CLINICAL TRIALS PROFILE FOR GLUCAGEN

All Clinical Trials for Glucagen

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00745186 ↗	Pharmacokinetics (PK) and Pharmacodynamics (PD) of Mayne Glucagon for Injection Compared With Glucagen® (Novo Nordisk) in Healthy Volunteers	Completed	Hospira, Inc.	Phase 1	2007-08-01	The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamic bioequivalence and safety of Hospira Glucagon for Injection and GlucaGen® in healthy volunteers.
NCT00745186 ↗	Pharmacokinetics (PK) and Pharmacodynamics (PD) of Mayne Glucagon for Injection Compared With Glucagen® (Novo Nordisk) in Healthy Volunteers	Completed	Hospira, now a wholly owned subsidiary of Pfizer	Phase 1	2007-08-01	The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamic bioequivalence and safety of Hospira Glucagon for Injection and GlucaGen® in healthy volunteers.
NCT00747968 ↗	The Effect of the GLP-1 Analogue Exenatide on Type 2 Diabetes in CNS and Heart During Hyperglycemia Assessed by PET	Completed	Aarhus University Hospital	Phase 2/Phase 3	2010-02-01	30 type 2 diabetic patients will be PET-scanned twice ( half of the patients heart-PET, half of the patients CNS-PET) in random order with infusions of placebo or GLP-1-analogue during hyperglycemic clamp to uncover the metabolic effects of GLP-1-analogues in perspectives of intervention of macrovascular late diabetic pathology such as stroke and AMI. Earlier studies have revealed tendencies towards steady glucose metabolism in the CNS despite fluctuations in blood sugar when infusing native GLP-1.
NCT00747968 ↗	The Effect of the GLP-1 Analogue Exenatide on Type 2 Diabetes in CNS and Heart During Hyperglycemia Assessed by PET	Completed	Eli Lilly and Company	Phase 2/Phase 3	2010-02-01	30 type 2 diabetic patients will be PET-scanned twice ( half of the patients heart-PET, half of the patients CNS-PET) in random order with infusions of placebo or GLP-1-analogue during hyperglycemic clamp to uncover the metabolic effects of GLP-1-analogues in perspectives of intervention of macrovascular late diabetic pathology such as stroke and AMI. Earlier studies have revealed tendencies towards steady glucose metabolism in the CNS despite fluctuations in blood sugar when infusing native GLP-1.
NCT00747968 ↗	The Effect of the GLP-1 Analogue Exenatide on Type 2 Diabetes in CNS and Heart During Hyperglycemia Assessed by PET	Completed	University of Aarhus	Phase 2/Phase 3	2010-02-01	30 type 2 diabetic patients will be PET-scanned twice ( half of the patients heart-PET, half of the patients CNS-PET) in random order with infusions of placebo or GLP-1-analogue during hyperglycemic clamp to uncover the metabolic effects of GLP-1-analogues in perspectives of intervention of macrovascular late diabetic pathology such as stroke and AMI. Earlier studies have revealed tendencies towards steady glucose metabolism in the CNS despite fluctuations in blood sugar when infusing native GLP-1.
NCT00797823 ↗	Sensor-Augmented Insulin Delivery: Insulin Plus Glucagon Versus Insulin Alone	Completed	Juvenile Diabetes Research Foundation	Phase 2	2008-11-01	This study aims to test an insulin and glucagon delivery algorithm designed to be used in conjunction with a continuous glucose monitoring system. This combined glucose sensing/hormone delivery approach is a step on the way to eventual development of an artificial (or automated) pancreas. The insulin and glucagon delivery algorithm is based on the difference between the current blood glucose and the target glucose (proportional error) and the rate of change in blood glucose (derivative error), both adjusted for the recent glucose history. This algorithm is called the Fading Memory Proportional-Derivative (FMPD) Algorithm. The principal investigator of this study has published previous research regarding the use of this algorithm and found it to be well-suited to control blood glucose in type 1 diabetic animals. The addition of glucagon was helpful; better glycemic control with fewer glucose excursions were observed when small intermittent infusions of subcutaneous glucagon were given during times of impending low blood sugar (Ward et al. 2008).

Clinical Trial Conditions for Glucagen

Condition Name

Condition Name for Glucagen
Intervention	Trials
Hypoglycemia	12
Diabetes Mellitus, Type 1	7
Type 1 Diabetes	5
Type 1 Diabetes Mellitus	4

Condition MeSH

Condition MeSH for Glucagen
Intervention	Trials
Diabetes Mellitus	17
Diabetes Mellitus, Type 1	17
Hypoglycemia	15
Diabetes Mellitus, Type 2	4

Clinical Trial Locations for Glucagen

Trials by Country

Trials by Country for Glucagen
Location	Trials
United States	32
Denmark	9
Germany	8
Canada	4
Austria	3

Trials by US State

Trials by US State for Glucagen
Location	Trials
Oregon	5
California	3
New York	3
Minnesota	3
Indiana	3

Clinical Trial Progress for Glucagen

Clinical Trial Phase

Clinical Trial Phase for Glucagen
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	5
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for Glucagen
Clinical Trial Phase	Trials
Completed	22
Recruiting	6
Active, not recruiting	1

Clinical Trial Sponsors for Glucagen

Sponsor Name

Sponsor Name for Glucagen
Sponsor	Trials
Steno Diabetes Center Copenhagen	6
Eli Lilly and Company	5
Zealand Pharma	4

Sponsor Type

Sponsor Type for Glucagen
Sponsor	Trials
Other	37
Industry	23
NIH	2

Glucagon: Clinical Trials, Market Analysis, and Projections

Introduction to Glucagon

Glucagon is a hormone that plays a crucial role in regulating blood sugar levels, particularly in individuals with diabetes. It is used to treat severe hypoglycemia, a life-threatening condition that can occur in people with insulin-treated diabetes. Here, we will delve into the recent clinical trials, market analysis, and future projections for glucagon products.

Clinical Trials Update

Xeris Pharmaceuticals' Ready-to-Use Glucagon

Xeris Pharmaceuticals has been at the forefront of developing a ready-to-use, stable liquid glucagon product. Recent Phase 3 clinical trials have shown promising results:

• Efficacy and Safety: The trials demonstrated that Xeris' ready-to-use glucagon rescue pen is effective and safe for treating severe hypoglycemia in both adults and children with type 1 diabetes. In one study, all participants treated with the Xeris rescue pen achieved the desired plasma glucose levels within 30 minutes, with no significant adverse events reported[4].
• Comparison to Existing Products: The Xeris glucagon autoinjector was compared to the traditional Glucagon Emergency Kit (GEK) in a randomized, controlled, double-blind, cross-over clinical trial. The results showed similar speed to relief and comparable efficacy between the two treatments, with the Xeris product being generally well-tolerated[4].

These positive outcomes support the application for European marketing authorization and reinforce the product's efficacy and utility.

Market Analysis

Global Glucagon Market Size

The global glucagon market is experiencing significant growth driven by the increasing prevalence of diabetes and the need for effective treatments for severe hypoglycemia.

• Current Market Size: The global glucagon market was valued at $278.5 million in 2022 and is projected to grow to $470.8 million by 2030, exhibiting a CAGR of 6.8% during the forecast period[3].
• Regional Dominance: North America dominates the glucagon market, accounting for 85.89% of the market share in 2022. This is due to a strong distribution network and growing awareness about severe hypoglycemia among insulin-dependent patients[3].

Distribution Channels

The market is segmented into hospital pharmacies, drug stores & retail pharmacies, and online pharmacies. Notably:

• Retail Pharmacies: Drug stores and retail pharmacies led the market in 2022 due to higher therapeutic procurement. However, online pharmacies are expected to grow at the highest CAGR during the forecast period, driven by improved accessibility and quality of services[3].

Reimbursement and Accessibility

To reduce the economic burden and increase treatment rates, several countries offer reimbursement for glucagon products. For example, in France, the recommended reimbursement rate for intranasal glucagon (BAQSIMI) is 65%, making these products more affordable and accessible[3].

Market Projections

Growth Drivers

Several factors are driving the growth of the glucagon market:

• Increasing Diabetic Population: The rising number of people with diabetes, particularly those undergoing insulin therapy, increases the risk of severe hypoglycemia episodes, thereby surging the demand for glucagon products[3].
• New Product Launches: Market players are focusing on introducing easy-to-administer products, such as ready-to-use glucagon rescue pens, which are expected to increase market penetration[3].
• COVID-19 Impact: The COVID-19 pandemic has highlighted the importance of managing diabetes and hypoglycemia, positively impacting the market for glucagon-like peptide-1 (GLP-1) agonists and, by extension, glucagon products[2].

Segment Analysis

• Hypoglycemia Segment: This segment dominated the global glucagon market in 2022 due to the high prevalence of severe hypoglycemia among diabetic patients. The segment is expected to continue growing as more products are approved for treating severe hypoglycemia[3].
• Diagnostic Aid Segment: Although this segment has a lower market share, it is poised to expand, albeit at a lower CAGR, due to the limited number of approved products for this indication[3].

Key Players and Competitive Landscape

The glucagon market is characterized by a few key players:

• Xeris Pharmaceuticals: Known for its innovative ready-to-use glucagon products, Xeris is a significant player in the market[1][4].
• Other Market Participants: Companies like Novo Nordisk, Eli Lilly, and Sanofi, although primarily known for their GLP-1 agonists, also play a role in the broader diabetes management market, which includes glucagon products[2].

Regulatory and Reimbursement Environment

The regulatory environment is supportive of glucagon products, with several countries offering reimbursement to make these treatments more accessible.

• Reimbursement Rates: For instance, in France, the recommended reimbursement rate for intranasal glucagon is 65%, which helps in driving the demand for these products[3].

Future Outlook

The future of the glucagon market looks promising, driven by several factors:

• Technological Advancements: The development of easy-to-use, ready-to-use glucagon products is expected to increase market penetration and patient compliance.
• Growing Awareness: Increasing awareness about severe hypoglycemia and the importance of having access to glucagon products will drive prescription rates.
• Expanding Distribution Channels: The growth of online pharmacies and improved distribution networks will enhance accessibility to glucagon products.

"Designing Growth Strategies is in our DNA" - This mantra reflects the industry's focus on innovation and accessibility, which will be crucial for the future growth of the glucagon market[3].

Key Takeaways

• Clinical Trials Success: Recent Phase 3 clinical trials have shown that ready-to-use glucagon products are effective and safe for treating severe hypoglycemia.
• Market Growth: The global glucagon market is projected to grow from $278.5 million in 2022 to $470.8 million by 2030, with a CAGR of 6.8%.
• Regional Dominance: North America dominates the market, but online pharmacies are expected to grow at the highest CAGR.
• Reimbursement and Accessibility: Reimbursement policies in various countries are making glucagon products more affordable and accessible.
• Technological Advancements: Easy-to-use products are driving market growth and patient compliance.

FAQs

What is the current size of the global glucagon market?

The global glucagon market was valued at $278.5 million in 2022[3].

What is the projected growth rate of the glucagon market?

The glucagon market is expected to grow at a CAGR of 6.8% from 2023 to 2030[3].

Which region dominates the glucagon market?

North America dominates the glucagon market, accounting for 85.89% of the market share in 2022[3].

What are the key drivers of the glucagon market growth?

The increasing diabetic population, new product launches, and reimbursement policies are key drivers of the glucagon market growth[3].

Which companies are major players in the glucagon market?

Xeris Pharmaceuticals is a significant player, along with other companies like Novo Nordisk and Eli Lilly, which are more broadly involved in diabetes management[1][2][3].

Sources

1. Xeris Pharmaceuticals Announces Additional Positive Outcomes from a Global Phase 3 Clinical Trial of Its Investigational Ready-to-Use Glucagon. Xeris Pharmaceuticals.
2. Glucagon-like Peptide-1 (GLP-1) Agonists Market Size. Mordor Intelligence.
3. Glucagon Market Size, Share, Growth & Trends Analysis [2030]. Fortune Business Insights.
4. Xeris Pharmaceuticals Announces Positive Phase 3 Clinical Trial Data on Its Investigational Ready-to-Use Glucagon Rescue Pen. Xeris Biopharma Holdings, Inc.
5. Leading GLP-1s expected to reach $50B in 2025 sales. BioCentury.