the potential side effects of Methylene Blue?

Potential side effects include nausea, excessive sweating, headache, confusion, and the synthesis of methemoglobin[5].

Sources

  1. ALZFORUM - HMTM | ALZFORUM
  2. Valuates Reports - Global Methylene Blue Market Insights, Forecast to 2030
  3. PubMed - Efficacy of methylene blue in refractory septic shock: study protocol
  4. MDPI - Evaluation of the Efficacy of Methylene Blue Administration in SARS-CoV-2-Affected Patients
  5. Maximize Market Research - Methylene Blue Market: Global Industry Analysis and Forecast

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