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.

Clinical Trial Conditions for OMNITROPE

Condition Name

Condition Name for OMNITROPE
Intervention	Trials
Prediabetic State	1
Pseudohypoparathyroidism Type 1a	1
Small for Gestational Age	1
Adult Growth Hormone Deficiency	1

Condition MeSH

Condition MeSH for OMNITROPE
Intervention	Trials
Endocrine System Diseases	1
Non-alcoholic Fatty Liver Disease	1
Dwarfism, Pituitary	1
Liver Diseases	1

Clinical Trial Locations for OMNITROPE

Trials by Country

Trials by Country for OMNITROPE
Location	Trials
Poland	7
United States	3
Germany	3
Romania	2
Belgium	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
Not yet recruiting	1
Active, not recruiting	1
Recruiting	1

Clinical Trial Sponsors for OMNITROPE

Sponsor Name

Sponsor Name for OMNITROPE
Sponsor	Trials
Center for Human Reproduction	1
Albert Einstein College of Medicine	1
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	1

Sponsor Type

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

OMNITROPE (somatropin) clinical trials update, market analysis, and projection (2026–2031)

Last updated: July 30, 2026

Omnitrope (somatropin) is a prescription recombinant human growth hormone (r-hGH) used for pediatric growth failure and adult growth hormone deficiency. Commercial performance is supported by established labeling, broad clinician familiarity, and multi-source competition typical for r-hGH. Public, drug-level clinical-trial visibility for “Omnitrope” specifically is limited; most recent activity in somatropin generally clusters around new presentations, biosimilar competition dynamics, and post-marketing safety rather than new, label-expanding phase 3 efficacy programs.

Market outlook through 2031 depends more on (1) share capture versus biosimilar/similar r-hGH entrants, (2) payer contracting and tendering patterns, (3) substitution rules in each country, and (4) any regulatory movement in switching guidance for interchangeability of r-hGH products. In the US, the presence of multiple r-hGH products and long-standing generic/similar competition compresses net pricing, shifting market value toward volume and rebates rather than premium brand pricing.

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What clinical trials are ongoing or recently completed for Omnitrope (somatropin) in 2024–2026?

Answer (featured snippet): Public trial registries show limited Omnitrope-branded late-stage programs; most recent labeled-relevance evidence is either older pivotal data for somatropin products or post-authorization commitments, with newer activity often tied to formulations, delivery devices, or comparative pharmacokinetic/safety studies rather than new indications.

How to read “Omnitrope” trial activity versus “somatropin” activity

Omnitrope is one trade name within the somatropin r-hGH class. In practice:

• Registries often list “somatropin” or “somatropin product” rather than “Omnitrope” by name, especially for device or formulation work.
• Competitor products run parallel comparative PK studies that can affect interchange decisions and payer acceptance even without label expansion.
• After launch, manufacturers typically run post-marketing safety and usability studies rather than new phase 3 efficacy programs.

Clinical endpoints that tend to dominate after launch

For r-hGH, newer trials (when they appear) usually evaluate:

• IGF-1 pharmacodynamics and dose normalization
• Growth velocity and height SDS in pediatric subpopulations
• Safety and immunogenicity (anti-drug antibodies, neutralizing antibodies)
• Device usability (pen/dosing step accuracy, adherence metrics)
• Switching, treatment continuity, and real-world adherence endpoints

Key risk to assumption of “new efficacy”

Absent label-expanding trials in recent years, clinical-trial updates for Omnitrope are more likely to be:

• PK/bioequivalence-style studies
• Post-marketing surveillance refinements
• Registry studies on safety in special populations

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What is the Orange Book status of Omnitrope and what does that imply for generic entry?

Answer (featured snippet): Omnitrope (somatropin) is regulated as a biologic; it is not listed in the FDA’s Orange Book in the way small-molecule drugs are. Generic “entry” is not the primary framework; competition generally comes through r-hGH biosimilar or related biologic pathways.

US exclusivity and “follow-on” competition mechanics

For biologics:

• Approval pathways use BLA frameworks, and competition relies on biosimilar approval.
• Pricing pressure is driven by tendering, payer policies, and biosimilar uptake.
• “Generic entry” language maps poorly to r-hGH; “biosimilar uptake” is the more accurate commercial driver.

Where “Orange Book style” confusion matters

Commercial teams sometimes look for Orange Book listings expecting Paragraph IV triggers. For Omnitrope:

• The relevant exclusivity and patent framework is still critical, but it is enforced through biologic-related litigation and BPCIA mechanisms rather than Orange Book Para IV.

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How strong is the patent estate for Omnitrope (somatropin) and what patents typically matter?

Answer (featured snippet): For older r-hGH brands, the controlling IP usually shifts from composition-of-matter to secondary IP such as dosing regimens, manufacturing process improvements, and formulation/device patents, while core expiry often occurred years earlier. For Omnitrope specifically, the actionable picture depends on jurisdiction and the exact filing family controlling the marketed presentation.

Patent estate components that influence exclusivity and litigation

Typical patent buckets in r-hGH markets:

1. Manufacturing/process patents (cell lines, fermentation, purification, formulation controls)
2. Formulation/device patents (injector/pen systems, concentration stability, reconstitution)
3. Method-of-use or dosing regimen patents (specific schedules, titration approaches)
4. Second medical use concepts (less common for well-established pediatric indications, but can exist)
5. Regulatory exclusivities (data exclusivity periods, pediatric labeling extensions) where applicable

Why the Omnitrope-specific estate matters less than uptake

Even when patents exist, real-world pricing is often dominated by:

• biosimilar/similar r-hGH availability
• payer tendering
• physician switching behavior
• contract position (best price, formulary placement)

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When does Omnitrope lose exclusivity in major markets and what drives time-to-biosimilar uptake?

Answer (featured snippet): Omnitrope exclusivity timelines are largely determined by biologics exclusivities and patent expiration across jurisdictions, and uptake is usually faster than patent countdown suggests due to multiple competing products already on market in many countries.

Primary drivers of “effective” exclusivity

• Payer formularies and switching policies: if a biosimilar is on formulary, switching can occur quickly.
• Tender results: contract-based winners can take meaningful share within quarters.
• Supply and delivery device acceptance: pen reliability and training support affect switching.
• Physician preference and patient history: r-hGH is long-term therapy, so stability and adherence drive behavior.

Market-by-market pattern

In mature r-hGH markets, effective exclusivity usually compresses when:

• a biosimilar is approved and listed
• a payer classifies products as substitutable
• reimbursement spreads savings quickly

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Which companies are competing with Omnitrope (somatropin) across biosimilars, similar biologics, and authorized generics?

Answer (featured snippet): Competition in r-hGH is multi-brand and largely biosimilar-driven across most major markets, with share shifting based on formulary placement and contract pricing.

Competitive landscape considerations for Omnitrope

• Concentration: each country tends to have a small set of r-hGH products that dominate reimbursement.
• Device ecosystem: switching friction is reduced when pens are familiar and needle-free options are available.
• Pediatric patient management: wholesalers and specialty pharmacies influence continuity.

How to evaluate competitor pressure

A practical competitor assessment uses:

• number of available r-hGH products on formulary
• penetration of biosimilars/similar r-hGH
• average net price trajectory and rebate intensity
• switching rate after tender awards

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What market size, revenue trends, and pricing dynamics apply to Omnitrope (r-hGH) from 2019–2025?

Answer (featured snippet): Omnitrope sits in a mature r-hGH market where price erosion is common and revenue growth comes more from volume retention and contract wins than from new indication-driven expansion.

Commercial value chain

• Prescription growth in pediatric indications is constrained by epidemiology and adherence.
• Adult GH deficiency can add incremental volume, but the category is still mature.
• Net revenue is heavily influenced by:
  • reimbursement levels
  • rebates
  • tendering frequency
  • pharmacy benefit strategy

Pricing mechanics

• In tendering markets, net pricing can drop quickly following competitor entry.
• In non-tender markets, pricing pressure happens through formulary re-tiering and annual contract renegotiations.

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What is the 2026–2031 revenue projection for Omnitrope and what scenarios drive upside or downside?

Answer (featured snippet): Through 2031, Omnitrope’s revenue trajectory is most likely to track market share against the most aggressive contract-tier r-hGH products, with modest top-line growth possible only if it holds net share amid continued price compression.

Projection framework (scenario-based, category-driven)

Given r-hGH market maturity, the projection hinges on:

• Share retention: probability of staying in preferred formulary tiers
• Net price: elasticity to tendering and rebate intensity
• Mix shift: pediatric versus adult use, and higher-dosing subpopulations
• Switching inertia: pediatric patients switching less frequently unless compelled by payer rules

Three scenarios

1. Base case (share stable, moderate price erosion):
   • revenue declines slightly or grows minimally
   • margin pressure from rebates continues
2. Downside (share loss due to aggressive tender wins):
   • revenue declines more noticeably
   • distribution relies on non-preferred channels
3. Upside (contract wins and device-driven adherence improvements):
   • revenue holds better than category average
   • limited rebound if net price erosion is slower

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How do formulation, device, and manufacturing updates affect Omnitrope switching and payer decisions?

Answer (featured snippet): In r-hGH, device usability and injection experience are major practical levers for adherence. Formulation or manufacturing changes can influence switching rates when they improve stability, reduce errors, or support pharmacy handling.

Key technical decision points that affect commercial uptake

• pen ergonomics and dosing accuracy
• injection-site tolerability and patient-reported outcomes
• reconstitution steps (if applicable) and stability windows
• cold-chain and distribution handling requirements

What this means for “clinical trials updates”

Trials that matter commercially are often:

• PK/safety bridging studies for reformulations
• usability studies and post-market adherence evidence
• immunogenicity monitoring after process changes

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What does biosimilar risk look like for Omnitrope (somatropin) in 2026–2031?

Answer (featured snippet): Biosimilar risk is structural and ongoing in r-hGH; the main risk is not whether biosimilars exist, but how quickly payers switch to the lowest net cost r-hGH contracts.

Biosimilar uptake accelerants

• multiple biosimilar options reducing differentiation
• active tendering cycles
• formulary switching rules for stable patients
• pharmacy channel pressure and patient support programs

Biosimilar defensibility levers (where applicable)

• patient support programs
• clinician confidence in device and titration support
• supply reliability and reduced injection errors

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How does Omnitrope compare with other somatropin brands on access, dosing options, and patient support?

Answer (featured snippet): Across somatropin brands, clinical efficacy is often viewed as comparable by prescribers at equal dosing due to shared class expectations, so differences that drive access are usually payer contracting, device experience, and patient support infrastructure.

Comparison dimensions that typically drive formulary access

• formulary tier and restricted prescribing criteria
• prior authorization burden
• reimbursement stability during tender cycles
• device training support
• specialty pharmacy dispensing model

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What patent litigation and settlements affect somatropin r-hGH competitors’ market entry?

Answer (featured snippet): R-hGH competition frequently includes patent enforcement around biologic IP and manufacturing/process claims, with settlement agreements used to structure entry dates and launch sequencing.

What to watch in somatropin-related disputes

• whether injunctions are sought and granted at district court level
• timing of FDA approval versus launch date
• carve-outs for specific presentations, strengths, or delivery devices
• settlement language that impacts shelf timing and reimbursement

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What FDA regulatory milestones affect Omnitrope performance, label coverage, and launch timing of competitors?

Answer (featured snippet): For r-hGH products, milestones that matter commercially include label updates, safety communications, and approvals of biosimilar products that trigger payer switching.

Milestone types

• post-marketing requirements and periodic safety reporting
• label updates for pediatric and adult subgroups
• manufacturing site updates and comparability reports
• approvals of new presentations that can affect substitution and adherence

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Key Takeaways

• Omnitrope operates in a mature r-hGH market where price and payer contracting dominate outcomes more than new clinical efficacy breakthroughs.
• Public “Omnitrope-branded” trial activity is likely limited; category-relevant data generally comes from PK, bridging, device/usability, and post-marketing safety work rather than label-expanding phase 3 programs.
• Exclusivity and patent control are less likely to determine outcomes than biosimilar and similar r-hGH availability plus payer switching behavior.
• 2026–2031 revenue projections should be built around net share against the lowest-net-cost r-hGH products in each country, with downside risk if tendering shifts volume to competitors.

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FAQs

1. Do biosimilars of somatropin automatically replace Omnitrope on formularies?
   Not automatically; substitution depends on each payer’s formulary tiering and switching rules.

2. What evidence matters most when payers decide between different somatropin products?
   Net cost, patient adherence impact, device reliability, and how the product performs in switching programs.

3. Can formulation or pen changes materially reduce switching friction for r-hGH?
   Yes; usability, injection accuracy, and patient-reported tolerability can affect persistence and uptake.

4. What is the typical clinical endpoint in post-authorization studies for r-hGH products?
   IGF-1 pharmacodynamics, growth velocity/height metrics in pediatric cohorts, and immunogenicity monitoring.

5. How should companies model Omnitrope risk from biosimilar entry?
   Use scenario planning on tender cycles, expected share shifts, and net price erosion rather than relying on a single approval date.

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References

1. FDA. “Biologics License Application (BLA) approval pathways and related guidance.” U.S. Food and Drug Administration.
2. FDA. “Orange Book guidance and listings.” U.S. Food and Drug Administration.
3. EMA. “Biosimilar medicines: regulatory framework.” European Medicines Agency.
4. ClinicalTrials.gov. Omnitrope and somatropin search results (trial registry records).