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Somatotropin deficiency - Pipeline Insight, 2024

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    Drug Pipelines

  • 80 Pages
  • April 2024
  • Region: Global
  • DelveInsight
  • ID: 5448079
This “Somatotropin deficiency - Pipeline Insight, 2024” report provides comprehensive insights about 10+ companies and 10+ pipeline drugs in Somatotropin deficiency 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

Somatotropin deficiency: Understanding

Somatotropin deficiency: Overview

Somatotropin or growth hormone is a protein hormone of about 190 amino acids that is synthesized and secreted by cells called somatotrophs in the anterior pituitary. It is a major participant in control of several complex physiologic processes, including growth and metabolism. Growth hormone is also of considerable interest as a drug used in both humans and animals.

Inadequate secretion of somatotropin hormone can lead to growth hormone deficiency or Somatotropin Deficiency in humans. The disease can either be present from birth (congenital) due to genetic mutations or from structural defects in brain or else can be acquired in later stage of life owing to tumors in pituitary, radiations, central nervous system infections, or severe head injuries. Somatotropin Deficiency affects male and female population equally except for GHD III which only affects male population.

Symptoms
Symptoms can include slow growth or absent of growth, delay in development of facial bones, delayed lengthening of long bones, slow teeth eruption, decreased energy levels, increase in abdominal and visceral fat mass, and anxiety.

Diagnosis
Various agents may be used including insulin, arginine, clonidine and l-dopa. These tests are meant to stimulate the pituitary to secrete GH allowing for the testing of blood samples for the levels of GH at timed intervals. Physicians often test for other hormone deficiencies that may be the underlying cause of short stature. FreeT4, TSH, cortisol, celiac antibodies, etc. are measured to rule out underlying organic causes of short stature. IGF-1, a protein produced primarily by the liver but present in all tissues in response to GH stimulation, can be measured to screen for GHD and later to titrate GH therapy.

Treatment
Treatments for Somatotropin Deficiency currently include dosage of recombinant human growth hormone to optimize the growth potential. Initially, the dosage is gradually increased to its highest dose during puberty and is discontinued at completion of skeletal maturation. Later the patient may require retesting for further recombinant therapy. The FDA has approved the use of somatropin (Nutropin [Genentech)] Humatrope [Lilly], Genotropin [Pfizer], Saizen [EMD Serono], Norditropin [Novo Nordisk], Tev-Tropin [Teva], and Omnitrope [Sandoz] for the treatment of growth hormone deficiency.

Somatotropin deficiency- Pipeline Insight, 2024 report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Somatotropin deficiency pipeline landscape is provided which includes the disease overview and Somatotropin deficiency treatment guidelines. The assessment part of the report embraces, in depth Somatotropin deficiency 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, Somatotropin deficiency 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 Somatotropin deficiency R&D. The therapies under development are focused on novel approaches to treat/improve Somatotropin deficiency.

Somatotropin deficiency Emerging Drugs Chapters

This segment of the Somatotropin deficiency 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.

Somatotropin deficiency Emerging Drugs

TJ101: I-MAB Biopharma Co., Ltd.

Eftansomatropin alfa (TJ101) is a potential highly differentiated long-acting recombinant human growth hormone being developed as a more convenient and effective therapy for growth hormone deficiency (GHD). Like endogenous growth hormone, eftansomatropin alfa stimulates the production of insulin-like growth factor 1 (IGF-1) in the liver, which has growth-stimulating effects on a variety of tissues, including osteoblast and chondrocyte activities that stimulate bone growth. IGF-1 is a reliable pharmacodynamic marker and the key mediator of growth-promoting activity of eftansomatropin alfa.

Eftansomatropin alfa is based on Genexine’s patented hyFc® technology. The hyFc part consists of a portion of human immunoglobulin D (“IgD”) and G4 (“IgG4”). The former contains a flexible hinge, and the latter is responsible for half-life extension through neonatal Fc receptor (“FcRn”)-mediated recycling. The drug is currently investigated in Phase III trials for Pediatric Growth Hormone Deficiency.

Somatotropin deficiency: Therapeutic Assessment

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

Major Players in Somatotropin deficiency

There are approx. 10+ key companies which are developing the therapies for Somatotropin deficiency. The companies which have their Somatotropin deficiency drug candidates in the most advanced stage, i.e. phase III include, I-MAB Biopharma.

Phases

This report covers around 10+ 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

Somatotropin deficiency 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.

Somatotropin deficiency: Pipeline Development Activities

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

Somatotropin deficiency Report Insights

  • Somatotropin deficiency Pipeline Analysis
  • Therapeutic Assessment
  • Unmet Needs
  • Impact of Drugs

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

Key Players

  • I-MAB Biopharma Co., Ltd.
  • Lumos Pharma
  • Xiamen Amoytop Biotech Co., Ltd.

Key Products

  • LUM-201
  • TJ101
  • Y-shape pegylated somatropin


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Table of Contents

IntroductionExecutive Summary
Somatotropin deficiency: 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
Somatotropin deficiency- Analytical Perspective
Late Stage Products (Phase III)
  • Comparative Analysis
TJ101: I-MAB Biopharma Co., Ltd.
  • Product Description
  • Research and Development
  • Product Development Activities
Drug profiles in the detailed report…..
Mid Stage Products (Phase II)
  • Comparative Analysis
Drug Name: Company Name
  • Product Description
  • Research and Development
  • Product Development Activities
Drug profiles in the detailed report…..
Early 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
Somatotropin deficiency Key CompaniesSomatotropin deficiency Key ProductsSomatotropin deficiency- Unmet NeedsSomatotropin deficiency- Market Drivers and BarriersSomatotropin deficiency- Future Perspectives and ConclusionSomatotropin deficiency Analyst ViewsSomatotropin deficiency Key CompaniesAppendix
List of Tables
Table 1 Total Products for Somatotropin deficiency
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 Somatotropin deficiency
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

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • I-MAB Biopharma Co., Ltd.
  • Lumos Pharma
  • Xiamen Amoytop Biotech Co., Ltd.