CLINICAL TRIALS PROFILE FOR AMLEXANOX

All Clinical Trials for AMLEXANOX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01975935 ↗	Efficacy of Amlexanox vs. Placebo in Type 2 Diabetic Patients	Completed	University of Michigan	Phase 2	2014-01-01	This study involves research about an investigational medicine called Amlexanox. The reason for this study is to find out how Amlexanox can improve type 2 diabetes, insulin resistance, obesity and non-alcoholic fatty liver disease (NAFLD). In this study, Amlexanox is considered to be investigational (not approved by the Food and Drug Administration [FDA]) for type 2 diabetes, insulin resistance, obesity and non-alcoholic fatty liver disease (NAFLD). This is a placebo controlled study. There is a 50-50 chance that the patient may either receive the study drug, Amlexanox, or a placebo (sugar pill). Neither the patient or the study doctors will know if the patient is receiving the study drug or placebo.
NCT01842282 ↗	Amlexanox for Type 2 Diabetes and Obesity	Suspended	University of Michigan	Phase 2	2013-07-19	This study involves the use of a research drug, Amlexanox, for the treatment of type 2 diabetes, insulin resistance, obesity and non-alcoholic fatty liver disease (NAFLD). Amlexanox is taken orally in a pill three times a day. The investigators plan to continue therapy for a period of 12 weeks followed by a follow-up 4 weeks after therapy ends. The investigators will evaluate the changes in metabolic parameters (e.g. blood cholesterol, liver function, insulin resistance) and body composition characteristics (e.g. the pattern of fat distribution in the body). Seven eligible subjects in this study will also be evaluated for a change in liver disease by a liver biopsy.
NCT01083875 ↗	Study to Determine the Effects Treatment With Amlexanox 0.5% Oral Rinse Solution on Oral Mucositis Associated With Radiation Therapy for Cancer of the Head and Neck Region	Completed	Advanced Clinical Research Services, LLC	Phase 2	2000-02-01	The purpose of this study was to determine the effect of 0.5% amlexanox oral rinse compared to a vehicle control on mucositis-related ulceration and erythema (objective score)and on mucositis-related oral pain (subjective score). A secondary objective was to evaluate the safety of 0.5% amlexanox oral rinse by determining the frequency of treatment-emergent drug-related adverse events or clinical laboratory abnormalities.
NCT01083875 ↗	Study to Determine the Effects Treatment With Amlexanox 0.5% Oral Rinse Solution on Oral Mucositis Associated With Radiation Therapy for Cancer of the Head and Neck Region	Completed	Access Pharmaceuticals, Inc.	Phase 2	2000-02-01	The purpose of this study was to determine the effect of 0.5% amlexanox oral rinse compared to a vehicle control on mucositis-related ulceration and erythema (objective score)and on mucositis-related oral pain (subjective score). A secondary objective was to evaluate the safety of 0.5% amlexanox oral rinse by determining the frequency of treatment-emergent drug-related adverse events or clinical laboratory abnormalities.

Clinical Trial Conditions for AMLEXANOX

Condition Name

Condition Name for AMLEXANOX
Intervention	Trials
Diabetes Mellitus Type 2	2
Obesity	2
Non Alcoholic Fatty Liver Disease	1
Non-alcoholic Fatty Liver Disease	1

Condition MeSH

Condition MeSH for AMLEXANOX
Intervention	Trials
Diabetes Mellitus	2
Non-alcoholic Fatty Liver Disease	2
Liver Diseases	2
Fatty Liver	2

Clinical Trial Locations for AMLEXANOX

Trials by Country

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−

Trials by Country for AMLEXANOX
Location	Trials
United States	12

Trials by US State

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−

Trials by US State for AMLEXANOX
Location	Trials
Michigan	3
Arkansas	1
Alabama	1
Texas	1
Tennessee	1

Clinical Trial Progress for AMLEXANOX

Clinical Trial Phase

Clinical Trial Phase for AMLEXANOX
Clinical Trial Phase	Trials
Phase 2	3

Clinical Trial Status

Clinical Trial Status for AMLEXANOX
Clinical Trial Phase	Trials
Completed	2
Suspended	1

Clinical Trial Sponsors for AMLEXANOX

Sponsor Name

Sponsor Name for AMLEXANOX
Sponsor	Trials
University of Michigan	2
Advanced Clinical Research Services, LLC	1
Access Pharmaceuticals, Inc.	1

Sponsor Type

Sponsor Type for AMLEXANOX
Sponsor	Trials
Other	3
Industry	1

Amlexanox: A Promising Drug with Diverse Clinical Applications

Introduction

Amlexanox, a drug initially used to treat asthma and aphthous ulcers, has been gaining attention for its potential in managing various other conditions, including type 2 diabetes, obesity, and non-alcoholic fatty liver disease (NAFLD). Here, we delve into the latest clinical trials, market analysis, and future projections for this versatile drug.

Clinical Trials Update

Type 2 Diabetes and Obesity

Recent clinical trials have shown promising results for amlexanox in the treatment of type 2 diabetes and obesity. A study conducted by Michigan Medicine and the University of California at San Diego found that obese patients with type 2 diabetes who took amlexanox for 12 weeks experienced a significant drop in blood glucose levels. This improvement was particularly notable in patients with higher levels of inflammation in their fat tissue at the beginning of the trial[1].

The trial involved 42 obese patients with type 2 diabetes, with half receiving amlexanox and the other half receiving a placebo. The results showed improved insulin sensitivity and a reduction in liver fat among the responders. The drug's mechanism involves inhibiting the enzymes IKKε and TBK1, which are associated with reduced energy expenditure and insulin resistance[1].

Ongoing and Future Trials

Current clinical trials are ongoing to further evaluate the efficacy of amlexanox in treating type 2 diabetes, insulin resistance, obesity, and NAFLD. These trials involve oral administration of amlexanox three times a day for 12 weeks, followed by a 4-week follow-up period. The investigators are assessing changes in metabolic parameters, body composition, and liver disease through liver biopsies[3].

Mechanism of Action

Amlexanox acts by inhibiting the enzymes IKKε and TBK1, which play crucial roles in inflammatory and metabolic pathways. By blocking these enzymes, amlexanox reduces the release of inflammatory mediators such as histamine and leukotrienes from mast cells, neutrophils, and monocytes. This anti-inflammatory action is key to its therapeutic effects in various conditions[5].

Market Analysis

Current Market Position

Amlexanox is currently approved for the treatment of aphthous ulcers and asthma in certain regions. Its use in these areas has established a baseline market presence. However, the potential expansion into the treatment of type 2 diabetes, obesity, and NAFLD could significantly broaden its market reach and impact.

Market Potential

The global market for type 2 diabetes treatments is substantial and growing, driven by the increasing prevalence of the disease. If amlexanox is approved for this indication, it could capture a significant share of this market due to its unique mechanism of action and the potential for improved outcomes in patients with high levels of inflammation.

Competitive Landscape

The market for type 2 diabetes treatments is highly competitive, with numerous established drugs and ongoing research into new therapies. However, amlexanox's anti-inflammatory properties and its ability to target specific molecular pathways could differentiate it from existing treatments, offering a competitive edge.

Future Projections

Regulatory Approval

For amlexanox to become a mainstream treatment for type 2 diabetes and related conditions, it will need to navigate the regulatory approval process. Given the promising results from clinical trials, there is a strong likelihood of approval, especially if future trials confirm the initial findings.

Patient Stratification

Researchers are planning to stratify patients based on their inflammatory profiles to predict who is most likely to respond to amlexanox. This personalized approach could enhance the drug's efficacy and reduce the number of nonresponders, making it a more attractive option for clinicians and patients[1].

Combination Therapies

There is also potential for amlexanox to be used in combination with other diabetes and obesity treatments. Studies exploring these combinations could lead to more effective treatment regimens and further expand the drug's market potential.

Safety and Side Effects

Amlexanox has shown a favorable safety profile in clinical trials. When used to treat aphthous ulcers, it has been associated with no significant topical or systemic adverse effects[2]. However, as with any drug, caution is advised, particularly in pregnant or nursing women, due to the lack of comprehensive human studies in these populations[2].

Key Takeaways

• Clinical Efficacy: Amlexanox has shown promising results in reducing blood glucose levels and improving insulin sensitivity in patients with type 2 diabetes.
• Mechanism of Action: The drug inhibits IKKε and TBK1 enzymes, reducing inflammation and improving metabolic outcomes.
• Market Potential: The global market for type 2 diabetes treatments is substantial, and amlexanox could capture a significant share if approved.
• Future Directions: Ongoing and future trials will focus on patient stratification, combination therapies, and long-term efficacy.
• Safety Profile: Amlexanox has a favorable safety profile, but caution is advised in certain populations.

FAQs

What is amlexanox primarily used for currently?

Amlexanox is currently used to treat aphthous ulcers and asthma.

How does amlexanox work in treating type 2 diabetes?

Amlexanox inhibits the enzymes IKKε and TBK1, reducing inflammation and improving insulin sensitivity and energy expenditure.

What are the potential side effects of amlexanox?

While generally safe, amlexanox should be used cautiously in pregnant or nursing women due to limited human studies in these populations.

Is amlexanox approved for treating type 2 diabetes?

No, amlexanox is not yet approved for treating type 2 diabetes but is under investigation in clinical trials.

Can amlexanox be used in combination with other diabetes treatments?

Yes, future studies are planned to explore the use of amlexanox in combination with other diabetes and obesity treatments.

Sources

1. Michigan Medicine: "Repurposed Asthma Drug Shows Blood Sugar Improvement Among Some Diabetics"[1]
2. RxList: "Aphthasol (Amlexanox): Side Effects, Uses, Dosage"[2]
3. ClinicalTrials.Veeva: "Amlexanox for Type 2 Diabetes and Obesity"[3]
4. Science.gov: "Amlexanox oral tablets: Topics by Science.gov"[4]
5. Oxford University Press: "Amlexanox targeted inhibition of TBK1 regulates immune cell function"[5]