Somatotropin Deficiency - Pipeline Insight, 2025

DelveInsight's, "Somatotropin Deficiency - Pipeline Insight, 2025" report provides comprehensive insights about 4+ companies and 4+ 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 deficiency, also known as growth hormone deficiency (GHD), is a condition resulting from insufficient secretion of growth hormone (GH) by the pituitary gland, leading to a range of physical, metabolic, and psychosocial issues. Initially recognized in pediatric populations, its impact on adults was not well understood until the 1980s, when recombinant human growth hormone (rhGH) became available, allowing for studies on its effects in adults. Adult GHD is often caused by pituitary or hypothalamic disease, cranial irradiation, or other factors leading to hypopituitarism. Symptoms can include reduced exercise tolerance, mood disturbances, increased body fat, and impaired bone and lipid metabolism. Clinical trials and subsequent studies have shown that GH replacement therapy can improve these symptoms, but challenges remain in diagnosing and treating less severe forms of GHD, especially in populations like those with traumatic brain injury, where testing and efficacy have not been fully explored.

The true prevalence and incidence of adult-onset growth hormone (GH) deficiency are challenging to determine with certainty. However, estimates suggest a prevalence of 2-3 cases per 10,000 people, based on data from pituitary macroadenomas and childhood-onset GH deficiency that persists into adulthood. A Danish nationwide study provided more specific incidence rates, showing 2.58 cases per 100,000 for childhood-onset males, 1.70 for childhood-onset females, 1.90 for adult-onset males, and 1.42 for adult-onset females. The study also found that the incidence rate was higher in males than females for both childhood and adult-onset GH deficiency, particularly in the older age groups (45-64 and 65+ years), while no significant gender difference was noted in the 18-44 age group.

Adult growth hormone (GH) deficiency presents with a wide range of clinical features, including significant changes in body composition, such as increased fat mass, particularly visceral fat, and reduced lean body mass. This contributes to decreased muscle strength, exercise tolerance, and a higher prevalence of obesity, even in non-obese individuals. Additionally, GH deficiency is associated with insulin resistance, impaired glucose tolerance, and an increased risk of diabetes, primarily due to increased central fat mass. Cardiovascular risks are heightened, with elevated cholesterol levels, hypertension, and a greater propensity for atherosclerosis. Bone mineral density is reduced, leading to an increased fracture risk, particularly in those with childhood-onset GH deficiency who did not reach peak bone mass. Psychological effects, including decreased quality of life and psychological well-being, are also significant, with GH replacement therapy often improving these symptoms. These features collectively highlight the clinical impact of GH deficiency on various body systems and underscore the importance of timely diagnosis and treatment.

The selection of patients for growth hormone (GH) replacement therapy in adults is based on established guidelines but remains influenced by factors such as clinical presentation, test results, and regional practices. Typically, patients are diagnosed with GH deficiency through tests like the insulin tolerance test (ITT) or other stimulation tests, including the glucagon or arginine-GHRH tests. Once diagnosed, treatment usually begins with a low initial dose of GH, with adjustments made based on serum IGF-I levels and clinical response. The dose is titrated carefully to avoid overtreatment. Common side effects of GH replacement include arthralgia, edema, carpal tunnel syndrome, and myalgia, typically related to sodium and water retention, though these can often be managed by adjusting the GH dose. Concerns regarding the potential mitogenic effects of IGF-I and the risk of neoplasia or tumor recurrence have been largely dispelled by extensive surveillance studies, which show no increased risk of malignancy. Long-term mortality studies have also been reassuring, indicating that GH replacement does not significantly increase mortality, though the outcomes can vary depending on the underlying cause of GH deficiency and any concurrent conditions.

"Somatotropin Deficiency- Pipeline Insight, 2025" report by DelveInsight 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 III, 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: TJ Biopharma Co., Ltd.

GX-H9 is one of the long-acting hGH products, which uses hyFc fusion protein technology to increase the half-life in the body, and it is administered once a week or twice-monthly. It is a biobetter product that significantly increases the convenience of administration for patients compared to the conventional short-acting hGH administered daily. It is a long-acting growth hormone preparation that combines a platform that has non-cytolytic properties because it uses a sequence that does not have the ability to induce cytotoxicity among the sites of IgG4 and IgD that exist in vivo and a human growth hormone secreted from the anterior pituitary. GX-H9 has a unique potential to be a convenient long-term GH providing not only weekly but also twice-monthly treatment option, with comparable safety and efficacy profile to daily products. Currently, the drug is in Phase III stage of its development for the treatment of Somatotropin Deficiency.

• LUM-201: Lumos Pharma

LUM-201, also known as ibutamoren, is an investigational, once-daily, orally administered small molecule that promotes the secretion of Growth Hormone (GH) from the pituitary gland. LUM-201 has been observed to increase the amplitude of endogenous pulsatile GH secretion, which mimics the natural pattern of GH secretion via potent agonism of the growth hormone secretagogue receptor. LUM-201 is a once-daily tablet that will provide an alternative to daily or weekly injections of growth hormone. LUM-201 has also received Orphan Drug Designation in both the US and EU. Currently, the drug is in Phase II stage of its clinical trial for the treatment of Somatotropin 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. 4+ 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 II include, TJ Biopharma Co., Ltd.
• Phases

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

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

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical
• Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy
• 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 III, 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

• TJ Biopharma Co., Ltd.
• Lumos Pharma
• Hanmi Pharm.Co.,Ltd.
• Kexing Biopharm

Key Products

• TJ101
• LUM-201
• Efpegsomatropin
• GB 08