CLINICAL TRIALS PROFILE FOR GLUCAGON HYDROCHLORIDE

505(b)(2) Clinical Trials for glucagon hydrochloride

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 hydrochloride

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.
NCT00064714 ↗	Effect of AC2993 With or Without Immunosuppression on Beta Cell Function in Patients With Type I Diabetes	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2	2003-07-01	This study will determine 1) the safety of AC2993 in patients with type I diabetes; 2) the ability of AC2993 to improve beta cell function; and 3) the effects of immunosuppression on beta cell function. Type I diabetes is an autoimmune disease, in which the immune system attacks the beta cells of the pancreas. These cells produce insulin, which regulates blood sugar. AC2993 may improve the pancreas's ability to produce insulin and help control blood sugar, but it may also activate the original immune response that caused the diabetes. Thus, this study will examine the effects of AC2993 alone as well as in combination with immunosuppressive drugs. Patients between 18 and 60 years of age who have type I diabetes mellitus may be eligible for this 20-month study. They must have had diabetes for at least 5 years and require insulin treatment. Candidates will be screened with a questionnaire, followed by medical history and physical examination, blood and urine tests, a chest x-ray and skin test for tuberculosis, electrocardiogram (EKG), and arginine stimulated C-peptide test (see description below). Participants will undergo the following tests and procedures: Advanced screening phase: Participants undergo a diabetes education program, including instruction on frequent blood glucose monitoring, dietary education on counting carbohydrates, intensive insulin therapy, review of signs and symptoms of low blood sugar (hypoglycemia), and potential treatment with glucagon shots. Patients must administer insulin via an insulin pump or take at least four injections per day including glargine (Lantus) insulin. 4-month run-in phase - Arginine-stimulated C-peptide test: This test measures the body's insulin production. The patient is injected with a liquid containing arginine, a normal constituent of food that increases insulin release from beta cells into the blood stream. After the injection, seven blood samples are collected over 10 minutes. - Mixed meal stimulated C-peptide test with acetaminophen: This test assesses the response of the beta cells to an ordinary meal and the time it takes for food to pass through the stomach. The patient drinks a food supplement and takes acetaminophen (Tylenol). Blood samples are then drawn through a catheter (plastic tube placed in a vein) every 30 minutes for 4 hours to measure levels of various hormones and the concentration of acetaminophen. - Euglycemic clamp: This test measures the body's level of insulin resistance by measuring the amount of glucose necessary to compensate for an increased insulin level while maintaining a prespecified blood glucose level.
NCT00064714 ↗	Effect of AC2993 With or Without Immunosuppression on Beta Cell Function in Patients With Type I Diabetes	Completed	AstraZeneca	Phase 2	2003-07-01	This study will determine 1) the safety of AC2993 in patients with type I diabetes; 2) the ability of AC2993 to improve beta cell function; and 3) the effects of immunosuppression on beta cell function. Type I diabetes is an autoimmune disease, in which the immune system attacks the beta cells of the pancreas. These cells produce insulin, which regulates blood sugar. AC2993 may improve the pancreas's ability to produce insulin and help control blood sugar, but it may also activate the original immune response that caused the diabetes. Thus, this study will examine the effects of AC2993 alone as well as in combination with immunosuppressive drugs. Patients between 18 and 60 years of age who have type I diabetes mellitus may be eligible for this 20-month study. They must have had diabetes for at least 5 years and require insulin treatment. Candidates will be screened with a questionnaire, followed by medical history and physical examination, blood and urine tests, a chest x-ray and skin test for tuberculosis, electrocardiogram (EKG), and arginine stimulated C-peptide test (see description below). Participants will undergo the following tests and procedures: Advanced screening phase: Participants undergo a diabetes education program, including instruction on frequent blood glucose monitoring, dietary education on counting carbohydrates, intensive insulin therapy, review of signs and symptoms of low blood sugar (hypoglycemia), and potential treatment with glucagon shots. Patients must administer insulin via an insulin pump or take at least four injections per day including glargine (Lantus) insulin. 4-month run-in phase - Arginine-stimulated C-peptide test: This test measures the body's insulin production. The patient is injected with a liquid containing arginine, a normal constituent of food that increases insulin release from beta cells into the blood stream. After the injection, seven blood samples are collected over 10 minutes. - Mixed meal stimulated C-peptide test with acetaminophen: This test assesses the response of the beta cells to an ordinary meal and the time it takes for food to pass through the stomach. The patient drinks a food supplement and takes acetaminophen (Tylenol). Blood samples are then drawn through a catheter (plastic tube placed in a vein) every 30 minutes for 4 hours to measure levels of various hormones and the concentration of acetaminophen. - Euglycemic clamp: This test measures the body's level of insulin resistance by measuring the amount of glucose necessary to compensate for an increased insulin level while maintaining a prespecified blood glucose level.

Clinical Trial Conditions for glucagon hydrochloride

Condition Name

Condition Name for glucagon hydrochloride
Intervention	Trials
Type 2 Diabetes	101
Obesity	90
Type 2 Diabetes Mellitus	75
Type 1 Diabetes	67

Condition MeSH

Condition MeSH for glucagon hydrochloride
Intervention	Trials
Diabetes Mellitus	366
Diabetes Mellitus, Type 2	282
Diabetes Mellitus, Type 1	149
Hypoglycemia	81

Clinical Trial Locations for glucagon hydrochloride

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for glucagon hydrochloride

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for glucagon hydrochloride

Sponsor Name

Sponsor Name for glucagon hydrochloride
Sponsor	Trials
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	53
Novo Nordisk A/S	40
University Hospital, Gentofte, Copenhagen	33

Sponsor Type

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

Glucagon Hydrochloride Clinical Trials Update, Market Analysis, and Exclusivity-Driven Projections

Last updated: May 21, 2026

Executive summary: Glucagon hydrochloride is an established endocrine rescue therapy with limited late-stage clinical expansion in the United States relative to newer, delivery-platform glucagon competitors. Near-term market growth is driven by (1) ongoing substitution away from emergency-needle workflows, (2) baseline demand for severe hypoglycemia management, and (3) incremental penetration where reimbursement and formulary coverage support glucagon rescue. Patent and regulatory exclusivity typically do not block generic or follow-on competition across all presentations, so commercial upside is mostly execution- and access-driven rather than long-duration exclusivity-led.

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Glucagon hydrochloride clinical trials update: what’s in the pipeline and what’s changed

Answer: Publicly available clinical-trials updates for glucagon hydrochloride in 2024-2026 are dominated by formulation, delivery device, and adjacent glucagon analog development rather than major new efficacy Phase 3 programs for the original active ingredient.

Phase mix and what tends to move outcomes

For glucagon rescue therapy, sponsor programs usually cluster into:

• Faster usability and time-to-injection administration (delivery-device human factors).
• Stability and usability under real-world storage conditions.
• Dose delivery reliability and consistency of glucagon reconstitution workflows.
• Pediatric usability endpoints, where regulators and payers push for demonstrated ease-of-use.

What to track in trial updates (decision-grade endpoints)

• Time from recognition of hypoglycemia to administration.
• Rate of successful administration and reconstitution errors.
• Proportion achieving predefined glucose thresholds after rescue.
• Safety signals tied to nausea/vomiting, headache, and injection-site events.
• Concomitant insulin regimen stratification that can shift effect timing.

Registration and reporting cadence: how to interpret “active” status

In glucagon, “active, not recruiting” often reflects readiness for final data locks rather than new enrollment. For business decisions, prioritize:

• Trial start and completion dates.
• Published results versus topline communications.
• FDA submission linkage (NDA/BLA supplements or 505(b)(2) filings).

(No further “update” specifics can be produced without trial-registration identifiers and result publications in the public record for the specific glucagon hydrochloride drug products under review.)

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Which glucagon hydrochloride formulations are in clinical development, and how do delivery systems change the profile

Answer: Formulation and delivery systems are the main differentiators in glucagon products. Switching from powder reconstitution to ready-to-use formats or improved delivery devices is the dominant commercial lever.

Delivery and usability categories that affect adoption

• Ready-to-use liquid reconstitution reduction.
• Autoinjector or handheld device workflows.
• Nasal or non-injectable rescue platforms (where compared, these can compress injection workflow advantage).
• Stability formulations that extend room-temperature usability.

Clinical relevance of device usability

Payers and hospitals shift adoption when trials show:

• Reduced administration failures.
• Lower caregiver training burden.
• Better “real world” timing performance than clinician-only administration.

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What patents protect glucagon hydrochloride, and how strong is the patent estate

Answer: The active ingredient glucagon hydrochloride is old and widely worked. The enforceable commercial barriers are typically product-specific: formulation, device, dosing regimen, and method-of-use patents. As a result, patent estates are usually fragmented by presentation and jurisdiction.

Common patent “buckets” in glucagon rescue

• Formulation patents (stabilizers, pH buffers, reconstitution chemistry).
• Delivery-device patents (autoinjector mechanics, needle safety features).
• Method-of-use patents (rescue workflows, dosing instructions).
• Manufacturing process patents (sterility assurance, lyophilization/reconstitution steps).

What matters for infringement and launch timing

For launch risk modeling, map protection by:

• Presentation: kit, vial-plus-syringe versus autoinjector.
• Strength and dosage form.
• Device assembly and usability claims.
• Any method-of-use limitations tied to severe hypoglycemia management in specific populations.

(No patent numbers, assignees, or expiration dates can be listed without a defined list of specific glucagon hydrochloride brand products and their Orange Book listings or equivalent regulatory dossiers.)

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When does glucagon hydrochloride lose exclusivity and when could generics launch

Answer: Exclusivity typically expires long ago for active ingredient glucagon hydrochloride; the practical question is whether protected presentation-specific IP remains (device/formulation) and whether FDA regulatory listings permit substitution.

Launch scenarios that drive market entry

• Generic injection kits: low IP friction if no active formulation/device patents block.
• Follow-on presentations: “substantially similar” kits can enter if patents do not cover the specific device workflow.
• Paragraph IV for presentation-specific patents: if a listed patent blocks a specific formulation or device, generic sponsors may challenge those patents.

Timing model drivers

• Patent expiry and any unexpired method-of-use claims.
• Orange Book listing status for each presentation.
• Litigation duration and settlement risk if Paragraph IV is filed.
• FDA review timelines and labeling negotiations.

(A complete exclusivity timeline requires named products, NDA/BLA numbers, Orange Book patent identifiers, and listed expiration dates.)

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What is the Orange Book status of glucagon hydrochloride products

Answer: Glucagon hydrochloride is expected to have an Orange Book presence for multiple NDA-labeled presentations, but the exact listing set depends on each marketed product and strength.

What you must extract for an investment-usable Orange Book map

• NDA number and label strength(s).
• Patent numbers listed under each NDA.
• Patent expiration dates by patent type (composition, formulation, method of use, device).
• Exclusivity codes (if any) tied to the original approval or supplemental approvals.

(No product-specific Orange Book status can be asserted without NDA numbers and patent listing data.)

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Which companies sell glucagon hydrochloride, and how does the competitive landscape affect pricing

Answer: The competitive set spans legacy glucagon injection brands and follow-on rescue options, with pricing and share influenced more by reimbursement and device convenience than by the underlying active ingredient.

Competitive factors that drive market share

• Formulary position in diabetes plans.
• Coverage policies for rescue kits and emergency response protocols.
• Institutional adoption in schools, workplaces, and care pathways.
• Consumer and caregiver preference based on usability.

How non-injectable competitors change the market

Where nasal rescue options are available, adoption can shift demand and reduce kit usage frequency. In competitive analyses, separate:

• Rescue availability in homes (caregiver ease-of-use).
• Institutional protocols (standard of care and procurement workflows).
• Pediatric and caregiver training constraints.

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Market analysis: current demand, reimbursement dynamics, and utilization drivers for glucagon rescue

Answer: Demand is tied to diabetes population size, hypoglycemia risk, and guideline adoption for severe hypoglycemia rescue. Utilization is pushed by insulin regimen intensity and by caregiver access.

Core utilization drivers

• Increased insulin use in type 1 diabetes and intensifying insulin in type 2 diabetes.
• Reduced tolerance for hypoglycemia events in payer policies and quality metrics.
• School and workplace mandates driving kit distribution.

Reimbursement and access

Key commercial determinants include:

• Prior authorization thresholds or formulary placement for rescue kits.
• Coverage for pediatric labeling and for caregiver purchases.
• Contracting with pharmacy benefit managers and institutional formularies.

Product economics by presentation

Injection kits often trade volume for margin based on:

• Storage and handling costs.
• Device manufacturing and kit assembly costs (if autoinjector).
• Contracted procurement pricing for institutions.

(No revenue figures or unit estimates can be provided without defined market-scope assumptions and source-specific metrics.)

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Revenue projection for glucagon hydrochloride: what growth rate is plausible and what caps upside

Answer: Growth is generally modest-to-moderate and capped by the maturity of the active ingredient, with upside driven by device convenience, expanded payer coverage, and substitutive pressure from non-injectable or next-generation glucagon products.

Projection framework (inputs you must model)

• Addressable patient population and hypoglycemia risk distribution.
• Kit penetration rates (home and institutional).
• Replacement cadence and adherence to having rescue supplies.
• Share shift from competing rescue platforms (injectable autoinjectors, nasal rescue, or glucagon analogs).

What can accelerate uptake

• Demonstrated reductions in administration failures in real-world workflows.
• Broader reimbursement and easier patient access.
• Pediatric guideline uptake and school/childcare adoption programs.

What limits growth

• Loss of differentiated exclusivity for legacy formulations.
• Procurement shift to lower total cost kits.
• Intensified competition from non-injectable rescue products.

(A numeric CAGR or revenue forecast is not possible without market sizing inputs, historical sales by product, and a defined geographic scope.)

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How does glucagon hydrochloride compare with glucagon analogs and nasal rescue in efficacy, safety, and adoption

Answer: Across rescue use, the commercial differentiator is often time-to-administration and caregiver usability rather than a large efficacy gap, with safety dominated by nausea/vomiting risk.

Side-by-side factors for commercial comparability

• Administration latency (device usability).
• Reconstitution burden and failure rates.
• Labeling for pediatric and caregiver administration.
• Safety tolerability in repeated rescue scenarios.

Adoption comparison

• Injectables win where institutional protocols require medical-grade kits.
• Non-injectables can win where caregiver training is limited.

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What generic entry risks exist for glucagon hydrochloride and how do settlements affect launch

Answer: Generic entry risk exists primarily around presentation-specific patents. Settlements can delay entry but rarely remove the structural pressure from mature active ingredients and competitive rescue portfolios.

Common litigation patterns

• Paragraph IV challenges to listed patents tied to formulation or device workflows.
• Settlement agreements that set a “carve-out” for non-infringing designs or specify launch dates.

How to model “design-around” risk

• If device claims cover core mechanics, design-around may be nontrivial.
• If formulation claims are narrow (specific excipient or ratio), reformulation can enable entry.

(No case-specific litigation timeline can be provided without named disputes and patent numbers.)

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Regulatory status: which FDA pathways apply to glucagon hydrochloride follow-ons

Answer: Follow-on glucagon products can enter via ANDA, NDA 505(b)(2), or other hybrid pathways depending on whether they rely on reference listed drug data and how they distinguish from protected formulation/device features.

Labeling and approval strategy

Regulatory strategy usually hinges on:

• Demonstrating equivalence for rescue performance endpoints.
• Stability and reconstitution specifications.
• Device performance qualification for autoinjectors.

(No product-specific FDA regulatory pathway can be asserted without NDA/ANDA identifiers for the candidate products.)

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Key Takeaways

• Glucagon hydrochloride market growth is driven by diabetes hypoglycemia risk and by usability-driven substitution more than by new clinical breakthroughs for the active ingredient.
• Competitive pressure concentrates on delivery format differentiation, with patents and exclusivity mostly presentation-specific rather than active ingredient–wide.
• For launch and investment modeling, the decisive variables are Orange Book listing coverage by presentation, device/formulation patent strength, and whether Paragraph IV challenges and settlements constrain entry timing.
• Numeric revenue projections require product-level history, market sizing, and a defined geography; without those, only directional growth logic can be stated.

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FAQs

1. What endpoints matter most in glucagon rescue clinical trials?
   Time-to-administration, successful rescue rates, glucose threshold attainment, and caregiver administration failure rates.

2. Do glucagon hydrochloride formulations have meaningful device usability IP?
   Often yes, particularly for autoinjectors and kit workflow claims that can block direct copying.

3. What regulatory pathway do glucagon rescue generics typically use in the US?
   Commonly ANDA or 505(b)(2), depending on reliance on reference data and differentiation strategy.

4. How does non-injectable rescue change glucagon kit demand?
   It can reduce kit utilization frequency where caregivers prefer nasal rescue and where reimbursement supports it.

5. What is the fastest path to commercial share gain for glucagon hydrochloride products?
   Improving caregiver workflow with payer-friendly coverage and achieving institutional formulary placement.

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References

1. American Diabetes Association. Standards of Care in Diabetes. (Most recent edition).
2. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
3. FDA guidance and labeling documents relevant to drug-device combination products and generic drug application pathways. U.S. Food and Drug Administration.