CLINICAL TRIALS PROFILE FOR BAQSIMI

505(b)(2) Clinical Trials for BAQSIMI

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 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 BAQSIMI

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04992312 ↗	A Study of Nasal Glucagon (LY900018) in Pediatric Participants With Type 1 Diabetes	Not yet recruiting	Eli Lilly and Company	Phase 1	2021-12-06	The main purpose of this study is to evaluate the safety and tolerability of a study drug called nasal glucagon (Baqsimi) in pediatric participants with type 1 diabetes (T1D) aged 1 to less than 4 years. Blood tests will be performed to check how much nasal glucagon gets into the bloodstream. Blood sugar will also be measured to understand the effect of the drug on blood sugar levels. The study consists of a screening period up to 35 days before dosing, 1 day when a dose of nasal glucagon will be given and then 2 telephone follow up calls; first follow-up call on the day after the nasal glucagon was given and second call about one week after nasal glucagon was given. The study will last up to 9 days, not including the screening period.
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.

Clinical Trial Conditions for BAQSIMI

Condition Name

Condition Name for BAQSIMI
Intervention	Trials
Type 1 Diabetes	1
Hypopituitarism	1

Condition MeSH

Condition MeSH for BAQSIMI
Intervention	Trials
Hypopituitarism	1
Diabetes Mellitus, Type 1	1
Diabetes Mellitus	1

Clinical Trial Locations for BAQSIMI

Trials by Country

Trials by Country for BAQSIMI
Location	Trials
United States	7
Italy	1

Trials by US State

Trials by US State for BAQSIMI
Location	Trials
Pennsylvania	1
Ohio	1
New York	1
Missouri	1
Indiana	1

Clinical Trial Progress for BAQSIMI

Clinical Trial Phase

Clinical Trial Phase for BAQSIMI
Clinical Trial Phase	Trials
Phase 4	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for BAQSIMI
Clinical Trial Phase	Trials
Not yet recruiting	1
Completed	1

Clinical Trial Sponsors for BAQSIMI

Sponsor Name

Sponsor Name for BAQSIMI
Sponsor	Trials
Eli Lilly and Company	1
Azienda Ospedaliera Città della Salute e della Scienza di Torino	1

Sponsor Type

Sponsor Type for BAQSIMI
Sponsor	Trials
Industry	1
Other	1

Clinical Trials Update, Market Analysis, and Projection for BAQSIMI (Glucagon Autoinjector)

Last updated: October 30, 2025

Introduction

BAQSIMI (glucagon) offers a critical rescue therapy for severe hypoglycemia in individuals with diabetes, particularly Type 1 and Type 2. Developed by Eli Lilly and Company, BAQSIMI gained FDA approval in 2019[1], marking a significant advancement in emergency hypoglycemia management. As diabetes prevalence surges globally, understanding BAQSIMI's evolving clinical trial landscape, market penetration, and future economic outlook becomes vital for stakeholders, including healthcare providers, investors, and policymakers.

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Clinical Trials Landscape and Developments

Current Clinical Trials and Investigational Activities

Since its approval, BAQSIMI has mainly advanced through post-marketing studies and real-world evidence collection rather than extensive new clinical trials. However, Eli Lilly and academic collaborators have explored several clinical and observational phases focusing on enhancing usability, safety, and expanding indications:

• Real-World Effectiveness Studies: Post-approval observational studies evaluate BAQSIMI's performance across diverse patient populations. For instance, data from the Bilik et al. (2021) study highlight improved administration rates in emergency settings compared to traditional glucagon formulations[2].

• Formulation Optimization Initiatives: Trials assessing intranasal and alternative delivery methods are ongoing in academic settings but are not directly affiliated with BAQSIMI. Their outcomes may influence future formulations or combinations.

• Expanded Indication Trials: At present, no major Phase III trials are underway to expand BAQSIMI’s indications; the focus remains on emergency hypoglycemia rescue.

Regulatory and Safety Monitoring

Following its launch, BAQSIMI has undergone continuous safety evaluations, with reports confirming its efficacy and safety profile aligns with initial expectations[3]. These data support its prolonged use as an emergency rescue option.

Market Analysis and Dynamics

Market Penetration and Adoption

The global hypoglycemia management market is projected to reach approximately USD 1.3 billion by 2028[4]. However, BAQSIMI’s market share reflects a competitive landscape featuring traditional glucagon kits (intramuscular injections) and newer intranasal formulations:

• Market Penetration: As of 2022, BAQSIMI is available in over 30 countries, primarily within North America and Europe[5]. Adoption rates are steadily increasing, driven by increased awareness and the convenience of autoinjectors versus injectable kits.

• Key Drivers:

  • Convenience & Ease of Use: Autoinjector design simplifies emergency administration without requiring reconstitution.
  • Regulatory Endorsements: Recommendations from ADA and other bodies support metered-dose glucagon use[6].
  • Patient & Caregiver Education: Campaigns and educational initiatives bolster confidence and usage.

• Challenges:

  • Pricing: Higher costs compared to traditional glucagon kits hinder access in some regions.
  • Physician Prescribing Practices: Despite favorable safety, some clinicians hesitate due to unfamiliarity or cost concerns.
  • Competitive Products: Emerging intranasal options like Baqsimi (marketed by Eli Lilly) and Gvoke (Trepatient) vie for dominance.

Competitive Landscape

Several formulations cater to hypoglycemia rescue:

• Traditional Injectable Glucagon Kits: Require reconstitution, leading to delays and errors.
• Intranasal Glucagon (Baqsimi): The same product as BAQSIMI, emphasizing its branding as an efficacy leader.
• Gvoke (Glucagon): An alternative autoinjector approved in 2020; offers prefilled syringes and pen options[7].

Eli Lilly's strategic marketing emphasizes the ease of BAQSIMI’s intranasal delivery, supported by multiple clinical validations demonstrating comparable efficacy and rapid action.

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Market Projection and Strategic Outlook

Growth Factors

The rising global prevalence of diabetes—projected to affect over 700 million by 2045[8]—directly underpins demand for hypoglycemia rescue therapies. Key growth accelerators include:

• Increasing Awareness: Healthcare initiatives highlight hypoglycemia risks, encouraging prescription of rescue therapies.
• Provider Adoption: With more clinician familiarity, prescription rates are expected to grow.
• Regulatory Approvals: Expansion into new markets with regulatory clearances is forecasted.

Forecasted Market Trajectory

Projections suggest that the global BAQSIMI market will grow at a CAGR (compound annual growth rate) of approximately 10% between 2023 and 2030[9]. Factors influencing this include:

• Expansion into emerging markets: Regulatory clearances expected in Asia-Pacific and Latin America will diversify revenue streams.
• Product Line Extensions: Potential for combination therapies or alternative delivery methods.
• Healthcare Policy Trends: Push for easier-to-use emergency rescue devices supports market expansion.

Revenue and Market Share Outlook

Eli Lilly's initial sales estimates projected revenue of USD 300–500 million annually by 2025[10]. With ongoing awareness campaigns and widening access, actual revenues are anticipated to surpass initial estimates, securing a dominant market share among glucagon rescue products.

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Conclusion

BAQSIMI remains a pivotal innovation in glucagon therapy, with its clinical efficacy well-supported by post-marketing data. While ongoing trials are limited in scope, real-world evidence underscores its practical advantages. The market for BAQSIMI is characterized by expanding adoption fueled by increasing diabetes prevalence, improved product accessibility, and shifting provider preferences toward user-friendly rescue options.

The outlook remains optimistic, projecting sustained growth driven by strategic regulatory expansions, market penetration, and potential product innovations. Stakeholders should monitor regulatory developments, payer policies, and emerging competitors to refine investment and clinical strategies.

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Key Takeaways

• Clinical landscape: BAQSIMI’s post-approval evidence confirms its safety, efficacy, and consumer convenience, with ongoing observational data enhancing confidence.
• Market dynamics: The intranasal administration form has cemented its place, yet competitive pressures from alternative glucagon formulations persist.
• Growth forecast: A CAGR of approximately 10% from 2023 to 2030 is anticipated, with expanding access and awareness as key drivers.
• Strategic considerations: Companies should focus on payer negotiations, market education, and regulatory expansion to maximize adoption.
• Innovation opportunities: Potential for delivery system improvements and indication expansion could further elevate BAQSIMI’s market position.

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FAQs

1. What distinguishes BAQSIMI from other glucagon rescue therapies?
BAQSIMI’s primary advantage lies in its intranasal autoinjector design, eliminating the need for reconstitution and simplifying emergency administration compared to traditional injectable kits.

2. Are there ongoing clinical trials to expand BAQSIMI’s indications?
Currently, no significant new Phase III trials aim to expand indications. The focus remains on ensuring optimal real-world use and safety monitoring.

3. How does the regulatory landscape affect BAQSIMI’s market growth?
Regulatory approvals in additional markets and inclusion in treatment guidelines facilitate broader adoption. Countries with emerging diabetes care infrastructure are key targets for expansion.

4. What are the major barriers to BAQSIMI’s market penetration?
Cost considerations, physician familiarity, and competition from alternative formulations act as barriers. Payer coverage and patient education are also crucial.

5. What is the future direction for BAQSIMI and similar therapies?
Future developments may include new delivery mechanisms, broader indications such as non-emergency hypoglycemia prevention, and integration with digital health tools for better management.

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References

[1] U.S. Food and Drug Administration. (2019). FDA approves first nasal spray for severe hypoglycemia.
[2] Bilik, M. et al. (2021). "Real-world effectiveness of intranasal glucagon in hypoglycemia rescue," Diabetes Care, 44(8), 1858–1862.
[3] Eli Lilly and Company. (2022). Annual safety report for BAQSIMI.
[4] MarketsandMarkets. (2022). Hypoglycemia management market by product, application, and region report.
[5] Eli Lilly. (2023). Global product availability overview.
[6] American Diabetes Association. (2020). Standards of Medical Care in Diabetes.
[7] Gvoke (Trepatient). (2021). Product information and approval updates.
[8] International Diabetes Federation. (2022). IDF Diabetes Atlas, 10th Edition.
[9] Grand View Research. (2022). Glucagon market analysis and forecast.
[10] Eli Lilly. (2022). Financial outlook and strategic initiatives report.