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.
New Combination	NCT01845792 ↗	Study of Abiraterone Acetate and Prednisone in Combination With Cabazitaxel in Patients With Prostate Cancer	Terminated	Janssen Services, LLC	Phase 2	2013-07-01	Patients are being asked to take place in this research study because they have advanced prostate cancer that has gotten worse after other treatments. If they join this study they will receive a new combination of drugs that are used to treat prostate cancer.
New Combination	NCT01845792 ↗	Study of Abiraterone Acetate and Prednisone in Combination With Cabazitaxel in Patients With Prostate Cancer	Terminated	University of Colorado, Denver	Phase 2	2013-07-01	Patients are being asked to take place in this research study because they have advanced prostate cancer that has gotten worse after other treatments. If they join this study they will receive a new combination of drugs that are used to treat prostate cancer.

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.
NCT00000401 ↗	Oral Collagen for Rheumatoid Arthritis	Completed	University of Tennessee	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.
NCT00000420 ↗	Safety of Estrogens in Lupus: Birth Control Pills	Completed	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Phase 3	1997-06-01	Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA) is a study to test whether women with systemic lupus erythematosus (SLE or lupus) can safely use estrogen. We will determine this by looking at the effects of oral contraceptives (birth control pills, also known as "the pill") on disease activity and severity in women with SLE. The results of the study will show whether it is safe for women with SLE to use the pill.

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 Clinical Trials Update, Market Analysis, and 2026–2036 Projection

Last updated: May 22, 2026

Executive summary

Prednisone is a generic, off-patent systemic corticosteroid with broad FDA approval for multiple inflammatory and autoimmune indications. Current clinical-trial activity is dominated by (1) supportive pharmacokinetic (PK), bioequivalence, and formulation studies, (2) steroid-sparing or regimen-optimization trials in specific disease areas, and (3) comparative studies versus alternative corticosteroid strategies rather than novel prednisone molecules. Market growth projections are constrained by generic competition and pricing normalization, with volume and guideline-driven use providing the main upside. The risk profile is mostly tied to reimbursement pressure, steroid adverse-event management, and label or guideline updates rather than patent or exclusivity expiry.

What is the current FDA status of prednisone (Orange Book, exclusivity, approved dosage forms)?

Prednisone is widely marketed in the US in generic form. In practice, most commercially available products are approved under Abbreviated New Drug Applications (ANDAs) using bioequivalence to an originator reference. Orange Book exclusivity typically does not provide a durable barrier for prednisone because the active ingredient is long off-patent.

What approved routes and dosage forms matter for market demand?

Prednisone is used as an oral corticosteroid across broad therapeutic categories:

• Oral tablets (immediate release; typical generic strengths vary by manufacturer)
• Oral liquid solutions (market presence depends on manufacturer and historical availability)
• Tapering regimens are common in clinical practice, which increases dosing flexibility needs (supply continuity and stable pricing matter more than “novel delivery systems”)

How does label scope affect utilization?

The multi-indication label supports usage across:

• Rheumatology and autoimmune disease flares
• Dermatology
• Pulmonology (eg, asthma/COPD exacerbation protocols depending on guidelines)
• Oncology supportive care (antiemetic regimens sometimes include corticosteroids as components, though specific combinations differ by regimen)
• Hematology (eg, inflammatory and lymphoproliferative supportive approaches) This broad label scope reduces dependency on any single indication’s trial outcomes.

What clinical trials are currently recruiting or active for prednisone, and what do they test?

A persistent theme across corticosteroid development programs is “how to use steroids” rather than “how to make prednisone better.” For prednisone specifically, trial designs that remain active typically fall into these buckets:

1) Regimen optimization trials (dose, duration, taper)

Common endpoints:

• Reduction in relapse rates or symptom recurrence
• Time to symptom resolution
• Steroid-related toxicity (hyperglycemia, infection risk, bone effects)
• Healthcare utilization (ER visits, hospitalization, rescue therapy)

2) Steroid-sparing trials using prednisone in comparator arms

Prednisone often functions as a standard-of-care comparator dose in trials of:

• Targeted biologics or small molecules meant to reduce systemic steroid exposure
• Novel anti-inflammatory agents where endpoints explicitly include “steroid-free” intervals

3) PK, bioequivalence, and formulation trials in generic development

These studies generally do not create demand growth but can affect:

• Supply reliability
• Local availability for specific strengths or pack sizes
• Short-term pricing competition at regional and pharmacy benefit manager levels

Which indications drive the bulk of prednisone usage, and how do trial trends map to them?

Because prednisone is off-patent and used widely, indicator-by-indicator trial “activity” does not automatically translate into market growth. The main demand drivers are guideline adherence and disease prevalence. Trial trends influence utilization mostly through:

• Updates to relapse management protocols
• Shifts toward steroid-sparing strategies in defined subsets

Rheumatology and autoimmune flares

Steroid tapers and bridging regimens still support prednisone volume, but trials testing steroid-sparing agents can reduce marginal prednisone exposure per patient.

Pulmonology exacerbation management

Systemic steroid courses are entrenched in exacerbation algorithms for acute airway inflammation. Clinical trial activity tends to focus on:

• Identifying shorter-course strategies
• Comparing systemic steroid regimens or adjuncts

Dermatology and allergic inflammation

Topical therapy may reduce systemic use in some conditions, but prednisone remains a mainstay for severe flares where systemic control is required.

Hematology and oncology supportive care

Use is often regimen-dependent and can vary by protocol. Steroid burden may change if targeted therapies replace older cytotoxic or supportive frameworks.

How do prednisone clinical trial outcomes typically affect market uptake in the generic era?

In an off-patent market, trial impacts tend to show up as:

• Formulary position changes (preferred steroid vs alternative corticosteroid)
• Protocol-driven changes in average daily dose and duration
• Shifts in patient selection (who gets systemic steroids, when to taper)

What metrics investors should track from trial readouts?

• Average duration of systemic corticosteroid exposure
• Proportion of patients reaching “steroid-free” status
• Hospitalization and relapse endpoints that translate into prescribing behavior
• Safety signals that drive guideline adjustments and clinician caution

How strong is the patent estate for prednisone, and where are the remaining IP barriers?

For active ingredient prednisone itself, patent barriers are not the central issue. The practical IP landscape is:

• Generic active ingredient is off-patent in major markets.
• Residual protections, if any, are more likely to be formulation-specific, manufacturing-process specific, or method-of-use specific for niche product presentations or specialized dosing regimens.
• In most cases, commercial differentiation is supply chain and pricing rather than legal exclusivity.

What should be assumed about Orange Book listings?

Prednisone’s Orange Book profile is typically characterized by very limited remaining exclusivity and many ANDA products. If a specific manufacturer’s product has listed patents, those rarely block generic entry at the active ingredient level, and they tend to be product-specific rather than drug-class wide.

What generic entry risks exist for prednisone?

Generic entry risk is low at the active ingredient level because prednisone is already widely available. New competitive risk is more about:

• Shortage-driven price spikes
• Pack size or concentration changes affecting pharmacy ordering patterns
• Regional supply disruptions or temporary manufacturing constraints

How does prednisone compare with other systemic corticosteroids (methylprednisolone, dexamethasone) in market positioning?

Clinicians compare efficacy and safety by:

• Potency and duration
• Route of administration needs
• Dose conversion familiarity
• Side-effect management and patient comorbidities

Market impact:

• If guidelines favor dexamethasone or methylprednisolone for certain acute protocols, prednisone’s share can soften in those specific settings.
• Prednisone remains advantaged where oral, taper-based, outpatient management is common.

What market size and growth outlook apply to prednisone (2026–2036)?

Prednisone is best treated as a mature, generic commodity-like therapy. Market growth is driven by:

• Patient population growth and persistence of steroid-responsive diseases
• Relative prescribing patterns among corticosteroids
• Payer formularies and contracting
• Safety-management trends that may reduce indiscriminate systemic steroid use

Projection logic used in generic corticosteroid markets

A reasonable base-case projection framework for prednisone market demand:

• Flat-to-low single digit CAGR from volume growth offset by pricing normalization
• Potential downside if steroid-sparing pathways expand quickly in high-volume indications
• Potential upside in scenarios with increased exacerbation burden (air quality, respiratory season intensity, healthcare access)

What level of upside is plausible without new patent exclusivity?

In off-patent systemic steroids, market upside typically comes from:

• Higher guideline adherence to systemic steroid courses when indicated
• Increased patient treatment rates in underdiagnosed populations
• Competitive pricing improving access

Downside typically comes from:

• Growth in steroid-sparing biologics and targeted agents in specific subpopulations
• Preference shifts to alternative corticosteroids in protocol-driven contexts

Clinical development pipeline impact: does prednisone have a “future” beyond generics?

Prednisone’s “pipeline” impact is mostly indirect:

• It is used as a comparator and background standard in trials of steroid-sparing drugs.
• If new agents reduce prednisone exposure, prednisone per-patient utilization can decline even while the treated population grows.

In the market model, this means:

• Total demand can still grow slowly due to treated prevalence
• Per-capita prednisone exposure can decline in responsive subsets

How to benchmark competitive landscape for prednisone distributors and manufacturers

Because product differentiation is limited, competitive advantages are operational:

• Manufacturing capacity and reliability
• Ability to supply multiple strengths and packaging configurations
• Contracting with GPOs and PBMs
• Pharmacovigilance quality and label compliance

Key commercial indicators

Track:

• Unit volume trends (tablets/liquid equivalents)
• Average net selling price (ANSP) by strength
• Pharmacy channel mix (retail vs mail)
• Shortage events and their duration
• Formulary utilization shifts between oral corticosteroids

What FDA regulatory and manufacturing risks matter most for prednisone?

The dominant risks in mature generics are:

• Manufacturing quality events (deviations, recalls, warning letters)
• Supply chain constraints for key intermediates and excipients
• Labeling compliance updates that require manufacturing and distribution adjustments

These events can temporarily move pricing and availability, but they do not create durable market exclusivity.

Key Takeaways

• Prednisone is off-patent and market behavior is primarily driven by guideline-driven clinical use and generic supply dynamics.
• Current clinical trial activity is concentrated on regimen optimization, steroid-sparing comparisons, and supporting bioequivalence/formulation work rather than new prednisone IP.
• Growth is likely low and volume-led with pricing pressure. Competitive positioning depends more on manufacturing reliability and contracting than patent protection.
• Market downside is linked to expansion of steroid-sparing therapies in high-impact indications; upside is linked to maintained or increased systemic steroid course use per guideline and access improvements.

FAQs

1. Do prednisone clinical trials focus on new prednisone formulations or on steroid-sparing strategies?
   Most active trial themes emphasize regimen optimization and steroid-sparing comparators, with prednisone commonly used as a standard arm.

2. How does prednisone safety monitoring (infection risk, hyperglycemia) influence prescribing patterns?
   Safety management affects duration and taper aggressiveness, with clinicians more likely to shorten systemic exposure when alternative therapies are available.

3. Is prednisone a target for biosimilar competition?
   No. Prednisone is a small-molecule generic drug, not a biologic, so biosimilar frameworks do not apply.

4. What drives pricing changes for prednisone in the US?
   Generic supply balance, pack size availability, PBM contracting, and intermittent manufacturing or distribution constraints.

5. Which corticosteroid is most likely to take share from prednisone?
   Share shifts depend on protocol-specific preferences for dexamethasone or methylprednisolone in particular exacerbation and regimen contexts, but prednisone remains entrenched for oral taper-based use.

References

1. FDA Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations). US Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
2. ClinicalTrials.gov. Prednisone studies and results. https://clinicaltrials.gov/
3. FDA Drug Trials Snapshots. US Food and Drug Administration. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots