CLINICAL TRIALS PROFILE FOR HUMATROPE

All Clinical Trials for HUMATROPE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001305 ↗	Growth Hormone Therapy in Osteogenesis Imperfecta	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 3	1991-11-05	Growth deficiency is a key feature of severe Osteogenesis Imperfecta (OI) and a frequent feature of mild to moderate forms of the disease. The reason that children with OI are short is not fully understood. We do know that details such as the number of fractures suffered or the type of OI do not fully explain the short stature of OI. Growth patterns have been defined for children with OI Types I, III, and IV. At about 12 months of age, children with Types III and IV OI demonstrate a predictable plateau of their linear growth rate. Type IV OI children begin to resume a normal growth rate at about age four to five years, but they will not "catch up" to a normal height, as they have "lost" a significant period of growth. The plateau usually continues for children with Type III OI. The reason for this growth plateau is unknown. There have been no studies which evaluate the growth of OI children in this age range. Our previous studies of growth in OI children have begun at age 5 years. We have studied growth in OI children for the past 10 years. Different medications have been tried to both stimulate growth and improve bone density. Some children have responded to growth hormone (their growth rate increased by at least 50%) and some did not. The majority of children who did respond were Type IV. However, we need to carefully treat and study more children to try to determine which children will benefit from growth hormone medication. The Goals of this Study Are: 1. We want to try to find a cause for the growth plateau common in types III and IV OI. Long-term, our goal is to develop a treatment to eliminate this plateau. 2. We want to see how long and how well OI bone will respond to growth stimulation. 3. We hope to find a "predictor" for who will respond to growth hormone and who will not, by measuring your child's endocrine and growth hormone function before receiving any growth hormone treatment. 4. We want to measure the effects of growth stimulation on bone density, and the quality of OI bone. 5. We want to see if there are long term benefits resulting from this treatment in the form of final adult height, trunk height, and possibly improved function of the respiratory system. Median Subject Age (on p. 1 of webpage): 1-15 years (replaces 0-20)
NCT00001343 ↗	The Effects of Hormones in Growth Hormone-Treated Girls With Turner Syndrome	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2	1992-12-11	Turners Syndrome is a genetic condition in females that is a result of abnormal chromosomes. Patients with Turner syndrome are typically short, have abnormal physical features, and lack the physical changes normally associated with puberty. In addition, some patients with Turner syndrome have low bone density (osteoporosis) and differences in learning abilities. This study will research the effects of steroid hormones on patients with Turner syndrome. It will look closely at how taking steroid hormones effects the patient's rate of growth as well as the patient's ability to learn. In addition the study will investigate how different hormones (androgen and estrogen) work when given together as a combination. All patients asked to participate in this study will receive growth hormone injections. However, half of the patients will receive an additional sex steroid hormone (oxandrolone) in the form of a pill. The other half of the patients will receive a placebo or "sugar pill". This will allow the researchers to determine if the combination of the hormones produces different results than growth hormone alone. The study will last approximately 2 years. After 2 years of research the patients may qualify for an additional 2 years of treatment. Patients may benefit directly from this research with increased growth and improved ability to learn.
NCT00190658 ↗	Somatropin Treatment in Patients With SHOX Deficiency and Turner Syndrome	Completed	Eli Lilly and Company	Phase 3	2000-02-01	This clinical trial will compare the mean first year height velocity of somatropin-treated prepubertal patients with SHOX deficiency with the height velocity of a control group of untreated prepubertal patients with SHOX deficiency. Both groups will be compared to a somatropin-treated group of girls with Turner syndrome. After the second year patients in the control group have the option to receive treatment as well. All patients will optionally be treated until they achieved adult height.
NCT00191074 ↗	Amendment (g) Unblinded Extension Phase of Somatropin in Patients With Idiopathic Short Stature	Completed	Eli Lilly and Company	Phase 3	2001-02-01	After approval of amendment (g), patients who were still receiving study drug at the time were scheduled for a study visit. In addition, patients who had discontinued early from the core, blinded phase of the study were contacted. All of these patients were offered the opportunity to enter the unblinded extension phase (if they met eligibility criteria) and continue somatropin treatment (regardless of initial treatment randomization) until they reached final height.

Clinical Trial Conditions for HUMATROPE

Condition Name

Condition Name for HUMATROPE
Intervention	Trials
Turner Syndrome	3
Dwarfism, Growth Hormone Deficiency	1
Hypothyroidism	1
Pseudohypoparathyroidism Type 1a	1

Condition MeSH

Condition MeSH for HUMATROPE
Intervention	Trials
Primary Ovarian Insufficiency	4
Gonadal Dysgenesis	4
Dwarfism	4
Turner Syndrome	4

Clinical Trial Locations for HUMATROPE

Trials by Country

Trials by Country for HUMATROPE
Location	Trials
United States	20
Canada	7
Italy	1
Netherlands	1
France	1

Trials by US State

Trials by US State for HUMATROPE
Location	Trials
Maryland	4
New York	3
Pennsylvania	3
Texas	2
Washington	1

Clinical Trial Progress for HUMATROPE

Clinical Trial Phase

Clinical Trial Phase for HUMATROPE
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	6
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for HUMATROPE
Clinical Trial Phase	Trials
Completed	12
Recruiting	2
Terminated	2

Clinical Trial Sponsors for HUMATROPE

Sponsor Name

Sponsor Name for HUMATROPE
Sponsor	Trials
Eli Lilly and Company	10
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	3
University Health Network, Toronto	2

Sponsor Type

Sponsor Type for HUMATROPE
Sponsor	Trials
Other	11
Industry	11
NIH	6

HUMATROPE Clinical Trials Update, Market Analysis, and Exclusivity/Patent Projection (Somatropin)

Last updated: July 30, 2026

Executive summary: HUMATROPE (somatropin) is a marketed recombinant human growth hormone with a long-established FDA presence, and its commercial outlook is dominated by (1) global demand for growth hormone therapy in pediatric growth failure and adult GH deficiency, (2) competitive pressure from other somatropin products and long-acting growth hormones, and (3) the timing and scope of brand protections in the jurisdictions where biosimilar entry is enabled. In the U.S., HUMATROPE is not protected in the same way newer biologics are; competitive access is driven by the Orange Book/BLA reference status and biosimilar/authorized generic supply rather than remaining broad exclusivity for the reference biologic. A forward-looking market projection for HUMATROPE is therefore best framed around class-level growth, substitution dynamics, payer formularies, and persistence/penetration of competing GH regimens.

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What is HUMATROPE and how is somatropin positioned in pediatric and adult growth hormone deficiency?

HUMATROPE is a somatropin (recombinant human growth hormone) brand. It is used for growth failure in pediatric patients and for adult growth hormone deficiency, with dosing adjusted by indication, weight, and response.

Which clinical indications drive demand for HUMATROPE?

Classically, somatropin use spans:

• Pediatric growth failure (including conditions such as GH deficiency and other approved pediatric growth disorders, depending on labeling)
• Adult growth hormone deficiency

How do prescriber and payer decisions typically allocate somatropin volume?

Demand allocation for growth hormone products is shaped by:

• Device usability and dosing convenience (pen vs vial/syringe formats)
• Coverage tiering, step therapy, and patient out-of-pocket cost
• Clinical familiarity and switching patterns in pediatric endocrinology clinics
• Substitution pressure from other somatropin products and longer-acting formulations when payers enforce regimen uniformity

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What are the latest HUMATROPE clinical trials updates and pipeline readouts?

HUMATROPE is an established biologic. Clinical-trial “updates” for a legacy somatropin product usually manifest as:

• Post-authorization studies (real-world evidence, safety registries)
• Switching or device/administration studies (if the formulation or delivery platform changes)
• Pharmacokinetic comparability studies when manufacturing changes occur

However, a complete and accurate “latest clinical trials update” requires trial identifiers, dates, trial registry entries, and outcome details that are not provided in the request.

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How big is the HUMATROPE market and what drives growth versus decline?

What segments matter for somatropin brand revenue?

Somatropin market dollars track:

• Pediatric patient starts and persistence (dose changes with growth and adherence patterns)
• Adult GH deficiency incidence and diagnosis rates
• Geographic reimbursement coverage and specialty pharmacy penetration

What forces change HUMATROPE’s share over time?

Key share-shifting variables:

• Long-acting growth hormone competition (where payers prefer reduced injection frequency)
• Biosimilar/authorized biosimilar penetration (where available and where interchangeability rules allow)
• Wholesale acquisition cost and net price pressures via contracting
• Pediatric endocrinology guideline updates that change diagnostic thresholds or preferred regimens

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How does HUMATROPE compare with other somatropin products and long-acting growth hormones?

Comparability dimensions payers use in formulary decisions

• Dosing frequency and regimen convenience
• Device format (training burden and adherence)
• Clinical evidence and labeling differences that influence prior authorization criteria
• Contracting and rebates (net cost competitiveness)

Brand-to-class substitution risk

For a mature somatropin brand, the dominant commercial threat is “class substitution” driven by:

• Authorized generics or biosimilar availability
• Longer-acting options that reduce weekly injection burden
• Payer mandates for product consolidation within a drug class

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What is the FDA regulatory status of HUMATROPE and what does it imply for new trials?

What is HUMATROPE’s regulatory pathway character?

HUMATROPE is a reference biologic product with established FDA marketing authorization. For established biologics, incremental regulatory activity is typically tied to:

• Label updates
• CMC/manufacturing changes
• Postmarketing commitments

A detailed regulatory status update (Orange Book/BLA linkage, current label, safety alerts, and postmarketing requirement history) requires a list of current FDA documents, which is not provided in the request.

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What patents protect HUMATROPE and when do they expire?

How do protections work for somatropin brands in the U.S.?

HUMATROPE’s long commercial history means exclusivity and blocking patents that once protected the reference drug generally move through a sequence:

• Core composition/primary method patents from early development
• Formulation and device-related patents
• Manufacturing process patents
• Regulatory exclusivities and exclusivity periods tied to biologic licensing approval and pediatric terms

A precise “what patents protect HUMATROPE” list with numbers, assignees, filing dates, and expiration dates requires access to patent registries and Orange Book/BLA listings that are not included in the request.

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When does HUMATROPE lose exclusivity and what generic or biosimilar entry risks exist?

U.S. entry dynamics to model

For growth hormones:

• Biosimilar entry is constrained by biologic exclusivity and patent estates at the time of application
• If biosimilar applicants challenge relevant patents via pathway-specific procedures, launch depends on litigation outcomes or settlements

Accurate exclusivity timelines and entry risk assessment require patent-specific status (e.g., which patents are listed and whether challenges occurred), which is not supplied in the request.

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What patent litigation affects HUMATROPE, including Paragraph IV and settlements?

For biologics, the relevant analog to “Paragraph IV” is patent litigation triggered by biosimilar application patent listings and FDA patent list procedures. Litigation affects:

• Launch dates
• Scope of injunctions
• Settlement terms (often licensing or carve-outs)

No litigation docket, court, or settlement terms are provided in the request, so a complete litigation update cannot be produced.

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What formulations are protected for HUMATROPE (and what changes can trigger new IP barriers)?

Somatropin product differentiation often involves:

• Concentration and excipient system
• Freeze-thaw stability parameters
• Device pairing and reconstitution method
• Manufacturing process controls

A formulation-level IP map requires a defined set of HUMATROPE patents and claim constructions that are not included in the request.

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Market projection for HUMATROPE (revenue, share, and launch/competition scenarios)

Projection framework (scenario logic)

For a mature somatropin brand, forward-looking projections should be built on:

1. TAM growth in growth hormone indications (pediatric starts, adult diagnosis/therapy adoption)
2. Persistence and adherence (treatment duration, switching rates)
3. Net pricing pressure from competitive contracting and rebates
4. Share shifts driven by:
   • long-acting growth hormones adoption
   • biosimilar penetration where permitted
   • payer formulary consolidation

Competitive scenarios to model

• Base case: modest share erosion from category competitors, stable pediatric and adult demand, price compression offset by volume stability.
• Downside case: payer mandates favoring alternative delivery regimens or products reduces HUMATROPE proportion in GH formularies faster than class growth.
• Upside case: contracting improves net price resilience; limited long-acting substitution in the pediatric segment; competitive supply disruptions or coverage gaps for competitors sustain share.

A numeric revenue forecast requires historical HUMATROPE sales, current share estimates, and competitive pricing data, none of which are provided in the request.

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Key Takeaways

• HUMATROPE is a mature somatropin brand; its near- to mid-term economics are driven more by payer contracting, adherence/persistence, and substitution dynamics than by fresh, material clinical trial programs.
• The most important commercial risk is class substitution, especially when longer-acting growth hormones or biosimilars gain formulary share.
• A defensible projection requires an IP and regulatory status map tied to specific patents and a competitive market dataset. Those inputs are not included in the request, so a numeric projection cannot be generated without fabricating data.

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FAQs

1. What are the main clinical endpoints used in somatropin real-world evidence studies?
2. How do payers compare somatropin products on net price and prior authorization criteria?
3. What drives switching from one somatropin regimen to another in pediatric endocrinology?
4. How do biosimilar and long-acting growth hormone launches typically affect reference brand utilization?
5. What data sources are best for tracking growth hormone prescribing share by product?

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References

No sources were provided or cited because the request does not include the specific FDA/patent/clinical trial datasets needed to produce a complete, accurate update.