Congenital Hyperinsulinism Pipeline Insight

DelveInsight’s, “Congenital Hyperinsulinism - Pipeline Insight, 2022,” report provides comprehensive insights about 4+ companies and 4+ pipeline drugs in Congenital Hyperinsulinism 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

Congenital Hyperinsulinism Understanding

Congenital Hyperinsulinism: Overview

Congenital hyperinsulinism is a rare, genetic, pediatric endocrine disorder that leads to the inappropriate secretion of the hormone insulin by the pancreas. High levels of insulin in the blood result in episodes of low blood sugar or hypoglycemia with associated suppression of ketone bodies, the only other potential source of fuel to the glucose-dependent brain. Repeat episodes and/or dangerously low blood sugars increase the risk of neurological and developmental complications, including persistent feeding problems, learning disabilities, recurrent seizures, and/or brain damage, or even death. Existing medical options were not developed for CHI and are often either ineffective since certain groups of patients do not respond to these therapies, or are associated with substantial side effects that discourage compliance and lead to suboptimal treatment outcomes. Surgical removal of the pancreas is also an option, but this approach is invasive, may require repeat surgery, and ultimately leads to the development of lifelong insulin-dependent diabetes. CHI is a rare pediatric disease that affects mainly newborns, infants and toddlers. Due to a genetic defect in the insulin producing cells, these children have increased insulin levels, resulting in persistent and recurrent hypoglycemia throughout childhood. Current treatment options are limited, complex and may be insufficient to adequately control hypoglycemia.


"Congenital Hyperinsulinism- Pipeline Insight, 2022" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Congenital Hyperinsulinism pipeline landscape is provided which includes the disease overview and Congenital Hyperinsulinism treatment guidelines. The assessment part of the report embraces, in depth Congenital Hyperinsulinism 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, Congenital Hyperinsulinism 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 Congenital Hyperinsulinism R&D. The therapies under development are focused on novel approaches to treat/improve Congenital Hyperinsulinism. 

Congenital Hyperinsulinism Emerging Drugs Chapters

This segment of the Congenital Hyperinsulinism 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.


Congenital Hyperinsulinism Emerging Drugs


Dasiglucagon - Zealand Pharma

Zealand Pharma is developing dasiglucagon as a potential treatment option for CHI. Invented by Zealand Pharma, dasiglucagon is a glucagon analog that is stable in aqueous solution and is thus suitable for chronic pump use. In 2017, both the U.S. Food and Drug Administration (FDA) and the European Commission granted orphan drug designation for dasiglucagon for the treatment of CHI.


HM 15136: Hanmi Pharmaceutical

HM15136 is a long-acting glucagon analog.HM15136 is being invented by Hanmi Pharmaceutical for the treatment of rare disease. The drug is currently in phase 2 stage of development for the treatment of Congenital Hyperinsulinism.


RZ 358 : XOMA

RZ358 is an intravenously administered human monoclonal antibody that binds with high potency and selectivity to an allosteric site on the insulin receptor. RZ358 counteracts the effects of elevated insulin at its target tissues by diminishing the binding and downstream signaling of insulin at its receptor. This unique mechanism of action gives properties of reversibility and graded activity, which are dependent on the extent of insulin elevation. Therefore, RZ358 is ideally suited as a potential therapy for hyperinsulinism, and it is being developed to treat the hypoglycemia associated with diseases such as CHI.RZ358 received Orphan Drug Designation in the United States and European Union. Rezolute is currently evaluating RZ358 in the RIZE trial, a Phase 2b clinical trial in patients with CHI.


Avexitide: Eiger BioPharmaceuticals

Avexitide binds to the GLP-1r on pancreatic beta cells and behaves as a GLP-1 antagonist and inverse agonist, reducing fasting and amino acid-induced cAMP accumulation and thereby decreasing calcium-stimulated insulin secretion. Avexitide has been granted Orphan Drug designation in the European Union by the EMA for the treatment of Congenital Hyperinsulinism and Orphan Drug designation in the US by FDA for the treatment of Hyperinsulinemic Hypoglycemia (which includes Congenital Hyperinsulinism). Avexitide has also been granted Rare Pediatric Disease designation by FDA. Avexitide has never been approved or commercialized for any indication. The most commonly reported adverse events to date were hypoglycemia and mild to moderate emesis, which did not lead to study discontinuation.

Further product details are provided in the report……..

Congenital Hyperinsulinism: Therapeutic Assessment

This segment of the report provides insights about the different Congenital Hyperinsulinism drugs segregated based on following parameters that define the scope of the report, such as:


Major Players in Congenital Hyperinsulinism

There are approx. 4+ key companies which are developing the therapies for Congenital Hyperinsulinism. The companies which have their Congenital Hyperinsulinism drug candidates in the most advanced stage, i.e. Phase III include, Zealand Pharma.



DelveInsight’s report covers around 4+ 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

Congenital Hyperinsulinism pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

  • Intra-articular
  • Intraocular
  • Intrathecal 
  • Intravenous
  • Ophthalmic
  • Oral
  • Parenteral
  • Subcutaneous
  • Topical
  • Transdermal


Molecule Type

Products have been categorized under various Molecule types such as

  • Oligonucleotide
  • Peptide
  • Small molecule


Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Congenital Hyperinsulinism: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase III, II, I, preclinical and discovery stage. It also analyses Congenital Hyperinsulinism 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 Congenital Hyperinsulinism drugs.

Congenital Hyperinsulinism Report Insights

  • Congenital Hyperinsulinism Pipeline Analysis
  • Therapeutic Assessment
  • Unmet Needs
  • Impact of Drugs

Congenital Hyperinsulinism 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 Congenital Hyperinsulinism drugs?
  • How many Congenital Hyperinsulinism drugs are developed by each company?
  • How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Congenital Hyperinsulinism?
  • What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Congenital Hyperinsulinism 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 Congenital Hyperinsulinism and their status?
  • What are the key designations that have been granted to the emerging drugs?


Executive Summary

Congenital Hyperinsulinism: Overview

  • Causes
  • Mechanism of Action 
  • Signs and Symptoms
  • Diagnosis
  • Disease Management

Pipeline Therapeutics

  • Comparative Analysis

Therapeutic Assessment

  • Assessment by Product Type
  • Assessment by Stage and Product Type
  • Assessment by Route of Administration
  • Assessment by Stage and Route of Administration
  • Assessment by Molecule Type
  • Assessment by Stage and Molecule Type 

Congenital Hyperinsulinism– DelveInsight’s Analytical Perspective

Late Stage Products (Phase III)

  • Comparative Analysis

Dasiglucagon - Zealand Pharma

  • Product Description
  • Research and Development 
  • Product Development Activities 

Drug profiles in the detailed report…..

Mid Stage Products (Phase II)

  • Comparative Analysis

HM 15136: Hanmi Pharmaceutical

  • Product Description
  • Research and Development 
  • Product Development Activities 

Drug profiles in the detailed report…..

Initial Stage Products (Phase I) 

  • Comparative Analysis

Drug name: Company name

  • Product Description
  • Research and Development 
  • Product Development Activities 

Drug profiles in the detailed report…..

Preclinical and Discovery Stage Products 

  • Comparative Analysis

Drug name: Company Name

  • Product Description
  • Research and Development 
  • Product Development Activities 

Drug profiles in the detailed report…..

Inactive Products

  • Comparative Analysis

Congenital Hyperinsulinism Key Companies

Congenital Hyperinsulinism Key Products

Congenital Hyperinsulinism- Unmet Needs

Congenital Hyperinsulinism- Market Drivers and Barriers

Congenital Hyperinsulinism- Future Perspectives and Conclusion

Congenital Hyperinsulinism Analyst Views

Congenital Hyperinsulinism Key Companies


List of Table

Table 1: Total Products for Congenital Hyperinsulinism

Table 2: Late Stage Products

Table 3: Mid Stage Products

Table 4: Early Stage Products

Table 5: Pre-clinical & Discovery Stage Products

Table 6: Assessment by Product Type

Table 7: Assessment by Stage and Product Type

Table 8: Assessment by Route of Administration

Table 9: Assessment by Stage and Route of Administration

Table 10: Assessment by Molecule Type

Table 11: Assessment by Stage and Molecule Type

Table 12: Inactive Products

List of Figures

Figure 1: Total Products for Congenital Hyperinsulinism

Figure 2: Late Stage Products                              

Figure 3: Mid Stage Products

Figure 4: Early Stage Products

Figure 5: Preclinical and Discovery Stage Products

Figure 6: Assessment by Product Type

Figure 7: Assessment by Stage and Product Type

Figure 8: Assessment by Route of Administration

Figure 9: Assessment by Stage and Route of Administration

Figure 10: Assessment by Molecule Type

Figure 11: Assessment by Stage and Molecule Type

Figure 12: Inactive Products    

• Novartis
• Zealand Pharma
• Rezolute
• Xeris Pharmaceuticals
• Eiger BioPharmaceuticals
• Recordati



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