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Congenital Hyperinsulinism (CHI) Drug Pipeline Analysis Report 2025- Product Image
Congenital Hyperinsulinism (CHI) Drug Pipeline Analysis Report 2025- Product Image
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Congenital Hyperinsulinism (CHI) Drug Pipeline Analysis Report 2025

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    Drug Pipelines

  • 200 Pages
  • June 2025
  • Region: Global
  • Expert Market Research
  • ID: 6102826
Description Jump to:
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.

Report Coverage

The Congenital Hyperinsulinism (CHI) Drug Pipeline Report by the publisher 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

The 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

The 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

The 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 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 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.

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)?

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Table of Contents

1 Preface
1.1 Introduction
1.2 Objectives of the Study
1.3 Research Methodology & Assumptions
2 Executive Summary
3 Overview of Congenital Hyperinsulinism (CHI)
3.1 Signs and Symptoms
3.2 Causes
3.3 Risk Factors
3.4 Diagnosis
3.5 Treatment
4 Patient Profile: Congenital Hyperinsulinism (CHI)
4.1 Patient Profile Overview
4.2 Patient Psychology and Emotional Impact Factors
4.3 Risk Assessment and Treatment Success Rate
5 Congenital Hyperinsulinism (CHI): Epidemiology Snapshot
5.1 Congenital Hyperinsulinism (CHI) Incidence by Key Markets
5.2 Congenital Hyperinsulinism (CHI) - Patients Seeking Treatment in Key Markets
6 Congenital Hyperinsulinism (CHI): Market Dynamics
6.1 Market Drivers and Constraints
6.2 SWOT Analysis
7 Congenital Hyperinsulinism (CHI): Key Facts Covered
7.1 Top Countries Contributing to Clinical Trials in Asia-Pacific
7.2 Top Countries Contributing to Clinical Trials in Europe
7.3 Top Countries Contributing to Clinical Trials in North America
7.4 Top Countries Contributing to Clinical Trials in Other Regions
8 Congenital Hyperinsulinism (CHI), Drug Pipeline Assessment
8.1 Assessment by Treatment Type
8.2 Assessment by Route of Administration
8.3 Assessment by Drug Class
9 Drug Pipeline Comparative Analysis
9.1 List of Congenital Hyperinsulinism (CHI) Pipeline Drugs
9.1.1 By Company
9.1.2 By Phase
9.1.3 By Indication
9.1.4 By Trial Status
9.1.5 By Funder Type
9.2 Attribute Scoring Analysis of Pipeline Drugs (Top Drugs)
10 Congenital Hyperinsulinism (CHI) Drug Pipeline - Late-Stage Products (Phase III and IV) (Top Drugs)
10.1 Comparative Analysis for Late-Stage Drugs
10.1.1 Study Type
10.1.2 Recruitment Status
10.1.3 Company
10.1.4 Funder Type
10.2 Product Level Analysis*
10.2.1 Drug: dasiglucagon
10.2.1.1 Product Description
10.2.1.2 Trial ID
10.2.1.3 Sponsor Name
10.2.1.4 Study Type
10.2.1.5 Drug Class
10.2.1.6 Eligibility Criteria
10.2.1.7 Study Record Dates
10.2.1.7.1 First Submitted
10.2.1.7.2 First Posted
10.2.1.7.3 Last Update Posted
10.2.1.7.4 Last Verified
10.2.1.8 Indication
10.2.1.9 Study Design
10.2.1.10 Recruitment Status
10.2.1.11 Enrollment (Estimated)
10.2.1.12 Location Countries
10.2.1.13 Recent Results
10.2.2 Drug: RZ358
10.2.3 Other Drugs
11 Congenital Hyperinsulinism (CHI) Drug Pipeline - Mid-Stage Products (Phase II) (Top Drugs)
11.1 Comparative Analysis for Mid-Stage Drugs
11.1.1 Study Type
11.1.2 Recruitment Status
11.1.3 Company
11.1.4 Funder Type
11.2 Product Level Analysis*
11.2.1 Drug: HM15136
11.2.1.1 Product Description
11.2.1.2 Trial ID
11.2.1.3 Sponsor Name
11.2.1.4 Study Type
11.2.1.5 Drug Class
11.2.1.6 Eligibility Criteria
11.2.1.7 Study Record Dates
11.2.1.7.1 First Submitted
11.2.1.7.2 First Posted
11.2.1.7.3 Last Update Posted
11.2.1.7.4 Last Verified
11.2.1.8 Indication
11.2.1.9 Study Design
11.2.1.10 Recruitment Status
11.2.1.11 Enrollment (Estimated)
11.2.1.12 Location Countries
11.2.1.13 Recent Results
11.2.2 Other Drugs
12 Congenital Hyperinsulinism (CHI) Drug Pipeline - Early-Stage Products (Phase I) (Top Drugs)
12.1 Comparative Analysis for Early-Stage Drugs
12.1.1 Study Type
12.1.2 Recruitment Status
12.1.3 Company
12.1.4 Funder Type
12.2 Product Level Analysis*
12.2.1 Drug: Fluorodopa F 18
12.2.1.1 Product Description
12.2.1.2 Trial ID
12.2.1.3 Sponsor Name
12.2.1.4 Study Type
12.2.1.5 Drug Class
12.2.1.6 Eligibility Criteria
12.2.1.7 Study Record Dates
12.2.1.7.1 First Submitted
12.2.1.7.2 First Posted
12.2.1.7.3 Last Update Posted
12.2.1.7.4 Last Verified
12.2.1.8 Indication
12.2.1.9 Study Design
12.2.1.10 Recruitment Status
12.2.1.11 Enrollment (Estimated)
12.2.1.12 Location Countries
12.2.2 Other Drugs
13 Congenital Hyperinsulinism (CHI) Drug Pipeline - Preclinical and Discovery Stage Products (Top Drugs)
13.1 Comparative Analysis for Preclinical and Discovery Stage Drugs
13.1.1 Study Type
13.1.2 Recruitment Status
13.1.3 Company
13.1.4 Funder Type
13.2 Product Level Analysis*
13.2.1 Drug 1
13.2.1.1 Product Description
13.2.1.2 Trial ID
13.2.1.3 Sponsor Name
13.2.1.4 Study Type
13.2.1.5 Drug Class
13.2.1.6 Eligibility Criteria
13.2.1.7 Study Record Dates
13.2.1.7.1 First Submitted
13.2.1.7.2 First Posted
13.2.1.7.3 Last Update Posted
13.2.1.7.4 Last Verified
13.2.1.8 Indication
13.2.1.9 Study Design
13.2.1.10 Recruitment Status
13.2.1.11 Enrollment (Estimated)
13.2.1.12 Location Countries
13.2.2 Other Drugs
14 Congenital Hyperinsulinism (CHI), Key Drug Pipeline Companies
14.1 Hanmi Pharmaceutical Company Limited
14.1.1 Company Snapshot
14.1.2 Pipeline Product Portfolio
14.1.3 Financial Analysis
14.1.4 Recent News and Developments
14.2 Zealand Pharma
14.2.1 Company Snapshot
14.2.2 Pipeline Product Portfolio
14.2.3 Financial Analysis
14.2.4 Recent News and Developments
14.3 Rezolute, Inc.
14.3.1 Company Snapshot
14.3.2 Pipeline Product Portfolio
14.3.3 Financial Analysis
14.3.4 Recent News and Developments
14.4 Greenstone Biosciences, Inc.
14.4.1 Company Snapshot
14.4.2 Pipeline Product Portfolio
14.4.3 Financial Analysis
14.4.4 Recent News and Developments
14.5 Eli Lilly and Company
14.5.1 Company Snapshot
14.5.2 Pipeline Product Portfolio
14.5.3 Financial Analysis
14.5.4 Recent News and Developments
15 Regulatory Framework for Drug Approval, By Region16 Terminated or Suspended Pipeline Products

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