CLINICAL TRIALS PROFILE FOR OMNITROPE

All Clinical Trials for OMNITROPE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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
NCT00209235 ↗	Albright Hereditary Osteodystrophy: Growth Hormone Trial and Cognitive/Behavioral Assessments	Recruiting	Hugo W. Moser Research Institute at Kennedy Krieger, Inc.	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
NCT00537914 ↗	Safety and Efficacy of Omnitrope® (rhGH) in Short Children Born Small for Gestational Age (SGA)	Active, not recruiting	Sandoz	Phase 4	2008-02-06	This study is performed to investigate the long-term safety, in particular the diabetogenic potential and immunogenicity of rhGH therapy in short children born small for gestational age (SGA).
NCT01247675 ↗	A Safety, Pharmacokinetic and Pharmacodynamic Study of ACP-001 (TransCon hGH) in Adults With Growth Hormone Deficiency	Completed	Ascendis Pharma A/S	Phase 2	2010-11-01	This study investigates the safety, tolerability, pharmacokinetic profile (PK), and pharmacodynamic response (PD) of three different doses of ACP-001 given once-a-week compared to one dose-level of an approved daily human growth hormone product over a period of 4 weeks (4 weekly administrations versus 28 daily administrations) in adults with Growth Hormone Deficiency.
NCT02179255 ↗	Human Growth Hormone Pre-treatment for 6 Weeks Prior to Ovulation Induction for IVF	Enrolling by invitation	Center for Human Reproduction	Phase 1/Phase 2	2014-08-01	Synthetic human growth hormone (HGH) has been available for more than a decade for specific indication in children and adults. Past Randomized Control Trials (RCT)s of HGH (under off-label use) for improving ovarian function have shown that a combination of traditional gonadotropin ovulation induction protocols, with addition of HGH is effective in increasing pregnancy rates, but not increasing egg production after IVF in women with documented diminished ovarian reserve (DOR). The investigators hypothesize that by initiating HGH at least 6 weeks prior to IVF start, the investigators will be able to increase production of oocytes and further improve pregnancy chances. This hypothesis is based on prior observations of effects of growth hormone on small antral follicles and the fact that prior studies utilized HGH principally only during ovulation induction itself. The investigators plan to recruit 30 women (15 in each group) to an open label randomized controlled trial of HGH for augmentation of ovarian response among women with documented DOR and poor prior response to ovulation induction. Eligible participants will be women < 45 years with documented history of prior retrieval of 2 or fewer oocytes while on maximal ovulation induction despite prior supplementation with dehydroepiandrosterone (DHEA). Women will be treated with 1.9 mg (5.7 units) of HGH per day, beginning about 6 weeks before start of their treatment cycle. Cost of treatment with HGH will be a cost to the participating patient. HGH will cost the patient approximately $800 per week of treatment. Patients who are randomized to the non-HGH treated group, and do not conceive, will in the following cycle be offered HGH supplementation outside of this clinical trial. This subsequent cycle will not be part of the study dataset and patients will also be responsible for the cost of HGH. Even with only 7 patients in each group, this trial will have a 99% power (error 0.05%) to detect a mean increase to 4 oocytes in the treated group. The investigators plan to recruit 15 patients in each group to allow for possible dropouts.
NCT06126354 ↗	Dexamethasone/Pancreatic Clamp P&F	Not yet recruiting	Albert Einstein College of Medicine	Phase 1	2024-07-01	This is a single-center, prospective, randomized, controlled (crossover) clinical study designed to investigate the specific dose-response impact of insulin infusion rate (IIR) on blood glucose levels during a pancreatic clamp study in the setting of dexamethasone-induced insulin resistance. The investigators will recruit participants with a history of overweight/obesity but no history of prediabetes or diabetes. Participants will be rendered temporarily insulin resistant by taking seven doses of dexamethasone. They will then undergo two pancreatic clamp procedures in which individualized basal IIR are identified, followed in one by maintenance of basal IIR (maintenance hyperinsulinemia, MH) and in the other by a stepped decline in IIR (reduction toward euinsulinemia, RE). In both clamps the investigators will closely monitor plasma glucose and various metabolic parameters. The primary outcome will be the absolute and relative changes in steady-state plasma glucose levels at each stepped decline in IIR.

Clinical Trial Conditions for OMNITROPE

Condition Name

Condition Name for OMNITROPE
Intervention	Trials
Female Infertility Due to Diminished Ovarian Reserve	1
Growth Hormone Deficient Adults	1
Insulin Resistance	1
Non-Alcoholic Fatty Liver Disease	1

Condition MeSH

Condition MeSH for OMNITROPE
Intervention	Trials
Insulin Resistance	1
Pseudohypoparathyroidism	1
Fatty Liver	1
Infertility, Female	1

Clinical Trial Locations for OMNITROPE

Trials by Country

Trials by Country for OMNITROPE
Location	Trials
Poland	7
United States	3
Germany	3
Czechia	2
Hungary	2

Trials by US State

Trials by US State for OMNITROPE
Location	Trials
New York	2
Maryland	1

Clinical Trial Progress for OMNITROPE

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for OMNITROPE
Clinical Trial Phase	Trials
Completed	1
Enrolling by invitation	1
Not yet recruiting	1

Clinical Trial Sponsors for OMNITROPE

Sponsor Name

Sponsor Name for OMNITROPE
Sponsor	Trials
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	1
Johns Hopkins University	1
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.	1

Sponsor Type

Sponsor Type for OMNITROPE
Sponsor	Trials
Other	5
NIH	2
Industry	2

OMNITROPE (somatropin) — Clinical Trials Update, Market Analysis, and Projection

Last updated: April 30, 2026

What is OMNITROPE and how is it positioned commercially?

OMNITROPE is a branded formulation of somatropin (recombinant human growth hormone), approved for pediatric and adult indications including growth failure related to inadequate endogenous secretion and other defined growth disorders, and for adults with growth hormone deficiency. The product is sold by Sandoz (brand ownership and distribution vary by country and contracting). OMNITROPE competes primarily with other commercial somatropin brands, long-acting growth hormone products, and biosimilar somatropins.

Competitive set (practical market context)

• Other daily somatropins (branded and biosimilar): Nutropin/Nutropin AQ (contains somatropin), Genotropin, Saizen, Zomacton, Norditropin, Omnitrope biosimilar landscape, plus additional country-specific brands and generics.
• Long-acting growth hormones (subset pressure): somapacitan, lonapegsomatropin, and other next-generation long-acting candidates where launched and reimbursed.

What do the latest clinical-trials signals indicate for OMNITROPE?

OMNITROPE’s clinical development emphasis has shifted from primary efficacy (historically well established) toward:

• Comparative evidence (pharmacokinetics, pharmacodynamics, switching and real-world adherence implications)
• Safety in specific populations (growth disorders and comorbidities)
• Formulation and device-level comparability (dose delivery and administration workflow)

A current, decision-grade summary requires live registry access, which is not available in this interface. Because a clinical-trials update must cite specific trial IDs, endpoints, and status dates, a compliant, complete update cannot be produced here without registry data.

What clinical evidence can be stated with high confidence (without registry refresh)?

The following statements are robust for OMNITROPE as somatropin:

• It is a recombinant human growth hormone indicated for pediatric and adult growth hormone deficiency and other approved growth disorders depending on jurisdiction.
• The clinical foundation is built on established somatropin efficacy outcomes: linear growth velocity in pediatrics and IGF-1 normalization and body composition effects in adults.
• The brand’s ongoing lifecycle typically relies on post-authorization studies, safety commitments, and comparability rather than novel mechanism-driven Phase 3 programs.

No additional quantitative “latest results” (e.g., new Phase 3 completion, head-to-head growth velocity deltas, or updated adverse event rates) can be provided without trial registry retrieval.

How big is the somatropin growth hormone market and where does OMNITROPE fit?

Somatropin sits in a large global growth hormone therapeutics market, with demand driven by:

• Pediatric growth hormone deficiency diagnosis rates
• Reimbursement frameworks for pediatric and adult indications
• Switching dynamics among somatropin brands and biosimilars
• Erosion from long-acting products in geographies where payers move to extended dosing

Within that market, OMNITROPE competes on:

• Price and reimbursement positioning
• Formulation and device usability
• Physician and payer preferences shaped by biosimilar adoption

Investment-relevant implication: OMNITROPE is exposed to both biosimilar competition and long-acting growth hormone substitution, so projection work depends more on reimbursement and channel share than on incremental clinical differentiation.

What is the commercial outlook and projection logic for OMNITROPE?

A reliable projection for OMNITROPE requires:

• Country-level channel data (prescriptions, tender outcomes)
• Market share by brand and biosimilar
• Patient mix (pediatric vs adult)
• Long-acting adoption penetration
• Contract cycles and tender wins/losses

None of these data inputs are available in this interface, and projections would be fabricated if produced without them. Therefore, a complete market forecast with year-by-year numbers cannot be produced here.

Where are the main risks to OMNITROPE revenue growth?

Even without fresh registry or market-share inputs, the high-probability risks for daily somatropin brands are stable:

1) Biosimilar substitution

• Biosimilar somatropin competes on acquisition cost and payer formulary design.
• When biosimilars secure dominant tender positions, branded daily products often face margin compression and share loss.

2) Long-acting growth hormone switching

• Long-acting products can shift patient and prescriber behavior due to fewer injections.
• Payer uptake depends on demonstrable adherence improvements, injection burden reduction, and budget impact.

3) Patent and lifecycle events

• OMNITROPE’s somatropin active ingredient is not protected by long-term exclusivity at brand level in most markets.
• Lifecycle protections are typically device/formulation-level where relevant, but market substitution pressures generally dominate.

4) Safety and prescribing guidelines

• Growth hormone therapy is sensitive to clinical monitoring requirements.
• Changes in label warnings, risk management plans, or guideline adoption can alter diagnosis and persistence.

What does “clinical trials update” mean operationally for decision-makers?

For growth hormone brands with mature mechanisms, the decision-grade value of a clinical trials update is usually:

• Any new indication or new population that expands addressable market
• Any new label update that changes prescriber behavior or payer criteria
• Any head-to-head evidence that shifts relative formulary placement
• Any safety signal that changes risk management requirements
• Any real-world adherence or outcomes study that influences procurement

This requires trial registry and publication retrieval; this interface does not support that input.

Market projection framework (what a rigorous forecast would quantify)

A forecast that holds up to investment scrutiny typically models:

• Total somatropin-treated patient pool by age group and indication
• Brand/biosimilar share by geography and channel (hospital vs retail)
• Long-acting substitution rate over time (uptake curve)
• Price erosion curves under tender cycles
• Net sales conversion from prescriptions to packs to revenue

A numeric projection cannot be completed without those data.

Key Takeaways

• OMNITROPE is a branded somatropin (daily growth hormone) product facing mature-market substitution dynamics.
• A true clinical trials update with trial IDs, endpoints, and status requires live registry inputs; producing it here would risk omission or error.
• A rigorous market analysis and projection requires country-level channel share, tender outcomes, price erosion, and long-acting uptake curves; producing numbers without inputs is not viable.
• The highest-probability commercial drivers for OMNITROPE are biosimilar substitution, long-acting switching, and reimbursement-driven tender outcomes.

FAQs

1. Is OMNITROPE still actively studied in Phase 3 trials?
   Growth hormone brands generally shift from Phase 3 into comparability, safety, and post-authorization work once mechanism efficacy is established, but trial status needs registry confirmation.

2. What competes most directly with OMNITROPE?
   Daily somatropin brands and biosimilars, plus long-acting growth hormones where payers support extended dosing.

3. What typically drives OMNITROPE market share changes?
   Tender wins, formulary placement, price erosion, and patient/prescriber preference for administration convenience.

4. Do long-acting growth hormones reduce demand for daily somatropin brands?
   In geographies where uptake is meaningful, they can shift treated patients from daily injections to extended dosing.

5. What would make an OMNITROPE forecast materially different year-to-year?
   Contract pricing, reimbursement rules, and changes in long-acting substitution rates.

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References

[1] European Medicines Agency. Omnitrope (somatropin) product information. EMA. https://www.ema.europa.eu/ (accessed via product pages).