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.

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.

Clinical Trial Conditions for prednisone

Condition Name

Condition Name for prednisone
Intervention	Trials
Prostate Cancer	170
Lymphoma	153
Multiple Myeloma	82
Leukemia	66

Condition MeSH

Condition MeSH for prednisone
Intervention	Trials
Lymphoma	476
Prostatic Neoplasms	349
Lymphoma, Large B-Cell, Diffuse	187
Lymphoma, B-Cell	183

Clinical Trial Locations for prednisone

Trials by Country

Trials by Country for prednisone
Location	Trials
Canada	838
Switzerland	90
Czechia	88
Argentina	87
Austria	80

Trials by US State

Trials by US State for prednisone
Location	Trials
California	435
New York	413
Texas	373
Maryland	306
Ohio	296

Clinical Trial Progress for prednisone

Clinical Trial Phase

Clinical Trial Phase for prednisone
Clinical Trial Phase	Trials
PHASE4	17
PHASE3	30
PHASE2	89

Clinical Trial Status

Clinical Trial Status for prednisone
Clinical Trial Phase	Trials
Completed	890
Recruiting	426
Terminated	201

Clinical Trial Sponsors for prednisone

Sponsor Name

Sponsor Name for prednisone
Sponsor	Trials
National Cancer Institute (NCI)	300
M.D. Anderson Cancer Center	59
Hoffmann-La Roche	50

Sponsor Type

Sponsor Type for prednisone
Sponsor	Trials
Other	2344
Industry	1075
NIH	457

PREDNISONE: GLOBAL CLINICAL TRIAL LANDSCAPE AND MARKET PROJECTION

Last updated: February 19, 2026

Prednisone is a widely used corticosteroid with established efficacy in treating a broad spectrum of inflammatory and autoimmune conditions. Its market presence is characterized by generic availability, significant real-world evidence of utility, and ongoing clinical investigations focused on novel delivery mechanisms, targeted indications, and combination therapies. The global prednisone market is projected to experience steady growth, driven by the persistent prevalence of its target diseases and evolving treatment paradigms.

WHAT IS THE CURRENT STATE OF PREDNISONE CLINICAL TRIALS?

Current clinical trial activity for prednisone spans several phases and focuses on refining its application and delivery. These trials aim to address unmet needs in disease management, improve patient outcomes, and explore synergistic effects with other therapeutic agents.

Active Clinical Trials by Phase:

As of the latest available data, trials involving prednisone are distributed across all clinical development phases:

• Phase 1: Focuses on safety, tolerability, and pharmacokinetics, often in healthy volunteers or specific patient populations with compromised organ function. These trials are generally fewer in number compared to later phases.
• Phase 2: Evaluates efficacy and optimal dosing in target patient groups. Trials in this phase explore the drug's effectiveness in specific inflammatory conditions such as rheumatoid arthritis, lupus, and various dermatological disorders.
• Phase 3: Confirms efficacy and monitors adverse reactions in larger patient cohorts, comparing prednisone to existing standards of care or placebo. These are critical for regulatory submission.
• Phase 4 (Post-Marketing Studies): Continues after drug approval to gather additional information on long-term effects, different patient populations, and comparative effectiveness in real-world settings. Many ongoing studies fall into this category, particularly those assessing long-term safety profiles or effectiveness in specific sub-populations.

Key Areas of Clinical Investigation:

Prednisone research is not primarily focused on discovering new therapeutic indications, given its extensive existing use. Instead, the emphasis is on optimizing its current application and delivery.

• Novel Delivery Systems: Research is exploring advanced formulations and delivery methods to improve prednisone's therapeutic index. This includes:
  • Targeted Delivery: Investigating methods to deliver prednisone more directly to inflamed tissues, potentially reducing systemic side effects. Examples include liposomal formulations or antibody-drug conjugates designed to target inflammatory cells.
  • Extended-Release Formulations: Development of formulations that provide sustained drug release, allowing for less frequent dosing and potentially more stable plasma concentrations, mitigating peaks and troughs associated with traditional oral formulations.
  • Inhaled or Topical Corticosteroids: While not directly prednisone, the success of these delivery methods for other corticosteroids fuels research into similar approaches for prednisone or its derivatives in specific localized inflammatory conditions.
• Combination Therapies: A significant area of research involves combining prednisone with newer or existing therapeutic agents to achieve greater efficacy or to allow for dose reduction of prednisone.
  • Immunomodulatory Agents: Studies are ongoing to assess the synergistic effects of prednisone with biologics (e.g., TNF inhibitors, IL-6 inhibitors) and targeted small molecules in autoimmune diseases like rheumatoid arthritis, inflammatory bowel disease, and systemic lupus erythematosus. The goal is to leverage the potent anti-inflammatory effects of prednisone while minimizing its long-term adverse effects.
  • Oncology Support: Prednisone is already used as an adjunct in certain cancer treatments (e.g., leukemia, lymphoma) to manage side effects or enhance chemotherapy efficacy. Ongoing research may refine these uses or explore new combinations.
• Specific Disease Sub-populations: Trials are identifying and evaluating prednisone's role in specific patient subgroups or disease phenotypes where its efficacy might be particularly pronounced or where standard treatments are insufficient. This includes investigating its use in:
  • Rare Inflammatory Disorders: Assessing prednisone's impact on diseases with limited treatment options.
  • Pediatric Populations: Further defining optimal dosing and safety profiles for children with inflammatory conditions.
  • Elderly Patients: Evaluating the risk-benefit ratio in older adults who may be more susceptible to corticosteroid-induced adverse events.
• Minimizing Side Effects: A perpetual focus of research is to find ways to mitigate the well-documented side effects of long-term prednisone use, such as osteoporosis, hyperglycemia, Cushingoid features, and immunosuppression. This involves exploring lower doses, intermittent dosing regimens, and co-administration of supportive medications.

Notable Ongoing Trials and Data Sources:

Information on clinical trials is primarily sourced from public registries and research publications.

• ClinicalTrials.gov: A database of privately and publicly funded clinical studies conducted around the world. A search for "prednisone" reveals numerous active and completed trials across various therapeutic areas. For instance, trials might investigate prednisone in combination with JAK inhibitors for rheumatoid arthritis or in specific protocols for managing acute exacerbations of COPD.
• European Union Clinical Trials Register (EUCTR): Provides similar data for trials conducted within the European Union.
• Peer-Reviewed Literature: Journals such as The New England Journal of Medicine, The Lancet, JAMA, and specialized rheumatology, immunology, and dermatology publications frequently report findings from prednisone trials.

Example of a Trial Focus: A Phase 3 study might compare a novel extended-release prednisone formulation against immediate-release prednisone in patients with moderate to severe rheumatoid arthritis, measuring disease activity scores (e.g., DAS28) and incidence of adverse events over a 12-month period.

WHAT IS THE CURRENT MARKET LANDSCAPE FOR PREDNISONE?

The prednisone market is mature and largely genericized, characterized by high volume sales and price competition. Its broad therapeutic utility ensures consistent demand, while innovation is driven by generic manufacturers seeking market share and specialty companies developing improved formulations or combinations.

Market Size and Key Drivers:

The global prednisone market, while difficult to quantify precisely due to its generic nature and inclusion in broader corticosteroid market reports, is estimated to be in the hundreds of millions of USD annually and is projected for stable, albeit modest, growth.

• Market Drivers:
  • Prevalence of Target Diseases: The persistent and often increasing incidence of chronic inflammatory and autoimmune diseases (e.g., asthma, rheumatoid arthritis, Crohn's disease, psoriasis, multiple sclerosis) directly fuels demand for prednisone.
  • Cost-Effectiveness: As a well-established generic medication, prednisone offers a significantly lower cost compared to many newer biologic or targeted therapies. This makes it a first-line or adjunctive treatment of choice, particularly in resource-constrained settings and for patients with limited insurance coverage.
  • Established Efficacy and Safety Profile: Decades of clinical use have provided extensive real-world data and physician familiarity with prednisone's benefits and risks, fostering continued prescribing.
  • Off-Label Use: Prednisone is often used off-label for a variety of inflammatory conditions beyond its approved indications, contributing to its broad market penetration.
  • Advancements in Formulations: While not revolutionary, the development of improved delivery systems (e.g., once-daily formulations, targeted delivery research) can create niche market opportunities and sustain interest.

Competitive Landscape:

The prednisone market is highly fragmented due to its generic status.

• Key Players: Major generic pharmaceutical manufacturers are the primary suppliers. Companies such as Teva Pharmaceutical Industries, Mylan (now Viatris), Sandoz (part of Novartis), and various Indian and Chinese generic producers dominate the market. These companies compete on price, supply chain efficiency, and the ability to meet regulatory quality standards.
• Specialty Pharmaceutical Companies: A smaller segment of the market involves companies developing proprietary formulations or combination products that may include prednisone. These companies aim to differentiate their offerings based on improved patient convenience, reduced side effects, or enhanced efficacy in specific indications.
• Pricing Pressure: Intense competition among generic manufacturers leads to significant pricing pressure, making volume and efficient production critical for profitability. Prices can vary widely based on region, dosage form, and supplier.

Regulatory Environment:

Prednisone is approved by major regulatory bodies worldwide, including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others.

• Generic Approvals: New market entrants must demonstrate bioequivalence to the reference listed drug to gain approval. The regulatory pathway for generics is well-established but requires stringent quality control and manufacturing standards.
• Labeling and Indications: Prescribing information typically covers a wide range of inflammatory, allergic, autoimmune, and neoplastic conditions. Ongoing research can lead to label expansions or clarifications.
• Post-Marketing Surveillance: Regulatory agencies continue to monitor the safety and effectiveness of prednisone through pharmacovigilance programs, collecting data on adverse events reported by healthcare professionals and patients.

Distribution Channels:

Prednisone is distributed through a multi-tiered system:

• Wholesalers and Distributors: Large pharmaceutical distributors supply prednisone to pharmacies and hospitals.
• Retail Pharmacies: This is a primary point of dispensing for outpatient use.
• Hospitals and Clinics: Prednisone is administered in inpatient and outpatient hospital settings.
• Compounding Pharmacies: Some specialized pharmacies may compound prednisone into specific dosage forms for niche applications.

WHAT ARE THE MARKET PROJECTIONS FOR PREDNISONE?

The market for prednisone is projected to exhibit stable, modest growth. This outlook is influenced by its established role in chronic disease management, the ongoing demand for cost-effective treatments, and the potential for innovation in formulation and combination therapy.

Projected Market Growth:

The global prednisone market is expected to grow at a compound annual growth rate (CAGR) of approximately 3-5% over the next five to seven years.

• Factors Supporting Growth:

  • Aging Global Population: As the global population ages, the incidence of age-related inflammatory and autoimmune conditions that are treated with prednisone is likely to increase.
  • Rising Incidence of Chronic Diseases: The global increase in the prevalence of conditions such as asthma, COPD, rheumatoid arthritis, and inflammatory bowel disease will continue to drive demand for prednisone as a foundational treatment.
  • Emerging Markets: Increasing access to healthcare and the availability of cost-effective generic medications like prednisone in emerging economies will contribute to market expansion.
  • Continued Use in Combination Therapies: As research validates new combinations of prednisone with novel agents, its use as an adjunctive therapy is expected to persist and potentially expand in specific disease areas.
  • Focus on Cost Containment: Healthcare systems worldwide are under pressure to control costs. Prednisone's affordability ensures its continued consideration, especially when compared to more expensive biologics or novel small molecules.

• Potential Restraints on Growth:

  • Development of Novel Therapies: The introduction of highly targeted therapies with potentially improved efficacy and reduced side effects for specific conditions could, in some instances, displace prednisone as a primary treatment.
  • Increased Awareness of Long-Term Side Effects: Growing awareness and emphasis on minimizing long-term corticosteroid toxicity may lead to more judicious prescribing and a preference for alternative treatments when feasible.
  • Stricter Regulatory Scrutiny on Steroid Use: Regulatory bodies may impose further restrictions or guidelines on the prolonged use of corticosteroids based on evolving safety data.

Regional Market Dynamics:

• North America and Europe: These mature markets will continue to represent a significant share of the global prednisone market. Growth here will be driven by the prevalence of chronic diseases, an aging population, and the ongoing use of prednisone in combination therapies. Cost containment efforts may also reinforce its use as a cost-effective option.
• Asia-Pacific: This region is expected to exhibit the highest growth rate. Increasing healthcare expenditure, expanding access to medical facilities, a growing understanding of chronic disease management, and the widespread availability of affordable generic prednisone will be key drivers.
• Latin America and Middle East/Africa: These regions will see steady growth, primarily driven by increasing healthcare infrastructure, rising disposable incomes, and the demand for essential, affordable medications for chronic inflammatory conditions.

Innovation and Future Trends:

While the core prednisone molecule is unlikely to undergo significant changes, innovation will focus on:

• Advanced Drug Delivery: Research into targeted delivery systems and extended-release formulations could lead to improved patient compliance and reduced adverse events, potentially carving out premium market segments.
• Precision Medicine Applications: Identifying specific biomarkers or genetic profiles that predict a favorable response to prednisone or identify patients at higher risk of adverse effects could lead to more personalized treatment strategies.
• Synergistic Regimens: Ongoing research into optimal combinations of prednisone with biologics and other targeted therapies will solidify its role as an indispensable part of multi-modal treatment regimens for complex inflammatory and autoimmune diseases.
• Focus on Depot Formulations: Development of long-acting injectable forms for specific indications could offer convenience and improved adherence.

Market Projection Example: By 2028, the global market for prednisone is anticipated to reach approximately $600-$700 million USD, up from an estimated $500-$550 million USD in 2023. This growth will be supported by a sustained demand in developed markets and accelerated uptake in emerging economies.

KEY TAKEAWAYS

• Prednisone clinical trials focus on optimizing delivery methods, exploring combination therapies, and refining its use in specific patient populations rather than discovering new indications.
• The market is mature and dominated by generic manufacturers, characterized by high volume sales and price competition.
• Key drivers for continued market demand include the high prevalence of inflammatory and autoimmune diseases, cost-effectiveness, and established clinical utility.
• The global prednisone market is projected for stable, modest growth (3-5% CAGR) driven by an aging population, rising chronic disease rates, and expansion in emerging markets.
• Innovation is anticipated in advanced drug delivery systems and synergistic treatment regimens, while cost containment pressures will continue to favor generic options.

FAQS

1. What are the primary regulatory hurdles for new prednisone formulations? New formulations of prednisone, such as extended-release versions or novel delivery systems, must demonstrate bioequivalence to the original product and possess a favorable safety and efficacy profile. They will undergo rigorous review by agencies like the FDA or EMA, requiring extensive clinical data to support their approval for specific indications.

2. How does the patent landscape affect the prednisone market? As prednisone is a well-established drug with expired core patents, the market is primarily driven by generic competition. Patent protection for new prednisone-related innovations would typically apply to novel formulations, unique delivery devices, or specific combination therapies, not the active pharmaceutical ingredient itself.

3. What is the projected impact of biosimil corticosteroids on the prednisone market? The concept of "biosimilar" traditionally applies to biologic drugs. For small molecules like prednisone, the market competition is primarily from generic manufacturers demonstrating bioequivalence. Therefore, the impact is not from biosimil entrants but from the continued introduction of cost-competitive generic versions by various pharmaceutical companies.

4. What are the main safety concerns associated with long-term prednisone use, and how are clinical trials addressing them? Long-term use is associated with significant adverse effects including osteoporosis, hyperglycemia, increased infection risk, Cushingoid features, and adrenal suppression. Clinical trials are addressing these by investigating lower effective doses, intermittent dosing schedules, co-administration of protective agents, and exploring alternative formulations that might reduce systemic exposure.

5. How do emerging markets influence the global prednisone market projections? Emerging markets significantly contribute to growth projections for prednisone. Increased healthcare access, rising disposable incomes, and the demand for affordable treatments for prevalent chronic inflammatory conditions make these regions key drivers for volume expansion and overall market value.

CITATIONS

[1] U.S. National Library of Medicine. (n.d.). ClinicalTrials.gov. Retrieved from https://clinicaltrials.gov/ [2] European Medicines Agency. (n.d.). European Union Clinical Trials Register. Retrieved from https://www.clinicaltrialsregister.eu/