CLINICAL TRIALS PROFILE FOR OMNITROPE

All Clinical Trials for OMNITROPE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00209235 ↗	Albright Hereditary Osteodystrophy: Growth Hormone Trial and Cognitive/Behavioral Assessments	Recruiting	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2/Phase 3	2003-01-01	We, the researchers, have found that growth hormone deficiency is very common in patients with pseudohypoparathyroidism type 1a, which falls under the broader condition termed Albright hereditary osteodystrophy. Patients with pseudohypoparathyroidism type 1a typically are short and obese. Some of these patients are not short during childhood, but due to a combination of factors, they end up short as adults. We are evaluating the effect of growth hormone treatment in those patients with pseudohypoparathyroidism type 1a who are found to be growth hormone deficient. We hypothesize that growth hormone deficiency may contribute to the short stature and obesity found in this condition. We are also evaluating the effect of growth hormone on patients with pseudohypoparathyroidism type 1a who are not growth hormone deficient (i.e., growth hormone sufficient) in those who had been on study drug through R01 FD003409 or who meet the criteria of idiopathic short stature or SGA. We are also evaluating neurocognitive and psychosocial functioning in participants with AHO in order to determine the specific impairments that are most common in the condition and to determine the best approach toward management. Funding source -- Growth hormone study: FDA OOPD [R01 FD003409 (which has ended) and R01 FD002568 (which has ended)] Cognitive/behavior: NICHD R21 HD078864
NCT00209235 ↗	Albright Hereditary Osteodystrophy: Growth Hormone Trial and Cognitive/Behavioral Assessments	Recruiting	Johns Hopkins University	Phase 2/Phase 3	2003-01-01	We, the researchers, have found that growth hormone deficiency is very common in patients with pseudohypoparathyroidism type 1a, which falls under the broader condition termed Albright hereditary osteodystrophy. Patients with pseudohypoparathyroidism type 1a typically are short and obese. Some of these patients are not short during childhood, but due to a combination of factors, they end up short as adults. We are evaluating the effect of growth hormone treatment in those patients with pseudohypoparathyroidism type 1a who are found to be growth hormone deficient. We hypothesize that growth hormone deficiency may contribute to the short stature and obesity found in this condition. We are also evaluating the effect of growth hormone on patients with pseudohypoparathyroidism type 1a who are not growth hormone deficient (i.e., growth hormone sufficient) in those who had been on study drug through R01 FD003409 or who meet the criteria of idiopathic short stature or SGA. We are also evaluating neurocognitive and psychosocial functioning in participants with AHO in order to determine the specific impairments that are most common in the condition and to determine the best approach toward management. Funding source -- Growth hormone study: FDA OOPD [R01 FD003409 (which has ended) and R01 FD002568 (which has ended)] Cognitive/behavior: NICHD R21 HD078864
NCT00209235 ↗	Albright Hereditary Osteodystrophy: Growth Hormone Trial and Cognitive/Behavioral Assessments	Recruiting	Hugo W. Moser Research Institute at Kennedy Krieger, Inc.	Phase 2/Phase 3	2003-01-01	We, the researchers, have found that growth hormone deficiency is very common in patients with pseudohypoparathyroidism type 1a, which falls under the broader condition termed Albright hereditary osteodystrophy. Patients with pseudohypoparathyroidism type 1a typically are short and obese. Some of these patients are not short during childhood, but due to a combination of factors, they end up short as adults. We are evaluating the effect of growth hormone treatment in those patients with pseudohypoparathyroidism type 1a who are found to be growth hormone deficient. We hypothesize that growth hormone deficiency may contribute to the short stature and obesity found in this condition. We are also evaluating the effect of growth hormone on patients with pseudohypoparathyroidism type 1a who are not growth hormone deficient (i.e., growth hormone sufficient) in those who had been on study drug through R01 FD003409 or who meet the criteria of idiopathic short stature or SGA. We are also evaluating neurocognitive and psychosocial functioning in participants with AHO in order to determine the specific impairments that are most common in the condition and to determine the best approach toward management. Funding source -- Growth hormone study: FDA OOPD [R01 FD003409 (which has ended) and R01 FD002568 (which has ended)] Cognitive/behavior: NICHD R21 HD078864
NCT00537914 ↗	Safety and Efficacy of Omnitrope® (rhGH) in Short Children Born Small for Gestational Age (SGA)	Active, not recruiting	Sandoz	Phase 4	2008-02-06	This study is performed to investigate the long-term safety, in particular the diabetogenic potential and immunogenicity of rhGH therapy in short children born small for gestational age (SGA).

Clinical Trial Conditions for OMNITROPE

Condition Name

Condition Name for OMNITROPE
Intervention	Trials
Non-Alcoholic Fatty Liver Disease	1
Overweight and Obesity	1
Prediabetic State	1
Pseudohypoparathyroidism Type 1a	1

Condition MeSH

Condition MeSH for OMNITROPE
Intervention	Trials
Endocrine System Diseases	1
Non-alcoholic Fatty Liver Disease	1
Dwarfism, Pituitary	1
Liver Diseases	1

Clinical Trial Locations for OMNITROPE

Trials by Country

Trials by Country for OMNITROPE
Location	Trials
Poland	7
United States	3
Germany	3
Czechia	2
Hungary	2

Trials by US State

Trials by US State for OMNITROPE
Location	Trials
New York	2
Maryland	1

Clinical Trial Progress for OMNITROPE

Clinical Trial Phase

Clinical Trial Phase for OMNITROPE
Clinical Trial Phase	Trials
Phase 4	1
Phase 2/Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for OMNITROPE
Clinical Trial Phase	Trials
Enrolling by invitation	1
Not yet recruiting	1
Active, not recruiting	1

Clinical Trial Sponsors for OMNITROPE

Sponsor Name

Sponsor Name for OMNITROPE
Sponsor	Trials
Center for Human Reproduction	1
Albert Einstein College of Medicine	1
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	1

Sponsor Type

Sponsor Type for OMNITROPE
Sponsor	Trials
Other	5
Industry	2
NIH	2

OMNITROPE Market Analysis and Financial Projection

Omnitrope: Clinical Trials, Market Analysis, and Projections

Introduction to Omnitrope

Omnitrope, a recombinant human growth hormone (somatropin), is used to treat various growth-related disorders in both children and adults. It is indicated for conditions such as growth hormone deficiency (GHD), Prader-Willi Syndrome, Small for Gestational Age, Turner Syndrome, and idiopathic short stature[1][3][4].

Clinical Trials and Efficacy

Pediatric Patients

Clinical trials involving Omnitrope have been conducted in pediatric patients with GHD and other growth disorders. These trials have shown that Omnitrope is effective in improving growth rates in children.

• In studies involving children with GHD, Omnitrope was administered subcutaneously at doses ranging from 0.16 to 0.24 mg/kg/week, divided into 6-7 daily injections. The results indicated significant improvements in growth velocity and height standard deviation scores (SDS)[1][3].
• For children with Prader-Willi Syndrome, the recommended dosage is 0.24 mg/kg/week, also divided into 6-7 daily injections. Clinical trials with another somatropin product have shown similar efficacy in this patient group[1][3].
• Children born small for gestational age (SGA) who fail to manifest catch-up growth by age 2 years can be treated with up to 0.48 mg/kg/week, divided into 6-7 daily injections[1][3].

Adverse Reactions

Clinical trials have identified several adverse reactions associated with Omnitrope treatment in pediatric patients. Common adverse events include:

• Elevated HbA1c
• Eosinophilia
• Hematoma
• Hypothyroidism
• Headache
• Hypertriglyceridemia
• Leg pain[1].

Adult Patients

For adults with GHD, Omnitrope is used to replace endogenous growth hormone. The recommended dosage is not more than 0.04 mg/kg/week, divided into daily injections, which can be increased gradually every 1-2 months to a maximum of 0.08 mg/kg/week[1][3].

Market Analysis

Current Market Size and Growth

The global Omnitrope market was valued at USD 1,256.1 million in 2023 and is projected to reach USD 2,308.2 million by 2032, growing at a Compound Annual Growth Rate (CAGR) of 7.1% from 2024 to 2032[5].

Regional Market Dynamics

• North America: This region holds the largest market share due to its well-established healthcare infrastructure, high awareness of growth hormone deficiencies, and strong demand for advanced medical treatments. The United States is a significant contributor to this market due to its large population, high healthcare spending, and broad availability of recombinant human growth hormone (rhGH) therapy[5].
• Asia-Pacific: This region is the fastest-growing market for Omnitrope, driven by rapid economic growth, increasing healthcare spending, and an expanding middle class in countries like China, India, and Japan. Increased awareness of hormone deficiencies and the adoption of sophisticated medical treatments are key drivers in this region[5].

Market Drivers and Restraints

• Market Drivers: Increasing diagnoses of growth hormone deficiencies, favorable payment regulations, and a strong desire for breakthrough medical treatments are driving the market growth.
• Market Restraints: High costs associated with growth hormone therapy, potential side effects, and regulatory hurdles can restrain market growth[5].

Key Market Players

The global Omnitrope market is dominated by several key players, including:

• Sandoz
• Novartis
• Roche
• Merck & Co., Inc.
• Pfizer Inc.
• Ipsen Pharma
• Sanofi S.A.
• Genentech, Inc.
• Ocean Breeze Healthcare
• BioPartners GmbH[5].

Market Projections

Forecast Period

The market forecast for Omnitrope spans from 2024 to 2032, with the base year being 2023. This period is expected to see significant growth driven by increasing demand for growth hormone therapy and expanding healthcare access in emerging markets[5].

Segment Analysis

The market is segmented by type, end user, and geography. The segmentation helps in understanding the specific needs and trends in different regions and patient groups, which is crucial for strategic planning and market penetration[5].

Regulatory Approval and Safety

Omnitrope has received regulatory approval from various agencies, including the FDA and the European Medicines Agency (EMA). The EMA has confirmed that Omnitrope has a comparable quality, safety, and effectiveness to other approved somatropin products like Genotropin[4].

Safety Precautions

Omnitrope must not be used in patients with active tumors or acute life-threatening illnesses. It is also contraindicated for promoting growth in children with closed epiphyses. Healthcare professionals and patients must follow the recommended precautions and dosages to ensure safe and effective use[4].

Key Takeaways

• Clinical Efficacy: Omnitrope has been shown to be effective in improving growth rates in children and adults with various growth-related disorders.
• Market Growth: The global Omnitrope market is projected to grow significantly, driven by increasing demand and expanding healthcare access.
• Regional Dynamics: North America is the largest market, while the Asia-Pacific region is the fastest-growing.
• Regulatory Approval: Omnitrope has received approval from major regulatory agencies, ensuring its safety and efficacy.
• Safety Precautions: Strict adherence to dosages and contraindications is necessary to avoid adverse reactions.

FAQs

Q: What are the indications for Omnitrope?

A: Omnitrope is indicated for the treatment of growth hormone deficiency (GHD) in children and adults, Prader-Willi Syndrome, Small for Gestational Age, Turner Syndrome, and idiopathic short stature[1][3][4].

Q: What are the common adverse reactions associated with Omnitrope in pediatric patients?

A: Common adverse reactions include elevated HbA1c, eosinophilia, hematoma, hypothyroidism, headache, hypertriglyceridemia, and leg pain[1].

Q: What is the projected market size of Omnitrope by 2032?

A: The global Omnitrope market is projected to reach USD 2,308.2 million by 2032, growing at a CAGR of 7.1% from 2024 to 2032[5].

Q: Which region is the fastest-growing market for Omnitrope?

A: The Asia-Pacific region is the fastest-growing market for Omnitrope, driven by rapid economic growth and increasing healthcare spending[5].

Q: Who are the key players in the Omnitrope market?

A: Key players include Sandoz, Novartis, Roche, Merck & Co., Inc., Pfizer Inc., Ipsen Pharma, Sanofi S.A., Genentech, Inc., Ocean Breeze Healthcare, and BioPartners GmbH[5].

Sources

1. FDA Labeling for OMNITROPE: Accessdata.fda.gov
2. Omnitrope Market Report 2024: Cognitivemarketresearch.com
3. Approval Package for OMNITROPE: Accessdata.fda.gov
4. Omnitrope | European Medicines Agency (EMA): Ema.europa.eu
5. Omnitrope Market Size - Global Industry, Share, Analysis, Trends: Acumenresearchandconsulting.com