CLINICAL TRIALS PROFILE FOR GENOTROPIN

All Clinical Trials for GENOTROPIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00119769 ↗	The Effect of Low-Dose Human Growth Hormone Therapy in HIV Infected Patients	Completed	Pfizer	Phase 4	2005-02-01	The purpose of this study is to investigate the effect of low-dose human growth hormone therapy on immune status and fat morphology.
NCT00119769 ↗	The Effect of Low-Dose Human Growth Hormone Therapy in HIV Infected Patients	Completed	Hvidovre University Hospital	Phase 4	2005-02-01	The purpose of this study is to investigate the effect of low-dose human growth hormone therapy on immune status and fat morphology.
NCT00136032 ↗	Growth Hormone Administration and Its Effects on Cardiovascular Risk Factors in Growth Hormone Deficient Women	Completed	Massachusetts General Hospital	N/A	2002-01-01	The purpose of the study is to evaluate the effects of growth hormone replacement on women with growth hormone deficiency. Growth hormone deficiency means the body no longer produces growth hormone due to a tumor or some kind of disease of the brain in an area called the pituitary/hypothalamic region. This is the area of the brain where growth hormone is normally produced. We, the researchers at Massachusetts General Hospital, will establish the effects of growth hormone replacement on cardiovascular parameters (laboratory tests, the flexibility of the arteries, changes in heart rate) in women with growth hormone deficiency. Our goal is to see if this therapy: - has effects on women's cardiovascular risk markers (special blood tests which indicate how healthy the heart and arteries are) - has effects on women's types and levels of various substances circulating in their blood - in women affects the stiffness of their arteries and heart rate variability in parallel with changes in cardiovascular risk markers - has different effects depending on whether women are pre or post menopausal. Participation in this study is expected to last approximately 12 months.
NCT00174408 ↗	Treatment Of Children With Short Stature At An Age Of 3-7 Years Who Were Born Small For Gestational Age	Completed	Pfizer	Phase 3	1990-03-01	The primary objective is to evaluate, if Genotonorm (Genotropin) increases linear growth in short children born SGA. Safety of the drug is a main objective as well. The growth promoting effect of two different dosages is compared. The effect of long-term treatment on final height is evaluated (according to several amendments)
NCT00174421 ↗	Treatment Of Short Stature With Genotropin In Children Born Small For Gestational Age Until Final Height	Completed	Pfizer	Phase 3	2001-04-01	This trial evaluates whether long-term treatment with Genotropin normalizes final (adult) height in short children born small for gestational age
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

Clinical Trial Conditions for GENOTROPIN

Condition Name

Condition Name for GENOTROPIN
Intervention	Trials
Growth Hormone Deficiency	9
Traumatic Brain Injury	4
Prader-Willi Syndrome	3
Idiopathic Short Stature	3

Condition MeSH

Condition MeSH for GENOTROPIN
Intervention	Trials
Dwarfism, Pituitary	16
Endocrine System Diseases	11
Brain Injuries, Traumatic	6
Brain Injuries	6

Clinical Trial Locations for GENOTROPIN

Trials by Country

Trials by Country for GENOTROPIN
Location	Trials
United States	66
Japan	30
Spain	8
India	6
Korea, Republic of	6

Trials by US State

Trials by US State for GENOTROPIN
Location	Trials
Texas	7
New York	5
Florida	4
Colorado	4
California	4

Clinical Trial Progress for GENOTROPIN

Clinical Trial Phase

Clinical Trial Phase for GENOTROPIN
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	17
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for GENOTROPIN
Clinical Trial Phase	Trials
Completed	37
Terminated	4
Active, not recruiting	3

Clinical Trial Sponsors for GENOTROPIN

Sponsor Name

Sponsor Name for GENOTROPIN
Sponsor	Trials
Pfizer	21
The University of Texas Medical Branch, Galveston	4
OPKO Health, Inc.	3

Sponsor Type

Sponsor Type for GENOTROPIN
Sponsor	Trials
Industry	38
Other	32
U.S. Fed	1

GENOTROPIN Market Analysis and Financial Projection

Genotropin: Clinical Trials, Market Analysis, and Projections

Introduction to Genotropin

Genotropin, a recombinant human growth hormone (somatropin), is a pivotal treatment for various growth hormone deficiency (GHD) conditions. Developed by Pfizer, it has been extensively studied and used in clinical settings for decades.

Clinical Trials Overview

Adult Growth Hormone Deficiency (GHD)

Genotropin has been evaluated in several clinical trials involving adult GHD patients. Six randomized clinical trials compared Genotropin with placebo, involving a total of 172 adult GHD patients. These trials included a 6-month double-blind treatment period followed by an open-label treatment period up to 24 months. Patients received Genotropin at doses of 0.04 mg/kg/week for the first month and 0.08 mg/kg/week for subsequent months. The results showed significant improvements in linear growth and other clinical parameters[1].

Pediatric Patients with Prader-Willi Syndrome (PWS)

In two randomized, open-label, controlled clinical trials, Genotropin was evaluated for its efficacy and safety in pediatric patients with PWS. Patients received either Genotropin or no treatment for the first year, and all patients received Genotropin during the second year. The treatment group showed significant increases in linear growth compared to the control group, with continued growth in the second year when both groups received Genotropin[1].

Pediatric Patients Born Small for Gestational Age (SGA)

Four randomized, open-label, controlled clinical trials assessed the safety and efficacy of Genotropin in pediatric patients born SGA who failed to manifest catch-up growth by age 2. Patients received either Genotropin or no treatment for the first 24 months, and all patients received Genotropin thereafter. The results indicated significant growth improvements in the treated groups[1].

Turner Syndrome

Two clinical trials evaluated Genotropin in Turner syndrome patients with short stature. Patients were treated with Genotropin alone or in combination with adjunctive hormonal therapy. The trials demonstrated statistically significant increases in linear growth variables, such as mean height velocity and height SDS, after treatment with Genotropin[1].

Idiopathic Short Stature (ISS)

A randomized, open-label clinical trial evaluated the long-term efficacy and safety of Genotropin in children with ISS. Patients were randomized to receive either Genotropin or observation only and were followed to final height. The trial showed that Genotropin treatment resulted in significant growth improvements compared to the observation group[1].

Market Analysis

Global Market Size and Growth

The global human growth hormone (hGH) market, which includes Genotropin, is projected to experience significant growth. By 2025, the market is expected to reach $7.1 billion, growing at a CAGR of 8.3% during the forecast period[2].

By 2030, the market is anticipated to grow further, with a projected size of $23.38 billion, registering a CAGR of 12.5% from 2024 to 2034[5].

Key Drivers

Several factors are driving the growth of the hGH market:

• Increasing Prevalence of Chronic Diseases: Growth retardation, GHD in the elderly, and pituitary dysfunction cases are on the rise, contributing to market growth[2].
• Product Innovations: Recent product launches, such as long-acting preparations, are enhancing patient compliance and convenience. For example, Pfizer and OPKO's somatrogon, a long-acting weekly treatment, has shown promising results in clinical trials[3][4].
• Robust Investigational Pipeline: Ongoing research and development, including new molecular entities like somatrogon, are fueling market demand[3][4].

Regional Market Dynamics

• North America: This region is expected to hold the largest market share due to favorable reimbursement scenarios, established healthcare infrastructure, and significant government initiatives. Major players like Pfizer, Eli Lilly, and Genentech are based in the U.S., contributing to the region's dominance[5].
• Asia-Pacific: This region is anticipated to grow rapidly, driven by product approvals and launches in countries like Japan and China. Companies like Novo Nordisk are actively engaging in clinical studies and market expansion in this region[5].

Market Projections

Short-Term Projections

By 2025, the global hGH market is expected to reach $7.1 billion, with a CAGR of 8.3% during the forecast period. This growth is driven by the increasing prevalence of GHD and other related conditions, as well as the introduction of new products[2].

Long-Term Projections

By 2034, the market is projected to expand significantly, reaching $23.38 billion with a CAGR of 12.5% from 2024 to 2034. The long-acting segment is expected to register the fastest growth rate due to its advantages in reduced administration frequency and improved patient compliance[5].

Competitive Landscape

Genotropin faces competition from other hGH products such as Humatrope (Eli Lilly), Saizen (Merck), and Norditropin (Novo Nordisk). New entrants like somatrogon (Pfizer and OPKO) and TransCon hGH (Ascendis) are also gaining traction due to their once-weekly administration and improved efficacy profiles[3][4].

Recent Developments

• Somatrogon: Pfizer and OPKO's somatrogon has demonstrated non-inferiority to Genotropin in clinical trials and is expected to improve patient compliance with its once-weekly dosing regimen[4].
• TransCon hGH: Ascendis' TransCon hGH has shown superior growth outcomes compared to Genotropin in some trials and is awaiting FDA approval[4].

Key Takeaways

• Clinical Efficacy: Genotropin has shown significant efficacy in various clinical trials for adult and pediatric GHD, PWS, SGA, Turner syndrome, and ISS.
• Market Growth: The global hGH market is expected to grow substantially, driven by increasing prevalence of related conditions and innovative product launches.
• Regional Dynamics: North America is the largest market, while Asia-Pacific is expected to grow rapidly.
• Competitive Landscape: Genotropin competes with other hGH products, and new long-acting preparations are gaining market share.

FAQs

What is Genotropin used for?

Genotropin is used to treat growth hormone deficiency in children and adults, as well as conditions like Prader-Willi syndrome, Turner syndrome, and idiopathic short stature.

How is Genotropin administered?

Genotropin is administered as a daily subcutaneous (SC) injection, although new long-acting preparations are being developed for less frequent administration.

What are the key drivers of the hGH market growth?

The key drivers include the increasing prevalence of chronic diseases, product innovations, and a robust investigational pipeline.

Which region is expected to dominate the hGH market?

North America is expected to hold the largest market share due to favorable reimbursement scenarios and established healthcare infrastructure.

What are the recent developments in the hGH market?

Recent developments include the introduction of long-acting preparations like somatrogon and TransCon hGH, which offer improved patient compliance and efficacy.

How does Genotropin compare to other hGH products?

Genotropin competes with other products like Humatrope, Saizen, and Norditropin. New products like somatrogon and TransCon hGH are gaining traction due to their once-weekly dosing regimens and improved efficacy profiles.

Sources

1. Pfizer Medical Information: GENOTROPIN® (somatropin) Clinical Studies - US.
2. KBV Research: Human Growth Hormone Market Size to Reach USD 7.1 Bn by 2025.
3. Grand View Research: Human Growth Hormone Market Size & Share Report, 2030.
4. BioSpace: Pfizer and OPKO's Growth Hormone Drug Effective in Late-Stage Trial.
5. Precedence Research: Human Growth Hormone Market Size To Hit USD 23.38 Bn By 2034.