Hypoglycemia: Clinical Overview, Company Landscape, Therapeutic Evaluation, Treatment Strategies, and Pipeline Analysis | Key Players: Amylyx Pharmaceuticals Inc., Zucara Therapeutics Inc., Vogenx Inc

DelveInsight's, "Hypoglycemia - Pipeline Insight, 2025" report provides comprehensive insights about 10+ companies and 12+ pipeline drugs in Hypoglycemia pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
According to DelveInsight, over 10 major companies are actively engaged in developing more than 12 therapeutic candidates aimed at treating Hypoglycemia.

Hypoglycemia Overview:

Hypoglycemia is generally defined as a plasma glucose concentration below 70 mg/dL, though symptoms typically appear when levels fall under 55 mg/dL. The diagnostic framework known as Whipple's triad, established in 1938, remains the gold standard for identifying hypoglycemia and consists of three components: the presence of hypoglycemic symptoms, confirmed low blood glucose levels, and symptom relief after glucose administration. Since glucose serves as the brain's primary energy source, maintaining adequate levels is critical for normal neurological function. During fasting, blood glucose is regulated mainly by hepatic processes such as gluconeogenesis and glycogenolysis. Hypoglycemia most commonly affects individuals with diabetes-particularly those with type 1 diabetes-who face approximately three times the risk compared to individuals with type 2 diabetes on medication.

Although rare in non-diabetic individuals, hypoglycemia can still result from various factors, including certain medications, excessive alcohol intake, severe illness, hormonal imbalances, or tumors. In diabetic patients, it is most often triggered by insulin, sulfonylureas, or meglitinides, while drugs such as metformin, GLP-1 receptor agonists, and SGLT-2 inhibitors pose a lower risk. In people with normal liver function, fasting hypoglycemia is uncommon due to efficient metabolic regulation but may occur following inappropriate insulin use. Alcohol-induced hypoglycemia can develop when gluconeogenesis is inhibited after liver glycogen stores are exhausted. Serious health conditions-such as liver failure, kidney disease, or sepsis-can also disrupt glucose homeostasis, leading to low blood sugar levels. Additionally, hormonal disorders like adrenal insufficiency and rare tumors, including insulinomas or non-islet cell tumors that secrete insulin-like growth factor 2 (IGF-2), may contribute to fasting hypoglycemia and should be carefully assessed during diagnostic evaluation.

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"Hypoglycemia Pipeline Insight 2025" report by DelveInsight provides a comprehensive analysis of the ongoing clinical development activities and growth prospects across the Hypoglycemia Therapeutics Market.

Key Takeaways from the Hypoglycemia Pipeline Report

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DelveInsight's Hypoglycemia pipeline report highlights a dynamic and evolving landscape, with more than 10 active companies advancing over 12 therapeutic candidates aimed at treating Hypoglycemia.

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On May 5, 2025, Rezolute announced that the FDA granted Breakthrough Therapy Designation to ersodetug for the treatment of hypoglycemia caused by tumor-related hyperinsulinism (such as insulinomas or non-islet cell tumors). This designation is intended to accelerate the drug's development based on encouraging early data, with a pivotal trial anticipated to begin in mid-2025 and topline results expected by late 2026.

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On March 18, 2025, the FDA expanded the approval of Baqsimi to include children aged 1 year and older with diabetes who experience severe hypoglycemia. Previously, the indication applied only to patients aged 4 and above. In a Phase I trial involving children aged 1-

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Leading players in the Hypoglycemia space-such as Amylyx Pharmaceuticals Inc., Zucara Therapeutics Inc., Vogenx Inc., Seraxis, Hanmi Pharmaceutical Co. Ltd., and Vertex Pharmaceuticals Incorporated-are actively developing innovative therapies to enhance the treatment landscape.

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Prominent candidates currently in various stages of development include Avexitide, ZT-01, Mizagliflozin, and others showing strong potential in addressing hypoglycemia management.

Hypoglycemia Pipeline Analysis

The report provides insights into:

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The report provides detailed insights into the key companies that are developing therapies in the Hypoglycemia Market.

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The report also evaluates different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Hypoglycemia treatment.

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It analyzes the key companies involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.

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It navigates the emerging drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.

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Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement, and financing details for future advancement of the Hypoglycemia market.

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Hypoglycemia Emerging Drugs

Avexitide: Amylyx Pharmaceuticals Inc.

Avexitide is a first-in-class, investigational glucagon-like peptide-1 (GLP-1) receptor antagonist being developed for the treatment of Post-Bariatric Hypoglycemia (PBH). The U.S. Food and Drug Administration (FDA) has granted it both Breakthrough Therapy and Orphan Drug Designations for its potential in managing Hyperinsulinemic Hypoglycemia. Avexitide functions by binding to GLP-1 receptors on pancreatic beta cells, inhibiting GLP-1 activity to decrease insulin secretion and maintain stable blood glucose levels. In PBH, excessive GLP-1 stimulation leads to overproduction of insulin, causing severe and sometimes debilitating hypoglycemia. Clinical studies have demonstrated that Avexitide can markedly reduce the frequency of hypoglycemic episodes-often associated with autonomic and neuroglycopenic symptoms that impair quality of life. The therapy is currently in Phase III clinical development for hypoglycemia treatment.

ZT-01: Zucara Therapeutics Inc.

ZT-01 is a first-in-class, once-daily therapy designed to prevent insulin-induced hypoglycemia in patients receiving insulin treatment. It acts by modulating somatostatin-a pancreatic hormone that disrupts the body's normal glucagon response to low blood sugar in individuals with insulin-dependent diabetes. By restoring this impaired glucagon secretion, ZT-01 helps prevent hypoglycemic episodes, offering the potential to significantly enhance diabetes management, health outcomes, and quality of life. The drug functions by blocking Somatostatin Type 2 (SSTR2) receptors on pancreatic -cells, which become overactivated by somatostatin during hypoglycemia, thereby suppressing glucagon release and hindering recovery from low blood sugar. ZT-01 is currently in Phase II clinical development for the treatment of hypoglycemia.

Hypoglycemia Companies

Around 10 or more key companies are currently developing therapies for Hypoglycemia. Among them, Amylyx Pharmaceuticals Inc. has a drug candidate in the most advanced stage of development-Phase III.

DelveInsight's report covers around 75+ products under different phases of clinical development like

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Late stage products (Phase III)

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Mid-stage products (Phase II)

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Early-stage product (Phase I) along with the details of

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Pre-clinical and Discovery stage candidates

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Discontinued & Inactive candidates

Hypoglycemia pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

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Intravenous

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Subcutaneous

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Oral

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Intramuscular

Hypoglycemia Products have been categorized under various Molecule types such as

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Monoclonal antibody

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Small molecule

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Peptide

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Hypoglycemia Pipeline Therapeutic Assessment

- Hypoglycemia Assessment by Product Type

- Hypoglycemia By Stage

- Hypoglycemia Assessment by Route of Administration

- Hypoglycemia Assessment by Molecule Type

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Table of Content

1. Report Introduction

2. Executive Summary

3. Hypoglycemia Current Treatment Patterns

4. Hypoglycemia - DelveInsight's Analytical Perspective

5. Therapeutic Assessment

6. Hypoglycemia Late-Stage Products (Phase-III)

7. Hypoglycemia Mid-Stage Products (Phase-II)

8. Early Stage Products (Phase-I)

9. Pre-clinical Products and Discovery Stage Products

10. Inactive Products

11. Dormant Products

12. Hypoglycemia Discontinued Products

13. Hypoglycemia Product Profiles

14. Hypoglycemia Key Companies

15. Hypoglycemia Key Products

16. Dormant and Discontinued Products

17. Hypoglycemia Unmet Needs

18. Hypoglycemia Future Perspectives

19. Hypoglycemia Analyst Review

20. Appendix

21. Report Methodology

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About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

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