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Last Updated: February 12, 2025

CLINICAL TRIALS PROFILE FOR HYDROCORTISONE


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505(b)(2) Clinical Trials for Hydrocortisone

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT00754247 ↗ A Randomized Comparative Study Evaluating the Tolerability and Efficacy of Two Topical Therapies for the Treatment of Keloids and Hypertrophic Scars Completed University of Miami Phase 4 2006-03-01 Keloids are thought to result from derailments in the typical wound healing process following cutaneous injury. Current treatment options for keloids include intralesional corticosteroids, silicone gel sheeting, compression, surgery and adjuvants to surgery, including radiation and cryotherapy. 0.5% hydrocortisone, silicone, vitamin E lotion (HSE) and onion extract gel (OE) are widely used over-the-counter medications for the treatment of keloids and hypertrophic scars. However, their efficacy and safety have not been compared in a blinded, placebo-controlled, prospective fashion. This study is being undertaken to determine the efficacy and safety of HSE versus OE versus placebo (Cetearyl alcohol; CEA) in subjects with hypertrophic scars and keloids. This is an investigator-blinded study, which means that the doctor evaluating you will not know if you are receiving the study medication or not. Another doctor will be supplying you with the medication and discussing any problems that you may have with the medication. You will be assigned to one of the three treatment groups: HSE, OE, or CEA. The group will be assigned by chance and you will have two in three chances of receiving treatment with a study medication, HSE or OE. The no treatment group will receive CEA, a bland lotion, containing no active ingredients such as steroids, silicone, vitamin E, or onion extract.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Hydrocortisone

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00001409 ↗ Genetically Modified Lymphocytes to Treat HIV-Infected Identical Twins - Study Modifications Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 1994-09-01 Certain patients enrolled in NIH protocol 94-I-0206 at the Clinical Center may be eligible to participate in one or more of the following new options: - Donor/recipient extension phase - Both the recipient (HIV-infected twin) and donor (non-infected twin) will participate in this extension of the CD4-zeta gene therapy study. It will evaluate the safety and activity of infusing gene-modified CD4+ cells as well as the modified CD8+ cells. - Corticosteroid administration - A corticosteroid, such as prednisone, hydrocortisone or prednisolone, will be added to the interleukin-2 (IL-2) regimen for preventing or treating side effects of IL-2 such as fever and other flu-like symptoms. - Extended follow-up - A more intensive follow-up will be scheduled for patients with substantial numbers of lymphocytes that harbor the CD4-zeta gene. Every 3 months, participants will have blood tests and specialized tests of CD4 counts, HIV-1 viral load and numbers of circulating cells containing the CD4-zeta gene every 3 months> the frequency of follow-up visits may be reduced as time goes by. - IL-2 continuation - Participants will continue to receive periodic treatment with IL-2 to see how long the genetically modified cells persist in the bloodstream and to evaluate the long-term response to IL-2. - Home treatment with interleukin-2 - Participants may receive future IL-2 treatment cycles at home. Home treatment involves less frequent data and safety monitoring and no medical evaluations at the Clinical Center except at the beginning of each cycle.
NCT00001521 ↗ Three Drug Combination Therapy Versus Conventional Treatment of Children With Congenital Adrenal Hyperplasia Active, not recruiting Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 2 1995-06-08 This study was developed to determine if a combination of four drugs (flutamide, testolactone, reduced hydrocortisone dose, and fludrocortisone) can normalize growth in children with congenital adrenal hyperplasia. The study will take 60 children, boys and girls and divide them into 2 groups based on the medications given. Group one will receive the new four- drug combination. Group two will receive the standard treatment for congenital adrenal hyperplasia (hydrocortisone and fludrocortisone). The boys in group one will take the medication until the age of 14 at which time they will stop taking the four drug combination and begin receiving the standard treatment for congenital adrenal hyperplasia. Girls in group one will take the four drug combination until the age of 13, at which time they will stop and begin receiving the standard treatment for congenital adrenal hyperplasia plus flutamide. Flutamide will be given to the girls until six months after their first menstrual period. All of the children will be followed until they reach their final adult height. The effectiveness of the treatment will be determined by measuring the patient's adult height, body mass index, and bone density. ...
NCT00002471 ↗ Combination Chemotherapy in Treating Patients With Acute B-Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma Completed Memorial Sloan Kettering Cancer Center Phase 2 1990-02-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have acute B-lymphoblastic leukemia or recurrent non-Hodgkin's lymphoma.
NCT00002494 ↗ Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma or Acute Lymphocytic Leukemia Completed National Cancer Institute (NCI) Phase 2 1992-05-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and alternating regimens of chemotherapy in treating patients who have non-Hodgkin's lymphoma or acute lymphocytic leukemia.
NCT00002494 ↗ Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma or Acute Lymphocytic Leukemia Completed Alliance for Clinical Trials in Oncology Phase 2 1992-05-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and alternating regimens of chemotherapy in treating patients who have non-Hodgkin's lymphoma or acute lymphocytic leukemia.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Hydrocortisone

Condition Name

Condition Name for Hydrocortisone
Intervention Trials
Septic Shock 35
Leukemia 31
Adrenal Insufficiency 24
Acute Lymphoblastic Leukemia 23
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Condition MeSH

Condition MeSH for Hydrocortisone
Intervention Trials
Leukemia 90
Leukemia, Lymphoid 70
Precursor Cell Lymphoblastic Leukemia-Lymphoma 69
Shock, Septic 43
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Clinical Trial Locations for Hydrocortisone

Trials by Country

Trials by Country for Hydrocortisone
Location Trials
Canada 148
Australia 60
United Kingdom 44
France 44
Germany 38
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Trials by US State

Trials by US State for Hydrocortisone
Location Trials
California 74
Texas 66
Tennessee 54
New York 53
Massachusetts 48
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Clinical Trial Progress for Hydrocortisone

Clinical Trial Phase

Clinical Trial Phase for Hydrocortisone
Clinical Trial Phase Trials
Phase 4 75
Phase 3 95
Phase 2/Phase 3 14
[disabled in preview] 141
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Clinical Trial Status

Clinical Trial Status for Hydrocortisone
Clinical Trial Phase Trials
Completed 233
Recruiting 58
Terminated 37
[disabled in preview] 73
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Clinical Trial Sponsors for Hydrocortisone

Sponsor Name

Sponsor Name for Hydrocortisone
Sponsor Trials
National Cancer Institute (NCI) 58
St. Jude Children's Research Hospital 20
Children's Oncology Group 18
[disabled in preview] 29
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Sponsor Type

Sponsor Type for Hydrocortisone
Sponsor Trials
Other 622
Industry 117
NIH 92
[disabled in preview] 5
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Hydrocortisone: Clinical Trials, Market Analysis, and Projections

Introduction to Hydrocortisone

Hydrocortisone, a synthetic form of the hormone cortisol, is widely used in medical treatments for various conditions, including adrenal insufficiency, skin allergies, and inflammatory diseases. This article will delve into the current clinical trials, market analysis, and projections for hydrocortisone, highlighting its significance and future outlook.

Clinical Trials and Research

ET-400: A New Oral Hydrocortisone Solution

Eton Pharmaceuticals has made significant strides with its New Drug Application (NDA) for ET-400, a proprietary patented formulation of hydrocortisone oral solution. The FDA has accepted the NDA and set a PDUFA target action date of February 28, 2025. This room temperature stable formulation is expected to enhance patient compliance and outcomes, particularly for children with adrenal insufficiency[1].

Corticosteroids in Severe Pancreatitis

The Corticosteroids to Reduce Inflammation in Severe Pancreatitis (CRISP) trial is a notable example of ongoing research. This multi-center, double-blind, randomized trial aims to determine the impact of hydrocortisone on organ injury in patients with severe acute pancreatitis. Patients receive 100 mg of hydrocortisone parenterally every 8 hours for 3 days, and the primary endpoint is the difference in the 72-hour change in the Sequential Organ Failure Assessment (SOFA) score between the hydrocortisone and placebo groups[4].

Market Analysis

Global Hydrocortisone Market

The hydrocortisone market is diverse, encompassing various formulations such as creams, oral solutions, and injectables.

Hydrocortisone Cream Market

The global hydrocortisone cream market was valued at USD 1352.2 million in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 6.50% from 2024 to 2031, reaching USD 2101.3 million by 2031. North America dominates this market, with a significant share of over 40% of the global revenue, driven by sophisticated healthcare infrastructure and a high prevalence of skin conditions[2].

Hydrocortisone Sodium Succinate Market

The hydrocortisone sodium succinate market was valued at USD 150 million in 2023 and is expected to reach USD 233.81 million by 2031, growing at a CAGR of 6% from 2024 to 2031. This growth is driven by the increasing incidence of autoimmune and inflammatory diseases, advancements in drug formulation, and higher healthcare expenditure in emerging economies[3].

Hydrocortisone Acetate Preparations Market

The hydrocortisone acetate preparations market is influenced by the rising incidence of skin allergies, increasing health awareness, and the robust expansion of the over-the-counter sector. The market faces challenges such as regulatory scrutiny and competition from alternative therapies, but opportunities lie in product diversification and leveraging digital health platforms[5].

Market Projections

ET-400 and Eton Pharmaceuticals

Eton Pharmaceuticals anticipates that the approval of ET-400 could allow the company to capture a larger share of the oral hydrocortisone market. Combined with ALKINDI SPRINKLE®, the company forecasts peak sales exceeding $50 million annually. The patent protection for ET-400 through 2043 ensures a sustained revenue stream without immediate generic competition[1].

Global Market Growth

The global hydrocortisone market is expected to grow significantly across various regions. North America and Europe are currently the major markets, but the Asia-Pacific region is expected to make significant gains due to increasing healthcare expenditure and growing consumer awareness of skin health. The Latin America and Middle East & Africa regions also show promising growth potential, albeit at a slower rate[2].

Key Drivers and Challenges

Drivers

  • Increasing Incidence of Skin and Autoimmune Conditions: The rising incidence of cutaneous conditions and autoimmune diseases is a major driver for the hydrocortisone market.
  • Advancements in Drug Formulation: Developments in drug formulation and delivery techniques are enhancing the efficacy and safety profile of hydrocortisone products.
  • Growing Healthcare Expenditure: Higher healthcare expenditure in emerging economies is driving the demand for hydrocortisone products[2][3].

Challenges

  • Regulatory Scrutiny: Long-term side effects of corticosteroids necessitate rigorous compliance and safety trials, which can be a challenge.
  • Competition from Alternative Therapies: The market faces competition from alternative therapies and a rising preference for natural or organic treatments[5].

Conclusion

Hydrocortisone remains a crucial medication in the treatment of various medical conditions. The ongoing clinical trials, such as the CRISP trial, and the development of new formulations like ET-400 by Eton Pharmaceuticals, highlight the continuous innovation in this field. The market projections indicate a strong growth trajectory driven by increasing demand, advancements in drug formulation, and expanding healthcare infrastructure.

Key Takeaways

  • ET-400: A new room temperature stable oral hydrocortisone solution with potential for significant market impact.
  • Clinical Trials: Ongoing trials like the CRISP trial aim to expand the therapeutic uses of hydrocortisone.
  • Market Growth: The global hydrocortisone market is projected to grow at a CAGR of 6.50% from 2024 to 2031.
  • Regional Dominance: North America and Europe currently dominate the market, but the Asia-Pacific region is expected to grow rapidly.
  • Challenges and Opportunities: Regulatory scrutiny and competition from alternative therapies are challenges, while advancements in drug formulation and digital health platforms offer opportunities.

FAQs

What is the current status of Eton Pharmaceuticals' ET-400?

ET-400, a proprietary patented formulation of hydrocortisone oral solution, has had its NDA accepted by the FDA with a PDUFA target action date set for February 28, 2025[1].

How is the global hydrocortisone cream market expected to grow?

The global hydrocortisone cream market is expected to grow at a CAGR of 6.50% from 2024 to 2031, reaching USD 2101.3 million by 2031[2].

What are the key drivers of the hydrocortisone sodium succinate market?

The key drivers include the increasing incidence of autoimmune and inflammatory diseases, advancements in drug formulation, and higher healthcare expenditure in emerging economies[3].

What challenges does the hydrocortisone acetate preparations market face?

The market faces challenges such as regulatory scrutiny concerning long-term side effects and competition from alternative therapies[5].

How does the patent protection for ET-400 impact Eton Pharmaceuticals?

The patent protection for ET-400 through 2043 ensures a sustained revenue stream without immediate generic competition, providing a strong competitive advantage for Eton Pharmaceuticals[1].

Sources

  1. Eton Pharmaceuticals Announces FDA Acceptance of New Drug Application for ET-400 (Hydrocortisone Oral Solution) - Stock Titan
  2. Hydrocortisone Cream Market Report 2024 (Global Edition) - Cognitive Market Research
  3. Hydrocortisone Sodium Succinate Market Size and Projections - Market Research Intellect
  4. Corticosteroids to Reduce Inflammation in Severe Pancreatitis - PubMed
  5. Hydrocortisone Acetate Preparations Market Size 2025-2030 - 360 Research Reports

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