CLINICAL TRIALS PROFILE FOR GLUCAGON HYDROCHLORIDE RECOMBINANT

505(b)(2) Clinical Trials for Glucagon Hydrochloride Recombinant

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 Recombinant

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.

Clinical Trial Conditions for Glucagon Hydrochloride Recombinant

Condition Name

Condition Name for Glucagon Hydrochloride Recombinant
Intervention	Trials
Type 2 Diabetes	101
Obesity	90
Type 2 Diabetes Mellitus	75
Type 1 Diabetes	67

Condition MeSH

Condition MeSH for Glucagon Hydrochloride Recombinant
Intervention	Trials
Diabetes Mellitus	366
Diabetes Mellitus, Type 2	282
Diabetes Mellitus, Type 1	149
Hypoglycemia	81

Clinical Trial Locations for Glucagon Hydrochloride Recombinant

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for Glucagon Hydrochloride Recombinant

Clinical Trial Phase

Clinical Trial Phase for Glucagon Hydrochloride Recombinant
Clinical Trial Phase	Trials
PHASE4	35
PHASE3	13
PHASE2	25

Clinical Trial Status

Clinical Trial Status for Glucagon Hydrochloride Recombinant
Clinical Trial Phase	Trials
Completed	484
Recruiting	147
Unknown status	82

Clinical Trial Sponsors for Glucagon Hydrochloride Recombinant

Sponsor Name

Sponsor Name for Glucagon Hydrochloride Recombinant
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 Recombinant
Sponsor	Trials
Other	1123
Industry	350
NIH	93

Last updated: May 15, 2026

Glucagon Hydrochloride Recombinant Clinical Trials Update, Market Analysis, and Revenue Projections

Executive summary

Recombinant glucagon hydrochloride is an established endocrine emergency therapy with a constrained but recurring demand profile tied to severe hypoglycemia management. The market is shaped less by pipeline novelty and more by (1) device and route-of-administration adoption, (2) regulatory and manufacturing capacity for injectable glucagon, and (3) exclusivity and patent/entry risk around existing branded products. Clinical activity is typically incremental (new presentations, dosing refinements, or observational safety/PK work) rather than broad late-stage efficacy trials, because the clinical endpoint space for glucagon is well characterized.

No patent, Orange Book, FDA approval history, trial registry identifiers, comparator brands, or jurisdictional regulatory status for “glucagon hydrochloride recombinant” were provided. Without those inputs, a complete and accurate clinical-trials-to-market mapping, including trial stage counts, timelines, and monetizable segment projections, cannot be produced.

What clinical trials are ongoing for recombinant glucagon hydrochloride?

Featured snippet answer: Ongoing trials for glucagon products typically focus on safety, PK/PD, rescue usability, route or formulation performance, and real-world effectiveness in severe hypoglycemia, with late-stage interventional efficacy trials being less common than earlier-stage and bridging work.

What trial endpoints are used for glucagon rescue therapy?

• Time to reversal of hypoglycemia (or recovery of clinically relevant glucose thresholds)
• Incidence of treatment-emergent adverse events
• Re-administration rates and repeat rescue time
• Usability endpoints for caregivers (where devices or delivery systems exist)

What trial designs dominate in this space?

• PK/PD bridging and formulation comparisons (including local tolerability)
• Randomized crossover studies in controlled hypoglycemia settings
• Observational registries in emergency and diabetes-care pathways

How big is the glucagon recombinant market today?

Featured snippet answer: Demand tracks severe hypoglycemia incidence in insulin-using populations and the penetration of emergency glucagon kits, including where payers and guidelines drive adoption.

Market sizing drivers

• Insulin and insulin secretagogue patient populations (type 1 diabetes, advanced type 2 requiring insulin)
• Guideline adherence and payer coverage for emergency rescue kits
• Penetration of auto-injector vs conventional injection formats
• Seasonal and acute-care utilization patterns (ED, EMS, inpatient rescue)

Supply-side constraints

• Sterile injectable manufacturing capacity and batch release lead times
• Cold-chain or handling requirements by presentation
• Lead product continuity risk (supply disruptions can swing near-term sales)

Where does recombinant glucagon revenue come from: US vs ex-US?

Featured snippet answer: US demand is typically the anchor due to guideline coverage and reimbursement infrastructure; ex-US markets vary based on regulatory approvals, kit adoption, and procurement channels.

US revenue structure

• Brand kit sales to retail and specialty channels
• Contract supply to diabetes programs, hospitals, and emergency networks
• Claims for severe hypoglycemia events that correlate with increased rescue kit distribution

Europe and other regions

• Tender-driven hospital procurement where emergency rescue protocols are codified
• National reimbursement rules that can delay or accelerate adoption

When does glucagon hydrochloride recombinant lose exclusivity?

Featured snippet answer: Exclusivity timing depends on the specific branded reference product, the formulation/presentation patents, and any data exclusivity granted at the time of original and supplemental approvals. Without a reference product name and listed FDA approvals/patents, exclusivity loss dates cannot be stated accurately.

What patents protect recombinant glucagon products?

Featured snippet answer: The patent estate for glucagon products usually concentrates on formulation, stability, device integration, manufacturing processes, and sometimes method-of-use claims tied to hypoglycemia rescue. Exact numbers and expiry dates require Orange Book listing identifiers for the relevant NDA(s).

Patent clusters that typically matter

• Formulation and stability (salt form, excipient system, pH, reconstitution)
• Process patents (sterile manufacturing, filling, lyophilization or solution stability)
• Device and method-of-use (auto-injector integration, administration steps, caregiver training)

What generic entry risks exist for glucagon recombinant?

Featured snippet answer: Generic or authorized alternative entry risk is mainly governed by whether FDA-listed patents are still in force for the specific presentation and whether Paragraph IV certifications would likely trigger litigation and settlement-driven launch delays.

Entry vectors

• Authorized generics
• NDA 505(b)(2) reformulations or presentation changes
• ANDA pathways for injectable glucagon equivalents (when permitted by regulatory framework and patent landscape)

How do biosimilar risks apply to recombinant glucagon hydrochloride?

Featured snippet answer: Biosimilar-style “exclusivity” risk generally applies to biologics with complex manufacturing and originator-specific reference products. For recombinant glucagon, biosimilar pathways are jurisdiction-dependent and hinge on whether the product is regulated as a biologic with a biologic license application reference and whether a biosimilar pathway is available for that specific product class.

What formulations are protected by IP for glucagon hydrochloride recombinant?

Featured snippet answer: Protection is typically formulation- and stability-centric, especially for injectable kits where reconstitution, storage, and delivery system performance are central. Exact protected formulations require the specific branded product and patent list.

Presentation-specific IP that changes value

• Pre-filled systems vs reconstitution kits
• Concentration strength and fill volume
• Autoinjector compatibility and usability constraints

How does recombinant glucagon compare with alternative rescue therapies?

Featured snippet answer: Market share is pressured by competing rescue options where guidelines or payer coverage support them, but glucagon remains a standard emergency therapy because it can be used regardless of exogenous glucose availability in the immediate rescue window.

Key commercial comparison dimensions

• Time to clinically relevant glucose recovery
• Ease of administration for caregivers
• Storage and handling constraints for households and emergency kits
• Adverse event profiles and repeat dosing requirements

Which companies are challenging the glucagon landscape?

Featured snippet answer: Challenge activity typically comes from (1) authorized generic makers, (2) device-focused entrants, and (3) reformulation manufacturers seeking 505(b)(2) routes. A company-level list requires the NDA/product identity and current competition mapping from FDA and litigation records.

What patent litigation affects recombinant glucagon hydrochloride launches?

Featured snippet answer: Litigation affects launch timing primarily through settlement agreements or court injunctions tied to specific NDA-listed patents. Without named reference products and Orange Book patent numbers, litigation cannot be mapped.

Common litigation triggers

• Paragraph IV certifications on formulation or process patents
• Settlement agreements that delay launch until specific dates
• Design-around efforts that attempt to avoid claim scope

What is the Orange Book status of recombinant glucagon products?

Featured snippet answer: The Orange Book status is product-specific and must be tied to the correct NDA and dosage form/presentation. Without the NDA number(s), Orange Book listings and patent expiry schedules cannot be produced.

Clinical development pipeline: what is likely to matter commercially?

Featured snippet answer: Commercially meaningful clinical activity is usually the subset that expands coverage or lowers usable barriers: improved ease-of-use, faster or more reliable rescue performance, or new presentation formats that increase kit uptake.

Commercially relevant trial outcomes

• Better usability for non-medical caregivers
• Reduced re-administration frequency
• Demonstrated stability under real-world storage conditions
• Comparable or improved recovery timelines versus legacy presentations

Revenue projections: base case, downside, upside

Featured snippet answer: A defensible forecast must anchor to named product sales history, identifiable exclusivity and entry dates, and trial milestones that could change adoption. Without product identifiers and current sales baselines, no accurate projections can be issued.

Projection framework that would be used once the product is identified

• Time-series baseline: US and ex-US sales by presentation
• Exclusivity and entry timing: patent expiry and settlement launch dates
• Market adoption: penetration of emergency kits and device formats
• Price trend: net price and reimbursement changes
• Supply continuity: impact of shortages or manufacturing remediation

What usually moves the numbers in this market

• New auto-injector or user-friendly presentation uptake
• Payer formulary changes for rescue glucagon kits
• Entry by authorized alternatives after patent cliffs
• Supply disruptions that shift channel inventory and ordering patterns

Key Takeaways

• The recombinant glucagon hydrochloride market is demand-stable and adoption-driven, with clinical development that usually supports usability, formulation performance, and bridging evidence rather than radical efficacy changes.
• Accurate clinical-trial updates and revenue projections require product-specific anchors: the exact branded reference product, FDA approval identifiers, and current trial registry entries.
• IP and entry timing are the primary determinants of medium-term pricing and volume outcomes, but they cannot be quantified without the Orange Book patent estate and litigation record for the relevant NDA(s).

FAQs

1. What are the most common endpoints in severe hypoglycemia glucagon studies?
2. How does an auto-injector glucagon presentation impact adoption and prescribing behavior?
3. What determines whether a glucagon alternative launches through ANDA vs 505(b)(2)?
4. How do settlement agreements usually affect glucagon generic or authorized alternative launch timing?
5. What real-world factors drive rescue kit utilization in insulin-treated diabetes populations?

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026-05-16).
2. ClinicalTrials.gov. (Accessed 2026-05-16).