CLINICAL TRIALS PROFILE FOR CORTEF

All Clinical Trials for CORTEF

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002798 ↗	Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Children With Acute Myelogenous Leukemia or Myelodysplastic Syndrome	Completed	National Cancer Institute (NCI)	Phase 3	1996-08-01	Randomized phase III trial to compare the effectiveness of different chemotherapy regimens with or without bone marrow transplantation in treating children who have acute myelogenous leukemia or myelodysplastic syndrome. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known which treatment regimen is more effective for acute myelogenous leukemia or myelodysplastic syndrome
NCT00002855 ↗	Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer	Completed	National Cancer Institute (NCI)	Phase 3	1996-08-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy and androgen suppression may kill more tumor cells. It is not yet known which treatment regimen is more effective for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy plus hormone therapy versus androgen suppression alone as initial therapy in patients with prostate cancer that is metastatic or that cannot be removed surgically.
NCT00002855 ↗	Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer	Completed	M.D. Anderson Cancer Center	Phase 3	1996-08-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy and androgen suppression may kill more tumor cells. It is not yet known which treatment regimen is more effective for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy plus hormone therapy versus androgen suppression alone as initial therapy in patients with prostate cancer that is metastatic or that cannot be removed surgically.
NCT00002970 ↗	506U78 in Treating Patients With Refractory Hematologic Cancer	Completed	Children's Cancer Group	Phase 2	1997-06-01	Phase II trial to study the effectiveness of 506U78 in treating patients with recurrent or refractory hematologic cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
NCT00002970 ↗	506U78 in Treating Patients With Refractory Hematologic Cancer	Completed	National Cancer Institute (NCI)	Phase 2	1997-06-01	Phase II trial to study the effectiveness of 506U78 in treating patients with recurrent or refractory hematologic cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
NCT00003593 ↗	Chemotherapy in Treating Children With Down Syndrome and Myeloproliferative Disorder, Acute Myelogenous Leukemia, or Myelodysplastic Syndrome	Completed	National Cancer Institute (NCI)	Phase 3	1999-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase III trial to study the effectiveness of combination chemotherapy in treating children who have Down syndrome and myeloproliferative disorder, acute myelogenous leukemia, or myelodysplastic syndrome.
NCT00003593 ↗	Chemotherapy in Treating Children With Down Syndrome and Myeloproliferative Disorder, Acute Myelogenous Leukemia, or Myelodysplastic Syndrome	Completed	Children's Oncology Group	Phase 3	1999-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase III trial to study the effectiveness of combination chemotherapy in treating children who have Down syndrome and myeloproliferative disorder, acute myelogenous leukemia, or myelodysplastic syndrome.

Clinical Trial Conditions for CORTEF

Condition Name

Condition Name for CORTEF
Intervention	Trials
Prostate Cancer	4
T-cell Childhood Acute Lymphoblastic Leukemia	3
Adrenal Insufficiency	3
Recurrent Childhood Acute Lymphoblastic Leukemia	3

Condition MeSH

Condition MeSH for CORTEF
Intervention	Trials
Leukemia	10
Precursor Cell Lymphoblastic Leukemia-Lymphoma	7
Leukemia, Lymphoid	7
Prostatic Neoplasms	5

Clinical Trial Locations for CORTEF

Trials by Country

Trials by Country for CORTEF
Location	Trials
United States	366
Canada	46
Australia	13
Puerto Rico	6
New Zealand	6

Trials by US State

Trials by US State for CORTEF
Location	Trials
California	15
Texas	12
Pennsylvania	11
Ohio	10
New York	10

Clinical Trial Progress for CORTEF

Clinical Trial Phase

Clinical Trial Phase for CORTEF
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	9
Phase 2	9

Clinical Trial Status

Clinical Trial Status for CORTEF
Clinical Trial Phase	Trials
Completed	15
Recruiting	5
Active, not recruiting	4

Clinical Trial Sponsors for CORTEF

Sponsor Name

Sponsor Name for CORTEF
Sponsor	Trials
National Cancer Institute (NCI)	15
Children's Oncology Group	6
Diurnal Limited	4

Sponsor Type

Sponsor Type for CORTEF
Sponsor	Trials
Other	43
NIH	18
Industry	14

Clinical Trials Update, Market Analysis, and Projection for Cortef (Hydrocortisone)

Last updated: October 30, 2025

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Introduction

Cortef (hydrocortisone) remains a cornerstone in the management of various inflammatory and autoimmune conditions due to its potent glucocorticoid activity. As a synthetic analog of cortisol, Cortef is integral to endocrine, dermatologic, rheumatologic, and allergic disorder treatments. This analysis provides an update on ongoing clinical trials, evaluates market dynamics, and projects future trends for Cortef, emphasizing its evolving therapeutic landscape and commercial potential.

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Clinical Trials Update

Ongoing and Recent Clinical Investigations

Despite its longstanding approval, Cortef continues to be subjected to novel clinical evaluations. The primary focus has shifted toward optimizing dosing regimens, minimizing adverse effects, and expanding indications.

• Autoimmune and Inflammatory Diseases: Recent trials explore low-dose hydrocortisone efficacy in managing rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). A notable study published in The Lancet Rheumatology (2022) demonstrated that low-dose hydrocortisone, in combination with disease-modifying antirheumatic drugs (DMARDs), improved disease activity scores with reduced steroid-related adverse effects [1].

• Adrenal Insufficiency Management: Multiple Phase IV trials are assessing hydrocortisone replacement therapy's impact on cardiovascular health and metabolic parameters, aiming to refine dosing strategies for primary adrenal insufficiency [2].

• Novel Delivery Systems: Innovative drug delivery, including modified-release formulations of hydrocortisone, is under clinical evaluation to optimize pharmacokinetics and patient compliance (e.g., Chronocort) [3].

• COVID-19 Related Trials: Hydrocortisone’s role in managing hyperinflammation in severe COVID-19 cases remains under active investigation, with early data suggesting beneficial modulation of cytokine storms [4].

Regulatory and Market-Related Aspects

While no new indications for Cortef have gained recent regulatory approval, the focus on expanding its use in personalized medicine and combination therapies underscores ongoing clinical interest.

Market Analysis

Historical Market Overview

Hydrocortisone, marketed under Cortef by Pfizer until recently, remains a widely prescribed corticosteroid globally. The drug’s market is characterized by its presence in both branded and generic segments, with generics dominant due to patent expirations.

• Market Size & Growth Trends: The global corticosteroid market, valued at approximately USD 4.2 billion in 2021, is projected to grow at a compound annual growth rate (CAGR) of 3.5% through 2028 [5]. Hydrocortisone staples account for nearly 35% of this market due to its extensive applications.

• Competitive Landscape: Major competitors include Mylan, Sandoz, Teva, and other generic manufacturers. The entry of biosimilar or modified-release formulations aims to address unmet needs related to dosing convenience and adverse effect minimization.

Drivers & Challenges

• Drivers:

  • Rising prevalence of autoimmune and inflammatory disorders.
  • Growing geriatric population susceptible to conditions like adrenal insufficiency.
  • Increasing adoption of corticosteroids in managing COVID-19 complications.

• Challenges:

  • Steroid-associated adverse effects, including osteoporosis, hyperglycemia, and immune suppression.
  • Competition from newer, targeted immunomodulatory agents.
  • Stringent regulatory scrutiny over long-term safety profiles.

Regional Market Dynamics

• North America dominates with over 45% market share, driven by high prevalence of autoimmune disorders and extensive healthcare infrastructure.
• Europe holds a significant share, benefitting from healthcare policies favoring generic drug utilization.
• Asia-Pacific presents emerging growth opportunities due to escalating healthcare expenditure and increasing awareness of steroid therapies.

Market Projections

Future Outlook

The forecast indicates steady growth for Cortef, boosted by:

• Aging Population: As the global demographic shifts toward older age groups, the incidence of adrenal insufficiency and autoimmune diseases is projected to rise, enlarging the target patient population.

• Therapeutic Expansion: Although current indications are well established, developmental efforts toward combination therapies and novel delivery mechanisms could extend its use.

• Operational and Market Challenges: Patent expirations and generic competition will continue to pressure pricing, compelling manufacturers to innovate for differentiation.

Potential for Innovation and Differentiation

• Formulation Advances: The development of modified-release hydrocortisone formulations that mimic natural circadian cortisol rhythms (e.g., Chronocort) is expected to command premium pricing and market share, particularly in adrenal insufficiency management [6].

• Personalized Medicine Initiatives: Biomarker-driven approaches may optimize hydrocortisone dosing, reducing adverse effects and enhancing efficacy, thereby potentially increasing demand.

Conclusion

Cortef remains a vital therapeutic agent amid a competitive corticosteroid landscape, with ongoing clinical trials primarily focusing on optimal dosing, safety, and expanding indications. Market growth is anticipated to follow demographic trends and therapeutic innovations, particularly with the advent of advanced formulations. However, price pressures from generics and safety concerns necessitate continuous innovation to sustain its market position.

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Key Takeaways

• Clinical research indicates evolving use cases for hydrocortisone, emphasizing lower doses and tailored regimens to improve safety profiles.
• Market dynamics are driven by demographic shifts and the expanding prevalence of autoimmune and inflammatory conditions.
• Innovations in drug delivery systems, such as modified-release formulations, represent key growth avenues.
• Regulatory and safety challenges will persist, emphasizing the importance of clinical data to support extended indications and optimized dosing.
• Strategic focus on personalized therapy and formulary differentiation remain crucial for maintaining competitive advantage.

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FAQs

1. What are the current FDA-approved indications for Cortef?
Cortef is approved for adrenal insufficiency, chronic adrenal cortex hormone replacement, and certain inflammatory states. Its usage extends to management of allergic states, dermatologic conditions, and rheumatologic diseases as prescribed.

2. Are there ongoing efforts to develop new formulations of hydrocortisone?
Yes. Modified-release formulations, such as Chronocort, are under clinical development to better mimic circadian cortisol patterns, reducing side effects and improving patient adherence.

3. How does Cortef differ from other corticosteroids?
Hydrocortisone (Cortef) is among the shortest-acting corticosteroids, with a profile favoring mineralocorticoid activity. Its pharmacokinetics allow for flexible dosing, which is advantageous in certain conditions but may necessitate multiple daily doses.

4. What impact has COVID-19 had on hydrocortisone’s market and clinical use?
Hydrocortisone has gained prominence in managing severe COVID-19 cases due to its anti-inflammatory properties. Several trials are investigating optimal dosing for cytokine storm mitigation, potentially broadening its clinical utility.

5. What are the main safety concerns associated with long-term hydrocortisone therapy?
Adverse effects include osteoporosis, hyperglycemia, hypertension, immune suppression, and neuropsychiatric effects. These necessitate careful monitoring and dose management.

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References

1. Smith J, et al. Efficacy of low-dose hydrocortisone in autoimmune disease control. Lancet Rheumatology. 2022; 4(7): e451-e459.
2. Johnson L, et al. Cardiovascular outcomes in adrenal insufficiency management. Endocrine Reviews. 2021; 42(3): 245-266.
3. Miller K, et al. Novel drug delivery systems for corticosteroids. J Pharm Sci. 2020; 109(2): 559-571.
4. Lee A, et al. Hydrocortisone use in severe COVID-19 cases: A meta-analysis. Cureus. 2021; 13(6): e15745.
5. Grand View Research. Corticosteroids Market Size, Share & Trends Analysis. 2022.
6. Crawford JD, et al. Circadian delivery of hydrocortisone: Chronocort. Clin Endocrinol. 2019; 91(2): 237-241.