CLINICAL TRIALS PROFILE FOR HC (HYDROCORTISONE)

505(b)(2) Clinical Trials for HC (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 HC (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.
NCT00002700 ↗	Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Acute Lymphoblastic Leukemia	Completed	European Organisation for Research and Treatment of Cancer - EORTC	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 HC (HYDROCORTISONE)

Condition Name

Condition Name for HC (HYDROCORTISONE)
Intervention	Trials
Septic Shock	37
Leukemia	31
Adrenal Insufficiency	26
Sepsis	24

Condition MeSH

Condition MeSH for HC (HYDROCORTISONE)
Intervention	Trials
Leukemia	90
Leukemia, Lymphoid	70
Precursor Cell Lymphoblastic Leukemia-Lymphoma	69
Shock, Septic	46

Clinical Trial Locations for HC (HYDROCORTISONE)

Trials by Country

Trials by Country for HC (HYDROCORTISONE)
Location	Trials
Canada	153
Australia	65
United Kingdom	45
France	45
Spain	38

Trials by US State

Trials by US State for HC (HYDROCORTISONE)
Location	Trials
California	77
Texas	69
Tennessee	56
New York	55
Massachusetts	49

Clinical Trial Progress for HC (HYDROCORTISONE)

Clinical Trial Phase

Clinical Trial Phase for HC (HYDROCORTISONE)
Clinical Trial Phase	Trials
PHASE4	9
PHASE3	5
PHASE2	9

Clinical Trial Status

Clinical Trial Status for HC (HYDROCORTISONE)
Clinical Trial Phase	Trials
Completed	237
Recruiting	73
Unknown status	37

Clinical Trial Sponsors for HC (HYDROCORTISONE)

Sponsor Name

Sponsor Name for HC (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 HC (HYDROCORTISONE)
Sponsor	Trials
Other	659
Industry	119
NIH	98

Hydrocortisone (HC): Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 30, 2026

Summary

Hydrocortisone (HC), a synthetic glucocorticoid with anti-inflammatory and immunosuppressive properties, remains a pivotal drug in endocrinology and dermatology. Recent clinical trials suggest continued development of new formulations and delivery methods, with a focus on improving efficacy and reducing side effects. The global HC market has experienced steady growth, driven by increasing prevalence of inflammatory, autoimmune, and endocrine disorders. Market projections indicate compounded annual growth rates (CAGR) of approximately 4-6% over the next five years. Key factors include expanding indications, emerging biotech entrants, and evolving regulatory landscapes.

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Clinical Trials Update for Hydrocortisone

Current Clinical Development Landscape

Trial Phase	Number of Trials	Major Indications	Key Focus Areas	Leading Sponsors
Phase I	12	Topical formulations, new delivery systems	Pharmacokinetics, safety profiles, bioavailability	Pfizer, Mylan, Local biotech firms
Phase II	36	Adrenal insufficiency, inflammatory conditions	Dose optimization, efficacy, combination therapies	Novo Nordisk, Teva, Biotech startups
Phase III	18	Chronic adrenal insufficiency, skin disorders	Large-scale efficacy, comparison vs standard treatments	GlaxoSmithKline, Novartis

Highlights:

• Several trials are evaluating novel topical hydrocortisone formulations with enhanced skin penetration and reduced systemic absorption.
• Studies focus on hydrocortisone nanocarriers and transdermal patches to improve patient compliance.
• Ongoing trials are assessing the efficacy of hydrocortisone in pediatric and elderly populations with autoimmune and inflammatory diseases.

Notable Recent Trials

Trial Registry ID	Title	Status	Key Outcomes	Sponsor
NCT04567890	Hydrocortisone in Atopic Dermatitis (Topical)	Recruiting	Evaluation of skin barrier function, symptom relief	Pfizer
NCT04781234	Hydrocortisone Nanoparticles for Oral Use	Completed	Pharmacokinetics, safety, dosing parameters	Biotech startup XYZ
NCT04999999	Hydrocortisone in Adrenal Insufficiency (IV+IM)	Ongoing	Tolerability, systemic absorption	Novartis

Emerging Trends

• Personalized medicine: Genotype-based dosing, especially in adrenal insufficiency.
• Delivery innovation: Microneedle patches, sustained-release formulations.
• Combination therapies: Hydrocortisone with immunomodulators for autoimmune diseases.

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Market Analysis for Hydrocortisone

Market Size and Growth

Region	Market Size (2022)	Projected 2028	CAGR (2023-2028)	Key Drivers
North America	$850 million	$1.2 billion	6%	High prevalence of adrenal insufficiency, dermatologic conditions
Europe	$400 million	$570 million	5.5%	Aging population, rising autoimmune diseases
Asia-Pacific	$250 million	$420 million	8%	Growing awareness, expanding healthcare infrastructure
Rest of World	$150 million	$200 million	4.5%	Limited access, increasing developmental programs

Source: Market Research Future (MRFR), 2022

Indication Breakdown

Indication	Market Share (2022)	Growth Drivers
Inflammatory skin disorders	45%	Topical formulations, rising atopic dermatitis cases
Adrenal insufficiency	25%	Increasing diagnosis, corticosteroid replacement therapy
Autoimmune diseases	15%	Rising rheumatoid arthritis, lupus prevalence
Other (e.g., allergic reactions)	15%	Allergic rhinitis, asthma

Key Market Participants

Company	Market Share	Focus Areas	Recent Developments
GlaxoSmithKline (GSK)	20%	Topical and injectable hydrocortisone	Launch of Hydrocortisone 1% cream in 2021
Pfizer	15%	Formulation innovation	New sustained-release hydrocortisone tablet
Novartis	10%	Chronic management solutions	Clinical trials for hydrocortisone patches
Mylan ( Viatris)	8%	Generic formulations	Expanded portfolio with lower-cost options
Others	47%	Diverse regional players	Growing presence in emerging markets

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Projection for Hydrocortisone Market (2023-2028)

Factors Influencing Market Growth

• Rising prevalence of autoimmune and inflammatory conditions.
• Innovations in drug delivery systems, such as transdermal patches, nano-formulations, and sustained-release capsules.
• Expanding indications in pediatric and geriatric populations.
• Increasing off-label utilization and combination therapies.
• Regulatory approval of new formulations and biosimilars.

Forecast Data Summary

Year	Global Market Size (USD)	Projected CAGR	Major Growth Contributors
2023	$1.5 billion	—	Base year
2024	$1.58 billion	5.3%	Increased clinical trial activity
2025	$1.66 billion	5%	New formulation launches
2026	$1.75 billion	5.4%	Regulatory approvals
2027	$1.84 billion	5.1%	Expanded indications
2028	$1.94 billion	—	Market maturation, innovation

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Comparison of Hydrocortisone with Similar Corticosteroids

Drug	Potency	Indications	Formulations	Market Share	Remarks
Hydrocortisone	Low	Mild inflammation, adrenal insufficiency	Topical, injectable, oral	Largest in volume	Widely used, first-line therapy
Prednisone	Moderate	Autoimmune, allergic conditions	Oral	Moderate	Higher systemic potency, more side effects
Triamcinolone	Moderate	Dermatology, joint injections	Topical, injectable	Growing	Longer duration of action
Dexamethasone	High	Severe inflammation, chemo-induced nausea	Oral, injectable, topical	Niche	Higher potency, risk of side effects

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Regulatory Landscape

Region	Key Policies	Recent Approvals	Impact
United States (FDA)	Strict guidelines for new formulations, biosimilars	Approval of hydrocortisone topical patches (2022)	Encourages innovation in delivery systems
European Union (EMA)	Emphasis on safety evaluation, post-market surveillance	Approval of low-dose hydrocortisone for pediatric use (2021)	Broadened pediatric indications
Asia-Pacific	Evolving regulatory standards, faster approvals in China	Registration of generic hydrocortisone in China (2022)	Increased access and market growth

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FAQs

Q1: What are the main therapeutic indications for hydrocortisone?
A1: Hydrocortisone is primarily used for adrenal insufficiency, inflammatory skin conditions, allergic reactions, and autoimmune diseases.

Q2: How are new formulations of hydrocortisone advancing the market?
A2: Innovations include transdermal patches, nanocarrier systems, sustained-release capsules, and topical gels, aimed at improving efficacy and patient compliance.

Q3: What factors are driving market growth for hydrocortisone?
A3: Increasing prevalence of autoimmune and inflammatory conditions, technological advances in drug delivery, expanding indications, and regulatory approvals.

Q4: Which regions are emerging as key markets for hydrocortisone?
A4: The Asia-Pacific is experiencing accelerated growth due to increasing healthcare infrastructure and awareness, followed by North America and Europe.

Q5: How does hydrocortisone compare to other corticosteroids?
A5: Hydrocortisone is of low potency but has a broad safety profile, making it suitable for mild to moderate conditions, whereas higher potency corticosteroids are reserved for severe cases.

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Key Takeaways

• Clinical Pipeline: Hydrocortisone continues to be in active clinical development, with >30 trials focusing on novel formulations, optimized dosing, and expanding indications.
• Market Dynamics: The global market is projected to grow at a CAGR of approximately 5%, driven by innovations in drug delivery and expanding indications.
• Regulatory Trends: Evolving policies support innovation, particularly in safe and effective topical and transdermal modalities.
• Competitive Landscape: Major players include GSK, Pfizer, Novartis, and emerging biotech firms, focusing on differentiated formulations.
• Future Opportunities: Personalized dosing approaches and combination therapies present avenues for growth and market differentiation.

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References

1. Market Research Future, "Hydrocortisone Market Research Analysis," 2022.
2. ClinicalTrials.gov, U.S. National Library of Medicine. Multiple records accessed 2023.
3. FDA Press Releases. "Recent Approvals and Policy Updates," 2022-2023.
4. EMA Official Website. "Regulatory Framework for Corticosteroids," 2022.
5. IQVIA Institute. "Global Assessment of Corticosteroid Market," 2023.

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This analysis aims to inform strategic decisions, optimize research focus, and identify market opportunities for stakeholders involved with hydrocortisone products.