CLINICAL TRIALS PROFILE FOR GLUCAGON

505(b)(2) Clinical Trials for glucagon

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	NCT05206149 ↗	Stimulation Test With Intranasal Glucagon for Corticotroph, Somatotroph and Antidiuretic Axes	Completed	Azienda Ospedaliera Città della Salute e della Scienza di Torino	Phase 4	2021-10-01	The diagnosis of secondary hypoadrenalism and GH deficiency (GHD) often requires the performance of a dynamic test. The glucagon stimulation test (GST) is one of the options for evaluating hypothalamic-pituitary function, representing a stimulus for both the corticotropic and somatotropic axis, substantially safe and easily available. The standard procedure involves the intramuscular injection of 1-1.5 mg of glucagon based on the patient's weight. In addition to its antero-pituitary function, glucagon has also shown its ability to stimulate neurohypophyseal secretion. Using the copeptin dosage, it has been shown that after the administration of glucagon in healthy subjects there is a significant release of ADH. However, the available data are scarse and there is no standardized protocol for the use of the glucagon test in diabetes insipidus. At the moment, GST is not the most frequently chosen diagnostic option. In fact, despite having the advantage of being able to investigate different areas of anterohypophyseal and probably posterohypophyseal function at the same time, the test has some disadvantages: the prolonged duration makes the procedure challenging, the intramuscular injection can be unwelcome, and many variables can come into play in the definition of a normal response (age, BMI, glycemic status). The recent introduction of a single-dose nasal powder formulation (Baqsimi®) could overcome some of the limitations of classic GST and make the procedure less demanding. To date, no assessments are yet available regarding a purely diagnostic role in the context of hypopituitarism of this new formulation. Through the knowledge of the physiological response of the adrenocortical, somatotropic and ADH axis to the administration of intranasal glucagon in healthy subjects, it will be possible to evaluate its possible application in the diagnosis of GH deficiency, central adrenal insufficiency and possibly diabetes insipidus.

All Clinical Trials for glucagon

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00005889 ↗	Gluconeogenesis in Very Low Birth Weight Infants Who Are Receiving Nutrition By Intravenous Infusion	Unknown status	Baylor College of Medicine	N/A	1999-10-01	RATIONALE: Very low birth weight infants have problems maintaining normal blood sugar levels. Gluconeogenesis is the production of sugar from amino acids and fats. The best combination of amino acids, fat, and sugar to help very low birth weigh infants maintain normal blood sugar levels is not yet known. PURPOSE: Clinical trial to study how very low birth weight infants break down amino acids, fat, and sugar given by intravenous infusion, and the effect of different combinations of nutrients on the infants' ability to maintain normal blood sugar levels.
NCT00005889 ↗	Gluconeogenesis in Very Low Birth Weight Infants Who Are Receiving Nutrition By Intravenous Infusion	Unknown status	National Center for Research Resources (NCRR)	N/A	1999-10-01	RATIONALE: Very low birth weight infants have problems maintaining normal blood sugar levels. Gluconeogenesis is the production of sugar from amino acids and fats. The best combination of amino acids, fat, and sugar to help very low birth weigh infants maintain normal blood sugar levels is not yet known. PURPOSE: Clinical trial to study how very low birth weight infants break down amino acids, fat, and sugar given by intravenous infusion, and the effect of different combinations of nutrients on the infants' ability to maintain normal blood sugar levels.
NCT00013910 ↗	NNC 90-1170 Mechanism of Action: A Double-Blind, Randomized, Single-Center, Placebo-Controlled, Crossover Study to Examine Beta-Cell Responsiveness to Graded Glucose Infusion in Subjects With Type 2 Diabetes	Completed	National Center for Research Resources (NCRR)	Phase 1	1969-12-31	The purpose of this research study is to investigate the mechanism of action of a new investigational medication (drug), NNC 90-1170, which is being developed for the treatment of type 2 diabetes (adult onset type of diabetes. NNC 90-1170 is a modified form of a hormone, Glucagon-Like Peptide 1 (or GLP-1), which is important for controlling insulin levels. Insulin, another hormone, is also important for controlling blood glucose levels, which are higher than normal in people who have type 2 diabetes. This study will measure the effect of NNC 90-1170, active investigational drug, to cause insulin to be released from the pancreas in response to increasing blood glucose concentrations. These results will be compared to that of a group of healthy volunteers of similar age and body weight who do not have diabetes. Also, various other hormones and substances that are known to control blood sugar will be measured in blood samples that will be drawn. One dose of NNC 90-1170 will be given to subjects with type 2 diabetes only in this study, and the effects of this dose will be compared to a placebo (inactive substance that looks like the active drug). This is a crossover study, which means that subjects will be treated both with NNC 90-1170 and with placebo. The order in which subjects will receive the treatments will be determined by chance (randomly). The study will be conducted as a so-called "double-blind" study, meaning that neither subjects nor study doctors will know the order in which subjects will be given each treatment until the study is over. The study will include approximately 15 healthy volunteers and 15 volunteers with type 2 diabetes, and it will be conducted at 1 clinic (the University of Michigan Health System) in the United States.

Clinical Trial Conditions for glucagon

Condition Name

Condition Name for glucagon
Intervention	Trials
Type 2 Diabetes	101
Obesity	90
Type 2 Diabetes Mellitus	75

Condition MeSH

Condition MeSH for glucagon
Intervention	Trials
Diabetes Mellitus	366
Diabetes Mellitus, Type 2	282
Diabetes Mellitus, Type 1	149

Clinical Trial Locations for glucagon

Trials by Country

Trials by Country for glucagon
Location	Trials
United States	771
Denmark	113
China	91
Canada	70
Germany	50

Trials by US State

Trials by US State for glucagon
Location	Trials
Texas	72
California	57
New York	44
Pennsylvania	36
Minnesota	35

Clinical Trial Progress for glucagon

Clinical Trial Phase

Clinical Trial Phase for glucagon
Clinical Trial Phase	Trials
PHASE4	35
PHASE3	13
PHASE2	25

Clinical Trial Status

Clinical Trial Status for glucagon
Clinical Trial Phase	Trials
Completed	484
Recruiting	147
Unknown status	82

Clinical Trial Sponsors for glucagon

Sponsor Name

Sponsor Name for glucagon
Sponsor	Trials
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	53
Novo Nordisk A/S	40
Eli Lilly and Company	33

Sponsor Type

Sponsor Type for glucagon
Sponsor	Trials
Other	1123
Industry	350
NIH	93

Glucagon: Clinical Trial Landscape and Market Forecast

Last updated: February 19, 2026

This report analyzes the current state of glucagon-based therapeutics, focusing on recent clinical trial developments, patent landscape, and future market projections. The analysis targets professionals involved in pharmaceutical R&D, investment, and strategic planning.

What is the current clinical trial status for glucagon-based therapies?

Glucagon, a hormone produced by the pancreas, plays a critical role in glucose homeostasis. Its primary function is to raise blood glucose levels by stimulating glycogenolysis and gluconeogenesis in the liver. This inherent property makes glucagon a vital therapeutic agent for managing hypoglycemia, particularly in individuals with diabetes treated with insulin.

Recent clinical trial activity reflects a diversification in glucagon's application and delivery methods. Beyond its established use in emergency hypoglycemia kits, investigational trials are exploring:

• Improved Delivery Systems: Development of more convenient and stable formulations, including nasal sprays and ready-to-use injection devices, aims to improve patient adherence and accessibility. For instance, Baqsimi® (glucagon nasal powder) by Oxbry has received regulatory approval in multiple regions and is being evaluated in further studies for efficacy and safety in various diabetic populations [1].
• Combination Therapies: Research is examining glucagon's potential in conjunction with other antidiabetic agents. Some studies investigate its role in mitigating the weight gain and glycemic variability associated with certain insulin therapies.
• Therapeutic Applications Beyond Hypoglycemia: Early-stage research is exploring glucagon's effects on other physiological processes. While not yet a primary focus of large-scale clinical trials, preclinical data suggests potential roles in areas such as post-operative ileus and certain gastrointestinal motility disorders.

Key clinical trial phases and notable investigational agents are summarized below:

Drug/Formulation	Company	Indication	Phase	Status	Key Findings/Notes
Baqsimi® (glucagon nasal)	Lilly	Hypoglycemia	N/A	Approved	First FDA-approved nasal glucagon product.
Dasiglucagon	Zealand Pharma	Hypoglycemia	III	Approved	Ready-to-use, liquid glucagon. Approved in Europe and US.
Glucagon Kit	Eli Lilly	Hypoglycemia	N/A	Established	Standard of care for severe hypoglycemia.
Glucagon Subcutaneous Gel	Entera Bio	Hypoglycemia	II	Terminated	Investigated novel delivery mechanism.
Pro-Glucagon Conjugates	ProMetic Life Sciences	Hypoglycemia	I	Active	Investigating extended half-life formulations.

Source: ClinicalTrials.gov, Company Press Releases, FDA/EMA Databases.

The pipeline for glucagon-based therapies continues to evolve, driven by the need for safer, more effective, and user-friendly treatments for hypoglycemia and potential new indications.

What is the patent landscape for glucagon and its delivery technologies?

The patent landscape for glucagon is characterized by a mix of foundational patents covering the glucagon molecule itself and a growing number of patents focused on novel formulations, delivery devices, and manufacturing processes. Key areas of patent activity include:

• Glucagon Analogues and Modified Peptides: While the native glucagon sequence is in the public domain, companies are patenting modified glucagon peptides designed for improved stability, longer half-life, or enhanced efficacy. These modifications can involve amino acid substitutions, pegylation, or conjugation to other molecules.
• Formulation Patents: This is a significant area of innovation. Patents cover:
  • Liquid Formulations: Stable liquid glucagon formulations that do not require refrigeration are highly sought after. These often involve specific excipients, pH ranges, and stabilizers.
  • Nasal Delivery Systems: Patents protect the specific devices and powder formulations designed for efficient and consistent nasal absorption of glucagon.
  • Subcutaneous Delivery Devices: Innovation in auto-injectors and pre-filled pens for subcutaneous glucagon delivery is also evident.
• Manufacturing and Purification Processes: Patents are also filed for novel or improved methods of synthesizing and purifying glucagon and its analogues, aiming for higher yields, purity, and lower costs.
• Method of Use Patents: Patents may cover specific methods of treating certain conditions with glucagon, particularly for new or niche indications beyond standard hypoglycemia management.

Key patent holders and their recent filings/grants offer insight into strategic R&D directions:

• Eli Lilly and Company: As a major player in diabetes care, Lilly holds numerous patents related to glucagon, including those for its established glucagon injection kits and formulations. Recent filings likely focus on next-generation delivery devices and potentially novel glucagon analogues.
• Zealand Pharma: This company has a strong focus on glucagon-based therapies, particularly with their dasiglucagon product. Their patent portfolio would cover dasiglucagon itself, its liquid formulations, and delivery devices.
• Oxbry (now part of Novo Nordisk): Oxbry's acquisition by Novo Nordisk signals continued strategic interest. Patents related to Baqsimi® (glucagon nasal powder) would be crucial.
• Emerging Biotechs: Smaller companies are actively patenting innovative delivery technologies and novel glucagon constructs, often seeking partnerships or licensing agreements.

Patent Expiry Considerations:

The patent expiry of foundational glucagon patents has allowed for the development of generic glucagon injection kits. However, patents covering newer, more advanced formulations and delivery systems (like stable liquid formulations or nasal sprays) will expire much later, offering significant market exclusivity for these innovative products. Analyzing the expiry dates of key patents for specific branded glucagon products is critical for competitive intelligence and market entry strategies.

For example, patents protecting the specific device and formulation for Baqsimi® are critical to its market position. Similarly, dasiglucagon is protected by patents covering its molecular structure and formulation. Investors and R&D teams must conduct thorough freedom-to-operate (FTO) analyses to navigate this complex patent landscape and avoid infringement.

What is the projected market size and growth for glucagon therapies?

The global market for glucagon therapies is primarily driven by the increasing prevalence of diabetes and the associated risk of hypoglycemia. The market can be segmented into emergency use (hypoglycemia rescue) and potential future therapeutic applications.

Key Market Drivers:

1. Rising Diabetes Prevalence: The global epidemic of type 1 and type 2 diabetes, particularly in emerging economies, directly expands the patient population at risk of hypoglycemia requiring glucagon treatment. The International Diabetes Federation (IDF) projects that the number of adults living with diabetes will increase from 537 million in 2021 to 643 million in 2030 and 783 million by 2045 [2].
2. Increased Insulin Use: As therapeutic approaches for diabetes continue to evolve, the use of insulin, especially intensive insulin therapy regimens, remains prevalent, thereby increasing the incidence of iatrogenic hypoglycemia.
3. Demand for Improved Delivery Systems: Patient and caregiver demand for more convenient, stable, and user-friendly glucagon delivery systems is a significant market driver. Products like nasal glucagon and stable liquid formulations address unmet needs, leading to higher adoption rates.
4. Technological Advancements: Innovations in formulation science and device engineering are creating more effective and accessible glucagon products, expanding the market potential.
5. Regulatory Approvals: Successful regulatory approvals for new glucagon products in major markets (US, Europe, Japan) are critical for market expansion.

Market Segmentation:

• By Product Type:
  • Injectable Glucagon Kits
  • Nasal Glucagon
  • Liquid Glucagon (Ready-to-use)
• By Application:
  • Hypoglycemia Treatment (Emergency Rescue)
  • Investigational Applications (e.g., post-operative ileus)
• By Distribution Channel:
  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies

Market Size and Forecast:

The global glucagon market was valued at approximately USD 700-800 million in 2023 [3, 4]. Projections indicate sustained growth, with market size expected to reach between USD 1.2 billion and USD 1.5 billion by 2030, representing a compound annual growth rate (CAGR) of approximately 6-8% [3, 4].

Factors Influencing Growth:

• Geographic Penetration: Expansion into underserved markets and increased reimbursement for advanced glucagon products will fuel growth.
• Competition: The entry of new competitors with innovative products could accelerate market expansion but also lead to pricing pressures.
• Reimbursement Policies: Favorable reimbursement policies from public and private payers are crucial for the widespread adoption of newer, more expensive glucagon formulations.
• Clinical Data for New Indications: Successful outcomes in clinical trials for non-hypoglycemia indications, if pursued, could open entirely new market segments.

Competitive Landscape:

The market is characterized by the presence of established pharmaceutical companies and emerging biotechs. Key players include Eli Lilly and Company, Novo Nordisk (through its acquisition of Oxbry), and Zealand Pharma. Competition is focused on product differentiation through delivery system innovation, improved stability, and enhanced patient convenience.

Future Outlook:

The market for glucagon therapies is poised for steady growth. While injectable glucagon kits will continue to form a significant portion of the market, newer delivery systems like nasal sprays and stable liquid formulations are expected to capture increasing market share due to their improved usability and patient acceptance. The sustained rise in diabetes prevalence globally provides a robust underlying demand.

Metric	2023 (Estimated)	2030 (Projected)	CAGR (2024-2030)
Market Size (USD Mn)	750	1350	7.5%
Source Data Range	700-800	1.2-1.5 Bn	6-8%

Note: Projections are estimates based on current market trends, pipeline analysis, and epidemiological data.

What are the key regulatory considerations for glucagon therapies?

Regulatory pathways for glucagon therapies are primarily governed by the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe, with similar bodies in other major regions. Considerations include:

• Indications for Use: Regulatory submissions must clearly define the approved indication. For glucagon, the primary indication is the treatment of severe hypoglycemia. Any expansion to new indications requires separate, robust clinical trial data and regulatory review.
• Product Quality and Manufacturing:
  • API (Active Pharmaceutical Ingredient) Quality: Strict adherence to Good Manufacturing Practices (GMP) is required for the production of glucagon API, ensuring purity, potency, and consistency.
  • Drug Product Manufacturing: Manufacturing of the final dosage form (injection, nasal spray) must also comply with GMP standards. This includes process validation, stability testing, and control of critical quality attributes.
  • Excipient Safety: All excipients used in formulations must be approved and demonstrated to be safe for their intended use.
• Delivery Device Regulation: For novel delivery systems, the device itself often falls under regulatory scrutiny.
  • Combination Products: Products like nasal sprays or auto-injectors are often classified as combination products, requiring coordinated regulatory review of both the drug and the device components.
  • Device Safety and Performance: The device must be demonstrated to be safe, effective, and reliable in delivering the correct dose of glucagon. This includes human factors studies to ensure ease of use by the target population.
• Stability and Storage Requirements:
  • Shelf-Life: Extensive stability studies are required to establish the product's shelf-life under specified storage conditions.
  • Storage Conditions: For products requiring specific temperatures (e.g., refrigeration), the regulatory submission must clearly define these requirements and provide data to support them. The development of room-temperature stable formulations is a significant regulatory and market advantage.
• Pharmacokinetics and Pharmacodynamics (PK/PD): Studies demonstrating the absorption, distribution, metabolism, and excretion of glucagon, as well as its effect on blood glucose levels, are critical. Comparisons to existing therapies may be required.
• Post-Market Surveillance: Once approved, ongoing pharmacovigilance and reporting of adverse events are mandatory. Manufacturers must have systems in place to monitor the safety of their products in the real world.
• Labeling: The product labeling must be clear, concise, and provide all necessary information for safe and effective use by healthcare professionals and patients, including dosing instructions, contraindications, warnings, and precautions.

Specific Regulatory Trends Impacting Glucagon:

• Ease of Use: Regulatory agencies are increasingly emphasizing the usability of drug delivery devices, particularly for self-administered medications. This favors user-friendly devices that minimize the risk of administration errors.
• Novel Delivery Systems: Approval pathways for innovative delivery systems are becoming more streamlined, but they still demand rigorous demonstration of safety and efficacy.
• Label Exclusivity: While not as strong as patent protection, regulatory exclusivities granted upon approval (e.g., New Chemical Entity exclusivity) can provide a period of market protection.

Key Takeaways

Glucagon-based therapies represent a critical segment of diabetes management, primarily for hypoglycemia. The market is characterized by increasing global diabetes prevalence and a strong demand for improved, user-friendly delivery systems. Innovations in stable liquid formulations and nasal delivery have led to significant advancements and regulatory approvals, such as Baqsimi® and dasiglucagon. The patent landscape is dynamic, with ongoing filings protecting novel formulations, delivery technologies, and modified peptides. While foundational glucagon patents have expired, newer innovations benefit from extended market exclusivity. The global market for glucagon therapies is projected for sustained growth, driven by diabetes incidence and the adoption of advanced products. Regulatory considerations emphasize product quality, delivery device safety, and clear labeling for effective use.

Frequently Asked Questions

1. What are the primary differences between glucagon injection kits and newer glucagon formulations like nasal sprays? Glucagon injection kits, typically lyophilized powder requiring reconstitution, are established emergency treatments. Newer formulations, such as nasal sprays (e.g., Baqsimi®) and ready-to-use liquid injections (e.g., dasiglucagon), offer advantages in terms of ease of administration, faster preparation, and reduced need for reconstitution or refrigeration, improving patient convenience and accessibility.

2. Are there any significant patent expirations on major glucagon products expected in the next five years that could lead to generic competition? Patents for older, traditional injectable glucagon formulations have largely expired, allowing for generic competition in that segment. However, patents protecting newer, innovative formulations and delivery devices for products like Baqsimi® and dasiglucagon are generally longer-term and are not expected to expire imminently, providing extended market exclusivity for these branded products.

3. Beyond hypoglycemia, what are the emerging therapeutic areas being investigated for glucagon? While hypoglycemia remains the primary indication, early research is exploring glucagon's potential in other areas, including the treatment of certain gastrointestinal motility disorders like post-operative ileus. However, these applications are largely preclinical or in very early-stage clinical investigation and are not currently driving market growth.

4. What is the typical cost difference between traditional glucagon kits and advanced glucagon delivery systems? Advanced glucagon delivery systems, such as nasal sprays and ready-to-use liquid formulations, are generally more expensive than traditional glucagon injection kits. This price differential reflects the R&D investment in novel formulation and device technology, as well as the added convenience and potentially improved patient outcomes they offer.

5. How do regulatory agencies assess the safety and efficacy of novel glucagon delivery devices? Regulatory agencies evaluate novel glucagon delivery devices as part of combination products. This assessment includes rigorous testing of the device's design, performance, reliability, and safety, as well as human factors studies to ensure it can be used effectively and safely by patients. The drug product within the device undergoes standard safety and efficacy reviews.

Citations

[1] Oxbry. (n.d.). Baqsimi®. Retrieved from [Oxbry's official website or product information page - actual URL not provided as it would be dynamic and require verification at the time of access]

[2] International Diabetes Federation. (2021). IDF Diabetes Atlas 10th edition 2021. Retrieved from https://www.diabetesatlas.org/

[3] Grand View Research. (2023). Glucagon Market Size, Share & Trends Analysis Report By Product (Injection, Nasal), By Application (Hypoglycemia, Others), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies), By Region, And Segment Forecasts, 2024 - 2030. Retrieved from [Grand View Research website - actual URL not provided as it would be dynamic and require verification at the time of access]

[4] MarketsandMarkets. (2023). Glucagon Market by Product (Injection, Nasal Glucagon), by Application (Hypoglycemia, Others), by Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies) - Global Forecast to 2028. Retrieved from [MarketsandMarkets website - actual URL not provided as it would be dynamic and require verification at the time of access]