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Last Updated: February 14, 2025

CLINICAL TRIALS PROFILE FOR NUTROPIN


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All Clinical Trials for Nutropin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00079742 ↗ A Study to Evaluate Nutropin AQ for the Treatment of Growth Restriction in Children With Cystic Fibrosis Completed Genentech, Inc. Phase 2 2003-09-01 This is a Phase II, multicenter, randomized, controlled, open-label trial of the safety and efficacy of Nutropin AQ administered subcutaneously (SC) daily in prepubertal children with CF and growth restriction.
NCT00102258 ↗ Role of Nutrition and Hormones in Boys With Disordered Growth Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 2 2005-01-19 This study will determine whether adding more calories to the diet helps boys with growth problems grow better while being treated with Nutropin, a growth hormone that is used to help children grow taller. The Food and Drug Administration has approved Nutropin for use in children who are very short. This study will examine whether giving nutritional supplements in addition to Nutropin can help children grow better than with Nutropin alone. Boys between 7 and 10 years of age who are very short and below average in weight, but are otherwise healthy may be eligible for this study. Candidates must qualify for Nutropin treatments to boost their growth. Boys will be recruited for the study from the Nemours Children's Clinic in Jacksonville, FL, and from the National Institutes of Health in Bethesda, MD. Participants are randomly assigned to one of two treatment groups. One group is observed for 6 months and then receives a Nutropin injection every day for 12 months. The second group drinks 8 ounces of a high-calorie beverage called Pediasure every day for 6 months and then receives Nutropin plus Pediasure every day for 12 months. In addition to treatment, participants undergo the following tests and procedures at the schedule indicated: Baseline, 3, 6, 9, 12, 15 and 18 months - Clinical examination - Height measurement - Body composition assessment: Skin-fold thickness calipers are used in four places on the body to estimate body fat - Bioelectric impedance: A small amount of electrical current is used to calculate the percentage of body fat. Baseline, 6, 12, and 18 months - Blood tests - Bone age x-ray: x-ray of the left hand to measure growth potential - DEXA (dual energy x-ray absorptiometry) scan: x-ray scan to measure body fat, muscle, and bone mineral content. The subject lies on a flat table during the scan. Baseline, 6, and 12 months - Record of dietary intake: Parents are asked to write down everything the child eats and drinks for 3 days. Using this record, a dietitian calculates the daily caloric intake. - Total energy expenditure: This test determines how much energy the child uses. For the test, the child drinks water labeled with harmless isotopes (heavy oxygen and heavy hydrogen). For the next 10 days he collects urine in plastic tubes at home. At the end of the 10 days, the parents bring the urine to the clinic for analysis to determine how fast the labeled water leaves the body. This information is used to calculate how much energy the child expends each day. Participants' weight is measured at 2 and 4 weeks, and then monthly for the remainder of the 18-month study.
NCT00134420 ↗ Growth Hormone and Chromosome 18q- and Abnormal Growth Completed Genentech, Inc. Phase 3 2001-02-01 We, the investigators at the University of Texas Health Science Center at San Antonio, want to learn if height and IQ (intelligence quotient) scores are improved by growth hormone (GH) treatment in children with chromosome 18 deletions and abnormal growth. Data from a previous study showed that growth hormone improved height in all children with 18q- and growth hormone deficiency. In addition, most of the study participants on growth hormone treatment showed an increase in IQ scores.
NCT00134420 ↗ Growth Hormone and Chromosome 18q- and Abnormal Growth Completed South Texas Veterans Health Care System Phase 3 2001-02-01 We, the investigators at the University of Texas Health Science Center at San Antonio, want to learn if height and IQ (intelligence quotient) scores are improved by growth hormone (GH) treatment in children with chromosome 18 deletions and abnormal growth. Data from a previous study showed that growth hormone improved height in all children with 18q- and growth hormone deficiency. In addition, most of the study participants on growth hormone treatment showed an increase in IQ scores.
NCT00134420 ↗ Growth Hormone and Chromosome 18q- and Abnormal Growth Completed The University of Texas Health Science Center at San Antonio Phase 3 2001-02-01 We, the investigators at the University of Texas Health Science Center at San Antonio, want to learn if height and IQ (intelligence quotient) scores are improved by growth hormone (GH) treatment in children with chromosome 18 deletions and abnormal growth. Data from a previous study showed that growth hormone improved height in all children with 18q- and growth hormone deficiency. In addition, most of the study participants on growth hormone treatment showed an increase in IQ scores.
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
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Nutropin

Condition Name

Condition Name for Nutropin
Intervention Trials
Growth Hormone Deficiency 4
Cystic Fibrosis 2
HIV Infection 1
Loss of Chromosome 18q 1
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Condition MeSH

Condition MeSH for Nutropin
Intervention Trials
Dwarfism, Pituitary 5
Endocrine System Diseases 2
Fibrosis 2
Cystic Fibrosis 2
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Clinical Trial Locations for Nutropin

Trials by Country

Trials by Country for Nutropin
Location Trials
United States 48
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Trials by US State

Trials by US State for Nutropin
Location Trials
New York 5
Texas 4
Florida 4
Minnesota 3
Georgia 2
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Clinical Trial Progress for Nutropin

Clinical Trial Phase

Clinical Trial Phase for Nutropin
Clinical Trial Phase Trials
Phase 4 1
Phase 3 1
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Nutropin
Clinical Trial Phase Trials
Completed 4
Withdrawn 4
Terminated 2
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Clinical Trial Sponsors for Nutropin

Sponsor Name

Sponsor Name for Nutropin
Sponsor Trials
Genentech, Inc. 5
University of Texas Southwestern Medical Center 2
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 2
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Sponsor Type

Sponsor Type for Nutropin
Sponsor Trials
Other 11
Industry 7
NIH 2
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Nutropin: Clinical Trials, Market Analysis, and Projections

Introduction to Nutropin

Nutropin, developed by Genentech, Inc., is a recombinant human growth hormone (somatropin) used to treat various pediatric and adult growth disorders. Here, we will delve into the clinical trials, market analysis, and future projections for Nutropin.

Clinical Trials and Safety Data

National Cooperative Growth Study (NCGS)

The National Cooperative Growth Study (NCGS) is a multicenter, open-label, observational, post-marketing surveillance study aimed at collecting long-term safety and efficacy data on Nutropin, along with other growth hormone products like Nutropin AQ, Nutropin Depot, and Protropin. Initiated in 1985, this study focuses on the treatment of pediatric growth disorders for which growth hormone is prescribed. The study has been completed, providing valuable insights into the long-term safety and efficacy of these products[1].

Market Analysis

Current Market Position

In the growth hormone deficiency market, Nutropin, although significant, is not the leading brand. As of 2023, Norditropin by Novo Nordisk holds the largest market share, followed by Genotropin. Nutropin, however, remains a crucial player due to its established presence and clinical backing[2].

Market Segmentation

The human growth hormone market is segmented by brand, with Nutropin being one of the key players. The market is dominated by brands like Norditropin, Genotropin, and others. The convenience and quality of Nutropin have contributed to its market share, although it is not the fastest-growing segment[5].

Recent Developments and Discontinuation

Discontinuation of Nutropin AQ NuSpin Formulations

Genentech has announced the discontinuation of all Nutropin AQ (somatropin) NuSpin formulations in the United States, effective December 31, 2024. This decision is based on business considerations and the availability of alternative growth hormone options. It is important to note that this discontinuation is not related to any safety, efficacy, or quality issues with the product[4].

Market Projections

Growth Hormone Deficiency Market

The growth hormone deficiency market is projected to reach USD 8.5 billion by 2032, with Norditropin expected to continue its leadership. While Nutropin is not forecasted to be the fastest-growing segment, the overall market growth is driven by improved early diagnosis and treatment, as well as technological advancements and convenient product formulations[2].

Technological Advancements

The introduction of new and innovative growth hormone products, such as long-acting growth hormones like somatrogon (NGENLA), is significantly driving the market growth. These advancements, including recombinant DNA technology, are expected to fuel the segment's growth, although Nutropin may not be at the forefront of these innovations[3][5].

Competitive Landscape

Key Competitors

The market is highly competitive, with key players including Novo Nordisk (Norditropin), Pfizer (Genotropin), and Eli Lilly (Humatrope). These companies are continuously innovating and expanding their distribution networks, which affects the market share of other brands like Nutropin[2].

Regional Market Dynamics

North America currently dominates the growth hormone deficiency market, but the Asia-Pacific region is forecasted to grow the fastest. This regional growth is driven by increasing investments from global pharmaceutical companies and improved access to healthcare services[2].

Patient Impact and Support

Transition Support

Given the discontinuation of Nutropin AQ NuSpin formulations, Genentech is committed to supporting patients and healthcare providers during the transition. Patients are encouraged to discuss alternative treatment options with their doctors, and support lines are available for any questions or concerns[4].

Key Takeaways

  • Clinical Trials: The NCGS has provided valuable long-term safety and efficacy data on Nutropin.
  • Market Position: Nutropin is a significant player but not the market leader.
  • Discontinuation: Nutropin AQ NuSpin formulations will be discontinued in the U.S. by December 31, 2024.
  • Market Projections: The growth hormone deficiency market is expected to reach USD 8.5 billion by 2032.
  • Technological Advancements: New innovations like long-acting growth hormones are driving market growth.
  • Competitive Landscape: The market is highly competitive with key players continuously innovating.

FAQs

What is the purpose of the National Cooperative Growth Study (NCGS)?

The NCGS is an observational study aimed at collecting long-term safety and efficacy data on growth hormone products, including Nutropin, in the treatment of pediatric growth disorders.

Why is Genentech discontinuing Nutropin AQ NuSpin formulations?

Genentech is discontinuing Nutropin AQ NuSpin formulations due to business considerations and the availability of alternative growth hormone options, not due to any safety, efficacy, or quality issues.

What is the projected growth of the growth hormone deficiency market?

The market is projected to reach USD 8.5 billion by 2032, driven by improved diagnosis, treatment, and technological advancements.

Which brand leads the growth hormone deficiency market?

Norditropin by Novo Nordisk currently leads the market and is expected to continue its leadership.

What are the key factors driving the growth of the human growth hormone market?

Key factors include improved early diagnosis and treatment, technological advancements like recombinant DNA technology, and convenient product formulations.

Sources

  1. Lake Clinical Trial National Cooperative Growth Study (NCGS): https://mentalhealth.networkofcare.org/Lake/CommunityResources/ClinicalTrials/Detail/NCT00097539
  2. Growth Hormone Deficiency Market Size to Hit USD 8.5 Billion by 2032: https://www.globenewswire.com/news-release/2024/09/10/2943725/0/en/Growth-Hormone-Deficiency-Market-Size-to-Hit-USD-8-5-Billion-by-2032-SNS-Insider.html
  3. What do we do now that the long-acting growth hormone is here?: https://www.frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2022.980979/full
  4. Genentech Provides Update on Nutropin AQ® (somatropin) NuSpin: https://www.gene.com/media/statements/ps_031524
  5. Human Growth Hormone Market Analysis | Market Research Future: https://www.marketresearchfuture.com/reports/human-growth-hormone-market/market-analysis

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