CLINICAL TRIALS PROFILE FOR BYDUREON PEN

505(b)(2) Clinical Trials for Bydureon Pen

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.

All Clinical Trials for Bydureon Pen

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00103935 ↗	Study Examining Exenatide Long-Acting Release in Subjects With Type 2 Diabetes	Completed	Eli Lilly and Company	Phase 2	2005-02-01	Exenatide LAR is a long-acting release formulation of exenatide, which is a twice-daily dosage form currently under investigation as a potential treatment for people with type 2 diabetes mellitus. This study will assess the safety, tolerability, and pharmacokinetics of Exenatide LAR administered weekly by subcutaneous injection in people with type 2 diabetes mellitus.
NCT00103935 ↗	Study Examining Exenatide Long-Acting Release in Subjects With Type 2 Diabetes	Completed	AstraZeneca	Phase 2	2005-02-01	Exenatide LAR is a long-acting release formulation of exenatide, which is a twice-daily dosage form currently under investigation as a potential treatment for people with type 2 diabetes mellitus. This study will assess the safety, tolerability, and pharmacokinetics of Exenatide LAR administered weekly by subcutaneous injection in people with type 2 diabetes mellitus.
NCT00308139 ↗	Effects of Exenatide Long-Acting Release on Glucose Control and Safety in Subjects With Type 2 Diabetes Mellitus(DURATION - 1)	Completed	AstraZeneca	Phase 3	2006-04-01	A Randomized, Open-Label, Multicenter, Comparator-Controlled Study to Examine the Effects of Exenatide Long-Acting Release (LAR) on Glucose Control (HbA1c) and Safety in Subjects with Type 2 Diabetes Mellitus Managed with Diet Modification and Exercise and/or Oral Antidiabetic Medications.
NCT00877890 ↗	A Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus (DURATION-5)	Completed	Eli Lilly and Company	Phase 3	2009-03-01	This study will compare the effects of commercially manufactured exenatide once weekly and exenatide BID in subjects whose type 2 diabetes is managed with diet and exercise alone or with oral antidiabetic medications. The study will examine glycemic control (as measured by HbA1C), safety, and tolerability.
NCT00877890 ↗	A Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus (DURATION-5)	Completed	AstraZeneca	Phase 3	2009-03-01	This study will compare the effects of commercially manufactured exenatide once weekly and exenatide BID in subjects whose type 2 diabetes is managed with diet and exercise alone or with oral antidiabetic medications. The study will examine glycemic control (as measured by HbA1C), safety, and tolerability.

Clinical Trial Conditions for Bydureon Pen

Condition Name

Condition Name for Bydureon Pen
Intervention	Trials
Type 2 Diabetes	8
Type 2 Diabetes Mellitus	6
Obesity	4
Diabetes Mellitus, Type 2	4

Condition MeSH

Condition MeSH for Bydureon Pen
Intervention	Trials
Diabetes Mellitus, Type 2	18
Diabetes Mellitus	14
Obesity	5
Atherosclerosis	2

Clinical Trial Locations for Bydureon Pen

Trials by Country

Trials by Country for Bydureon Pen
Location	Trials
United States	136
China	2
Mexico	2
Kuwait	2
Denmark	2

Trials by US State

Trials by US State for Bydureon Pen
Location	Trials
Texas	12
California	8
Florida	8
Washington	7
New York	7

Clinical Trial Progress for Bydureon Pen

Clinical Trial Phase

Clinical Trial Phase for Bydureon Pen
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	10
Phase 2	7

Clinical Trial Status

Clinical Trial Status for Bydureon Pen
Clinical Trial Phase	Trials
Completed	23
Recruiting	6
Unknown status	4

Clinical Trial Sponsors for Bydureon Pen

Sponsor Name

Sponsor Name for Bydureon Pen
Sponsor	Trials
AstraZeneca	9
The University of Texas Health Science Center, Houston	4
Eli Lilly and Company	2

Sponsor Type

Sponsor Type for Bydureon Pen
Sponsor	Trials
Other	40
Industry	15
NIH	2

BYDUREON Pen: Clinical Trials, Market Analysis, and Projections

Introduction

The BYDUREON Pen, containing the drug exenatide, is a significant player in the management of type 2 diabetes. This article will delve into the recent clinical trial updates, market analysis, and future projections for this drug.

Clinical Trials Update: Exenatide-PD3 Study

A recent and notable clinical trial involving exenatide is the Exenatide-PD3 study. This phase 3 clinical trial, conducted in the UK, aimed to determine if exenatide could slow the progression of Parkinson's disease. However, the results indicated that the study did not meet its primary endpoint, showing no significant difference in the progression of motor symptoms between the treatment and placebo groups[1].

This outcome is a contrast to the encouraging results from earlier phase 2 trials of GLP-1 receptor agonists, including exenatide. The study team is now working to understand the discrepancies and to identify learnings that can inform future research in the GLP-1 field.

Clinical Efficacy in Diabetes Management

In the context of type 2 diabetes, BYDUREON has demonstrated significant efficacy. The FDA-approved BYDUREON Pen delivers exenatide via microsphere technology in a once-weekly dose, which has been shown to improve glycemic control. In the DURATION-5 clinical trial, patients treated with BYDUREON experienced a mean reduction in HbA1c of 1.6 percentage points, compared to 0.9 percentage points for those treated with BYETTA[3].

Market Analysis: Injection Pens Market

The global injection pens market, which includes devices like the BYDUREON Pen, is projected to grow significantly. Here are some key points from the market analysis:

• Market Size and Growth: The global injection pens market is expected to reach USD 67.9 billion by 2025, growing at a CAGR of 9.4% during the forecast period[2].
• Product Segmentation: Reusable injectable pens, such as the BYDUREON Pen, are the largest and fastest-growing segment due to their cost-effectiveness and patient convenience[2].
• Dosage Segmentation: Variable dosage pens are the fastest-growing segment, offering customization and flexibility for patients[2].
• Regional Analysis: North America dominates the market, followed by Europe, while the Asia Pacific region is expected to be the fastest-growing due to better healthcare accessibility and increasing healthcare expenditure[2].

Key Players and Market Dynamics

The market for injection pens is highly competitive, with several key players:

• Major Players: Companies like AstraZeneca, Novo Nordisk, Sanofi, and Eli Lilly are prominent in the market. These companies are driving innovation and expanding their geographical reach[2].
• Market Drivers: Increasing prevalence of chronic diseases such as diabetes and arthritis, along with government healthcare expenditure and favorable insurance policies, are driving the market growth[2].
• Market Restraints: Slow approval procedures and low awareness about pen injectors are some of the restraints affecting the market[2].

Technological Advancements and Patient Convenience

The BYDUREON Pen is designed for patient convenience, featuring a pre-filled device that requires no titration and can be administered at any time of the day, with or without meals. This ease of use is a significant factor in the growing adoption of injection pens[3].

Safety and Adverse Reactions

Clinical trials have identified common adverse reactions associated with BYDUREON, including nausea, which is reported less frequently compared to other GLP-1 receptor agonists like BYETTA. Other adverse reactions include cholelithiasis and cholecystitis, as well as an increase in heart rate[4].

Patent Expirations and Generic Competition

Several patents related to exenatide are set to expire between 2024 and 2028, which could lead to the entry of generic versions into the market. For example, patents such as US9238076 and US7612176 are set to expire in 2024 and 2025, respectively[5].

Future Projections

Given the growing demand for convenient and effective diabetes management solutions, the BYDUREON Pen is likely to remain a significant player in the market. Here are some future projections:

• Market Growth: The injection pens market is expected to continue growing, driven by increasing disease prevalence and technological advancements.
• Generic Competition: The expiration of key patents may introduce generic competition, potentially affecting the market share of branded products like BYDUREON.
• Research and Development: Ongoing research into the use of GLP-1 receptor agonists in other diseases, such as Parkinson’s, could expand the therapeutic applications of exenatide and similar drugs.

Key Takeaways

• The BYDUREON Pen has shown efficacy in managing type 2 diabetes but did not meet its primary endpoint in the Exenatide-PD3 study for Parkinson’s disease.
• The global injection pens market is projected to grow significantly, driven by increasing disease prevalence and patient convenience.
• Key players are driving innovation, and the market is expected to see generic competition as patents expire.
• Technological advancements and ongoing research will continue to shape the future of diabetes management and potentially other therapeutic areas.

FAQs

What is the BYDUREON Pen used for?

The BYDUREON Pen is used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

What were the results of the Exenatide-PD3 study?

The Exenatide-PD3 study did not meet its primary endpoint, showing no significant difference in the progression of motor symptoms between the treatment and placebo groups in patients with Parkinson’s disease.

How does the BYDUREON Pen compare to other GLP-1 receptor agonists?

The BYDUREON Pen has been shown to have a lower incidence of nausea compared to other GLP-1 receptor agonists like BYETTA and offers the convenience of a once-weekly dose.

What are the common adverse reactions associated with BYDUREON?

Common adverse reactions include nausea, cholelithiasis, cholecystitis, and an increase in heart rate.

When do key patents related to exenatide expire?

Several patents related to exenatide are set to expire between 2024 and 2028, which could lead to the entry of generic versions into the market.

Sources

1. Cure Parkinson's: Exenatide-PD3 results shared with participants.
2. PR Newswire: Global Injection Pens Market, 2018-2025 Featuring Key Players.
3. AstraZeneca: US FDA approves Bydureon Pen (exenatide extended-release for injectable suspension).
4. FDA: BYDUREON BCISE Label.
5. GreyB: 30 Diabetes Drug Patents Expiring from 2024 till 2028.

Last updated: 2025-01-01