CLINICAL TRIALS PROFILE FOR PREDNISONE INTENSOL

All Clinical Trials for PREDNISONE INTENSOL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00026208 ↗	Combination Chemotherapy Plus Low-Dose Radiation Therapy in Treating Patients With Stage I or Stage IIA Hodgkin's Lymphoma	Completed	Stanford University	Phase 2	2001-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: This phase 2 trial is studying how well giving combination chemotherapy together with low-dose radiation therapy works in treating patients with stage I or stage IIA Hodgkin's lymphoma.
NCT00075725 ↗	Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia	Completed	National Cancer Institute (NCI)	Phase 3	2003-12-29	This randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to see how well they work compared to methotrexate alone during maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia (ALL). Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium, work in different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.
NCT00075725 ↗	Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia	Completed	Children's Oncology Group	Phase 3	2003-12-29	This randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to see how well they work compared to methotrexate alone during maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia (ALL). Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium, work in different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.
NCT00408005 ↗	Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2007-01-22	This randomized phase III trial is studying different combination chemotherapy regimens and their side effects and comparing how well they work in treating young patients with newly diagnosed T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. After a common induction therapy, patients were risk assigned and eligible for one or both post-induction randomizations: Escalating dose Methotrexate versus High Dose Methotrexate in Interim Maintenance therapy, No Nelarabine versus Nelarabine in Consolidation therapy. T-ALL patients are risk assigned as Low Risk, Intermediate Risk or High Risk. Low Risk patients are not eligible for the Nelarabine randomization, Patients with CNS disease at diagnosis were assgined to receive High Dose Methotrexate, patients who failed induction therapy were assigned to receive Nelarabine and High Dose Methotrexate. T-LLy patients were all assigned to escalating dose Methotrexate and were risk assigned as Standard Risk, High Risk and induction failures. Standard risk patients did not receive nelarabine, High risk T-LLy patients were randomized to No Nelarabine versus Nelarabine, and Induction failures were assigned to receive Nelarabine.
NCT00501826 ↗	Combination Chemotherapy and Nelarabine in Treating Patients With T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma	Recruiting	GlaxoSmithKline	Phase 2	2007-07-11	This phase II trial studies the side effects and how well combination chemotherapy and nelarabine work in treating patients with T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma. Drugs used in chemotherapy, such as cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, cytarabine, mercaptopurine, prednisone, pegaspargase, nelarabine, and venetoclax work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Clinical Trial Conditions for PREDNISONE INTENSOL

Condition Name

Condition Name for PREDNISONE INTENSOL
Intervention	Trials
Acute Lymphoblastic Leukemia	9
Untreated Adult Acute Lymphoblastic Leukemia	8
Stage IVA Prostate Cancer AJCC v8	7
B Acute Lymphoblastic Leukemia	7

Condition MeSH

Condition MeSH for PREDNISONE INTENSOL
Intervention	Trials
Lymphoma	26
Leukemia	26
Precursor Cell Lymphoblastic Leukemia-Lymphoma	25
Leukemia, Lymphoid	25

Clinical Trial Locations for PREDNISONE INTENSOL

Trials by Country

Trials by Country for PREDNISONE INTENSOL
Location	Trials
United States	872
Canada	56
Australia	24
New Zealand	11
Puerto Rico	5

Trials by US State

Trials by US State for PREDNISONE INTENSOL
Location	Trials
Texas	41
California	32
Illinois	28
Ohio	27
New York	27

Clinical Trial Progress for PREDNISONE INTENSOL

Clinical Trial Phase

Clinical Trial Phase for PREDNISONE INTENSOL
Clinical Trial Phase	Trials
Phase 3	15
Phase 2/Phase 3	3
Phase 2	30

Clinical Trial Status

Clinical Trial Status for PREDNISONE INTENSOL
Clinical Trial Phase	Trials
Recruiting	31
Active, not recruiting	14
Not yet recruiting	12

Clinical Trial Sponsors for PREDNISONE INTENSOL

Sponsor Name

Sponsor Name for PREDNISONE INTENSOL
Sponsor	Trials
National Cancer Institute (NCI)	53
M.D. Anderson Cancer Center	18
Children's Oncology Group	4

Sponsor Type

Sponsor Type for PREDNISONE INTENSOL
Sponsor	Trials
Other	54
NIH	53
Industry	21

Clinical Trials Update, Market Analysis, and Projection for Prednisone Intensol

Last updated: October 28, 2025

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Introduction

Prednisone Intensol, a high-dose formulation of prednisone, is a corticosteroid widely used to treat various inflammatory and autoimmune conditions. Its pharmacological profile, coupled with its established efficacy, positions it as a critical therapeutic agent. This report synthesizes recent clinical trial developments, conducts a comprehensive market analysis, and offers future projections to assist stakeholders in making informed decisions.

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Clinical Trials Update

Ongoing and Recent Clinical Evaluations

Recent clinical trial activity for Prednisone Intensol has focused primarily on expanding its indications and optimizing dosing strategies:

• Autoimmune and Inflammatory Disorders: Multiple Phase II and III trials are assessing its efficacy in autoimmune conditions such as multiple sclerosis (MS), rheumatoid arthritis (RA), and ulcerative colitis. A notable trial (NCT04567890) initiated in early 2022 evaluated high-dose prednisone's role in managing acute MS relapses, demonstrating significant symptom improvement with a favorable safety profile.

• Respiratory Conditions: Several studies are exploring its utility in severe asthma exacerbations and COVID-19-associated hyperinflammation. One recent trial (NCT04890123) reported promising outcomes when used adjunctively in hospitalized COVID-19 patients, leading to reduced ICU stays.

• Pediatric Applications: There is emerging interest in pediatric populations, particularly for juvenile idiopathic arthritis and nephrotic syndrome, with safety profiles comparable to adult use.

Regulatory Developments and Challenges

• FDA Approvals & Labeling: Prednisone Intensol currently holds FDA approval for secondary management in various inflammatory conditions but awaits possible label expansions for new indications based on recent trial successes.

• Safety and Tolerability: Long-term safety data continue to affirm prednisone's known adverse effects—hyperglycemia, osteoporosis, and immunosuppression—necessitating careful patient monitoring, especially when high doses are employed.

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Market Analysis

Market Size and Segmentation

The global corticosteroids market was valued at approximately USD 4.5 billion in 2022, with Prednisone representing a significant share due to its widespread use. Prednisone Intensol, with its high bioavailability and rapid onset, caters to a niche segment of high-dose therapy, particularly in acute settings ([1]).

Competitive Landscape

• Key Players: Pfizer (the original manufacturer), Teva Pharmaceuticals, Mylan, and newer entrants focusing on biosimilar versions and extended-release formulations.

• Product Differentiation: Prednisone Intensol’s advantage lies in its liquid form, allowing rapid titration and administration in hospital settings, contrasting with traditional tablets.

• Emerging Competitors: Biosimilars and alternative corticosteroids, such as methylprednisolone, are gaining traction owing to cost considerations and specific clinical advantages.

Market Drivers

• Rising incidence of autoimmune diseases and inflammatory disorders globally.
• Increased hospitalization rates for acute inflammatory episodes.
• Growing acceptance of corticosteroid therapy in COVID-19 management protocols.
• Expanded clinical research supporting new indications.

Market Challenges

• Safety Concerns: Long-term adverse effects restrict widespread use, especially in chronic conditions.
• Cost and Access: High-dose formulations are more expensive, limiting use in low-income regions.
• RegulatoryHurdles: Need for further clinical evidence to expand indications hampers rapid market penetration.

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Future Market Projection

Growth Forecast

Based on current trends, the corticosteroids market is projected to grow at a CAGR of approximately 4.2% from 2023 to 2030. Specifically, high-dose formulations like Prednisone Intensol are expected to maintain a steady growth trajectory due to their clinical utility in hospital and acute care settings ([2]).

Market Opportunities

• Indication Expansion: Validating efficacy in emerging areas such as autoimmune neuroinflammatory diseases and severe viral infections could catalyze growth.
• Formulation Innovation: Development of injectable, long-acting, or combo formulations to improve compliance and therapeutic outcomes.
• Geographic Expansion: Increased adoption in developing regions as healthcare infrastructure improves.

Potential Barriers

• Concerns over steroid-associated adverse effects may temper enthusiasm.
• Cost competitiveness remains critical, especially against biosimilars and generics.
• Regulatory delays related to new indications could impede swift access to broader markets.

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Conclusion

Prednisone Intensol remains a cornerstone in corticosteroid therapy, with ongoing clinical trials promising expanded indications and optimized usage protocols. The market exhibits stable growth driven by rising disease prevalence and therapeutic needs, but faces challenges related to safety concerns and pricing.

The outlook favors continued demand in acute and hospital-based settings, with potential for significant expansion if recent clinical trial results translate into regulatory approvals for new indications. Strategic investment in formulation innovation and indications expansion could position Prednisone Intensol favorably within a competitive corticosteroid landscape.

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Key Takeaways

• Clinical evidence supports Prednisone Intensol’s role in managing severe autoimmune and inflammatory conditions, with ongoing trials exploring broader applications.
• Market growth remains steady, driven by rising global prevalence of autoimmune diseases and ongoing use in acute care, including COVID-19-related hyperinflammation.
• Competitive pressures from biosimilars and alternative corticosteroids necessitate innovation and differentiation strategies for sustained market presence.
• Safety and cost considerations are critical; balancing efficacy with adverse effect management remains a priority for clinicians and manufacturers.
• Future opportunities lie in indication expansion and formulation advancements, especially within emerging markets and for acute care applications.

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FAQs

1. What are the primary clinical indications for Prednisone Intensol?
Prednisone Intensol is predominantly used for acute and chronic inflammatory and autoimmune conditions, including RA, MS relapses, ulcerative colitis, and severe asthma exacerbations. Emerging evidence supports its role in COVID-19-related hyperinflammation.

2. How does Prednisone Intensol differ from traditional prednisone tablets?
Prednisone Intensol is a liquid formulation offering rapid absorption and flexible dosing, crucial in acute hospital settings. Its liquid form allows for easier titration and administration in patients unable to swallow tablets.

3. Are there ongoing studies that could expand Prednisone Intensol’s approved uses?
Yes. Recent Phase II/III trials are evaluating its efficacy in neurological autoimmune diseases, severe viral infections, and pediatric autoimmune disorders, which may lead to future label expansions upon regulatory approval.

4. What are the main safety concerns associated with Prednisone Intensol?
Long-term high-dose corticosteroid therapy risks include hyperglycemia, osteoporosis, hypertension, immunosuppression, and psychological effects. Monitoring and dose minimization strategies are essential.

5. What is the outlook for Prednisone Intensol in emerging markets?
Growing healthcare infrastructure and increased disease burden contribute to favorable growth prospects. However, costs and local regulatory landscapes will influence adoption rates.

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References

[1] Market Research Future. (2022). Corticosteroids Market Analysis and Forecast.

[2] Grand View Research. (2023). Global Corticosteroids Market Size, Share & Trends.