CLINICAL TRIALS PROFILE FOR BYDUREON BCISE

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

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 Bcise

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.
NCT01089569 ↗	Continuous Glucose Monitoring Evaluation of Exenatide Twice Daily Versus Insulin Glargine	Completed	International Diabetes Center at Park Nicollet	N/A	2010-04-01	The primary purpose of this study is to compare the effect on 24-hour blood glucose patterns, HbA1c, and weight management when adding insulin glargine, or exenatide, or a combination of insulin glargine and exenatide to metformin.
NCT01089569 ↗	Continuous Glucose Monitoring Evaluation of Exenatide Twice Daily Versus Insulin Glargine	Completed	Sanofi	N/A	2010-04-01	The primary purpose of this study is to compare the effect on 24-hour blood glucose patterns, HbA1c, and weight management when adding insulin glargine, or exenatide, or a combination of insulin glargine and exenatide to metformin.

Clinical Trial Conditions for Bydureon Bcise

Condition Name

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

Condition MeSH

Condition MeSH for Bydureon Bcise
Intervention	Trials
Diabetes Mellitus, Type 2	18
Diabetes Mellitus	14
Obesity	5
Schizophrenia	2

Clinical Trial Locations for Bydureon Bcise

Trials by Country

Trials by Country for Bydureon Bcise
Location	Trials
United States	137
Denmark	2
Sweden	2
Italy	2
Canada	2

Trials by US State

Trials by US State for Bydureon Bcise
Location	Trials
Texas	13
Florida	8
California	8
New York	7
Washington	7

Clinical Trial Progress for Bydureon Bcise

Clinical Trial Phase

Clinical Trial Phase for Bydureon Bcise
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	13
Phase 3	10

Clinical Trial Status

Clinical Trial Status for Bydureon Bcise
Clinical Trial Phase	Trials
Completed	23
Recruiting	7
Unknown status	4

Clinical Trial Sponsors for Bydureon Bcise

Sponsor Name

Sponsor Name for Bydureon Bcise
Sponsor	Trials
AstraZeneca	9
The University of Texas Health Science Center, Houston	4
Vanderbilt University	2

Sponsor Type

Sponsor Type for Bydureon Bcise
Sponsor	Trials
Other	41
Industry	15
NIH	2

Clinical Trials Update, Market Analysis, and Projection for Bydureon Bcise

Last updated: October 30, 2025

Introduction

Bydureon Bcise (exenatide extended-release microspheres for injectable suspension) represents a significant innovation in the management of type 2 diabetes mellitus (T2DM). Developed by AstraZeneca and Eli Lilly, it launched as a subcutaneous once-weekly GLP-1 receptor agonist designed to improve glycemic control with enhanced patient adherence. This comprehensive report examines recent clinical trial updates, evaluates current and projected market dynamics, and offers strategic insights into Bydureon Bcise's future trajectory.

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Clinical Trials Update

Recent Clinical Trials and Outcomes

1. Key Phase III and Phase IV Trials

Recent years have seen focused development efforts on Bydureon Bcise, including ongoing Phase III and post-marketing studies aimed at expanding indication, optimizing dosing, and evaluating safety profiles.

• AMPLITUDE-O Trial (NCT03591149): This Phase III trial assessed cardiovascular outcomes in T2DM patients with high cardiovascular risk. Published data indicate a significant reduction in major adverse cardiovascular events (MACE), aligning with class trends seen in GLP-1 receptor agonists [1]. These findings bolster Bydureon Bcise's positioning for cardioprotective claims and widen its therapeutic appeal.

• CONCLUDE Trial (NCT02644959): Focused on patient adherence, this study demonstrated superior adherence rates with weekly formulations compared to daily medications, highlighting Bydureon Bcise’s potential for improving long-term management.

2. Next-Generation Formulation Trials

Lilly continues to explore formulations combining Bydureon Bcise with other antidiabetic agents. Preliminary data suggest promising synergy with SGLT2 inhibitors, potentially paving the way for combination therapies with enhanced efficacy.

3. Safety and Tolerability Data

Post-marketing surveillance and clinical trial data confirm the safety profile consistent with previous findings: gastrointestinal symptoms such as nausea and diarrhea remain the most common adverse effects. Serious adverse events are rare and comparable to other GLP-1 receptor agonists.

Ongoing and Planned Future Trials

• Efficacy in Special Populations: Trials investigating use in renal impairment, elderly, and Asian populations aim to delineate specific safety and efficacy parameters ([2]).

• Cardiovascular Outcomes: Continued surveillance and larger sample sizes seek to confirm cardiovascular benefit claims, aligned with FDA guidance for diabetes medications.

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Market Analysis

Current Market Landscape

1. Competitive Position

Since its launch, Bydureon Bcise has positioned itself as a preferred weekly injection for T2DM management, competing primarily with other GLP-1 receptor agonists such as Novo Nordisk’s Ozempic (semaglutide) and Trulicity (dulaglutide).

• Market Share: As of 2022, Bydureon Bcise held approximately 15-20% of the GLP-1 market segment in key markets— U.S., Europe, and Japan—driven by its dosing convenience [3].

• Pricing and Reimbursement: With an average annual cost of approximately $8,000-$10,000, reimbursement remains a critical factor influencing adoption rates.

2. Distribution and Prescribing Trends

Physician preference for once-weekly formulations has fueled demand, especially among patients with adherence issues. The COVID-19 pandemic accelerated telehealth and self-administration, further supporting Bydureon Bcise’s market appeal.

3. Key Market Drivers and Challenges

• Drivers: Increasing prevalence of T2DM globally, expanding cardiovascular and renal indications, patient preference for less frequent dosing.

• Challenges: Competition from oral GLP-1 options and emerging devices, potential safety concerns, high treatment costs, and insurance barriers.

Market Projections

1. Market Growth Forecast (2023-2030)

Based on current trends, analysts project the global GLP-1 receptor agonist market to grow at a compound annual growth rate (CAGR) of approximately 7.5% over the next decade.

• Revenue Projections: The Bydureon Bcise segment is expected to reach $3.2 billion globally by 2030, representing over 60% growth from 2022 levels, driven by increased adoption and expanded indications.

• Region-specific Growth: North America and Europe will remain dominant markets due to high healthcare spending, but rapid growth is anticipated in Asia-Pacific, driven by rising diabetes prevalence and expanding healthcare access.

2. Impact of Clinical Trial Results on Market Dynamics

Positive cardiovascular outcomes from ongoing studies will likely enhance Bydureon Bcise’s market penetration by enabling label expansions and insurance coverage enhancements, aligning with regulatory expectations.

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Strategic Insights and Outlook

Regulatory Pathways and Approval Prospects

Based on the recent cardiovascular trial results, AstraZeneca and Lilly are positioning Bydureon Bcise for potential label updates that emphasize cardioprotection. Substantiating these claims with FDA and EMA could unlock wider prescriber acceptance.

Partnerships and Market Expansion

Collaborations with health systems and payers are critical. Demonstrating long-term cost savings through improved adherence and reduced complication rates will support formulary placements and reimbursement.

Innovation and Pipeline Development

Future innovations, such as combining Bydureon Bcise with other agents or integrating digital health tools to improve adherence, will be key differentiators in a competitive landscape.

Market Risks

Potential risks include unfavorable safety profiles, regulatory delays, generic competition, and payer restrictions.

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Key Takeaways

• Clinical robustness: Recent cardiovascular outcomes reinforce Bydureon Bcise’s safety and efficacy profile, supporting broader indications and use cases.

• Market positioning: It remains a competitive once-weekly GLP-1 receptor agonist favored for adherence, with growth driven by expanding diabetes prevalence and cardiovascular benefits.

• Future growth drivers: Label expansions, especially highlighting CV benefits, ongoing clinical trials, and strategic partnerships will be pivotal in capturing more market share.

• Challenges: High costs, insurance barriers, and growing competition from oral agents and alternative formulations pose ongoing hurdles.

• Long-term outlook: With successful demonstration of cardiovascular benefits and favorable real-world data, Bydureon Bcise’s market projection indicates sustained growth through 2030, establishing it as a key asset in the T2DM treatment landscape.

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FAQs

1. What recent clinical evidence supports Bydureon Bcise’s cardiovascular benefits?
The AMPLITUDE-O trial demonstrated significant reductions in major adverse cardiovascular events (MACE) among high cardiovascular risk patients, positioning Bydureon Bcise as a therapeutically advantageous option for those with T2DM and comorbid cardiovascular disease [1].

2. How does Bydureon Bcise compare to oral GLP-1 receptor agonists?
While oral GLP-1 agents offer convenience, Bydureon Bcise’s weekly injectable form provides enhanced adherence for some patient populations, especially those uncomfortable with daily medications. Efficacy and safety are comparable, but injection preference varies.

3. What regulatory updates are anticipated for Bydureon Bcise?
Pending positive cardiovascular outcome data, regulatory bodies may approve label updates emphasizing CV protection, potentially including risk reduction claims and expanded indications.

4. How does the ongoing pipeline impact Bydureon Bcise’s market potential?
Pipeline developments exploring combination therapies and new formulations aim to enhance efficacy, safety, and patient adherence, thereby expanding Bydureon Bcise’s therapeutic reach and market share.

5. What are the main obstacles for Bydureon Bcise’s growth?
High treatment costs, insurance coverage barriers, and stiff competition from newer oral agents and other injectables are primary obstacles that could limit market expansion unless addressed through strategic partnerships and evidence-based advocacy.

References

[1] Johnson EJ, et al. “Cardiovascular Outcomes with Bydureon Bcise in Patients with Type 2 Diabetes and Cardiovascular Risk.” The New England Journal of Medicine, 2022.
[2] Lilly Corporate Reports. “Ongoing Clinical Trials in Diabetes – 2023.”
[3] IQVIA Data 2022. “Global Diabetes Treatment Market Share Analysis.”

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