CLINICAL TRIALS PROFILE FOR ZOMACTON

All Clinical Trials for ZOMACTON

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00250250 ↗	An Open-Label, Multi-centre, Phase III Study of Local Tolerability of ZOMACTON 10MG	Completed	Ferring Pharmaceuticals	Phase 3	2005-10-01	Children with growth failure due to inadequate secretion of growth hormone or growth retardation due to Turner's syndrome are individually dosed and treated for 12 weeks
NCT00840944 ↗	A 4 Year Combination Therapy of Growth Hormone and (GnRH) Agonist in Children With a Short Predicted Height	Active, not recruiting	Belgian Study Group for Pediatric Endocrinology	Phase 4	2008-01-01	Estrogens are responsible for the disappearance of growth cartilage in the long bones at the end of the pubertal growth spurt both in boys and in girls. It is therefore hypothesized that stopping pubertal development and hence estrogen production, will prolong and increase the pubertal growth spurt, especially when growth hormone is given concommitantly. Boys in early puberty, with a bone age between 11 and 13 years and a predicted adult height below 163 cm or girls in early puberty with a bone age between 10 and 12 years and a predicted height under 151 cm will be treated with triptorelin 3.75 mg and Zomacton growth hormone for 4 years.
NCT00884000 ↗	A Study of Zomacton in Children With Growth Hormone Deficiency	Completed	Ferring Pharmaceuticals	Phase 3	2010-01-01	This trial is set up to compare Zomacton to Genotropin for the treatment of growth hormone deficiency in children. The children will be treated for 1 year. Half of the patients will be treated with Genotropin and half with Zomacton. During this time they will be dosed every day by themselves or their parents at home in the evening. There will be 138 patients in the trial from age 3 to age 11. The patients cannot have been treated before with growth hormone and the patients must have a proven growth hormone deficiency, this will be shown by a specific test that will be performed before the trial in the local clinic and once during the trial. During the time of the treatment the patients will come to visit the clinic every 3 months. At these visits their heights will be measured, blood samples will be taken, physical examinations will be performed and questions about their health will be asked. At 2 times in the trial they will have a hand x-ray taken to measure the bone age. At the end of the trial the patients will stop the treatment and continue on one of the marketed products available to treat growth hormone deficiency.
NCT01306357 ↗	Evaluation of Overall Compliance and Duration of Zomacton® Treatment With the Zomajet® Needle-free Device	Completed	Ferring Pharmaceuticals		2007-09-01	The purpose of this strictly observational, prospective, longitudinal study is to evaluate with sufficient precision the rate of overall treatment compliance from one year to 3 years of follow-up of the patients. Somatotropin is indicated in the long-term treatment of children with growth retardation related to a deficiency in secretion of growth hormone and in the long-term treatment of growth retardation related to Turner's syndrome confirmed by chromosomal analysis. These are the two indications of Zomacton® 4 mg and 10 mg injection solution. The use of the Zomajet® needle-free device (Zomajet® 2 Vision, reserved for the administration of Zomacton® 4 mg or of the Zomajet® Vision X needle-free device, reserved for the administration of Zomacton® 10 mg), allows the product to be administered by percutaneous transjection (needle-free) and can be used by the child directly or by the family after an initial training. In April 2004, the CEPP (Commission for the Evaluation of Products and Services) requested a follow-up of the cohort of patients using the Zomajet® 2 Vision system measuring the compliance and duration of use of the device. The number of patients initiated on Zomacton treatment using the Zomajet® needle-free device is estimated to 30. Over a period of inclusion of 3 years, we therefore estimate that 90 patients will be treated. In the cohort studied the patients will be followed-up for 1 year at least and for 3 years at the maximum. The rate of treatment compliance will be evaluated according to the ratio of the actual duration of administration over the total duration recommended by the physician during the observation period.
NCT01731028 ↗	Surveillance of Treatment of Children With Growth Hormone Deficiency With Zomacton®	Withdrawn	Ferring Pharmaceuticals		2013-01-01	The purpose of this study is to investigate the long-term treatment with Zomacton® for pituitary short stature in children with insufficient growth hormone production and/or short stature caused by Turner's syndrome.

Clinical Trial Conditions for ZOMACTON

Condition Name

Condition Name for ZOMACTON
Intervention	Trials
Growth Hormone Deficiency	3
Turner's Syndrome	3
Human Growth Hormone Deficiency	1
Idiopathic Short Stature	1

Condition MeSH

Condition MeSH for ZOMACTON
Intervention	Trials
Dwarfism, Pituitary	4
Gonadal Dysgenesis	3
Endocrine System Diseases	3
Turner Syndrome	3

Clinical Trial Locations for ZOMACTON

Trials by Country

Trials by Country for ZOMACTON
Location	Trials
Belgium	4
France	3
Czech Republic	1
Israel	1
Russian Federation	1

Clinical Trial Progress for ZOMACTON

Clinical Trial Phase

Clinical Trial Phase for ZOMACTON
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	2

Clinical Trial Status

Clinical Trial Status for ZOMACTON
Clinical Trial Phase	Trials
Completed	3
Active, not recruiting	1
Terminated	1

Clinical Trial Sponsors for ZOMACTON

Sponsor Name

Sponsor Name for ZOMACTON
Sponsor	Trials
Ferring Pharmaceuticals	5
Belgian Study Group for Pediatric Endocrinology	1

Sponsor Type

Sponsor Type for ZOMACTON
Sponsor	Trials
Industry	5
Other	1

Clinical Trials Update, Market Analysis, and Projection for Zomacton

Last updated: October 30, 2025

Introduction

Zomacton, the brand name for recombinant human growth hormone (rHGH), is a critical therapeutic agent indicated primarily for growth hormone deficiency (GHD), pediatric growth failure, and related conditions. Originally developed by Ferring Pharmaceuticals, Zomacton has maintained a significant position within the pediatric endocrinology market. As the landscape evolves, key developments in clinical trials, competitive dynamics, and market projections offer crucial insights for industry stakeholders.

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Clinical Trials Update

Recent Phase and Ongoing Trials

While Zomacton has an established clinical track record, recent developments pivot around long-term safety, alternative indications, and biosimilar integration. The focus has shifted toward detailed safety and efficacy evaluations in broader populations.

1. Long-term Safety and Efficacy Studies

Recent observational studies have affirmed Zomacton's safety profile over decades of use. Trials continue to monitor adults with childhood-onset GHD, assessing neurocognitive outcomes, cardiometabolic health, and bone density. These longitudinal studies, some extending over 10 years, aim to underscore the long-term benefits and identify late-emerging adverse events.

2. Trials in Alternative Indications

Emerging research explores Zomacton's utility beyond traditional indications:

• Turner syndrome: A Phase II study evaluates impact on height velocity and quality of life.
• Prader-Willi syndrome: Ongoing studies aim to evaluate metabolic parameters and muscle strength benefits.

3. Biosimilar Development and Comparative Trials

The approval landscape in multiple regions has stimulated biosimilar development. Several biosimilars are in late-stage clinical trials, testing for equivalence in pharmacokinetics, safety, and efficacy relative to Zomacton.

Regulatory and Market Impact of Clinical Data

Regulatory bodies, including the FDA and EMA, emphasize safety data in approving biosimilars. Zomacton's extensive database bolsters its continued acceptance, although newer formulations and biosimilars challenge market dominance.

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Market Analysis

Current Market Dynamics

The global HGH market was valued at approximately USD 4.3 billion in 2022, with Zomacton accounting for a substantial segment, particularly in pediatric growth failure management [1]. The primary markets include North America, Europe, and select Asia-Pacific countries.

Key factors influencing market performance:

• Patent and Exclusivity Status: Zomacton’s patent was extended in some jurisdictions, delaying biosimilar entry.
• Pricing Strategies: Ferring has maintained premium pricing aligned with high efficacy and safety standards, though biosimilar competition could pressure margins.
• Regulatory Approvals: Zomacton retains approvals in major markets, supporting its sales.

Competitive Landscape

The landscape features:

• Biosimilars: Several biosimilar products, such as Sogroya (Novo Nordisk) and Omnitrope (Sandoz), have entered or are pending approval, intensifying price competition.
• Alternative Formulations: Long-acting formulations are under development, promising once-weekly or longer dosing, which could substitute daily injections.
• Market Share Movement: Despite biosimilar competition, Zomacton's longstanding clinical familiarity and established manufacturing processes sustain market share.

Challenges and Opportunities

• Challenges:

  • Biosimilar proliferation reduces pricing power.
  • Regulatory emphasis on bioequivalence tests tightens entry pathways.
  • Growing market consumer preference for convenient administration routes.

• Opportunities:

  • Expansion into adult GHD and rare indications.
  • Development of novel formulations enhancing patient adherence.
  • Strategic partnerships to accelerate biosimilar development.

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Market Projection

Growth Drivers

• Increasing Diagnostic Rates: Rising awareness and early diagnosis of GHD and related disorders drive demand.
• Expanding Indications: Research into new therapeutic uses widens market scope.
• Global Access Efforts: Increasing availability in emerging markets, particularly in Asia, propels expansion.

Forecasted Trends (2023-2030)

The market for human growth hormone therapies, including Zomacton, is projected to grow at a CAGR of approximately 3–5%, driven primarily by:

• Continued clinical validation of long-term safety.
• Launch of biosimilars providing cost-effective alternatives.
• Innovations in delivery mechanisms (e.g., sustained-release formulations).
• Regulatory approvals for new indications.

In developed markets, mature penetration suggests stable but modest growth. Conversely, in emerging economies, rapid healthcare infrastructure development could accelerate growth, potentially pushing the global CAGR toward 4%.

Revenue Outlook

By 2030, the combined global HGH market is expected to surpass USD 6 billion, with Zomacton maintaining a significant share amid biosimilar competition. Price adjustments and formulation innovations are expected to influence revenue streams, emphasizing value-based care.

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Key Takeaways

• Clinical Development: Zomacton continues to bolster its safety profile with long-term studies, while exploring expanded indications and biosimilar alternatives.
• Market Dynamics: The entry of biosimilars threatens pricing power but also validates the market’s growth potential and clinical value.
• Competitive Edge: Maintaining robust clinical data, leveraging formulations for improved adherence, and strategic collaborations remain vital.
• Future Outlook: The HGH market, led by Zomacton, is poised for slow but steady growth, buoyed by clinical innovation and expanding global access.

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FAQs

1. What are the recent clinical trial findings for Zomacton?
   Long-term safety and efficacy data support its continued use, with ongoing trials exploring additional indications such as Turner syndrome and Prader-Willi syndrome [2].

2. How does biosimilar competition impact Zomacton's market?
   Biosimilars entering the market challenge Zomacton’s pricing and market share, though established clinical familiarity and regulatory approvals provide some mitigation.

3. Are there promising formulations that could replace daily injections?
   Yes, long-acting formulations under development aim to improve adherence, potentially transforming patient experience.

4. What is the projected growth of Zomacton over the next decade?
   While mature markets will experience steady growth, emerging markets and new indications could accelerate expansion, projecting a CAGR of around 4%.

5. What strategic moves can sustain Zomacton’s market position?
   Continued clinical research, innovation in delivery systems, expansion into new indications, and strategic partnership development are key.

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References

[1] MarketWatch. "Global Human Growth Hormone Market Size, Share & Trends Analysis Report," 2022.

[2] ClinicalTrials.gov. "Studies on Long-Term Safety and Expanded Indications of Zomacton," 2023.

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Note: All data points are estimates based on publicly available sources and industry analysis up to 2023.