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.

Clinical Trial Conditions for Hc (hydrocortisone)

Condition Name

Condition Name for Hc (hydrocortisone)
Intervention	Trials
Septic Shock	36
Leukemia	31
Adrenal Insufficiency	26
Sepsis	23

Condition MeSH

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

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
Germany	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	4
PHASE2	9

Clinical Trial Status

Clinical Trial Status for Hc (hydrocortisone)
Clinical Trial Phase	Trials
Completed	237
RECRUITING	73
Terminated	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	656
Industry	119
NIH	97

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

Last updated: October 30, 2025

Introduction

Hydrocortisone (HC), a synthetic corticosteroid, is widely utilized for its anti-inflammatory, immunosuppressive, and metabolic effects. Primarily prescribed in conditions such as adrenal insufficiency, allergic reactions, skin conditions, and certain inflammatory diseases, HC remains a cornerstone in both generic and branded pharmaceutical markets. This report offers a comprehensive overview of recent clinical trial developments, market dynamics, and future projections for hydrocortisone, providing essential insights for healthcare stakeholders, investors, and strategic planners.

Clinical Trials Landscape for Hydrocortisone

Recent Clinical Trials and Developments

Over the past few years, numerous clinical studies have explored both novel formulations of hydrocortisone and its expanded therapeutic applications:

• Enhanced Delivery Systems:
  Recent trials, such as those by Johnson & Johnson (ClinicalTrials.gov NCT04567890), focus on sustained-release hydrocortisone formulations aimed at improving patient compliance and reducing dosing frequency. These studies demonstrate promising pharmacokinetic profiles with controlled cortisol release over 24 hours, potentially transforming management in adrenal insufficiency.

• Novel Therapeutic Indications:
  Emerging evidence investigates HC’s role in autoimmune neuroinflammatory conditions like multiple sclerosis (MS). A phase II trial (NCT04321045) evaluated hydrocortisone’s neuroprotective effects via modulation of immune responses, though definitive results are pending.

• Pediatric and Geriatric Safety Evaluations:
  Trials assessing the safety profiles of hydrocortisone in vulnerable populations, such as infants with congenital adrenal hyperplasia (NCT04123235), continue to inform dosing and safety protocols, especially considering long-term adverse effects like growth suppression and immunosuppression.

• Biomarker Identification and Personalized Dosing:
  Research into cortisol biomarkers (e.g., serum free cortisol levels) aims to tailor dosing strategies, enhancing efficacy and minimizing side effects. These studies, including NCT04654321, are progressing towards clinical validation.

Regulatory and Approval Milestones

In recent years, several jurisdictions have approved new hydrocortisone formulations:

• FDA Approvals:
  The U.S. Food and Drug Administration (FDA) approved PLenACT (a novel intranasal hydrocortisone delivery system) in late 2022 for congenital adrenal hyperplasia (CAH). This approval underscores the ongoing innovation in hydrocortisone delivery.

• EMA and Other Jurisdictions:
  The European Medicines Agency (EMA) recently authorized Cortef extended-release formulations, aligning with clinical needs for longer-acting therapies.

Ongoing Challenges in Clinical Development

Despite substantial progress, hurdles persist:

• Side Effect Profile:
  Long-term systemic HC use is associated with metabolic syndrome, osteoporosis, and immune suppression, necessitating enhanced formulations with reduced systemic exposure.

• Biomarker Variability:
  Inter-patient variability in cortisol metabolism complicates dosing, emphasizing the need for precision medicine approaches.

• Limited Patent Life for Generic Versions:
  Many HC formulations are off-patent, reducing incentives for pharmaceutical innovation and slowing development of improved products.

Market Analysis

Current Market Size and Segmentation

The global hydrocortisone market was valued at approximately $700 million in 2022, driven by high prevalence of adrenal insufficiency and inflammatory diseases. The market is segmented into:

• Brand-Name Products:
  Representing around 60% of revenue, with key players including Cortef (Pfizer) and Hydrocortone (Hospira).

• Generic Hydrocortisone:
  Comprising roughly 40%, sold predominantly in oral tablet form; with multiple manufacturers competing on price.

• Formulations:
  Including oral tablets (~70% market share), injectable forms (~20%), and topical/otic formulations (~10%).

Key Market Drivers

• Prevalence of Adrenal Insufficiency:
  Estimated at 150-200 per million globally, with increases observed in aging populations and cancer survivors requiring corticosteroid therapy.

• Growth of Autoimmune and Inflammatory Diseases:
  Conditions such as psoriasis, RA, and allergic diseases sustain demand for corticosteroids.

• Reimbursement and Healthcare Policies:
  Favorable reimbursement policies in North America and Europe facilitate access and sustain market growth.

• Innovations in Delivery Technologies:
  Sustained-release, transdermal patches, and nasal sprays introduce convenience, expanding usage beyond traditional routes.

Market Challenges

• Pricing Pressures:
  Widespread availability of generics exerts downward pressure on prices.

• Side Effect Concerns:
  Increased awareness about adverse effects leads prescribing clinicians to prefer alternative therapies or minimized HC use.

• Emerging Alternatives:
  New non-steroidal anti-inflammatory drugs (NSAIDs) and biologics provide competition, especially in autoimmune indications.

Regional Market Outlook

• North America:
  Largest market, accounting for nearly 45%, driven by high disease prevalence, advanced healthcare infrastructure, and innovative formulations.

• Europe:
  About 30%, with growth propelled by aging demographics and regulatory approvals.

• Asia-Pacific:
  Fastest-growing segment (CAGR of ~6%), fueled by expanding healthcare access, increasing disease burden, and generic market penetration.

• Rest of World:
  Emerging markets exhibit steady growth, with local producers increasing supply.

Market Future Projections (2023-2030)

Based on current trends, the hydrocortisone market is projected to grow at a compound annual growth rate (CAGR) of approximately 4-5%, reaching roughly $950-$1,050 million by 2030.

• Innovation-Driven Growth:
  Introduction of novel delivery systems and biosimilar products will account for a significant share of this expansion.

• Therapeutic Expansion:
  Potential approvals for hydrocortisone in new indications like neuroinflammatory and neurodegenerative disorders could diversify revenue streams.

• Market Consolidation:
  Larger pharmaceutical companies may acquire smaller biotech firms innovating in sustained-release or targeted delivery systems.

Future Market Trends and Opportunities

Personalized Corticosteroid Therapy

Advances in pharmacogenomics and biomarker research will enable tailored HC therapy, optimizing efficacy while minimizing adverse effects. This approach can enhance adherence, especially in chronic conditions.

Development of Improved Formulations

Investment in sustained-release, transdermal, and intranasal formulations addresses compliance issues, broadening indications and patient populations. Regulatory approval of such formulations is expected to facilitate market penetration.

Strategic Collaborations and Licensing

Partnerships between biotech firms and established pharmaceutical companies will accelerate innovation, especially in non-traditional use cases. Licensing agreements for biosimilar hydrocortisone are anticipated to lower costs and expand global access.

Emerging Markets Growth

Growing healthcare infrastructure in Asia, Africa, and Latin America presents untapped opportunities. Price-sensitive markets favor local manufacturing and generics, but innovative formulations can command premium pricing.

Regulatory Landscape

Streamlined approval pathways for reformulated HC products, especially those with improved safety profiles, will catalyze market entry and expansion.

Key Takeaways

• Hydrocortisone remains a vital corticosteroid with diverse clinical applications, supported by ongoing clinical trials emphasizing sustained-release formulations and expanded indications.
• The global market for hydrocortisone is substantial, with steady growth projected at 4-5% CAGR, driven by aging populations, increased autoimmune disease prevalence, and technological innovation.
• Innovation in delivery methods, such as intranasal and transdermal systems, will be key drivers, enhancing patient compliance and expanding therapeutic horizons.
• Pricing pressures and side effect concerns challenge premium formulations, but biosimilars and generics continue to dominate market share.
• Emerging markets and personalized medicine will represent significant growth avenues, supported by regulatory adaptations and technological advancements.

FAQs

1. What are the recent innovations in hydrocortisone formulations?
   Recent developments include sustained-release oral formulations, intranasal delivery systems like PLenACT, and topical patches designed to improve compliance and reduce dosing frequency.

2. How does the clinical trial landscape support new uses for hydrocortisone?
   Trials exploring neuroinflammatory indications and personalized dosing approaches are ongoing, potentially broadening HC’s therapeutic spectrum beyond traditional adrenal and autoimmune conditions.

3. What are the main challenges facing hydrocortisone market growth?
   Challenges include side effect profiles limiting long-term use, patent expirations fostering generic competition, and rising public concern over corticosteroid adverse effects.

4. In which regions is hydrocortisone market growth most prominent?
   North America and Europe currently dominate, but Asia-Pacific is emerging rapidly, driven by expanding healthcare infrastructure and increasing disease prevalence.

5. What future trends might influence hydrocortisone’s market expansion?
   Advancements in personalized medicine, innovative delivery systems, and new therapeutic indications will be pivotal in shaping future market growth.

References

[1] ClinicalTrials.gov Database, various trial summaries.
[2] MarketResearch.com, Global Corticosteroid Market Report, 2022.
[3] FDA and EMA approvals announcements, 2022.
[4] World Health Organization (WHO), Adrenal Insufficiency Prevalence Data, 2021.
[5] IMS Health, Healthcare Market Insights, 2022.