Hypoglycemia - Pipeline Insight, 2024

This “Hypoglycemia - Pipeline Insight, 2024” report provides comprehensive insights about 6+ companies and 6+ 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 often defined by a plasma glucose concentration below 70 mg/dL; however, signs and symptoms may not occur until plasma glucose concentrations drop below 55 mg/dL. The symptoms of Whipple's triad have been used to describe hypoglycemia since 1938. For Whipple's triad, the practitioner must first recognize symptoms of hypoglycemia, then obtain low blood glucose, and finally, demonstrate immediate relief of symptoms by the correction of the low blood glucose with glucose treatment. Glucose is the primary metabolic fuel for the brain under physiologic conditions. Unlike other tissues of the body, the brain is very limited in supplying its glucose. Expectedly, the brain requires a steady supply of arterial glucose for adequate metabolic function. Potential complications can arise from an interruption in the glucose supply. As such, protective mechanisms to guard against low serum blood glucose (hypoglycemia) have evolved in the body. The body's defense against hypoglycemia involves intricate hormonal and neural mechanisms. Initially, decreased insulin production enables hepatic glucose output. As glucose levels drop, gluconeogenesis and glycogenolysis increase to maintain euglycemia. If needed, glucagon and epinephrine secretion further raise blood glucose levels. In prolonged hypoglycemia, growth hormone and cortisol release provide additional counter-regulatory support. These responses ensure glucose homeostasis even in challenging metabolic conditions.

Hypoglycemia manifests through a variety of symptoms, ranging from mild to severe, as glucose levels fall below normal thresholds. Common symptoms include palpitations, sweating, trembling, and feelings of anxiety or irritability. Additionally, individuals may experience hunger, weakness, and confusion, accompanied by visual disturbances such as blurred vision. As hypoglycemia progresses, more severe symptoms such as seizures, loss of consciousness, and coma may occur. The severity and combination of symptoms can vary widely among individuals and depend on factors such as the rate of glucose decline and individual susceptibility.

The diagnosis of hypoglycemia involves confirming low blood glucose levels and ruling out exogenous insulin administration through documentation of Whipple's triad and assessment of insulin, proinsulin, and C-peptide levels. Low C-peptide levels alongside high insulin levels indicate exogenous insulin use. Elevated C-peptide levels, in conjunction with insulin, may suggest the use of secretagogue agents like sulfonylureas. Once exogenous insulin is ruled out, investigations for sources of endogenous hyperinsulinemia, often via abdominal CT or MRI, are pursued to localize potential insulin-secreting tumors or other etiologies. Early and accurate diagnosis is crucial for appropriate management and to mitigate the risk of recurrent hypoglycemic episodes. The treatment of hypoglycemia involves prompt intervention to raise blood glucose levels, which can be achieved through administration of intravenous dextrose for severe cases, oral carbohydrates for conscious patients, or glucagon for those unable to take oral agents. Non pharmacological management focuses on patient education, lifestyle modifications, and regular monitoring to prevent recurrent episodes. In diabetes mellitus type 2, glycemic control is crucial, but intensive therapy targeting hemoglobin A1C levels below 6.0% may not necessarily reduce major cardiovascular events and may even increase mortality and risk of hypoglycemia. Surgical management is often pursued for insulinomas, while investigation for potential multiple endocrine neoplasia (MEN) disorders should be considered in cases of insulinoma.

"Hypoglycemia- Pipeline Insight, 2024" 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 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

RZ358: Rezolute

RZ358 is a fully human monoclonal antibody that works downstream from the pancreas and other sources of insulin or related paraneoplastic substances, and instead binds to a unique allosteric site on insulin receptors in the liver, fat, and muscle. The antibody counteracts excess insulin receptor activation by insulin and other effector substances (such as IGF-2), thereby improving hypoglycemia. Because RZ358 acts downstream from the pancreas at the insulin receptor, it has the potential to be universally effective at treating hypoglycemia due to congenital HI, regardless of the causative genetic defect, as well as acquired forms of HI such as those mediated by insulinomas (ICTs) and other tumor types (NICTs). Currently, the drug is in Phase III stage of its clinical trial for the treatment of hypoglycemia.

VX-880: Vertex Pharmaceuticals

VX-880 is an investigational allogeneic stem cell-derived, fully differentiated, insulin-producing islet cell therapy manufactured using proprietary technology. It is being evaluated for patients who have type 1 diabetes with impaired hypoglycemic awareness and severe hypoglycemia. VX-880 is being investigated as an infusion into the hepatic portal vein and requires immunosuppressive therapy to protect the islet cells from immune rejection. Currently, the drug is in Phase I/II stage of its clinical trial 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. 6+ 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, Rezolute.

Phases

This report covers around 6+ 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 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

• Rezolute
• Vertex Pharmaceuticals
• MBX Biosciences
• Eli Lilly and Company

Key Products

• RZ 358
• VX-880
• MBX 1416
• Tirzepatide

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