hypoglycemia pipeline insight

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.

 

Geography Covered

• Global coverage

 

Hypoglycemia: Understanding

Hypoglycemia: Overview

Hypoglycemia is commonly defined as a plasma glucose concentration below 70 mg/dL, although symptoms often don't manifest until levels fall below 55 mg/dL. Whipple's triad, established in 1938, describes the diagnostic criteria for hypoglycemia: symptoms of hypoglycemia, low blood glucose levels, and immediate symptom relief upon glucose administration. Glucose is the primary fuel for the brain, and a steady supply is critical for its function. During fasting, the body maintains glucose levels through gluconeogenesis and glycogenolysis, processes that occur primarily in the liver. Hypoglycemia is most commonly observed in diabetic patients, particularly those with type 1 diabetes, who are three times more likely to experience it compared to those with type 2 diabetes undergoing pharmacologic treatment.

 

Hypoglycemia is rare in non-diabetic individuals but can occur due to various causes, including pharmacologic factors, alcohol consumption, critical illness, counter-regulatory hormone deficiencies, and non-islet cell tumors. In diabetic patients, hypoglycemia is most often triggered by medications like meglitinides, sulfonylureas, or insulin. Drugs such as metformin, GLP-1 receptor agonists, and SGLT-2 inhibitors are less likely to cause hypoglycemia. In non-diabetic individuals with intact liver function, fasting hypoglycemia is uncommon due to protective mechanisms, though it may occur due to iatrogenic causes such as insulin misuse. Alcohol can induce hypoglycemia by inhibiting gluconeogenesis once glycogen stores are depleted. Critical illnesses, including end-stage liver disease, sepsis, or renal failure, can lead to an imbalance between glucose utilization and production, causing hypoglycemia. Hormonal deficiencies, such as adrenal insufficiency, can also contribute, though these cases are rare. Non-islet cell tumors may cause hypoglycemia through excessive secretion of insulin-like growth factor 2 (IGF-2), which increases glucose utilization. Additionally, insulinomas, rare tumors of the pancreas, lead to hyperinsulinism and fasting hypoglycemia, requiring careful consideration in diagnosis.

 

The body has inherent counter-regulatory mechanisms to prevent hypoglycemia, primarily involving hormones and neural signals that regulate insulin release, increase hepatic glucose output, and adjust peripheral glucose utilization. The reduction in insulin production is one of the key defenses, but it is not the first response to low glucose levels. As plasma glucose decreases, insulin secretion from beta cells diminishes, which in turn stimulates hepatic glycogenolysis and gluconeogenesis, processes that help maintain blood glucose levels for 8 to 12 hours. As glycogen stores deplete, gluconeogenesis becomes the primary source of glucose production. These initial responses occur when glucose levels are in the low-normal range, a key feature of the body's defense system. If glucose levels drop further, glucagon is secreted from pancreatic alpha cells to promote glucose release, and if this is insufficient, epinephrine is released from the adrenal medulla. In cases of prolonged hypoglycemia, additional counter-regulatory measures, including the release of growth hormone and cortisol, help restore glucose balance. These mechanisms work in stages, with early defenses addressing acute hypoglycemia and later ones coming into play during prolonged episodes. 

 

Identifying and treating hypoglycemia is critical due to the risk of severe complications, including coma or death. Severe hypoglycemia is managed with intravenous (IV) dextrose or oral fast-acting carbohydrates for conscious patients. If the patient cannot take oral agents, glucagon can be administered intramuscularly or intranasally. After regaining consciousness, complex carbohydrates should be given, and frequent blood glucose monitoring is essential to prevent further drops. Nonpharmacological management of recurrent hypoglycemia includes patient education, lifestyle changes, and routine glucose monitoring. Intensive glycemic control, as shown in the 2008 ACCORD trial, carries increased hypoglycemia risk and has not significantly improved cardiovascular outcomes. Surgical management is recommended for insulinomas, and their presence may suggest multiple endocrine neoplasia (MEN) disorders.

 

"Hypoglycemia- Pipeline Insight, 2025" report by DelveInsight 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, 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: Amylyx Pharmaceuticals Inc.

Avexitide is an investigational, first-in-class glucagon-like peptide-1 (GLP-1) receptor antagonist that has been evaluated in clinical trials for Post-Bariatric Hypoglycemia (PBH). The US Food and Drug Administration (FDA) has granted avexitide Breakthrough Therapy Designation and Orphan Drug Designation for the treatment of Hyperinsulinemic Hypoglycemia. Avexitide is designed to bind to the GLP-1 receptor on pancreatic islet beta cells and inhibit the effect of GLP-1 to mitigate hypoglycemia by decreasing insulin secretion and stabilizing blood glucose levels. In PBH, excessive GLP-1 can lead to the hypersecretion of insulin and subsequent debilitating hypoglycemia events. In Clinical trials, avexitide demonstrated highly statistically significant reductions in hypoglycemia events. These events can lead to autonomic and neuroglycopenic symptoms that can have a devastating impact on daily living. Currently, the drug is in Phase III stage of its development for the treatment of Hypoglycemia.

 

• ZT-01: Zucara Therapeutics Inc.

ZT-01 is a first-in-class, once-daily therapeutic to prevent insulin-induced hypoglycemia in patients using insulin therapy. ZT-01 is designed to inhibit somatostatin, a pancreatic hormone that impairs the glucagon response to hypoglycemia in people with insulin dependent diabetes. ZT-01 restores glucagon secretion to prevent hypoglycemia, which could dramatically change diabetes disease management and improve both patient health and quality of life. The approach is to block Somatostatin Type 2 (SSTR2) receptors on α-cells in the pancreas, which are stimulated at a higher than normal level by somatostatin during hypoglycemia in insulin-dependent diabetic patients. The effect of this dysregulated somatostatin on α-cells is to suppress glucagon secretion, which results in the insulin-dependent diabetic patient being unable to avoid or recover from hypoglycemia. Currently, the drug is in Phase II stage of its development for the treatment of Hypoglycemia.

 

• Mizagliflozin: Vogenx, Inc.

Mizagliflozin is an investigational first-in-class, oral, small molecule drug candidate that reduces postprandial glucose absorption, secretion of insulin, and secretion of gastric inhibitory peptide (GIP). The molecule is being developed by Vogenx for the treatment of PBH and gastroparesis. Mizagliflozin has been administered to over 500 subjects in clinical studies and has shown to be safe and well-tolerated. Currently, the drug is in Phase II stage of its development for the treatment of Hypoglycemia.

Further product details are provided in the report……..

 

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, Amylyx Pharmaceuticals Inc.

 

Phases

DelveInsight’s 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 

• Oral
• Intravenous
• Subcutaneous
• Parenteral 
• Topical

 

Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer 
• Gene therapy

 

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 III, 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?