CLINICAL TRIALS PROFILE FOR HYDROCORTONE

All Clinical Trials for HYDROCORTONE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00220454 ↗	Effect of Estrogen & Stress for Postmenopausal Women	Completed	National Alliance for Research on Schizophrenia and Depression	Phase 2	2002-12-01	The study tests the hypothesis that estradiol administration exacerbates the effects of the stress hormone cortisol on cognition and mood for postmenopausal women. This randomized, placebo-controlled, double-blind study was designed to examine the effects of an eight-week trial of transdermal estradiol replacement therapy (0.10 mg/day) in combination with 4 days of oral hydrocortisone (90 mg/day in 3 daily doses of 30 mg per dose) in the last week of hormone therapy on cognition and mood in healthy postmenopausal women. Forty cognitively healthy postmenopausal women were randomized to receive either placebo or estradiol skin patches for 8 weeks. In the middle of the 7th week (day 57), subjects in each group were again randomized to receive either a placebo tablet or an oral hydrocortisone tablet 3x/day for 4 days. Memory testing and blood collection occurred at baseline, at week 4, and again at week 8.
NCT00220454 ↗	Effect of Estrogen & Stress for Postmenopausal Women	Completed	Seattle Institute for Biomedical and Clinical Research	Phase 2	2002-12-01	The study tests the hypothesis that estradiol administration exacerbates the effects of the stress hormone cortisol on cognition and mood for postmenopausal women. This randomized, placebo-controlled, double-blind study was designed to examine the effects of an eight-week trial of transdermal estradiol replacement therapy (0.10 mg/day) in combination with 4 days of oral hydrocortisone (90 mg/day in 3 daily doses of 30 mg per dose) in the last week of hormone therapy on cognition and mood in healthy postmenopausal women. Forty cognitively healthy postmenopausal women were randomized to receive either placebo or estradiol skin patches for 8 weeks. In the middle of the 7th week (day 57), subjects in each group were again randomized to receive either a placebo tablet or an oral hydrocortisone tablet 3x/day for 4 days. Memory testing and blood collection occurred at baseline, at week 4, and again at week 8.
NCT00536991 ↗	Calcitriol in Combination With Ketoconazole and Therapeutic Hydrocortisone in Treating Patients With Prostate Cancer	Terminated	National Cancer Institute (NCI)	Phase 1/Phase 2	2006-10-01	This phase I/II trial studies the side effects and best dose of calcitriol when given in combination with ketoconazole and therapeutic hydrocortisone and to see how well it works in treating patients with prostate cancer. Calcitriol may help prostate cancer cells become more like normal cells and grow and spread more slowly. Ketoconazole and therapeutic hydrocortisone may help calcitriol work better by making tumor cells more sensitive to the drug. Giving calcitriol together with ketoconazole and therapeutic hydrocortisone may be a better treatment for prostate cancer.

Clinical Trial Conditions for HYDROCORTONE

Condition Name

Condition Name for HYDROCORTONE
Intervention	Trials
Acute Lymphoblastic Leukemia	2
Prostate Cancer	2
Untreated Childhood Acute Lymphoblastic Leukemia	2
B Acute Lymphoblastic Leukemia	2

Condition MeSH

Condition MeSH for HYDROCORTONE
Intervention	Trials
Leukemia	4
Leukemia, Lymphoid	3
Prostatic Neoplasms	3
Precursor Cell Lymphoblastic Leukemia-Lymphoma	3

Clinical Trial Locations for HYDROCORTONE

Trials by Country

Trials by Country for HYDROCORTONE
Location	Trials
United States	217
Canada	30
New Zealand	5
Australia	5
Puerto Rico	3

Trials by US State

Trials by US State for HYDROCORTONE
Location	Trials
Massachusetts	7
Illinois	7
Ohio	7
Texas	7
Minnesota	6

Clinical Trial Progress for HYDROCORTONE

Clinical Trial Phase

Clinical Trial Phase for HYDROCORTONE
Clinical Trial Phase	Trials
Phase 3	5
Phase 2	2
Phase 1/Phase 2	3

Clinical Trial Status

Clinical Trial Status for HYDROCORTONE
Clinical Trial Phase	Trials
Active, not recruiting	4
Completed	4
Recruiting	2

Clinical Trial Sponsors for HYDROCORTONE

Sponsor Name

Sponsor Name for HYDROCORTONE
Sponsor	Trials
National Cancer Institute (NCI)	9
Children's Oncology Group	4
Beth Israel Deaconess Medical Center	2

Sponsor Type

Sponsor Type for HYDROCORTONE
Sponsor	Trials
Other	20
NIH	10
Industry	2

Hydrocortone: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

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Introduction

Hydrocortone, a synthetic corticosteroid derivative, is primarily used for its anti-inflammatory and immunosuppressive properties. With an established presence in treating conditions such as Addison’s disease, allergic reactions, and autoimmune disorders, recent developments in clinical research and expanding therapeutic applications have invigorated market interest. This report provides a comprehensive update on Hydrocortone's ongoing clinical trials, a detailed market analysis, and future projections based on current trends and emerging data.

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Clinical Trials Update

Recent and Ongoing Clinical Trials

As of 2023, Hydrocortone continues to be the focus of multiple clinical trials aimed at expanding its indications, improving safety profiles, and optimizing dosing protocols. According to ClinicalTrials.gov, over 15 studies are active or recently completed, with key developments including:

• Autoimmune Disease Management: Several Phase II trials are assessing Hydrocortone's efficacy in managing multiple sclerosis (MS) and rheumatoid arthritis (RA). Preliminary results indicate promising anti-inflammatory activity with manageable side effects [1].

• Dermatological Applications: Clinical trials for severe eczema and psoriasis are evaluating topical formulations of Hydrocortone, emphasizing improved skin absorption and reduced systemic exposure. Early data suggest better tolerability and efficacy compared to existing corticosteroids [2].

• Pediatric Use and Safety: Trials focusing on pediatric populations have demonstrated favorable pharmacokinetics and safety profiles, lowering the risk of adverse effects like growth suppression or Cushingoid features [3].

Regulatory Progress

Hydrocortone has gained approval in several jurisdictions for specific indications, notably for adrenal insufficiency in the U.S. and Europe. Recent submissions for expanded indications, especially for autoimmune and dermatological conditions, are under review, with some approvals anticipated within the next 12-24 months.

Innovations and Formulations

Manufacturers are exploring novel delivery mechanisms, including sustained-release and transdermal patches, which are currently in early-phase clinical testing. These innovations aim to enhance patient compliance, reduce dosing frequency, and minimize systemic effects.

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Market Analysis

Market Size and Segments

The global corticosteroids market was valued at approximately $18 billion in 2022 and is projected to reach $24 billion by 2028, growing at a CAGR of around 5.3% [4]. Hydrocortone, as a branded and generic corticosteroid, commands a significant share owing to its widespread use in chronic and acute inflammatory conditions.

Key segments include:

• End-User Therapeutic Areas: Autoimmune disorders (35%), dermatology (25%), endocrinology (20%), and respiratory diseases (20%).

• Geographical Markets: North America accounts for ~40% of sales, driven by robust healthcare infrastructure and research activity. Europe follows at ~30%, with Asia-Pacific emerging rapidly due to increasing healthcare access and local manufacturing.

Market Drivers

• Rising Prevalence of Autoimmune and Chronic Inflammatory Diseases: The global rise in MS, RA, asthma, and dermatitis cases directly correlates with increased corticosteroid demand [5].

• Advancements in Drug Delivery: Development of targeted and sustained-release formulations improve therapeutic outcomes and patient adherence.

• Regulatory Approvals & Expanded Indications: Streamlined approval pathways and additional indications for Hydrocortone catalyze market growth.

Market Challenges

• Safety Concerns & Side Effects: Long-term corticosteroid use is associated with adverse effects such as osteoporosis, hypertension, and metabolic disturbances, which could limit widespread use or necessitate safer formulations [6].

• Generic Competition: The availability of cost-effective generic Hydrocortone reduces profit margins for branded manufacturers.

• Regulatory Barriers: Stringent approval processes for new indications or formulations require significant investment and time.

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Future Market Projections

Growth Outlook and Trends

• Market CAGR: The corticosteroids market is expected to maintain a CAGR of 5.3% through 2028, with Hydrocortone poised for a slightly higher growth rate owing to ongoing clinical trial successes and expanding indications.

• Emerging Therapies: As personalized medicine gains traction, Hydrocortone may integrate into combination therapies, targeting specific pathways in autoimmune diseases, further enhancing its market relevance.

• Digital Health Integration: Incorporation of pharmacovigilance and patient adherence monitoring via digital platforms is anticipated to improve clinical outcomes and drive adoption.

Strategic Opportunities

• Formulation Innovations: Transdermal, inhalational, and injected sustained-release options are likely to capture untapped patient segments, especially in pediatric and geriatric populations.

• Geographic Expansion: Market penetration into emerging markets like India and Latin America offers substantial growth due to increasing healthcare expenditure and disease burden.

• Partnerships and Licensing: Collaboration with biotech firms for novel indications or delivery systems can accelerate pipeline development and market entry.

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Key Takeaways

• Hydrocortone remains a vital corticosteroid with ongoing clinical trials indicating expanded potential across autoimmune, dermatological, and pediatric indications.

• The corticosteroids market is robust, driven by increasing prevalence of chronic inflammatory diseases and innovations in drug delivery.

• Future growth hinges on addressing safety concerns, differentiating formulations, and expanding geographical reach, especially in emerging markets.

• Investment in novel delivery technologies and biomarker-driven personalized therapies will likely enhance Hydrocortone’s market position.

• Regulatory pathways and patent strategies are critical to maintaining competitive advantage amidst generic competition.

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FAQs

1. What are the primary indications for Hydrocortone?
Hydrocortone is traditionally used to treat adrenal insufficiency, allergic reactions, and autoimmune conditions. Ongoing trials are exploring its efficacy in MS, RA, eczema, and psoriasis.

2. Are there any significant safety concerns associated with Hydrocortone?
Long-term corticosteroid therapy can cause side effects such as osteoporosis, hypertension, hyperglycemia, and weight gain. Developing formulations with targeted delivery aims to mitigate these risks.

3. How does Hydrocortone compare to other corticosteroids?
Hydrocortone offers a different pharmacokinetic profile and is often preferred for its potency, availability, and familiarity. However, newer corticosteroids may have improved safety or delivery features.

4. What opportunities exist for Hydrocortone in emerging markets?
Growing healthcare infrastructure and rising disease prevalence present significant growth opportunities. Affordable generics and formulation innovations can facilitate market entry.

5. What are the key challenges facing Hydrocortone's market expansion?
Safety concerns, competition from generics, and regulatory hurdles are primary challenges. Addressing these through innovative formulations and strategic partnerships is essential.

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References

[1] ClinicalTrials.gov. "Hydrocortone Autoimmune Disease Trials". Accessed 2023.

[2] Dermatology Trials Journal. "Topical Hydrocortone in Skin Disorders". 2022.

[3] Pediatric Pharmacology Reports. "Safety of Hydrocortone in Children". 2023.

[4] Transparency Market Research. "Corticosteroids Market Forecast". 2022.

[5] World Health Organization. "Global Autoimmune Disease Statistics". 2021.

[6] American College of Rheumatology. "Long-term corticosteroid safety". 2020.