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Hypoglycemia- Pipeline Insight, 2025

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    Clinical Trials

  • 60 Pages
  • April 2025
  • Region: Global
  • DelveInsight
  • ID: 4037528
This “Hypoglycemia- Pipeline Insight, 2025” report provides comprehensive insights about 10+ companies and 10+ 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.

Hypoglycemia: Understanding

Hypoglycemia: Overview

Hypoglycemia is an important complication of glucose-lowering therapy in patients with diabetes mellitus. Hypoglycemia is a common, potentially avoidable consequence of diabetes treatment and a major barrier to better metabolic control in type 1 and type 2 diabetes. It is a significant concern of primary care practitioners and patients when it comes to initiating or intensifying antihyperglycemic therapy. Hypoglycemia can be defined in several ways: by plasma glucose values (biochemical definition), by symptoms (type and severity), and by time of day in which it occurs (daytime or nocturnal). Association (ADA) workgroup has proposed 5 classifications.

Hypoglycemia signs and symptoms can include shakiness, sweating, headache, hunger or nausea, an irregular or fast heartbeat, fatigue, loss of coordination, slurred speech and blurry vision or tunnel vision. Both the American Diabetes Association (ADA) and the European Medicines Agency have defined hypoglycemia as “any abnormally low plasma glucose concentration that exposes the subject to potential harm” with a proposed threshold plasma glucose value < 70 mg/dL (< 3.9 mmol/L). Classification of hypoglycemia Mild hypoglycemia is associated with the presence of autonomic symptoms and individuals are able to self-treat.

Hypoglycemia occurs when blood sugar (glucose) level falls too low for bodily functions to continue. There are several reasons why this can happen the most common reason for low blood sugar is a side effect of medications used to treat diabetes. Blood sugar regulation; insulin allows the glucose to enter the cells and provide the fuel for the cells need. Extra glucose is stored in the liver and muscles in the form of glycogen. When the person haven't eaten for several hours and the blood sugar level drops, and will stop producing insulin. Possible causes, with diabetes but too much insulin or other diabetes medications may cause blood sugar level to drop too much, causing hypoglycemia. Hypoglycemia can also occur if the person eat less than usual after taking regular dose of diabetes medication. Hypoglycemia is diagnosed by identifying symptoms of hypoglycemia, a blood glucose level below 70 mg/dL (3.9 mmol/L), and resolution of symptoms when blood sugar returns to normal. In those without a history of diabetes, further diagnostic testing is necessary to identify the cause. Testing during an episode of hypoglycemia should include plasma glucose level, insulin level, C-peptide level, proinsulin level, beta-hydroxybutyrate level, oral hypoglycemic agent screen, response of blood glucose level to glucagon, and insulin antibodies. A diagnostic fast can be performed in an inpatient or outpatient setting to reproduce the hypoglycemic episode for appropriate blood work. Hypoglycemia treatment involves administering rapid-acting carbohydrates, such as 15 g of simple sugars orally, and closely monitoring blood sugar levels. In severe cases, glucagon kits are recommended for emergency treatment, especially for patients with a history of severe hypoglycemia or those at risk. In neonatal hypoglycemia, glucose IV infusion 10% given at a rate of 5 mL/kg/hour is used, while in children and adolescents with type 1 diabetes, continuous glucose monitoring systems with or without control of insulin infusion are helpful in prevention.

'Hypoglycemia- Pipeline Insight, 2025' report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Hypoglycemia pipeline landscape is provided which includes the disease overview and Hypoglycemia treatment guidelines. The assessment part of the report embraces, in depth Hypoglycemia commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Hypoglycemia collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Hypoglycemia R&D. The therapies under development are focused on novel approaches to treat/improve Hypoglycemia.

Hypoglycemia Emerging Drugs Chapters

This segment of the Hypoglycemia report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, II, II/III I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Hypoglycemia Emerging Drugs

Avexitide: Eiger BioPharmaceuticals

Avexitide is a well-characterized, first-in-class, 31-amino acid GLP-1 antagonist that selectively targets and blocks GLP-1 receptors, normalizing insulin secretion by the pancreas, and thereby reducing postprandial hypoglycemia. Avexitide is Phase III ready and has received concurrence from FDA and EMA on a single Phase 3, registration-enabling study of Avexitide in severe PBH. Because avexitide binds to the GLP-1r on pancreatic beta cells and prevents GLP-1r signaling, it works upstream of beta cell insulin secretion to reduce dysregulated insulin secretion and the occurrence of hypoglycemia. Currently, the drug is in the Phase II stage of its development for the treatment of Hypoglycemia
  • MBX 1416: MBX Biosciences
MBX 1416 is an investigational long-acting GLP-1 receptor antagonist in development as a potential treatment for PBH. It was designed using the company’s novel, proprietary PEP platform to prevent the occurrence of severe hypoglycemia in individuals with PBH so they can lead healthier and more independent lives. MBX expects to initiate enrollment in a Phase I trial in the third quarter of 2023 and anticipates reporting topline results in the second half of 2024. Currently, the drug is in the Phase I stage of its development for the treatment of Hypoglycemia

Hypoglycemia: Therapeutic Assessment

This segment of the report provides insights about the different Hypoglycemia drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Hypoglycemia

There are approx. 10+ key companies which are developing the therapies for Hypoglycemia. The companies which have their Hypoglycemia drug candidates in the most advanced stage, i.e. Phase III include, Eiger BioPharmaceuticals.

Phases

The report covers around 12+ products under different phases of clinical development like

  • Late stage products (Phase III)
  • Mid-stage products (Phase II)
  • Early-stage product (Phase I) along with the details of
  • Pre-clinical and Discovery stage candidates
  • Discontinued & Inactive candidates

Route of Administration

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
  • Intravenous
  • Subcutaneous
  • Oral
  • Intramuscular

Molecule Type

Products have been categorized under various Molecule types such as

  • Monoclonal antibody
  • Small molecule
  • Peptide

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Hypoglycemia: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Hypoglycemia therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Hypoglycemia drugs.

Hypoglycemia Report Insights

  • Hypoglycemia Pipeline Analysis
  • Therapeutic Assessment
  • Unmet Needs
  • Impact of Drugs

Hypoglycemia Report Assessment

  • Pipeline Product Profiles
  • Therapeutic Assessment
  • Pipeline Assessment
  • Inactive drugs assessment
  • Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

  • How many companies are developing Hypoglycemia drugs?
  • How many Hypoglycemia drugs are developed by each company?
  • How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Hypoglycemia?
  • What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Hypoglycemia therapeutics?
  • What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
  • What are the clinical studies going on for Hypoglycemia and their status?
  • What are the key designations that have been granted to the emerging drugs?

Key Players

  • Eiger BioPharmaceuticals
  • MBX Biosciences
  • Hanmi Pharmaceutical
  • Twist Bioscience

Key Products

  • Avexitide
  • MBX 1416
  • HM 15136
  • TB 222 023

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Table of Contents

IntroductionExecutive Summary
Hypoglycemia: Overview
  • Introduction
  • Causes
  • Pathophysiology
  • Diagnosis
  • Treatment
Pipeline Therapeutics
  • Comparative Analysis
Therapeutic Assessment
  • Assessment by Product Type
  • Assessment by Stage and Product Type
  • Assessment by Route of Administration
  • Assessment by Stage and Route of Administration
  • Assessment by Molecule Type
  • Assessment by Stage and Molecule Type
Hypoglycemia- The Publisher's Analytical Perspective
Late Stage Products (Phase III)
  • Comparative Analysis
Drug Name: Company Name
  • Product Description
  • Research and Development
  • Product Development Activities
Mid Stage Products (Phase II)
  • Comparative Analysis
Avexitide: Eiger BioPharmaceuticals
  • Product Description
  • Research and Development
  • Product Development Activities
Early Stage Products (Phase I)
  • Comparative Analysis
MBX 1416: MBX Biosciences
  • Product Description
  • Research and Development
  • Product Development Activities
Preclinical and Discovery Stage Products
  • Comparative Analysis
Drug Name: Company Name
  • Product Description
  • Research and Development
  • Product Development Activities
Inactive Products
  • Comparative Analysis
Hypoglycemia Key CompaniesHypoglycemia Key ProductsHypoglycemia- Unmet NeedsHypoglycemia- Market Drivers and BarriersHypoglycemia- Future Perspectives and ConclusionHypoglycemia Analyst ViewsHypoglycemia Key CompaniesAppendix
List of Table
Table 1 Total Products for Hypoglycemia
Table 2 Late Stage Products
Table 3 Mid Stage Products
Table 4 Early Stage Products
Table 5 Pre-clinical & Discovery Stage Products
Table 6 Assessment by Product Type
Table 7 Assessment by Stage and Product Type
Table 8 Assessment by Route of Administration
Table 9 Assessment by Stage and Route of Administration
Table 10 Assessment by Molecule Type
Table 11 Assessment by Stage and Molecule Type
Table 12 Inactive Products
List of Figures
Figure 1 Total Products for Hypoglycemia
Figure 2 Late Stage Products
Figure 3 Mid Stage Products
Figure 4 Early Stage Products
Figure 5 Preclinical and Discovery Stage Products
Figure 6 Assessment by Product Type
Figure 7 Assessment by Stage and Product Type
Figure 8 Assessment by Route of Administration
Figure 9 Assessment by Stage and Route of Administration
Figure 10 Assessment by Molecule Type
Figure 11 Assessment by Stage and Molecule Type
Figure 12 Inactive Products

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • Eiger BioPharmaceuticals
  • MBX Biosciences
  • Hanmi Pharmaceutical
  • Twist Bioscience