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Report Overview

Congenital hyperinsulinism refers to a genetic disorder in which the pancreas produces abnormally high levels of insulin, leading to low blood sugar or hypoglycemia. The incidence of this condition is estimated to be around 1 in 25,000 to 1 in 50,000 live births  in the general population. In certain populations with high rates of consanguinity, the incidence of congenital hyperinsulinism can go as high as 1 in 2,500. Existing medications often fail to reach optimal glycemic control or show significant side effects. Thus, there is a need for new drugs that can safely and effectively manage the activity of insulin and address other complications associated with congenital hyperinsulinism.

  • Major companies involved in the congenital hyperinsulinism (CHI) pipeline drugs market include Hanmi Pharmaceutical Company Limited and Zealand Pharma, among others.

  • Leading drugs currently under the pipeline include dasiglucagon and RZ358, among others.

  • The increasing government support through research grants and funding along with robust pipeline activity from several pharmaceutical companies is expected to accelerate the development of new therapeutic agents.

Report Coverage

The Congenital Hyperinsulinism (CHI) Drug Pipeline Report by Expert Market Research gives comprehensive insights into congenital hyperinsulinism (CHI) drugs currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for congenital hyperinsulinism (CHI). The report includes the analysis of over 100 pipeline drugs and 50+ companies. The congenital hyperinsulinism (CHI) pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials including their adverse effects on patients suffering from congenital hyperinsulinism (CHI).

The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing congenital hyperinsulinism (CHI) pipeline development activities.

Congenital Hyperinsulinism (CHI) Drug Pipeline Outlook

Congenital hyperinsulinism is the most common cause of persistent elevated levels of insulin or hypoglycemia in neonates, infants, and children. In this condition, the beta cells in the pancreas secrete too much insulin. Frequent episodes of hypoglycemia can cause lethargy, shakiness, difficulty feeding, and seizures.

Congenital hyperinsulinism (CHI) treatment includes medications such as chlorothiazide, glucagon, diazoxide, and octreotide. Studies reveal that this treatment is effective in around half of the children. However, if the patient fails to respond to medical therapy, surgical intervention is an option. Moreover, since congenital hyperinsulinism demonstrates heterogeneity in disease presentation and treatment response, there is a growing focus on the development of personalized medicine approaches that can address these genetic differences.

Congenital Hyperinsulinism (CHI) – Drug Pipeline Therapeutic Assessment

This section of the report covers the analysis of congenital hyperinsulinism (CHI) drug candidates based on several segmentations including:

By Phase

EMR’s pipeline assessment report covers 50+ drug analyses based on phase:

  • Late-Stage Products (Phase 3 and Phase 4)
  • Mid-Stage Products (Phase 2)
  • Early-Stage Products (Phase I)
  • Preclinical and Discovery Stage Products

By Drug Class

EMR’s congenital hyperinsulinism (CHI) therapeutic assessment report covers 50+ drug analyses based on drug classes:

  • Recombinant Fusion Proteins
  • Small Molecule
  • Monoclonal Antibody
  • Peptide
  • Polymer
  • Gene Therapy

By Route of Administration

EMR’s pipeline assessment report covers 50+ drug analyses based on the route of administration.

  • Oral
  • Parenteral
  • Others

Congenital Hyperinsulinism (CHI) – Pipeline Assessment Segmentation, By Phases

The report covers phase I, phase II, phase III, phase IV, and early phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis, phase II covers a major share of the total clinical trials for congenital hyperinsulinism (CHI).

Congenital Hyperinsulinism (CHI) – Pipeline Assessment Segmentation, By Drug Classes

The drug molecule categories covered under the congenital hyperinsulinism (CHI) pipeline analysis include recombinant fusion proteins, small molecules, monoclonal antibodies, peptides, polymers, and gene therapy. The report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for congenital hyperinsulinism (CHI).

Congenital Hyperinsulinism (CHI) Clinical Trials Therapeutic Assessment – Competitive Dynamics

The EMR congenital hyperinsulinism (CHI) drug report insights cover the profile of key companies involved in clinical trials and their drugs under development. Below is the list of a few players involved in congenital hyperinsulinism (CHI) clinical trials:

  • Hanmi Pharmaceutical Company Limited
  • Zealand Pharma
  • Rezolute, Inc.
  • Greenstone Biosciences, Inc.
  • Eli Lilly and Company

Congenital Hyperinsulinism (CHI) – Emerging Drugs Profile

This section covers the detailed analysis of each drug under multiple phases including phase I, phase II, phase III, phase IV, and emerging drugs for congenital hyperinsulinism (CHI). It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of congenital hyperinsulinism (CHI) drug candidates.

Drug: dasiglucagon

Sponsored by Zealand Pharma, the primary objective of this open-label, multicenter Phase III clinical trial is to assess the long-term safety of the congenital hyperinsulinism (CHI) drug candidate dasiglucagon administered as a subcutaneous infusion in an estimated 44 children with congenital hyperinsulinism.

Drug: RZ358

Rezolute is conducting a Phase III clinical trial aimed at investigating the safety and efficacy of RZ358 for the treatment of congenital hyperinsulinism (CHI). The interventional study has enrolled about 56 subjects and is expected to be completed by September 2026.

*Please note that this is only a partial list; the complete list of drugs will be available in the full report.*

Reasons To Buy This Report

The Congenital Hyperinsulinism (CHI) Drug Pipeline Insight Report provides a strategic overview of the latest and future landscape of treatments for congenital hyperinsulinism (CHI). It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into congenital hyperinsulinism (CHI) collaborations, regulatory environments, and potential growth opportunities within the treatment landscape.

Key Questions Answered in the Congenital Hyperinsulinism (CHI) – Pipeline Insight Report

  • Which companies/institutions are leading the congenital hyperinsulinism (CHI) drug development?
  • What is the efficacy and safety profile of congenital hyperinsulinism (CHI) pipeline drugs?
  • Which company is leading the congenital hyperinsulinism (CHI) pipeline development activities?
  • What is the current congenital hyperinsulinism (CHI) commercial assessment?
  • What are the opportunities and challenges present in the congenital hyperinsulinism (CHI) drug pipeline landscape?
  • What is the efficacy and safety profile of congenital hyperinsulinism (CHI) pipeline drugs?
  • Which company is conducting major trials for congenital hyperinsulinism (CHI) drugs?
  • Which companies/institutions are involved in congenital hyperinsulinism (CHI) collaborations aimed at providing enhanced therapeutic alternatives for patients?
  • What are the geographies covered for clinical trials in congenital hyperinsulinism (CHI)?

Related Reports

Global Congenital Hyperinsulinism Treatment Market

Global Clinical Trials Market

*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*

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Report Summary

Explore our key highlights of the report and gain a concise overview of key findings, trends, and actionable insights that will empower your strategic decisions.

Key Highlights of the Report

Please note that the figures mentioned in the description serve as estimates and may vary from the actual figures presented in the final report.

Scope of the Report

Details

Drug Pipeline by Clinical Trial Phase

  • Late-Stage Products (Phase III and Phase IV)
  • Mid-Stage Products (Phase II)
  • Early-Stage Products (Phase I)
  • Preclinical and Discovery Stage Products

Route of Administration

  • Oral
  • Parenteral
  • Others

Drug Classes

  • Recombinant Fusion Proteins
  • Small Molecule
  • Monoclonal Antibody
  • Peptide
  • Polymer
  • Gene Therapy

Leading Sponsors Covered

  • Hanmi Pharmaceutical Company Limited
  • Zealand Pharma
  • Rezolute, Inc.
  • Greenstone Biosciences, Inc.
  • Eli Lilly and Company

Geographies Covered

  • North America
  • Europe
  • Asia Pacific
  • Others

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