CLINICAL TRIALS PROFILE FOR HYDROCORTISONE ACETATE

All Clinical Trials for Hydrocortisone Acetate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00915343 ↗	Once-daily Oral Modified Release Hydrocortisone in Patients With Adrenal Insufficiency	Completed	Shire	Phase 2/Phase 3	2007-08-21	This is a randomised, controlled, open, two-armed, two-period cross-over, multi-centre phase II/III study to assess the safety, tolerability and pharmacokinetics of once-daily oral modified-release hydrocortisone in comparison to conventional thrice-daily oral hydrocortisone tablets in patients with adrenal insufficiency
NCT01014364 ↗	Low Doses Corticosteroids as Adjuvant Therapy for the Treatment of Severe H1N1 Flu	Terminated	Assistance Publique - Hôpitaux de Paris	Phase 3	2010-03-01	The H1N1 flu pandemic is one of the major infectious threat of the past half century. it is rapidly progressing worldwide and a substantial number of patients get severe H1N1 related pneumonia that requires mechanical ventilation and admission to the intensive care unit. The acute respiratory distress syndrome is associated with a substantial mortality and morbidity partly as a consequence of uncontrolled lung and systemic inflammation. many physicians are trying to counteract this pro-inflammatory storm by the use of corticosteroids albeit these drugs may cause super infection or metabolic disorders. Thus, there is a need for a randomized double blind, placebo controlled trial to define the benefit to risk ratio of corticosteroids in this patient.
NCT01014364 ↗	Low Doses Corticosteroids as Adjuvant Therapy for the Treatment of Severe H1N1 Flu	Terminated	University of Versailles	Phase 3	2010-03-01	The H1N1 flu pandemic is one of the major infectious threat of the past half century. it is rapidly progressing worldwide and a substantial number of patients get severe H1N1 related pneumonia that requires mechanical ventilation and admission to the intensive care unit. The acute respiratory distress syndrome is associated with a substantial mortality and morbidity partly as a consequence of uncontrolled lung and systemic inflammation. many physicians are trying to counteract this pro-inflammatory storm by the use of corticosteroids albeit these drugs may cause super infection or metabolic disorders. Thus, there is a need for a randomized double blind, placebo controlled trial to define the benefit to risk ratio of corticosteroids in this patient.

Clinical Trial Conditions for Hydrocortisone Acetate

Condition Name

Condition Name for Hydrocortisone Acetate
Intervention	Trials
Adrenal Insufficiency	2
Congenital Adrenal Hyperplasia	2
Internal Hemorrhoids	2

Condition MeSH

Condition MeSH for Hydrocortisone Acetate
Intervention	Trials
Adrenal Hyperplasia, Congenital	4
Adrenogenital Syndrome	4
Hyperplasia	3

Clinical Trial Locations for Hydrocortisone Acetate

Trials by Country

Trials by Country for Hydrocortisone Acetate
Location	Trials
United States	18
China	4
Norway	2
Netherlands	1
Brazil	1

Trials by US State

Trials by US State for Hydrocortisone Acetate
Location	Trials
Michigan	4
California	3
Texas	3
New York	2
Maryland	2

Clinical Trial Progress for Hydrocortisone Acetate

Clinical Trial Phase

Clinical Trial Phase for Hydrocortisone Acetate
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	3
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Hydrocortisone Acetate
Clinical Trial Phase	Trials
Completed	10
Unknown status	5
Recruiting	2

Clinical Trial Sponsors for Hydrocortisone Acetate

Sponsor Name

Sponsor Name for Hydrocortisone Acetate
Sponsor	Trials
University of Michigan	2
University of Texas Southwestern Medical Center	2
Haukeland University Hospital	2

Sponsor Type

Sponsor Type for Hydrocortisone Acetate
Sponsor	Trials
Other	20
Industry	11
NIH	2

Hydrocortisone Acetate: Clinical Trials, Market Analysis, and Projections

Introduction to Hydrocortisone Acetate

Hydrocortisone acetate is a synthetic corticosteroid medication widely used for its anti-inflammatory and immunosuppressive properties. It is employed in various forms, including injections, tablets, ointments, and eye drops, to treat a range of conditions such as skin inflammations, allergic reactions, and other inflammatory disorders.

Clinical Trials Update

Phase 3 Study for Ulcerative Colitis

A significant clinical trial currently underway is the Phase 3 study to evaluate the safety and efficacy of hydrocortisone acetate suppositories for the treatment of moderate to severe ulcerative colitis (UC) of the rectum. Here are the key details:

• Study Design: This is a randomized, multi-center, double-blind, three-arm placebo-controlled study.
• Participants: The study includes male and non-pregnant, non-lactating female subjects aged 18 years and older with a confirmed diagnosis of active UC of the rectum.
• Treatment: Two arms of the study will receive different dosage regimens of hydrocortisone acetate (90 mg), and the third arm will receive a placebo. All subjects will administer the study drug twice a day (morning and evening) for 28 days using a Sephure suppository applicator[1][4].

This trial, sponsored by Cristcot LLC, aims to assess the efficacy and safety of hydrocortisone acetate suppositories in managing UC symptoms, which could potentially expand the treatment options for this condition.

Market Analysis

Current Market Size and Growth

The global hydrocortisone acetate market has been experiencing steady growth, driven by several key factors:

• Aging Population: An increase in the aging population has led to a higher incidence of skin disorders and other inflammatory conditions, thereby increasing the demand for hydrocortisone acetate[3][5].
• Advancements in Medical Technology: Improvements in medical technology and rising awareness of skin health have also contributed to the market's growth.
• Market Size: The global hydrocortisone acetate market was valued at US$ 132.4 million in 2023 and is anticipated to reach US$ 183.1 million by 2030, with a Compound Annual Growth Rate (CAGR) of 4.6% during the forecast period[3][5].

Market Segmentation

The hydrocortisone acetate market is segmented based on several criteria:

• Type: The market includes various forms such as injections, tablets, ointments, eye drops, and others. Each type serves different therapeutic needs and has its own market share[2][5].
• Application: The primary applications are in hospitals, clinics, and other healthcare settings. The demand varies across these segments based on the specific needs of patients and healthcare providers[2][5].
• Geographical Regions: The market is analyzed across regions including North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region has its own market dynamics and growth prospects[2][5].

Key Players and Competitive Landscape

The market is competitive, with several key players such as Pfizer, Novartis, Akorn Pharmaceuticals, Teva Pharmaceuticals, and others. These companies are focusing on product innovation and improving marketing strategies to maintain their market share and drive growth[5].

Market Projections

Forecasted Market Size

The global hydrocortisone acetate market is expected to continue its growth trajectory. Here are some key projections:

• Forecasted Market Size: The market is anticipated to reach US$ 183.1 million by 2030, growing at a CAGR of 4.6% from 2024 to 2030[3][5].
• Regional Growth: The Asia-Pacific region is expected to show significant growth due to increasing healthcare spending and a rising awareness of skin health[5].

Drivers and Challenges

• Drivers: The market is driven by an aging population, increasing incidence of skin disorders, and advancements in medical technology. Rising awareness of skin health and the need for effective treatments also contribute to the market's growth[3][5].
• Challenges: Intense market competition and the need for continuous product innovation and marketing improvements are significant challenges. Additionally, regulatory changes and the emergence of new treatments could impact market dynamics[3][5].

Technological Trends and New Product Developments

The hydrocortisone acetate market is witnessing several technological trends and new product developments:

• Delivery Systems: Innovations in delivery systems, such as the Sephure suppository applicator used in the clinical trial for UC, are enhancing the efficacy and patient compliance of hydrocortisone acetate treatments[1][4].
• Formulations: New formulations and combinations of hydrocortisone acetate with other medications are being developed to improve therapeutic outcomes and reduce side effects[5].

Conclusion

Hydrocortisone acetate remains a vital medication in the treatment of various inflammatory conditions. The ongoing Phase 3 clinical trial for its use in ulcerative colitis highlights its potential in new therapeutic areas. The market analysis indicates a steady growth trajectory driven by demographic changes, technological advancements, and increasing awareness of skin health.

Key Takeaways

• Clinical Trials: The Phase 3 study on hydrocortisone acetate suppositories for UC is a significant development in expanding treatment options.
• Market Growth: The global hydrocortisone acetate market is expected to grow from US$ 132.4 million in 2023 to US$ 183.1 million by 2030.
• Market Segmentation: The market is segmented by type, application, and geographical regions.
• Competitive Landscape: Key players are focusing on product innovation and marketing strategies to maintain market share.
• Technological Trends: Innovations in delivery systems and formulations are enhancing treatment efficacy and patient compliance.

FAQs

What is the current status of the Phase 3 clinical trial for hydrocortisone acetate suppositories?

The Phase 3 clinical trial is ongoing, evaluating the safety and efficacy of hydrocortisone acetate suppositories for the treatment of moderate to severe ulcerative colitis of the rectum.

What are the primary drivers of the hydrocortisone acetate market?

The market is driven by an aging population, increasing incidence of skin disorders, advancements in medical technology, and rising awareness of skin health.

Which regions are expected to show significant growth in the hydrocortisone acetate market?

The Asia-Pacific region is expected to show significant growth due to increasing healthcare spending and rising awareness of skin health.

What are the key challenges facing the hydrocortisone acetate market?

The market faces intense competition, the need for continuous product innovation, and the potential impact of regulatory changes and new treatments.

Who are the major players in the hydrocortisone acetate market?

Major players include Pfizer, Novartis, Akorn Pharmaceuticals, Teva Pharmaceuticals, and others.

Sources

1. Lake Clinical Trial Phase 3 Study to Evaluate the Safety and Efficacy of Hydrocortisone Acetate Suppositories. Mental Health Network of Care.
2. Hydrocortisone Acetate Market Size, Scope And Forecast Report. Market Research Intellect.
3. Global Hydrocortisone Acetate Market Research Report 2024. QY Research.
4. Phase 3 Study to Evaluate the Safety and Efficacy of Hydrocortisone Acetate Suppositories. CenterWatch.
5. Global Hydrocortisone Acetate Market Insights, Forecast to 2030. QY Research.