Hypoglycemia Clinical, Companies, Therapeutic Assessment, Therapies, Treatment Algorithm, Pipeline Analysis | Amylyx Pharmaceuticals Inc., Zucara Therapeutics Inc., Vogenx, Inc., Seraxis, Hanmi Pharmaceutical Company Limited, Vertex Pharmaceuticals Incorp

Hypoglycemia Pipeline constitutes 10+ key companies continuously working towards developing 12+ Hypoglycemia treatment therapies, analyzes DelveInsight.

Hypoglycemia Overview:

Hypoglycemia is typically defined as a plasma glucose level below 70 mg/dL, though symptoms generally emerge when levels drop under 55 mg/dL. Whipple's triad-first outlined in 1938-remains the standard for diagnosing hypoglycemia and includes three key elements: the presence of hypoglycemic symptoms, low blood glucose measurements, and symptom resolution after glucose intake. Because glucose is the brain's primary energy source, its consistent availability is essential for proper neurological function. During periods of fasting, glucose levels are maintained primarily through liver-based processes such as gluconeogenesis and glycogenolysis. Hypoglycemia is most frequently seen in individuals with diabetes, especially those with type 1 diabetes, who are approximately three times more likely to experience it than those with type 2 diabetes using medication.

Though uncommon in people without diabetes, hypoglycemia can still occur due to various factors such as certain medications, alcohol use, serious illness, hormonal imbalances, or tumors. In diabetic individuals, low blood sugar is most often caused by drugs like insulin, sulfonylureas, or meglitinides. Other medications, including metformin, GLP-1 receptor agonists, and SGLT-2 inhibitors, carry a lower risk of inducing hypoglycemia. In people with healthy liver function, fasting hypoglycemia is rare due to robust metabolic safeguards, but may arise from external factors like inappropriate insulin administration. Alcohol consumption can trigger hypoglycemia by suppressing gluconeogenesis after liver glycogen stores are depleted. Severe illnesses such as liver failure, sepsis, or kidney disease can disrupt the balance between glucose production and use, leading to hypoglycemia. Although rare, hormonal issues like adrenal insufficiency may also play a role. Additionally, non-islet cell tumors may induce hypoglycemia by secreting excess insulin-like growth factor 2 (IGF-2), which increases glucose utilization. Insulinomas-rare pancreatic tumors that produce insulin-are another cause of fasting hypoglycemia and should be carefully evaluated during diagnosis.

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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

DelveInsight's Hypoglycemia pipeline report depicts a robust space with 10+ active players working to develop 12+ pipeline therapies for Hypoglycemia treatment.
On May 5, 2025, Rezolute announced FDA designation of ersodetug as a Breakthrough Therapy for treating hypoglycemia caused by tumor-driven hyperinsulinism (e.g., insulinomas or non-islet cell tumors). The designation aims to expedite development due to promising early data. A pivotal study is expected mid‐2025, with topline results in late 2026
On March 18, 2025, the FDA broadened the indication for Baqsimi to include children aged 1 year and older with diabetes who experience severe hypoglycemia. Previously, the indication was limited to children aged 4+ and adults. In a Phase I trial (n=7, ages 1-

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