You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: February 8, 2025

CLINICAL TRIALS PROFILE FOR HUMATROPE


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for Humatrope

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00001305 ↗ Growth Hormone Therapy in Osteogenesis Imperfecta Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 3 1991-11-05 Growth deficiency is a key feature of severe Osteogenesis Imperfecta (OI) and a frequent feature of mild to moderate forms of the disease. The reason that children with OI are short is not fully understood. We do know that details such as the number of fractures suffered or the type of OI do not fully explain the short stature of OI. Growth patterns have been defined for children with OI Types I, III, and IV. At about 12 months of age, children with Types III and IV OI demonstrate a predictable plateau of their linear growth rate. Type IV OI children begin to resume a normal growth rate at about age four to five years, but they will not "catch up" to a normal height, as they have "lost" a significant period of growth. The plateau usually continues for children with Type III OI. The reason for this growth plateau is unknown. There have been no studies which evaluate the growth of OI children in this age range. Our previous studies of growth in OI children have begun at age 5 years. We have studied growth in OI children for the past 10 years. Different medications have been tried to both stimulate growth and improve bone density. Some children have responded to growth hormone (their growth rate increased by at least 50%) and some did not. The majority of children who did respond were Type IV. However, we need to carefully treat and study more children to try to determine which children will benefit from growth hormone medication. The Goals of this Study Are: 1. We want to try to find a cause for the growth plateau common in types III and IV OI. Long-term, our goal is to develop a treatment to eliminate this plateau. 2. We want to see how long and how well OI bone will respond to growth stimulation. 3. We hope to find a "predictor" for who will respond to growth hormone and who will not, by measuring your child's endocrine and growth hormone function before receiving any growth hormone treatment. 4. We want to measure the effects of growth stimulation on bone density, and the quality of OI bone. 5. We want to see if there are long term benefits resulting from this treatment in the form of final adult height, trunk height, and possibly improved function of the respiratory system. Median Subject Age (on p. 1 of webpage): 1-15 years (replaces 0-20)
NCT00001343 ↗ The Effects of Hormones in Growth Hormone-Treated Girls With Turner Syndrome Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 2 1992-12-11 Turners Syndrome is a genetic condition in females that is a result of abnormal chromosomes. Patients with Turner syndrome are typically short, have abnormal physical features, and lack the physical changes normally associated with puberty. In addition, some patients with Turner syndrome have low bone density (osteoporosis) and differences in learning abilities. This study will research the effects of steroid hormones on patients with Turner syndrome. It will look closely at how taking steroid hormones effects the patient's rate of growth as well as the patient's ability to learn. In addition the study will investigate how different hormones (androgen and estrogen) work when given together as a combination. All patients asked to participate in this study will receive growth hormone injections. However, half of the patients will receive an additional sex steroid hormone (oxandrolone) in the form of a pill. The other half of the patients will receive a placebo or "sugar pill". This will allow the researchers to determine if the combination of the hormones produces different results than growth hormone alone. The study will last approximately 2 years. After 2 years of research the patients may qualify for an additional 2 years of treatment. Patients may benefit directly from this research with increased growth and improved ability to learn.
NCT00190658 ↗ Somatropin Treatment in Patients With SHOX Deficiency and Turner Syndrome Completed Eli Lilly and Company Phase 3 2000-02-01 This clinical trial will compare the mean first year height velocity of somatropin-treated prepubertal patients with SHOX deficiency with the height velocity of a control group of untreated prepubertal patients with SHOX deficiency. Both groups will be compared to a somatropin-treated group of girls with Turner syndrome. After the second year patients in the control group have the option to receive treatment as well. All patients will optionally be treated until they achieved adult height.
NCT00191074 ↗ Amendment (g) Unblinded Extension Phase of Somatropin in Patients With Idiopathic Short Stature Completed Eli Lilly and Company Phase 3 2001-02-01 After approval of amendment (g), patients who were still receiving study drug at the time were scheduled for a study visit. In addition, patients who had discontinued early from the core, blinded phase of the study were contacted. All of these patients were offered the opportunity to enter the unblinded extension phase (if they met eligibility criteria) and continue somatropin treatment (regardless of initial treatment randomization) until they reached final height.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Humatrope

Condition Name

Condition Name for Humatrope
Intervention Trials
Turner Syndrome 3
Growth Disorder 1
Myopathy 1
Growth Hormone (GH) Deficiency 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Humatrope
Intervention Trials
Turner Syndrome 4
Primary Ovarian Insufficiency 4
Gonadal Dysgenesis 4
Dwarfism 4
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Humatrope

Trials by Country

Trials by Country for Humatrope
Location Trials
United States 20
Canada 7
France 1
Italy 1
Netherlands 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Humatrope
Location Trials
Maryland 4
Pennsylvania 3
New York 3
Texas 2
Washington 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Humatrope

Clinical Trial Phase

Clinical Trial Phase for Humatrope
Clinical Trial Phase Trials
Phase 4 2
Phase 3 6
Phase 2/Phase 3 2
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Humatrope
Clinical Trial Phase Trials
Completed 12
Terminated 2
Recruiting 2
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Humatrope

Sponsor Name

Sponsor Name for Humatrope
Sponsor Trials
Eli Lilly and Company 10
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 3
University Health Network, Toronto 2
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Humatrope
Sponsor Trials
Industry 11
Other 11
NIH 6
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

HUMATROPE: Clinical Trials, Market Analysis, and Projections

Introduction to HUMATROPE

HUMATROPE, also known as somatropin, is a recombinant human growth hormone (hGH) used to treat various growth hormone-related disorders. It is manufactured by Eli Lilly and Company and has been approved by the FDA since 1987[3].

Clinical Trials and Efficacy

Pediatric Patients

Clinical trials have demonstrated the efficacy of HUMATROPE in pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone (GH). Studies have shown that HUMATROPE significantly increases height velocity and final height in children with GH deficiency, Turner syndrome, idiopathic short stature (ISS), and other conditions such as SHOX deficiency and small for gestational age (SGA) without catch-up growth[3].

For example, a double-blind trial involving pediatric patients with short stature received subcutaneous injections of either HUMATROPE or placebo. The HUMATROPE group achieved a mean final height Standard Deviation Score (SDS) of -1.8, compared to -2.3 for the placebo group, indicating a significant improvement in height outcomes[1].

Adult Patients

In adult patients with GH deficiency, HUMATROPE has been shown to increase lean body mass and decrease body fat. Clinical trials involving adult-onset and childhood-onset GH-deficient patients revealed significant increases in lean body mass (2.59 kg vs. -0.22 kg, p < 0.001) and decreases in body fat (-3.27 kg vs. 0.56 kg, p < 0.001) compared to placebo groups[1].

Safety and Side Effects

While HUMATROPE is generally well-tolerated, clinical trials have highlighted some safety concerns. For instance, two placebo-controlled clinical trials in non-GH-deficient adult patients showed a significant increase in mortality, although these findings were not seen in GH-deficient patients[1].

Market Analysis

Market Size and Growth

The global human growth hormone (hGH) market, which includes HUMATROPE, is projected to reach $7.1 billion by 2025, growing at a Compound Annual Growth Rate (CAGR) of 8.3% during the forecast period[2].

Regional Market

North America currently holds the largest market share in the global hGH market, while the Asia Pacific region is expected to be the fastest-growing market segment due to increasing healthcare expenditure and awareness of growth hormone deficiencies[5].

Key Players

Eli Lilly and Company, the manufacturer of HUMATROPE, is one of the major players in the global hGH market. Other key players include AnkeBio Co. Ltd, Ferring BV, Novo Nordisk AS, and Ipsen S.A.[5].

Market Drivers

Increasing Prevalence of Chronic Diseases

The rise in chronic diseases such as growth retardation, GH deficiency in the elderly, and pituitary dysfunction cases is driving the demand for hGH treatments like HUMATROPE[2].

Advances in Healthcare

Improvements in healthcare infrastructure and increased awareness about growth hormone deficiencies are also contributing to the growth of the hGH market[5].

Market Challenges

Regulatory Scrutiny

The hGH market, including HUMATROPE, is subject to stringent regulatory requirements. Ensuring compliance with these regulations can be a significant challenge for manufacturers[3].

Competition

The market is competitive, with several other hGH products available, such as Norditropin. This competition can impact market share and pricing strategies for HUMATROPE[4].

Future Projections

Market Forecast

The global hGH market is expected to continue growing, driven by the increasing prevalence of GH deficiencies and advancements in healthcare. The market is projected to register a CAGR of 8.61% from 2025 to 2030[5].

Emerging Markets

The Asia Pacific region is anticipated to be a key growth area due to its large population and increasing healthcare spending. This presents significant opportunities for HUMATROPE and other hGH products[5].

Conclusion

HUMATROPE has been a cornerstone in the treatment of growth hormone-related disorders, with robust clinical trial data supporting its efficacy in both pediatric and adult patients. The market for hGH is poised for significant growth, driven by increasing demand and advancements in healthcare. As the market continues to evolve, HUMATROPE is likely to remain a key player.

Key Takeaways

  • Clinical Efficacy: HUMATROPE has been shown to significantly improve height outcomes in pediatric patients and body composition in adult patients with GH deficiency.
  • Market Growth: The global hGH market is projected to reach $7.1 billion by 2025, with a CAGR of 8.3%.
  • Regional Dynamics: North America holds the largest market share, while the Asia Pacific region is the fastest-growing segment.
  • Market Drivers: Increasing prevalence of chronic diseases and advancements in healthcare are driving market growth.
  • Future Projections: The market is expected to continue growing, with the Asia Pacific region offering significant opportunities.

FAQs

What is HUMATROPE used for?

HUMATROPE is used to treat growth hormone deficiency in pediatric and adult patients, as well as other conditions such as Turner syndrome, idiopathic short stature, and SHOX deficiency[3].

What are the key findings from clinical trials of HUMATROPE?

Clinical trials have shown that HUMATROPE significantly increases height velocity and final height in pediatric patients and improves body composition in adult patients with GH deficiency[1].

What is the projected market size for the global hGH market by 2025?

The global hGH market is projected to reach $7.1 billion by 2025, growing at a CAGR of 8.3% during the forecast period[2].

Which region is expected to be the fastest-growing market for hGH?

The Asia Pacific region is expected to be the fastest-growing market segment for hGH due to increasing healthcare expenditure and awareness of growth hormone deficiencies[5].

Who are the major players in the global hGH market?

Major players include Eli Lilly and Company, AnkeBio Co. Ltd, Ferring BV, Novo Nordisk AS, and Ipsen S.A.[5].

Sources

  1. FDA Label for HUMATROPE: https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019640s047,019640s052lbl.pdf
  2. KBV Research - Human Growth Hormone Market: https://www.kbvresearch.com/human-growth-hormone-market/
  3. Drugs.com - Humatrope Package Insert: https://www.drugs.com/pro/humatrope.html
  4. Power - Norditropin vs Humatrope: https://www.withpower.com/guides/norditropin-vs-humatrope-1bbc
  5. Mordor Intelligence - Human Growth Hormone Market: https://www.mordorintelligence.com/industry-reports/human-growth-hormone-market

More… ↓

⤷  Free Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.