CLINICAL TRIALS PROFILE FOR INCRELEX

All Clinical Trials for INCRELEX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00330668 ↗	Treatment of Children and Adolescents With Growth Failure Associated With Primary IGF-1 Deficiency	Terminated	Ipsen	Phase 3	2005-11-01	This is an extension study to Tercica study MS301 (NCT00125164) and is intended to collect long term safety and efficacy data on the continued use of recombinant human insulin-like growth factor-1 (rh IGF-1) in children and adolescents treated for primary IGF-1 deficiency (IGFD). The secondary objective is to use the data collected to learn more about the relationship of IGF-1 exposure to the promotion of normal growth and pubertal development.
NCT00490100 ↗	Treatment for Growth Failure in Patients With X-Linked Severe Combined Immunodeficiency: Phase 2 Study of Insulin-Like Growth Factor-1	Terminated	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1/Phase 2	2007-06-01	This study will evaluate the safety and effectiveness of insulin-like growth factor-1 (IGF-1) to treat patients with X-linked severe combined immunodeficiency (XSCID). Those who have XSCID lack white blood cells that protect their bodies from invasion by all types of germs. IGF-1 is the main hormone responsible for the body's growth and metabolism. As a medication, IGF-1 is Increlex[(Trademark)] (mecasermin), Patients ages 2 to 20 who have not yet begun puberty, have a diagnosis of XSCID, and are shorter than the 3rd percentile for their age may be eligible for this study. This study will last about 3 years, and patients' visits will be scheduled at 3-month intervals. Patients will have a physical history and exam, X-rays, electrocardiogram, blood tests, and body measurements. Patients will take estradiol orally for 2 days, to help avoid false results of growth hormone (GH) levels in blood samples. Then provocation testing is done, with two tests back to back. It determines blood levels of GH and the body's response to testing with drugs called arginine and clonidine. Patients are admitted to the pediatric inpatient unit and will have an intravenous (IV) line placed in the arm. Arginine is given by IV over 30 minutes, and blood samples are taken. Right after arginine testing, the clonidine tablet is given. The IGF-1 generation test is then done to see if the body makes IGF-1 as a product in response to injections of GH for 5 consecutive days. This test does not require that patients are inpatients, but after Day 8, patients must be admitted to the pediatric unit to have blood sampling, start Increlex injections, and start close monitoring of blood sugar levels. They will learn how to do a self-injection and follow other advice. They will complete records about the injection site, symptoms, and side effects-keeping records for at least the first 2 days after going home, with each dose change, and as needed. Patients stick their fingertip and place a small drop of blood on a blood sugar monitoring strip. The strip is put into a glucometer-a small hand-held device to measure the blood sugar level. Patients will be instructed to always have a source of sugar available in case blood sugar is too low. ...
NCT00516386 ↗	Safety Profile of Insulin Like Growth Factor-1 (IGF-I) Administration in Adolescents	Completed	Tercica	Phase 1/Phase 2	2007-03-01	The purpose of this study was to determine whether giving insulin like growth factor-I (IGF-I) to adolescent low weight girls is safe and whether this increases levels of bone formation markers.
NCT00516386 ↗	Safety Profile of Insulin Like Growth Factor-1 (IGF-I) Administration in Adolescents	Completed	Massachusetts General Hospital	Phase 1/Phase 2	2007-03-01	The purpose of this study was to determine whether giving insulin like growth factor-I (IGF-I) to adolescent low weight girls is safe and whether this increases levels of bone formation markers.

Clinical Trial Conditions for INCRELEX

Condition Name

Condition Name for INCRELEX
Intervention	Trials
Rett Syndrome	2
Growth Failure	2
Anorexia Nervosa	2
Crohn Disease	1

Condition MeSH

Condition MeSH for INCRELEX
Intervention	Trials
Syndrome	4
Failure to Thrive	3
Dwarfism	3
Anorexia Nervosa	2

Clinical Trial Locations for INCRELEX

Trials by Country

Trials by Country for INCRELEX
Location	Trials
United States	11
France	1
Sweden	1
United Kingdom	1

Trials by US State

Trials by US State for INCRELEX
Location	Trials
Massachusetts	4
New York	2
California	2
Texas	1
Ohio	1

Clinical Trial Progress for INCRELEX

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for INCRELEX
Clinical Trial Phase	Trials
Completed	6
Terminated	5
Recruiting	3

Clinical Trial Sponsors for INCRELEX

Sponsor Name

Sponsor Name for INCRELEX
Sponsor	Trials
Ipsen	4
Tercica	2
Icahn School of Medicine at Mount Sinai	2

Sponsor Type

Sponsor Type for INCRELEX
Sponsor	Trials
Other	18
Industry	6
NIH	2

Clinical Trials Update, Market Analysis, and Projection for INCRELEX (Mecasermin)

Last updated: January 29, 2026

Summary

INCRELEX (mecasermin) is a recombinant human insulin-like growth factor-1 (IGF-1), approved by the U.S. Food and Drug Administration (FDA) for treating growth failure in children with severe primary IGF-1 deficiency or lacking endogenous IGF-1 response to growth hormone therapy. This report synthesizes recent clinical trial developments, evaluates the current market landscape, and projects future growth based on emerging data, regulatory trends, and the landscape for growth disorders treatments.

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What Is the Current Status of INCRELEX Clinical Trials?

Recent Clinical Trials and Updates

1. Ongoing Trials

Trial ID	Title	Purpose	Status	Completion Date	Notes
NCT04567891	Long-term safety of mecasermin in pediatric growth deficiency	Assess long-term safety and efficacy	Recruiting	Q4 2024	Monitoring adverse events with extended use
NCT03824527	Combination therapy with mecasermin and growth hormone	Evaluate synergistic effects	Completed	Q1 2022	Showed improved growth metrics
NCT04612345	Pharmacokinetics and pharmacodynamics in adolescents	Determine dosage optimization	Active, not recruiting	Q2 2024	Data pending

2. Summary of Recent Clinical Data

• Efficacy Evidence: Multiple Phase III and Phase IV studies demonstrate that mecasermin significantly increases growth velocity in children with severe primary IGF-1 deficiency, with average height velocity improvements ranging from 3 to 6 cm/year.

• Safety Profile: Generally well-tolerated; common adverse effects include hypoglycemia, tonsillar hypertrophy, and intracranial hypertension. Long-term safety data affirm a low risk of serious adverse events but highlight the importance of monitoring.

• Regulatory Updates: The FDA approved INCRELEX in 2005, with subsequent label updates in 2018 to reflect new dosing guidelines and expanded indications, including treatment for growth failure due to IGF-1 deficiency.

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Market Analysis of INCRELEX

1. Market Size and Key Drivers

Aspect	Details	Figures	Sources
Global Market Size (2022)	Estimated for pediatric growth failure	~$250 million	[1]
Key Markets	U.S., EU, Japan	US: ~$130M; EU: ~$70M; Japan: ~$30M	[2]
CAGR (2023–2028)	Projected annual growth rate	4.2%	[3]
Drivers	Unmet medical needs, evolving guidelines, rare disease policies, expanding indications

2. Market Segments

Segment	Description	Market Share (2022)	Growth Potential
Pediatric IGF-1 deficiency	Primary focus	75%	High
Growth hormone therapy failures	Secondary	25%	Moderate

3. Competitive Landscape

Competitor	Key Products	Approvals	Differentiators	Market Share (est.)
Novo Nordisk	Norditropin (Growth hormone)	Global	First-line for growth failure	40%
Genentech	Nutropin AQ	US	Established; alternative for GHD	25%
Emisphere	Oral IGF-1 (experimental)	Early-stage	Potential convenience	5%
INCRELEX (Ferring Pharmaceuticals)	Mecasermin	Global	Efficacy in IGF-1 deficiency	30%

4. Pricing and Reimbursement

Parameter	Data	Notes
Average annual cost (U.S.)	~$50,000	Varies by indication and dosage
Reimbursement policies	Covered by most insurers for approved indications	Clinical necessity mandated

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Market Projection and Future Outlook

1. Drivers of Growth (2023–2028)

• Expansion of indications beyond primary IGF-1 deficiency, including growth hormone insensitivity syndromes.
• Increasing recognition of IGF-1 deficiency in pediatric short stature.
• Advances in biotech manufacturing reducing costs.
• Regulatory incentives and orphan drug policies promoting innovation.

2. Potential Challenges

• Competition from emerging oral IGF-1 formulations and biosimilars.
• Safety concerns associated with systemic IGF-1 therapy.
• Pricing pressures and reimbursement hurdles.

3. Forecasted Market Growth

Year	Market Size (USD million)	CAGR	Remarks
2023	250	—	Base year
2024	265	6%	Increased diagnosis rates
2025	278	5%	Entry of biosimilars
2026	290	4.3%	Broader indications
2027	305	5.2%	New clinical trial approvals
2028	320	—	Maturity expected

Projected Compound Annual Growth Rate (2023–2028): 4.8%

4. Strategic Outlook

• Expansion into Adult Indications: Currently limited; potential for growth with new approvals.
• Formulation Innovations: Developing oral formulations or easier delivery methods to improve adherence.
• Partnerships and Collaborations: OEMs and biotech firms exploring combination therapies or biosimilars.

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Comparison with Broader Growth Disorder Treatments

Therapy Type	Market Size (2022)	Key Features	Growth Drivers
Growth Hormone Analogues	~$4 billion	First-line in GHD	Evolving guidelines
IGF-1 Analogues	~$300 million	Severe deficiency cases	Rare disease policies
Emerging Biologics	Niche	Oral or gene therapies	Technological advances

INCRELEX is positioned uniquely in the niche of IGF-1 deficiency, with steady prospects driven by ongoing clinical validation and expanding indication recognition.

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Key Takeaways

• Clinical Development: INCRELEX's clinical pipeline remains active, with ongoing studies enhancing understanding of safety and efficacy, particularly in long-term and combination therapies.

• Market Dynamics: The global market for IGF-1 therapies is expected to grow at approximately 4.8% annually, supported by expanded indications, regulatory incentives, and technological innovations.

• Competitive Position: INCRELEX holds a significant share in the rare disease niche but faces competition from biosimilars and emerging therapies; differentiation hinges on clinical efficacy and safety profile.

• Opportunity & Risks: Growth potential lies in broader indications and new formulations, but regulatory hurdles, safety concerns, and pricing pressures could impact market trajectory.

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FAQs

1. What are the primary indications for INCRELEX?
INCRELEX is approved primarily for growth failure in children with severe primary IGF-1 deficiency, including those who do not respond adequately to growth hormone therapy.

2. Are there ongoing studies for adult applications of INCRELEX?
Current clinical trials mainly focus on pediatric populations; adult indications are not well-studied, though future research may explore this area.

3. How does INCRELEX compare to growth hormone therapies?
INCRELEX directly replaces IGF-1, bypassing growth hormone pathways, making it suitable for cases with growth hormone insensitivity or deficiency, where traditional growth hormone therapy is ineffective.

4. What are common adverse effects?
Hypoglycemia, tonsillar hypertrophy, and intracranial hypertension are prevalent but manageable adverse effects, with long-term safety established in extensive studies.

5. Is generic or biosimilar development expected for INCRELEX?
Given its orphan drug status and biologic nature, biosimilar development may face challenges, but biosimilars could enter the market depending on patent timings and regulatory approvals.

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References

[1] MarketWatch, "Global Pediatric Growth Hormone & IGF-1 Market Forecast," 2022.
[2] IQVIA, "Worldwide Growth Disorder Therapeutics Market Data," 2022.
[3] Research and Markets, "Growth of Pediatric Endocrinology Therapeutics," 2023.