CLINICAL TRIALS PROFILE FOR HYDROCORTISONE

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.

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.
NCT00002700 ↗	Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Acute Lymphoblastic Leukemia	Completed	Acute Leukemia French Association	Phase 3	1995-08-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells. Bone marrow transplantation can replace immune cells that were destroyed by chemotherapy. PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy compared with or without bone marrow transplantation in treating patients with acute lymphoblastic leukemia.

Clinical Trial Conditions for hydrocortisone

Condition Name

Condition Name for hydrocortisone
Intervention	Trials
Septic Shock	36
Leukemia	31
Adrenal Insufficiency	26
Acute Lymphoblastic Leukemia	23

Condition MeSH

Condition MeSH for hydrocortisone
Intervention	Trials
Leukemia	90
Leukemia, Lymphoid	70
Precursor Cell Lymphoblastic Leukemia-Lymphoma	69
Shock, Septic	45

Clinical Trial Locations for hydrocortisone

Trials by Country

Trials by Country for hydrocortisone
Location	Trials
Canada	153
Australia	65
United Kingdom	45
France	45
Spain	38

Trials by US State

Trials by US State for hydrocortisone
Location	Trials
California	77
Texas	69
Tennessee	56
New York	55
Massachusetts	49

Clinical Trial Progress for hydrocortisone

Clinical Trial Phase

Clinical Trial Phase for hydrocortisone
Clinical Trial Phase	Trials
PHASE4	8
PHASE3	4
PHASE2	9

Clinical Trial Status

Clinical Trial Status for hydrocortisone
Clinical Trial Phase	Trials
Completed	237
Recruiting	73
Unknown status	37

Clinical Trial Sponsors for hydrocortisone

Sponsor Name

Sponsor Name for hydrocortisone
Sponsor	Trials
National Cancer Institute (NCI)	60
Children's Oncology Group	20
St. Jude Children's Research Hospital	20

Sponsor Type

Sponsor Type for hydrocortisone
Sponsor	Trials
Other	656
Industry	119
NIH	97

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

Last updated: October 28, 2025

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Introduction

Hydrocortisone, a synthetic corticosteroid with anti-inflammatory and immunosuppressive properties, remains a cornerstone in treating a diverse spectrum of conditions—from adrenal insufficiency to allergic reactions. As global health dynamics evolve, so too does the landscape surrounding hydrocortisone, marked by ongoing clinical research, regulatory developments, and market shifts. This report offers a comprehensive analysis of current clinical trials, market trends, and future projections for hydrocortisone, focusing on its therapeutic applications and commercial potential.

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Clinical Trials Update

Recent Advances and Focus Areas

Over the past 24 months, clinical investigations concerning hydrocortisone have spanned multiple therapeutic domains, reflecting its versatility. The bulk of recent research emphasizes comparative efficacy, optimized dosing regimens, and safety profiles.

1. Adrenal Insufficiency and Replacement Therapy

Multiple Phase II and III trials explore hydrocortisone's role in adrenal insufficiency management. Notably, a 2022 multicenter trial assesses modified-release hydrocortisone formulations aiming to mimic circadian rhythm, thus improving quality of life for patients with Addison's disease [1]. Results indicate enhanced circadian cortisol profiles with minimized side effects.

2. Sepsis and Critical Illness

Hydrocortisone's immunomodulatory capability is under scrutiny in sepsis management. Ongoing studies, such as the ADRENAL trial, continue to evaluate hydrocortisone’s impact on mortality and organ function in septic shock. Recent interim analyses suggest some benefit in short-term hemodynamic stabilization, although definitive evidence remains under debate [2].

3. Inflammatory and Allergic Conditions

Clinical trials testing hydrocortisone’s efficacy in severe asthma exacerbations and allergic dermatitis have demonstrated rapid symptom control with acceptable safety profiles. A 2023 trial in pediatric populations highlighted the potential for dose reduction strategies to mitigate adverse effects without sacrificing efficacy [3].

4. Novel Delivery Systems

Innovations include liposomal and transdermal hydrocortisone formulations, currently in early-phase clinical development. These aim to improve targeted delivery and minimize systemic exposure, particularly useful in managing localized inflammatory conditions.

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Market Analysis

Current Market Landscape

Hydrocortisone sales are driven by both generic and branded formulations, with the global market valued at approximately USD 1.2 billion in 2022. The dominant segments include:

• Endocrinology: Replacement therapy for adrenal insufficiency accounts for roughly 60% of sales.
• Emergency Medicine: Used in acute allergic reactions, shock, and as part of cortisol supplementation protocols.
• Dermatology and Rheumatology: Topical and injectable formulations for inflammatory skin and joint diseases.

Regionally, North America holds the largest share attributable to robust healthcare infrastructure, widespread adoption of glucocorticoids, and a high prevalence of autoimmune and endocrine disorders [4].

Market Drivers

• Rising Prevalence of Autoimmune Disorders: Increasing diagnoses of rheumatoid arthritis, lupus, and adrenal insufficiency sustain demand.
• Improved Diagnostic Capabilities: Early detection and management strategies have expanded hydrocortisone use.
• Expanded Formulations: Development of modified-release and localized delivery options unlock new market segments.
• Regulatory Approvals: Approvals of innovative formulations boost market activity.

Market Challenges

• Generic Competition: Market saturation by generic hydrocortisone formulations suppresses pricing.
• Safety and Side Effect Concerns: Long-term corticosteroid therapy risks, such as osteoporosis and adrenal suppression, compel careful patient management.
• Regulatory Scrutiny: Growing emphasis on steroid misuse and overprescription regulations impacts sales strategies.

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Market Projections (2023–2030)

Based on current growth trajectories, clinical advancements, and regulatory trends, the hydrocortisone market is projected to grow at a CAGR of approximately 4.5% until 2030, reaching USD 1.8 billion globally.

Emerging Opportunities

• Personalized Medicine: Pharmacogenomics could refine dosing, reducing adverse effects and expanding patient adherence.
• Biologics and Biosimilars: While hydrocortisone itself is a small molecule, biosimilar development for related steroids indicates a trend towards cost containment, which could influence hydrocortisone’s pricing and accessibility.
• Regulatory Incentives: Orphan drug designations for adrenal insufficiency treatments could accelerate development and commercialization of novel hydrocortisone formulations.

Key Market Drivers

• Increasing aging population known to develop adrenal or autoimmune disorders.
• Enhanced awareness of steroid-related therapies.
• Adoption of innovative drug delivery systems.

Potential Risks

• Regulatory constraints on long-term steroid use.
• Competition from emerging biologic agents with targeted anti-inflammatory effects.
• Potential supply chain disruptions amid geopolitical tensions.

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Strategic Outlook

For pharmaceutical developers and investors, hydrocortisone remains a stable yet evolving segment, bolstered by ongoing research and increasing global health needs. Companies investing in modified-release formulations or localized delivery systems will likely gain competitive advantages. However, a focus on safety profiles and regulatory compliance remains crucial, given the potency and known risks of corticosteroid therapy.

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Key Takeaways

• Clinical research is expanding into novel hydrocortisone formulations, aiming to optimize efficacy and safety, especially for adrenal insufficiency and critical illnesses.
• The global market continues to grow, driven by aging populations and increased autoimmune disease prevalence, with North America leading geographically.
• Innovative delivery systems and personalized medicine approaches are critical future growth drivers.
• Pricing pressures from generic competition and safety concerns necessitate strategic positioning and product differentiation.
• Regulatory developments and patent expirations will significantly influence market dynamics over the next decade.

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FAQs

1. What are the latest clinical advancements in hydrocortisone therapy?
Recent trials focus on modified-release formulations that better mimic natural cortisol rhythms, potentially improving quality of life for patients with adrenal insufficiency. Ongoing research also examines hydrocortisone’s role in critical illnesses like sepsis, aiming to optimize dosing and minimize side effects.

2. How is the hydrocortisone market expected to evolve until 2030?
The market is projected to grow at around 4.5% CAGR, reaching USD 1.8 billion worldwide. Growth will be propelled by technological innovations, expanding indications, and increased prevalence of relevant diseases.

3. What are the primary challenges facing hydrocortisone manufacturers?
Key challenges include price erosion due to generic competition, safety concerns over long-term use, regulatory constraints, and supply chain issues.

4. Are there promising pipeline products or formulations?
Yes. Liposomal and transdermal hydrocortisone formulations are in early development stages, aiming to improve delivery efficiency and reduce systemic side effects.

5. What regions offer the most growth potential for hydrocortisone products?
North America remains the dominant market, but emerging economies in Asia-Pacific and Latin America present significant opportunities due to rising disease burden and improving healthcare infrastructure.

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References

[1] ClinicalTrials.gov. (2022). Modified-release hydrocortisone in adrenal insufficiency.
[2] Annane, D., et al. (2021). Hydrocortisone in septic shock: The ADRENAL trial. New England Journal of Medicine.
[3] Sharma, N., et al. (2023). Dose optimization of hydrocortisone in pediatric inflammatory conditions. Pediatric Drugs.
[4] Grand View Research. (2022). Corticosteroids market analysis.

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This comprehensive analysis underscores hydrocortisone’s ongoing clinical relevance and market resilience amid scientific innovation and healthcare shifts.