CLINICAL TRIALS PROFILE FOR NUTROPIN

All Clinical Trials for NUTROPIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00079742 ↗	A Study to Evaluate Nutropin AQ for the Treatment of Growth Restriction in Children With Cystic Fibrosis	Completed	Genentech, Inc.	Phase 2	2003-09-01	This is a Phase II, multicenter, randomized, controlled, open-label trial of the safety and efficacy of Nutropin AQ administered subcutaneously (SC) daily in prepubertal children with CF and growth restriction.
NCT00102258 ↗	Role of Nutrition and Hormones in Boys With Disordered Growth	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2	2005-01-19	This study will determine whether adding more calories to the diet helps boys with growth problems grow better while being treated with Nutropin, a growth hormone that is used to help children grow taller. The Food and Drug Administration has approved Nutropin for use in children who are very short. This study will examine whether giving nutritional supplements in addition to Nutropin can help children grow better than with Nutropin alone. Boys between 7 and 10 years of age who are very short and below average in weight, but are otherwise healthy may be eligible for this study. Candidates must qualify for Nutropin treatments to boost their growth. Boys will be recruited for the study from the Nemours Children's Clinic in Jacksonville, FL, and from the National Institutes of Health in Bethesda, MD. Participants are randomly assigned to one of two treatment groups. One group is observed for 6 months and then receives a Nutropin injection every day for 12 months. The second group drinks 8 ounces of a high-calorie beverage called Pediasure every day for 6 months and then receives Nutropin plus Pediasure every day for 12 months. In addition to treatment, participants undergo the following tests and procedures at the schedule indicated: Baseline, 3, 6, 9, 12, 15 and 18 months - Clinical examination - Height measurement - Body composition assessment: Skin-fold thickness calipers are used in four places on the body to estimate body fat - Bioelectric impedance: A small amount of electrical current is used to calculate the percentage of body fat. Baseline, 6, 12, and 18 months - Blood tests - Bone age x-ray: x-ray of the left hand to measure growth potential - DEXA (dual energy x-ray absorptiometry) scan: x-ray scan to measure body fat, muscle, and bone mineral content. The subject lies on a flat table during the scan. Baseline, 6, and 12 months - Record of dietary intake: Parents are asked to write down everything the child eats and drinks for 3 days. Using this record, a dietitian calculates the daily caloric intake. - Total energy expenditure: This test determines how much energy the child uses. For the test, the child drinks water labeled with harmless isotopes (heavy oxygen and heavy hydrogen). For the next 10 days he collects urine in plastic tubes at home. At the end of the 10 days, the parents bring the urine to the clinic for analysis to determine how fast the labeled water leaves the body. This information is used to calculate how much energy the child expends each day. Participants' weight is measured at 2 and 4 weeks, and then monthly for the remainder of the 18-month study.
NCT00134420 ↗	Growth Hormone and Chromosome 18q- and Abnormal Growth	Completed	Genentech, Inc.	Phase 3	2001-02-01	We, the investigators at the University of Texas Health Science Center at San Antonio, want to learn if height and IQ (intelligence quotient) scores are improved by growth hormone (GH) treatment in children with chromosome 18 deletions and abnormal growth. Data from a previous study showed that growth hormone improved height in all children with 18q- and growth hormone deficiency. In addition, most of the study participants on growth hormone treatment showed an increase in IQ scores.
NCT00134420 ↗	Growth Hormone and Chromosome 18q- and Abnormal Growth	Completed	South Texas Veterans Health Care System	Phase 3	2001-02-01	We, the investigators at the University of Texas Health Science Center at San Antonio, want to learn if height and IQ (intelligence quotient) scores are improved by growth hormone (GH) treatment in children with chromosome 18 deletions and abnormal growth. Data from a previous study showed that growth hormone improved height in all children with 18q- and growth hormone deficiency. In addition, most of the study participants on growth hormone treatment showed an increase in IQ scores.
NCT00134420 ↗	Growth Hormone and Chromosome 18q- and Abnormal Growth	Completed	The University of Texas Health Science Center at San Antonio	Phase 3	2001-02-01	We, the investigators at the University of Texas Health Science Center at San Antonio, want to learn if height and IQ (intelligence quotient) scores are improved by growth hormone (GH) treatment in children with chromosome 18 deletions and abnormal growth. Data from a previous study showed that growth hormone improved height in all children with 18q- and growth hormone deficiency. In addition, most of the study participants on growth hormone treatment showed an increase in IQ scores.
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

Clinical Trial Conditions for NUTROPIN

Condition Name

Condition Name for NUTROPIN
Intervention	Trials
Growth Hormone Deficiency	4
Cystic Fibrosis	2
Mucopolysaccharidosis VI	1
Dwarfism, Pituitary	1

Condition MeSH

Condition MeSH for NUTROPIN
Intervention	Trials
Dwarfism, Pituitary	5
Endocrine System Diseases	2
Fibrosis	2
Cystic Fibrosis	2

Clinical Trial Locations for NUTROPIN

Trials by Country

Trials by Country for NUTROPIN
Location	Trials
United States	48

Trials by US State

Trials by US State for NUTROPIN
Location	Trials
New York	5
Texas	4
Florida	4
Minnesota	3
Georgia	2

Clinical Trial Progress for NUTROPIN

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for NUTROPIN
Clinical Trial Phase	Trials
Completed	4
Withdrawn	4
Terminated	2

Clinical Trial Sponsors for NUTROPIN

Sponsor Name

Sponsor Name for NUTROPIN
Sponsor	Trials
Genentech, Inc.	5
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	2
University of Texas Southwestern Medical Center	2

Sponsor Type

Sponsor Type for NUTROPIN
Sponsor	Trials
Other	11
Industry	7
NIH	2

Last updated: April 28, 2026

Nutropin (somatropin): clinical trials update, market analysis, and demand projection

What is Nutropin in the current clinical and commercial landscape?

Nutropin is a brand of somatropin (human growth hormone, hGH), used for approved indications across pediatric growth disorders and adult growth hormone deficiency (GHD). The product competes in a crowded somatropin category that includes multiple originator and biosimilar brands, plus additional long-acting growth hormone therapies.

From a clinical perspective, Nutropin is not a “new entrant” molecule in 2026. The commercial and clinical narrative is driven by (1) label updates that occur over time for existing growth hormone products, and (2) prescribing behavior shaped by device/administration convenience, payer positioning, and biosimilar penetration.

What does “clinical trials update” mean for Nutropin specifically?

For legacy brands of an established biologic like somatropin, “clinical trials updates” generally show up as:

• Post-authorization commitments and label expansions (often years after initial approval).
• Comparative bioequivalence and switching studies for different formulations or devices.
• Real-world evidence (RWE) studies that track growth outcomes, safety, and persistence by product and patient subgroup.

At the molecule level, somatropin’s clinical activity is now largely maintained through incremental comparative programs, not broad new efficacy-defining Phase 3 programs that would reset the evidence base. That pattern is consistent with how regulators treat long-established proteins once core efficacy is established and multiple products compete in the same therapeutic class.

What is the market structure for somatropin products where Nutropin competes?

Nutropin’s market sits inside the global growth hormone therapy market, split by:

• Daily somatropin products (short-acting).
• Long-acting growth hormones (a different dosing profile with distinct market behavior).
• Biosimilars (multiple somatropin brands in many markets).

Commercial performance for any single brand depends less on incremental clinical superiority and more on:

• Formulation and device differentiation (ease of use, stability, dosing accuracy).
• Pricing and rebate dynamics (especially in US managed care).
• Interchangeability and payer policies that steer toward lower-cost alternatives.

Clinical trial pipeline risk for Nutropin: what changes and what does not

Because Nutropin is somatropin, the category’s core endpoints are well established:

• Growth velocity in pediatric populations.
• IGF-1 normalization and clinical outcomes in GHD.
• Safety monitoring focused on known class risks (e.g., intracranial hypertension, slipped capital femoral epiphysis, edema, glucose intolerance, malignancy surveillance depending on indication and history).

The competitive risk for Nutropin is not “clinical failure,” it is market share erosion from:

• Biosimilars at lower net price.
• Long-acting growth hormone therapies that can change adherence and payer contracting strategies.

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Market analysis: where Nutropin sits by region and payer behavior

How does biosimilar competition typically affect Nutropin-like brands?

In markets where biosimilars dominate, originator-like brands usually face:

• Lower list price positioning but higher rebate complexity.
• Concentration of demand in specific formularies where the brand remains preferred.
• Gradual decline in new starts if a biosimilar is designated as preferred.

The practical effect is that brand trajectories are often measured in:

• Share of new prescriptions (initiation share).
• Persistence and switch rates under payer pressure.
• Net pricing after rebates rather than list price.

What is the growth driver outlook for growth hormone therapy demand?

Demand for growth hormone therapy in general is supported by:

• Pediatric diagnosis and earlier detection of growth disorders.
• Ongoing prevalence of GHD and Turner syndrome-related growth deficits.
• Adult GHD identification and treatment expansion in treated populations.

However, growth in total units is tempered by:

• Competition from lower-cost somatropins and biosimilars.
• Switching to long-acting products in some patient segments (not uniform across all payers).

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Demand projection framework for Nutropin (somatropin): unit and revenue directionality

What can be projected with high confidence for Nutropin-like daily somatropins?

Without creating a false precision on brand-level numbers, the directional projection is robust:

1. Total category demand rises modestly over the medium term due to prevalence and diagnosis.
2. Share shifts away from single-brand daily products toward:
   • biosimilars within daily somatropin,
   • and long-acting products where payer coverage supports them.
3. Nutropin’s revenue trend is more sensitive to net price and formulary placement than to biologic “clinical differentiation.”

Three scenario projection (directional, not point estimates)

Scenario	Macro growth hormone demand	Share outcome vs biosimilars	Share outcome vs long-acting	Net direction for Nutropin
Base	Moderate	Partial loss	Partial loss	Stagnation to mid-single-digit decline
Upside	Stronger diagnosis uptake	Slower share erosion	Limited long-acting penetration	Flat to slight growth
Downside	Managed care intensifies	Rapid share erosion	Faster switching	Low to mid-single-digit decline accelerating

This is the expected shape for a legacy daily somatropin brand once biosimilar and long-acting competitors consolidate share.

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Actionable competitive takeaways for R&D and investment decisions

What matters most for Nutropin commercial durability?

• Formulary status in major plans and PBMs (preferred tier and step edits).
• Net pricing after rebates and contracting.
• Patient support infrastructure (start and adherence programs tend to matter for daily injectables).
• Switch management (both clinical protocol readiness and payer pathways).

Where clinical differentiation is likely to appear (if at all)

For existing somatropin brands, “differentiation” tends to be operational:

• Device usability and injection confidence.
• Dosing workflow integration with patient support programs.
• Adherence advantages tied to real-world injection burden rather than new clinical efficacy claims.

What signals to track to refine the projection

• Formulary changes by large payers.
• Bioequivalence and interchangeability decisions in key markets.
• Uptake metrics for long-acting growth hormones in pediatric and adult subsets.
• Persistence and switching rates captured in RWE datasets and claims analyses.

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Key Takeaways

• Nutropin is somatropin, a well-established growth hormone biologic where clinical evidence is mature and incremental updates are mostly operational or label-supporting rather than efficacy-resetting.
• Market outcomes are primarily pricing and formulary driven, with biosimilar penetration and long-acting product uptake shifting share away from single-brand daily products.
• Directional demand projection: category demand likely rises modestly, while Nutropin brand share and net revenue face gradual erosion unless it maintains preferred formulary positioning and contracting.
• Competitive monitoring should focus on payer policy, net price, and switch/persistence metrics, not new blockbuster clinical claims.

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FAQs

1) Is Nutropin still undergoing major new clinical trials?

For legacy somatropin brands, evidence updates are typically incremental and not characterized by new large Phase 3 efficacy-defining programs.

2) What is the biggest risk to Nutropin revenue?

Biosimilar and payer-driven substitution pressure, plus potential switching to long-acting growth hormone therapies when coverage enables it.

3) What is the biggest upside for Nutropin?

Maintaining preferred formulary status and favorable net pricing through contracting, plus stable patient persistence and lower switching rates.

4) Does long-acting growth hormone replace Nutropin one-to-one?

Not uniformly. Adoption depends on payer coverage, patient selection, and injection-administration constraints, so the substitution is segment-specific.

5) How should investors model Nutropin’s near-term trajectory?

Use scenario-based share and net price assumptions tied to payer contracting, rather than assuming new clinical efficacy breakthroughs.

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References

[1] FDA. Nutropin (somatropin) product information and labeling resources. U.S. Food and Drug Administration. (Accessed via FDA labeling database).
[2] EMA. Somatropin-related assessment information and public assessment documents. European Medicines Agency. (Accessed via EMA product/EPAR resources).
[3] ClinicalTrials.gov. Search results for Nutropin and somatropin clinical studies. U.S. National Library of Medicine.
[4] OECD/WHO and national surveillance sources. Growth disorder prevalence and diagnostic trend publications. (Used for demand-side logic in market forecasting frameworks).
[5] IQVIA / EvaluatePharma style market coverage (general category dynamics). Growth hormone market trends, biosimilar penetration, and long-acting uptake dynamics. (Used for directional market modeling conventions).