CLINICAL TRIALS PROFILE FOR SEROSTIM

All Clinical Trials for SEROSTIM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00071240 ↗	Growth Hormone to Increase Immune Function in People With HIV	Completed	EMD Serono	Phase 2	2002-10-01	Growth hormone plays an important role in the development of the immune system. Studies suggest that growth hormone may promote growth of the thymus, a gland responsible for the production of important immune cells called T cells. Since these cells are lost during the course of HIV infection, it is possible that growth hormone treatment could help restore the immune system. This study will determine whether the administration of growth hormone can increase the size and function of the thymus and cause an increase in the number of new T cells in the blood of people infected with HIV. Study hypothesis: Growth hormone treatment will enhance T cell production in HIV infected adults.
NCT00071240 ↗	Growth Hormone to Increase Immune Function in People With HIV	Completed	National Center for Research Resources (NCRR)	Phase 2	2002-10-01	Growth hormone plays an important role in the development of the immune system. Studies suggest that growth hormone may promote growth of the thymus, a gland responsible for the production of important immune cells called T cells. Since these cells are lost during the course of HIV infection, it is possible that growth hormone treatment could help restore the immune system. This study will determine whether the administration of growth hormone can increase the size and function of the thymus and cause an increase in the number of new T cells in the blood of people infected with HIV. Study hypothesis: Growth hormone treatment will enhance T cell production in HIV infected adults.
NCT00071240 ↗	Growth Hormone to Increase Immune Function in People With HIV	Completed	The J. David Gladstone Institutes	Phase 2	2002-10-01	Growth hormone plays an important role in the development of the immune system. Studies suggest that growth hormone may promote growth of the thymus, a gland responsible for the production of important immune cells called T cells. Since these cells are lost during the course of HIV infection, it is possible that growth hormone treatment could help restore the immune system. This study will determine whether the administration of growth hormone can increase the size and function of the thymus and cause an increase in the number of new T cells in the blood of people infected with HIV. Study hypothesis: Growth hormone treatment will enhance T cell production in HIV infected adults.
NCT00071240 ↗	Growth Hormone to Increase Immune Function in People With HIV	Completed	University of California, San Francisco	Phase 2	2002-10-01	Growth hormone plays an important role in the development of the immune system. Studies suggest that growth hormone may promote growth of the thymus, a gland responsible for the production of important immune cells called T cells. Since these cells are lost during the course of HIV infection, it is possible that growth hormone treatment could help restore the immune system. This study will determine whether the administration of growth hormone can increase the size and function of the thymus and cause an increase in the number of new T cells in the blood of people infected with HIV. Study hypothesis: Growth hormone treatment will enhance T cell production in HIV infected adults.

Clinical Trial Conditions for SEROSTIM

Condition Name

Condition Name for SEROSTIM
Intervention	Trials
HIV Infections	5
Human Immunodeficiency Virus Infections	2
Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS)	2
HIV Wasting Syndrome	1

Condition MeSH

Condition MeSH for SEROSTIM
Intervention	Trials
HIV Infections	7
Syndrome	3
Lipodystrophy	3
Immunologic Deficiency Syndromes	3

Clinical Trial Locations for SEROSTIM

Trials by Country

Trials by Country for SEROSTIM
Location	Trials
United States	19
Canada	1

Trials by US State

Trials by US State for SEROSTIM
Location	Trials
New York	4
Massachusetts	2
California	2
Washington	1
Virginia	1

Clinical Trial Progress for SEROSTIM

Clinical Trial Phase

Clinical Trial Phase for SEROSTIM
Clinical Trial Phase	Trials
Phase 3	2
Phase 2/Phase 3	2
Phase 2	1

Clinical Trial Status

Clinical Trial Status for SEROSTIM
Clinical Trial Phase	Trials
Completed	7
Enrolling by invitation	1
Active, not recruiting	1

Clinical Trial Sponsors for SEROSTIM

Sponsor Name

Sponsor Name for SEROSTIM
Sponsor	Trials
EMD Serono	5
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	2
University of California, San Francisco	1

Sponsor Type

Sponsor Type for SEROSTIM
Sponsor	Trials
Other	6
Industry	5
NIH	4

Last updated: May 21, 2026

Serostim (somatrem) Clinical Trials Update, Market Analysis, and Exclusivity-Protected Revenue Projection

Serostim (somatrem) is an older branded recombinant human growth hormone therapy indicated for pediatric and adult growth hormone deficiency. Publicly accessible, drug-specific clinical trial reporting, payer coverage, and recent revenue data are not sufficient in the provided context to produce a complete, citation-backed trials update and market forecast tied to Serostim’s current commercialization status.

What is the current clinical development status of Serostim?

No complete, up-to-date, Serostim-specific clinical trial listings with dates, phases, endpoints, and sponsors are available in the provided context to support a factual “clinical trials update” section.

Which Serostim trials are ongoing, recruiting, or completed?

No Serostim trial record set (e.g., ClinicalTrials.gov identifiers with statuses and timelines) is available in the provided context.

What are the latest published efficacy and safety outcomes for Serostim?

No Serostim-specific publication list with study design and results is available in the provided context.

How has Serostim’s market changed since launch, and what are current sales drivers?

Serostim commercialization is not supported here with current market metrics (sales, share, inventory trends, or real-world utilization) by indication, geography, or formulation.

What are the main use cases driving Serostim demand?

No indication-level utilization and prescribing trend data are available in the provided context.

How do GLP-1, insulin, and other growth-hormone competitors affect Serostim demand?

No competitor mapping with substitution rates, switching drivers, or formulary placement is available in the provided context.

What is Serostim’s projected revenue through patent and market exclusivity timelines?

A revenue projection requires anchored inputs (brand sales base year, volume and price drivers, launch/entry dates for competitors, and exclusivity or patent expiry events). None of these Serostim-specific inputs are available in the provided context.

When does Serostim lose exclusivity and what entry risks exist for generics?

No exclusivity calendar (Orange Book and related exclusivity identifiers), patent expiration schedule, or Paragraph IV/biosimilar-style entry pathway mapping is available in the provided context.

What is the revenue sensitivity to generic or therapeutic substitution scenarios?

No historical price erosion curves, generic entry timing assumptions, or payer reimbursement constraints are available in the provided context.

What patents protect Serostim, and when do they expire?

No Serostim patent estate data (publication numbers, US patents, assignees, expiration dates, or listed Orange Book/NDA links) are available in the provided context.

What is the Orange Book status of Serostim, and what filings could threaten exclusivity?

No Orange Book listing snapshot or associated FDA approval history (NDA/BLA, exclusivity codes, supplements) is available in the provided context to support this section.

Which companies compete with Serostim in growth-hormone deficiency and HIV-associated wasting, and how do their products compare?

No Serostim competitor list with head-to-head product profiles, dosing forms, and reimbursement status is available in the provided context.

How does Serostim compare with somatropin products on efficacy, dosing, and administration?

No comparative dosing and label-specific parameters are available in the provided context.

What litigation affects Serostim’s competitive landscape?

No Serostim patent litigation records (lawsuits, Paragraph IV notices, settlement dates, or court outcomes) are available in the provided context.

Key Takeaways

• Serostim clinical trials update cannot be produced from the provided context without a Serostim-specific trial record set (e.g., ClinicalTrials.gov identifiers and statuses).
• Serostim market analysis and revenue projection cannot be produced from the provided context without anchored sales/utilization data and a dated exclusivity and competitor-entry calendar.
• Patent and Orange Book status cannot be produced from the provided context without the drug’s FDA listing and patent/expiration dataset.

FAQs

1. Is Serostim still authorized for prescribing in the US, and what indications are active?
2. What recent clinical trial endpoints are most likely to affect Serostim’s label or reimbursement?
3. Which growth hormone alternatives have the highest substitution risk for Serostim by payer tier?
4. What exclusivity periods and patent expirations would determine the earliest credible generic or alternative entry date?
5. How do cost, dosing frequency, and administration route influence real-world switching away from Serostim?

References

No sources were cited because the provided context contains no drug-specific clinical, regulatory, patent, litigation, or market datasets.