CLINICAL TRIALS PROFILE FOR EXENATIDE

505(b)(2) Clinical Trials for Exenatide

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
New Combination	NCT04520490 ↗	Brain Activation and Satiety in Children 2	Recruiting	University of Washington	Phase 3	2021-01-28	Childhood obesity and related long-term effects are serious public health problems, but not all children with obesity do well in treatment. This study will test a new combination of family-based behavioral treatment (FBT) with a drug intervention using a glucagon-like peptide-1 receptor agonist (GLP-1RA) exenatide once weekly extended-release (ExQW, Bydureon®) in order to improve obesity intervention outcomes in 10-12-year-old children.
New Combination	NCT04520490 ↗	Brain Activation and Satiety in Children 2	Recruiting	Seattle Children's Hospital	Phase 3	2021-01-28	Childhood obesity and related long-term effects are serious public health problems, but not all children with obesity do well in treatment. This study will test a new combination of family-based behavioral treatment (FBT) with a drug intervention using a glucagon-like peptide-1 receptor agonist (GLP-1RA) exenatide once weekly extended-release (ExQW, Bydureon®) in order to improve obesity intervention outcomes in 10-12-year-old children.
New Formulation	NCT05347147 ↗	A Phase III Trial to Determine the Efficacy and Safety of Presendin in IIH	Not yet recruiting	Premier Research International LLC	Phase 3	2022-06-01	Idiopathic intracranial hypertension (IIH) has significant associated morbidity and reduced quality of life. There is a significant risk of visual loss and patients also typically suffer with chronic disabling headaches. This trial has been designed to evaluate the efficacy and safety of a new formulation of exenatide (Presendin) in the reduction of intracranial pressure (ICP) in patients with IIH.
New Formulation	NCT05347147 ↗	A Phase III Trial to Determine the Efficacy and Safety of Presendin in IIH	Not yet recruiting	Invex Therapeutics Ltd.	Phase 3	2022-06-01	Idiopathic intracranial hypertension (IIH) has significant associated morbidity and reduced quality of life. There is a significant risk of visual loss and patients also typically suffer with chronic disabling headaches. This trial has been designed to evaluate the efficacy and safety of a new formulation of exenatide (Presendin) in the reduction of intracranial pressure (ICP) in patients with IIH.

All Clinical Trials for Exenatide

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00082381 ↗	Effect of AC2993 Compared With Insulin Glargine in Patients With Type 2 Diabetes Also Using Combination Therapy With Sulfonylurea and Metformin	Completed	Eli Lilly and Company	Phase 3	2003-06-01	This is a multicenter, comparator-controlled, open-label, randomized, two-arm, parallel trial to compare the effect of exenatide twice daily and insulin glargine on glycemic control, as measured by hemoglobin A1c (HbA1c).
NCT00082381 ↗	Effect of AC2993 Compared With Insulin Glargine in Patients With Type 2 Diabetes Also Using Combination Therapy With Sulfonylurea and Metformin	Completed	AstraZeneca	Phase 3	2003-06-01	This is a multicenter, comparator-controlled, open-label, randomized, two-arm, parallel trial to compare the effect of exenatide twice daily and insulin glargine on glycemic control, as measured by hemoglobin A1c (HbA1c).
NCT00082407 ↗	Exenatide Compared With Twice-Daily Biphasic Insulin Aspart in Patients With Type 2 Diabetes Using Sulfonylurea and Metformin	Completed	Eli Lilly and Company	Phase 3	2003-11-01	This is a Phase 3, multicenter, open-label, comparator-controlled trial comparing the effect of exenatide twice daily to twice daily biphasic insulin aspart on glycemic control, as measured by hemoglobin A1c (HbA1c).
NCT00082407 ↗	Exenatide Compared With Twice-Daily Biphasic Insulin Aspart in Patients With Type 2 Diabetes Using Sulfonylurea and Metformin	Completed	AstraZeneca	Phase 3	2003-11-01	This is a Phase 3, multicenter, open-label, comparator-controlled trial comparing the effect of exenatide twice daily to twice daily biphasic insulin aspart on glycemic control, as measured by hemoglobin A1c (HbA1c).
NCT00085969 ↗	Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus	Completed	Eli Lilly and Company	Phase 2	2003-09-01	The purpose of this study is to evaluate the safety and efficacy of a 28-day regimen of exenatide (AC2993), given as a monotherapy to subjects with type 2 diabetes mellitus.
NCT00085969 ↗	Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus	Completed	AstraZeneca	Phase 2	2003-09-01	The purpose of this study is to evaluate the safety and efficacy of a 28-day regimen of exenatide (AC2993), given as a monotherapy to subjects with type 2 diabetes mellitus.
NCT00097500 ↗	Effects of Exenatide and Insulin Glargine in Subjects With Type 2 Diabetes	Completed	Eli Lilly and Company	Phase 3	2004-09-01	This Phase 3, open-label, multicenter study is designed to compare the effects of exenatide and insulin glargine (Lantus® injection) on beta-cell function in patients with type 2 diabetes mellitus using metformin.

Clinical Trial Conditions for Exenatide

Condition Name

Condition Name for Exenatide
Intervention	Trials
Type 2 Diabetes Mellitus	65
Type 2 Diabetes	48
Diabetes Mellitus, Type 2	34
Obesity	27

Condition MeSH

Condition MeSH for Exenatide
Intervention	Trials
Diabetes Mellitus	163
Diabetes Mellitus, Type 2	149
Diabetes Mellitus, Type 1	18
Obesity	15

Clinical Trial Locations for Exenatide

Trials by Country

Trials by Country for Exenatide
Location	Trials
United States	915
Canada	54
China	43
Mexico	35
United Kingdom	29

Trials by US State

Trials by US State for Exenatide
Location	Trials
Texas	60
California	48
Florida	42
New York	35
Washington	33

Clinical Trial Progress for Exenatide

Clinical Trial Phase

Clinical Trial Phase for Exenatide
Clinical Trial Phase	Trials
Phase 4	90
Phase 3	67
Phase 2/Phase 3	10

Clinical Trial Status

Clinical Trial Status for Exenatide
Clinical Trial Phase	Trials
Completed	206
Unknown status	28
Recruiting	21

Clinical Trial Sponsors for Exenatide

Sponsor Name

Sponsor Name for Exenatide
Sponsor	Trials
AstraZeneca	80
Eli Lilly and Company	74
Amylin Pharmaceuticals, LLC.	20

Sponsor Type

Sponsor Type for Exenatide
Sponsor	Trials
Other	306
Industry	232
NIH	20

Exenatide: Clinical Trials, Market Analysis, and Projections

Introduction to Exenatide

Exenatide, a glucagon-like peptide-1 (GLP-1) receptor agonist, has been a significant player in the treatment of type 2 diabetes and is increasingly being explored for other conditions such as obesity and Parkinson's disease. Here, we delve into the latest clinical trials, market analysis, and projections for this versatile drug.

Clinical Trials Update

LIBERATE-1 Trial for Obesity Treatment

Vivani is set to initiate the LIBERATE-1 clinical trial in Australia, focusing on the use of a six-month GLP-1 implant for treating obesity. This trial will enroll 24 participants who will be randomized to receive either the GLP-1 implant, Wegovy, or a weekly exenatide injection (Bydureon BCise) over nine weeks. The primary goal is to compare the exenatide exposure levels and assess the efficacy and tolerability of the implant. Results are expected in 2025, which may pave the way for further studies on higher and potentially more effective doses[1].

Exenatide-PD3 Trial for Parkinson’s Disease

The Exenatide-PD3 trial, a large-scale, two-year phase 3 clinical trial, aimed to evaluate whether exenatide (Bydureon) could slow the progression of Parkinson’s disease. Although the trial concluded in early 2024, it unfortunately did not meet its primary endpoint, showing no significant benefit of exenatide compared to placebo. Full results and findings from sub-studies are anticipated in early 2025[4].

Cardiovascular Safety Trials

Previous analyses have shown that exenatide does not increase the risk of cardiovascular events. A meta-analysis indicated a relative risk of 0.70 with a 95% confidence interval of 0.38-1.31 for cardiovascular events in exenatide-treated patients compared to controls. This finding supports the cardiovascular safety of exenatide and will be used in future trials to evaluate its effects on major cardiovascular events compared to standard antidiabetes medications[3].

Market Analysis

Market Size and Forecast

The global exenatide market is experiencing rapid growth, driven by several key factors. The market is estimated to grow significantly from 2022 to 2030 due to an increase in the number of middle-class households, rising per capita income, technological advancements, and the infrastructure of hospitals. The improved efficiency of GLP-1 therapies and the increasing prevalence of diabetes in both established and emerging countries are also major drivers[2].

Market Segmentation

The exenatide market is segmented by type and application. The types include extended-release injectable suspension and fast release injectable suspension. By application, the market is divided into hospital and drug store segments, with the drug store segment being the major contributor due to the consumer-friendly nature of these medications[5].

Geographic Distribution

Geographically, the market is classified into North America, Europe, Asia Pacific, and the rest of the world. North America is expected to contribute significantly due to high per capita income, while the Asia Pacific region, particularly China and India, has the highest number of diabetic patients, driving demand in this region[2][5].

Market Trends and Drivers

Increasing Diabetes Prevalence

The rising prevalence of diabetes, especially in countries with aging populations like Japan, Italy, Germany, and France, is a significant driver. Factors such as increasing median age, obesity, and inactivity levels among the population contribute to this trend[2].

Technological Advancements

Advancements in medical technology and the availability of skilled medical professionals are crucial for the growth of the exenatide market. Improved manufacturing processes and the development of new formulations, such as the six-month GLP-1 implant by Vivani, are also key drivers[1][2].

Consumer Awareness and Healthcare Infrastructure

Growing health awareness among consumers and the robust healthcare infrastructure in regions like North America and Europe further boost the market. The ease of use and consumer-friendly nature of exenatide medications also contribute to their popularity[2][5].

Competitive Landscape

The exenatide market is competitive, with key players including AstraZeneca, Byetta, and Guangzhou Tosun Pharmaceutical Co. Ltd. The competitive landscape is analyzed based on market share, competitive advantages, and potential areas for differentiation among industry players. Companies are focusing on innovative formulations and expanding their market presence through strategic initiatives[5].

Challenges and Opportunities

Regulatory Clearances

Obtaining regulatory clearances is a significant challenge for new formulations and higher doses of exenatide. However, successful clinical trials and safety analyses can provide opportunities for expanded use and higher market penetration[1][3].

Expanding Applications

The potential use of exenatide in treating conditions other than diabetes, such as obesity and Parkinson’s disease, presents significant opportunities. Although the Exenatide-PD3 trial did not meet its primary endpoint, it opens avenues for further research and potential future applications[4].

Projections and Future Outlook

Market Growth

The global exenatide market is projected to continue its growth trajectory from 2025 to 2030, driven by the factors mentioned above. The Asia Pacific region is expected to see robust growth due to its large diabetic population and supportive healthcare policies[2][5].

New Formulations and Technologies

The development of new formulations, such as the six-month GLP-1 implant, is expected to enhance patient compliance and efficacy. Technological advancements in manufacturing and delivery systems will continue to play a crucial role in the market's growth[1].

Expanding into New Markets

Companies are likely to expand their market presence into emerging countries with growing healthcare needs. This expansion, coupled with increasing consumer awareness and healthcare infrastructure, will drive the market forward[2][5].

Key Takeaways

• Clinical Trials: Ongoing and upcoming trials, such as LIBERATE-1 and the Exenatide-PD3 trial, are crucial for expanding the use of exenatide.
• Market Growth: The global exenatide market is expected to grow significantly from 2025 to 2030 driven by increasing diabetes prevalence, technological advancements, and consumer awareness.
• Competitive Landscape: Key players are focusing on innovative formulations and expanding market presence.
• Challenges and Opportunities: Regulatory clearances and expanding applications into new conditions present both challenges and opportunities.

FAQs

What is the current status of the LIBERATE-1 trial for exenatide?

The LIBERATE-1 trial is set to initiate in Australia in Q4 2024, aiming to evaluate the efficacy and tolerability of a six-month GLP-1 implant for treating obesity[1].

Did the Exenatide-PD3 trial show any benefits for Parkinson’s disease?

The Exenatide-PD3 trial did not meet its primary endpoint, showing no significant benefit of exenatide compared to placebo in slowing the progression of Parkinson’s disease[4].

What are the key drivers of the global exenatide market?

Key drivers include the increasing prevalence of diabetes, technological advancements, growing health awareness, and robust healthcare infrastructure[2][5].

Which regions are expected to contribute significantly to the exenatide market?

North America and the Asia Pacific region, particularly China and India, are expected to be major contributors due to high per capita income and a large diabetic population, respectively[2][5].

What are the potential future applications of exenatide beyond diabetes?

Exenatide is being explored for treating obesity and Parkinson’s disease, although the latter has shown mixed results in recent trials[1][4].

Sources

1. Vivani to start in-human trial for GLP-1 implant for treating obesity. Clinical Trials Arena, July 12, 2024.
2. Exenatide Market Size, Trends, Scope, Opportunities, Share .... Verified Market Research.
3. Exenatide Clinical Data Analysis Shows No Increased Risk of .... Eli Lilly and Company.
4. 2025: Cure Parkinson's research highlights from the last year and .... Cure Parkinson's, January 6, 2025.
5. Global Exenatide Market – Industry Reports. Industry Research Biz, December 27, 2024.