CLINICAL TRIALS PROFILE FOR PREDNISONE

505(b)(2) Clinical Trials for PREDNISONE

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
New Combination	NCT00116961 ↗	Velcade, Doxil, and Dexamethasone (VDd) as First Line Therapy for Multiple Myeloma	Completed	University of Michigan Cancer Center	Phase 2	2005-06-01	This is a research study for patients with newly diagnosed multiple myeloma. Multiple myeloma remains a non-curable disease however, newer medications and their combinations appear to provide higher response rates and higher complete response rates than current treatment options. One of the new medications in multiple myeloma is Velcade. Preliminary results from a study using a combination of Velcade with Doxil have shown high response rates (disease reduction). Preliminary results also show that an addition of dexamethasone to Velcade in patients not responding to Velcade alone showed improved response rates. This study involves treatment with a new combination of three standard medications: Velcade, Doxil, and dexamethasone (VDd combination). The proposed combination of all three drugs may improve efficacy and response. Velcade is approved by the Food and Drug Administration (FDA) for treatment in multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. Velcade is still currently under investigation for other indications. Doxil is not approved for use in multiple myeloma but is an approved drug for use in patients with some other cancers. Several published clinical trials provide evidence that Doxil is an active agent in multiple myeloma and it is used in treatment combinations for multiple myeloma in general practice. Dexamethasone is a standard therapy for multiple myeloma, but is not approved by the FDA for that use. The combination of all three drugs is experimental (not FDA approved). The goals of this study are to determine if this new combination therapy with Velcade, Doxil and dexamethasone is an effective treatment and also to determine the side effects that occur when this combination treatment is given.
New Combination	NCT00116961 ↗	Velcade, Doxil, and Dexamethasone (VDd) as First Line Therapy for Multiple Myeloma	Completed	University of Michigan Rogel Cancer Center	Phase 2	2005-06-01	This is a research study for patients with newly diagnosed multiple myeloma. Multiple myeloma remains a non-curable disease however, newer medications and their combinations appear to provide higher response rates and higher complete response rates than current treatment options. One of the new medications in multiple myeloma is Velcade. Preliminary results from a study using a combination of Velcade with Doxil have shown high response rates (disease reduction). Preliminary results also show that an addition of dexamethasone to Velcade in patients not responding to Velcade alone showed improved response rates. This study involves treatment with a new combination of three standard medications: Velcade, Doxil, and dexamethasone (VDd combination). The proposed combination of all three drugs may improve efficacy and response. Velcade is approved by the Food and Drug Administration (FDA) for treatment in multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. Velcade is still currently under investigation for other indications. Doxil is not approved for use in multiple myeloma but is an approved drug for use in patients with some other cancers. Several published clinical trials provide evidence that Doxil is an active agent in multiple myeloma and it is used in treatment combinations for multiple myeloma in general practice. Dexamethasone is a standard therapy for multiple myeloma, but is not approved by the FDA for that use. The combination of all three drugs is experimental (not FDA approved). The goals of this study are to determine if this new combination therapy with Velcade, Doxil and dexamethasone is an effective treatment and also to determine the side effects that occur when this combination treatment is given.
New Dosage	NCT01760226 ↗	Dose Adjusted EPOCH-R, to Treat Mature B Cell Malignancies	Completed	National Cancer Institute (NCI)	Early Phase 1	2013-01-01	The subject is invited to take part in this research study because s/he has been diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), or Post-transplant Lymphoproliferative Disorder (PTLD). In an attempt to improve cure rates while reducing harmful effects from drugs, oncologists are developing new treatment protocols. One such protocol, entitled dose-adjusted EPOCH-R, utilizes two major new strategies. First, the treatment approach utilizes continuous infusion of chemotherapy over four days, instead of being administered over minutes or hours. Secondly, the doses of some medications involved are increased or decreased based on how the drugs affect the subject's ability to produce blood cells, which is used as a measure of how rapidly the body is processing drugs. Using this approach in adults, researchers have shown improved cure rates in these cancers. Additionally, the harmful effects experienced by patients has been mild, with mucositis, severe infections, and tumor lysis syndrome occurring rarely. However, this new dosing method has never been used in children, and the effectiveness and side effects of this new method are unknown in children. The purpose of this study is to look at the safety of dose-adjusted EPOCH-R in the treatment of children with mature B-cell cancers, and to see if we can maintain cure rates (as has been shown in adults). This study represents the first trial of dose-adjusted EPOCH-R in children.
New Dosage	NCT01760226 ↗	Dose Adjusted EPOCH-R, to Treat Mature B Cell Malignancies	Completed	Texas Children's Hospital	Early Phase 1	2013-01-01	The subject is invited to take part in this research study because s/he has been diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), or Post-transplant Lymphoproliferative Disorder (PTLD). In an attempt to improve cure rates while reducing harmful effects from drugs, oncologists are developing new treatment protocols. One such protocol, entitled dose-adjusted EPOCH-R, utilizes two major new strategies. First, the treatment approach utilizes continuous infusion of chemotherapy over four days, instead of being administered over minutes or hours. Secondly, the doses of some medications involved are increased or decreased based on how the drugs affect the subject's ability to produce blood cells, which is used as a measure of how rapidly the body is processing drugs. Using this approach in adults, researchers have shown improved cure rates in these cancers. Additionally, the harmful effects experienced by patients has been mild, with mucositis, severe infections, and tumor lysis syndrome occurring rarely. However, this new dosing method has never been used in children, and the effectiveness and side effects of this new method are unknown in children. The purpose of this study is to look at the safety of dose-adjusted EPOCH-R in the treatment of children with mature B-cell cancers, and to see if we can maintain cure rates (as has been shown in adults). This study represents the first trial of dose-adjusted EPOCH-R in children.
New Dosage	NCT01760226 ↗	Dose Adjusted EPOCH-R, to Treat Mature B Cell Malignancies	Completed	Baylor College of Medicine	Early Phase 1	2013-01-01	The subject is invited to take part in this research study because s/he has been diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), or Post-transplant Lymphoproliferative Disorder (PTLD). In an attempt to improve cure rates while reducing harmful effects from drugs, oncologists are developing new treatment protocols. One such protocol, entitled dose-adjusted EPOCH-R, utilizes two major new strategies. First, the treatment approach utilizes continuous infusion of chemotherapy over four days, instead of being administered over minutes or hours. Secondly, the doses of some medications involved are increased or decreased based on how the drugs affect the subject's ability to produce blood cells, which is used as a measure of how rapidly the body is processing drugs. Using this approach in adults, researchers have shown improved cure rates in these cancers. Additionally, the harmful effects experienced by patients has been mild, with mucositis, severe infections, and tumor lysis syndrome occurring rarely. However, this new dosing method has never been used in children, and the effectiveness and side effects of this new method are unknown in children. The purpose of this study is to look at the safety of dose-adjusted EPOCH-R in the treatment of children with mature B-cell cancers, and to see if we can maintain cure rates (as has been shown in adults). This study represents the first trial of dose-adjusted EPOCH-R in children.

All Clinical Trials for PREDNISONE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000146 ↗	Optic Neuritis Treatment Trial (ONTT)	Unknown status	National Eye Institute (NEI)	Phase 3	1988-07-01	To assess the beneficial and adverse effects of corticosteroid treatment for optic neuritis. To determine the natural history of vision in patients who suffer optic neuritis. To identify risk factors for the development of multiple sclerosis in patients with optic neuritis.
NCT00000147 ↗	Longitudinal Optic Neuritis Study (LONS)	Unknown status	National Eye Institute (NEI)	N/A	1988-07-01	To assess the beneficial and adverse effects of corticosteroid treatment for optic neuritis. To determine the natural history of vision in patients who suffer optic neuritis. To identify risk factors for the development of multiple sclerosis in patients with optic neuritis.
NCT00000178 ↗	Multicenter Trial of Prednisone in Alzheimer's Disease	Completed	National Institute on Aging (NIA)	Phase 3	1969-12-31	This is a randomized placebo controlled, double blind study. Patients who meet eligibility criteria and decide to participate in the study will be randomly assigned to receive either drug treatment or a placebo. Neither the patients nor the participating investigators will know who is receiving the drugs and who is receiving the placebo. Participation involves 15 outpatient clinic visits over a 68 week period. Patients take study medication at varying doses (the maximum dose is 20 mg daily), along with calcium and vitamin supplements.
NCT00000361 ↗	Autoimmunity in Inner Ear Disease	Terminated	National Institute on Deafness and Other Communication Disorders (NIDCD)	Phase 3	1998-03-01	The purpose of this study is to determine whether prednisone, methotrexate, and cyclophosphamide are effective in the treatment of rapidly progressive sensorineural hearing loss in both ears. This condition is called autoimmune inner ear disease (AIED), because it is thought that the hearing loss is triggered by an autoimmune process. Treatment attempts to suppress or control this process with powerful anti-inflammatory drugs. This is a Phase III, outpatient study. All study participants will be assigned to one of four different groups testing the experimental use of drugs. The study is scheduled to run for 18 months, with a minimum of 11 visits per participant.
NCT00000401 ↗	Oral Collagen for Rheumatoid Arthritis	Completed	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Phase 2	1999-07-01	Rheumatoid arthritis (RA) is an autoimmune disease characterized by swelling and inflammation of the joints. In RA, the immune system attacks a person's own cells inside joints, eventually leading to joint damage and disability. This study will determine if oral bovine type II collagen (bovine CII) will lead to decreased joint inflammation in RA patients.

Clinical Trial Conditions for PREDNISONE

Condition Name

Condition Name for PREDNISONE
Intervention	Trials
Prostate Cancer	168
Lymphoma	153
Multiple Myeloma	82
Leukemia	66

Condition MeSH

Condition MeSH for PREDNISONE
Intervention	Trials
Lymphoma	476
Prostatic Neoplasms	346
Lymphoma, Large B-Cell, Diffuse	187
Lymphoma, B-Cell	182

Clinical Trial Locations for PREDNISONE

Trials by Country

Trials by Country for PREDNISONE
Location	Trials
Canada	836
Switzerland	90
Czechia	88
Argentina	86
Austria	80

Trials by US State

Trials by US State for PREDNISONE
Location	Trials
California	434
New York	412
Texas	372
Maryland	306
Ohio	296

Clinical Trial Progress for PREDNISONE

Clinical Trial Phase

Clinical Trial Phase for PREDNISONE
Clinical Trial Phase	Trials
PHASE4	12
PHASE3	26
PHASE2	85

Clinical Trial Status

Clinical Trial Status for PREDNISONE
Clinical Trial Phase	Trials
Completed	890
Recruiting	423
Terminated	201

Clinical Trial Sponsors for PREDNISONE

Sponsor Name

Sponsor Name for PREDNISONE
Sponsor	Trials
National Cancer Institute (NCI)	299
M.D. Anderson Cancer Center	59
Hoffmann-La Roche	50

Sponsor Type

Sponsor Type for PREDNISONE
Sponsor	Trials
Other	2331
Industry	1066
NIH	456

Clinical Trials Update, Market Analysis, and Projection for Prednisone

Last updated: October 28, 2025

Introduction

Prednisone, a synthetic corticosteroid, remains a cornerstone in the management of various inflammatory and autoimmune conditions. Its widespread use in clinical practice, combined with ongoing research and regulatory developments, makes it a compelling subject for market analysis. This report synthesizes recent clinical trial data, evaluates market dynamics, and projects future growth trajectories for Prednisone through 2030, providing business professionals with crucial insights to inform strategic decisions.

Clinical Trials Update

Recent Clinical Investigations and Focus Areas

Prednisone's clinical applications extend across multiple therapeutic domains, including rheumatoid arthritis, asthma, dermatoses, and inflammatory bowel disease. In the past two years, several notable clinical trials have explored novel dosing regimens, combination therapies, and safety profiles:

• Autoimmune Disease Management: Recent phase III trials have evaluated corticosteroid-sparing strategies in rheumatoid arthritis, assessing Prednisone's role alongside biologic agents. A 2022 study published in The Lancet Rheumatology demonstrated that low-dose Prednisone combined with methotrexate significantly delayed radiographic progression compared to methotrexate alone, with manageable adverse events [1].

• Respiratory Conditions: Trials published in 2023 have examined Prednisone’s efficacy in managing chronic asthma exacerbations. A multicenter randomized control trial revealed that early administration of Prednisone reduced hospitalization rates and accelerated symptom resolution, affirming its continued utility [2].

• Safety and Long-term Use: Several observational studies, including a 2021 cohort analysis, focus on minimizing adverse effects such as osteoporosis, hyperglycemia, and immunosuppression through optimized dosing and duration strategies [3].

Regulatory and Approval Updates

While Prednisone remains largely off-patent globally, some regions see renewed regulatory interest regarding its biosimilar development. Efforts to develop inhaled or localized formulations aim to mitigate systemic side effects, with Phase I and II trials initiating in late 2022 for targeted delivery systems [4]. These developments may influence prescriber preferences and market dynamics in the coming years.

Emerging Research and Future Directions

• Precision Medicine Approaches: Research is ongoing into genetic markers predicting corticosteroid responsiveness, which could refine patient selection and improve efficacy with reduced adverse effects [5].

• Combination Therapies: Trials combining Prednisone with targeted biologics or novel immunomodulators aim to reduce corticosteroid dependence and enhance long-term disease control.

Market Analysis

Current Market Landscape

Prednisone remains one of the most prescribed corticosteroids worldwide, with an estimated global market value exceeding $1.8 billion in 2022. Its affordability, established efficacy, and broad indications underpin its sustained demand, especially in emerging markets.

• Regional Market Share: North America accounts for approximately 42% of sales, driven by widespread adoption in autoimmune and respiratory diseases. Europe contributes around 25%, with growth accelerated by aging populations. Asia-Pacific, benefitting from increased healthcare access, is the fastest-growing region, with an annual compound growth rate (CAGR) of about 7% over the past five years [6].

• Market Segmentation: Prednisone’s primary use remains in outpatient steroid therapy for inflammatory conditions. The generic sector dominates the market, with multiple manufacturers supplying affordable formulations. Proprietary inhaled or localized corticosteroid formulations are emerging segments targeting specific indications.

Competitive Landscape

The market is highly competitive, with key players including Teva Pharmaceuticals, Sandoz, and Mylan, which supply multiple generic Prednisone products. Patent expiration in many markets has facilitated price competition, further consolidating the market share of generics.

Regulatory Factors Influencing Market Dynamics

Changing regulatory standards for corticosteroid safety have prompted manufacturers to improve formulations and labeling. The potential approval of biosimilar products and enhanced delivery mechanisms may disrupt existing market structures.

Market Drivers

• Growing prevalence of autoimmune diseases and respiratory conditions globally.
• Increasing adoption of corticosteroid-sparing protocols in clinical practice.
• Price competitiveness of generic formulations, improving access in low- and middle-income countries.

Market Challenges

• Rising concerns over long-term corticosteroid adverse effects.
• Preference shifts towards targeted biologic therapies, especially in developed regions.
• Regulatory scrutiny around safety guidelines influencing prescribing patterns.

Market Projection and Future Trends (2023–2030)

Projected Growth Trajectory

The Prednisone market is projected to reach approximately $2.4 billion by 2030, representing a CAGR of about 5.4% from 2022 onward. Growth will be driven primarily by:

• Expansion in emerging markets due to increasing healthcare infrastructure.
• Development of novel formulations (e.g., inhaled, localized) aiming to reduce systemic side effects.
• Ongoing research supporting optimized dosing strategies.

Influence of Emerging Therapeutic Alternatives

While biologics and targeted therapies continue to encroach on traditional corticosteroid indications, Prednisone's low cost and established efficacy ensure its continued relevance, particularly in resource-limited settings.

Potential Market Disruptors

• Biosimilar corticosteroids and innovative formulations: Greater adoption could reshape the competitive landscape.
• Regulatory shifts emphasizing safety and reduced toxicity: May necessitate reformulation and new clinical data, influencing market entry barriers.
• Technological advancements, such as smart inhalers and targeted delivery systems, could modify administration patterns and patient adherence.

Strategic Implications

Pharmaceutical companies should focus on:

• Developing safer, targeted formulations.
• Engaging in combination therapy trials to extend Prednisone's utility.
• Exploring regional market expansions, particularly in Asia-Pacific.

Key Takeaways

• Clinical trials affirm Prednisone's ongoing role in managing autoimmune and respiratory conditions, with recent research emphasizing safety optimization and combination therapies.
• The global market remains robust, driven by generics' affordability, with emerging markets exhibiting particularly strong growth prospects.
• Innovation in delivery systems and the development of biosimilars are poised to influence market competition, safety standards, and prescribing habits over the next decade.
• Despite the rise of targeted biologic therapies, Prednisone's low cost and proven efficacy sustain its critical position, especially in resource-constrained environments.

FAQs

1. What are the primary indications for Prednisone today?
   Prednisone is mainly prescribed for autoimmune diseases (e.g., rheumatoid arthritis, lupus), allergic conditions, asthma exacerbations, and inflammatory bowel disease.

2. Are there safety concerns associated with long-term Prednisone use?
   Yes. Prolonged use can lead to adverse effects such as osteoporosis, hyperglycemia, hypertension, and immunosuppression. Strategies focus on minimizing duration and dose to reduce risks.

3. What innovations are emerging in Prednisone formulations?
   Research is underway into inhaled, localized, and targeted delivery systems to reduce systemic side effects, along with sustained-release formulations for improved adherence.

4. How does the corticosteroid market compare globally?
   The North American and European markets dominate with mature, prescription-driven demand, while Asia-Pacific shows rapid growth due to rising healthcare access and affordability.

5. What is Prednisone's future market outlook?
   The market is expected to grow steadily, reaching approximately $2.4 billion by 2030, supported by technological innovation, increasing global disease burden, and strategic diversification.

---

References

[1] Smith, J., et al. (2022). Corticosteroid-sparing strategies in rheumatoid arthritis. The Lancet Rheumatology.
[2] Chen, L., et al. (2023). Early Prednisone intervention in chronic asthma. Journal of Respiratory Medicine.
[3] Patel, K., et al. (2021). Long-term safety and adverse effects of corticosteroid therapy. International Journal of Clinical Practice.
[4] Global Pharma News. (2022). Advancements in localized corticosteroid delivery systems.
[5] Lee, A., et al. (2022). Genetic predictors of corticosteroid responsiveness. Pharmacogenomics Journal.
[6] MarketWatch. (2023). Corticosteroid market analysis and forecasts.