Geography Covered
- Global coverage
Hypoglycemia Understanding
Hypoglycemia: Overview
Hypoglycemia is an important complication of glucose-lowering therapy in patients with diabetes mellitus.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 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.1 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).2 The literature is inconsistent in describing biochemical hypoglycemia, and these definitions may vary in clinical trials in inpatient versus outpatient settings; thus, an American Diabetes Association (ADA) workgroup has proposed 5 classifications. As Seaquist et al2 have noted, the ADA standard of =70 mg/dL (3.9 mmol/L) is an alert value, intended to provide a margin of error for the limited accuracy of glucose monitoring devices at lower glucose levels. Because this value is above the threshold for symptoms, it allows sufficient time for corrective action to be taken.
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, 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 in Hypoglycemia R&D. The therapies under development are focused on novel approaches to treat/improve in Hypoglycemia.
- In June 2021, The PEC-Direct Phase 2 study enrolled additional patients to evaluate the safety and efficacy of PEC-Direct implanted subcutaneously in patients with T1D who have hypoglycemia unawareness and/or extreme glycemic lability. Study participants upon enrollment are required to be negative for C-peptide, which is not confounded by exogenous insulin. The Company anticipates reporting additional patient data readouts from the PEC-Direct study in the first half of 2022.
Hypoglycemia Emerging Drugs
VC-02: ViaCytePEC-Direct (VC-02) product candidate is being developed for treatment of patients with type 1 diabetes who have hypoglycemia unawareness and/or extreme glycemic lability. It is an investigational cell replacement therapy comprised of pancreatic islet progenitor cells in a pouch designed to allow blood vessels to enter the device, which permits direct vascularization of the implanted cells but will necessitate the use of immune suppression therapy because the implanted cells are not hidden from the immune system. PEC-Direct is designed to enable production of both insulin and glucagon to modulate blood glucose, improve time in range, and ameliorate or prevent complications associated with type 1 diabetes. volunteers.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. 5+ 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 II include Eiger BioPharmaceuticals.Phases
This report covers around 5+ 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
Products have been categorized under various Molecule types such as
- Small molecule
- Peptides
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?
- 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
- XOMA
- Eiger BioPharmaceuticals
- Zucara Therapeutics
- Vectura
- ViaCyte
Key Products
- RZ 358
- Avexitide
- ZT 01
- SKP-1052
- VC-02
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Table of Contents
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- XOMA
- Eiger BioPharmaceuticals
- Zucara Therapeutics
- Vectura
- ViaCyte