CLINICAL TRIALS PROFILE FOR PREDNISONE INTENSOL

All Clinical Trials for PREDNISONE INTENSOL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
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.

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
Leukemia	26
Lymphoma	26
Leukemia, Lymphoid	25
Precursor Cell Lymphoblastic Leukemia-Lymphoma	25

Clinical Trial Locations for PREDNISONE INTENSOL

Trials by Country

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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

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−

Trials by US State for PREDNISONE INTENSOL
Location	Trials
Texas	41
California	32
Illinois	28
Washington	27
Ohio	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
Janssen Scientific Affairs, LLC	4

Sponsor Type

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

Prednisone Intensol: Clinical Trials, Market Analysis, and Projections

Introduction

Prednisone Intensol, a formulation of the corticosteroid prednisone, is widely used for its anti-inflammatory and immunosuppressive properties. This article will delve into the current clinical trials involving prednisone, analyze the market trends, and provide projections for its future use.

Clinical Trials Involving Prednisone

Current Trials and Objectives

One notable clinical trial involving prednisone is the phase II trial for the treatment of metastatic castration-resistant prostate cancer (mCRPC) with a specific genetic mutation. This trial, identified as NCT05689021, combines abiraterone acetate/niraparib (CJNJ-67652000) with prednisone to treat patients who have failed prior androgen receptor (AR)-targeted therapy and have a deleterious SPOP gene mutation.

• Primary Objective: To determine the efficacy of the combination therapy as assessed by prostate-specific antigen (PSA) decline ≥ 50% response rate[1].
• Secondary Objectives: Include assessing radiologic progression-free survival (rPFS), best radiographic response, time to PSA progression, and safety and tolerability[1].

Role of Prednisone in Clinical Trials

Prednisone is often used in clinical trials to reduce inflammation and lower the body's immune response, thereby helping to mitigate the side effects of other treatments. In the context of cancer trials, it is used to enhance the efficacy of other drugs and manage symptoms.

Market Analysis of Prednisone

Market Size and Growth

The prednisone market is projected to experience significant growth over the coming years. By 2036, the market size is estimated to cross USD 9 billion, expanding at a compound annual growth rate (CAGR) of around 5% from 2024 to 2036. In 2023, the market size was over USD 6 billion[2].

Growth Drivers

Several factors are driving the growth of the prednisone market:

• Increasing Prevalence of Skin Diseases: Skin allergies, including acne, are prevalent globally, affecting about 8% of the population. This segment is expected to hold 40% of the global prednisone market by 2036[2].
• Rising Prevalence of Asthma: In North America, asthma affects approximately 7% of the population, contributing to the high demand for prednisone in this region[2].
• Growing Healthcare Investments: Hospitals, which are the primary users of prednisone, are seeing increased investments and patient admissions, further boosting the market[2].

Market Segmentation

The prednisone market is segmented based on application and geography:

• Application: The hospital segment is expected to generate the highest revenue share, driven by the growing number of patients with various serious illnesses[2].
• Geography: North America is projected to hold the highest share of the market, followed by the Asia Pacific region, which is experiencing growth due to the lack of physical activity and rising prevalence of diseases such as chronic kidney disease[2].

Projections for Prednisone Intensol

Future Demand

Given the increasing prevalence of skin diseases, asthma, and other conditions that require corticosteroid treatment, the demand for prednisone is expected to rise. The growing population, especially in regions like Asia Pacific, and the lack of physical activity contributing to various health issues, will further drive this demand[2].

Technological and Pharmaceutical Advancements

Advancements in pharmaceutical formulations, such as the development of more efficient delivery systems and combination therapies, are likely to enhance the efficacy and safety profile of prednisone. For instance, the combination of abiraterone acetate/niraparib with prednisone in clinical trials for prostate cancer highlights the potential for improved treatment outcomes[1].

Regulatory and Market Trends

Regulatory initiatives and awareness campaigns by governments to address skin diseases and other conditions will continue to influence the market. The increasing investment in healthcare infrastructure and the availability of a wide range of medicines in hospitals will also contribute to the growth of the prednisone market[2].

Mechanism of Action and Uses

Pharmacological Profile

Prednisone is a glucocorticoid agonist that binds to the glucocorticoid receptor, inhibiting pro-inflammatory signals and promoting anti-inflammatory signals. It is metabolized in the liver to its active form, prednisolone, and has a short duration of action with a half-life of 2-3 hours[4].

Indications

Prednisone is indicated for a wide range of conditions, including allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, infectious, endocrine, and neoplastic conditions. It is also used in organ transplant settings[4].

Safety and Tolerability

Adverse Effects

Prednisone can have several adverse effects, including hypothalamic-pituitary-adrenal axis suppression and increased susceptibility to infections. Patients on long-term corticosteroid therapy need to be counseled about these risks[4].

Clinical Considerations

The use of prednisone requires careful clinical management, especially in trials where it is combined with other drugs. For example, in the trial for mCRPC, the safety and tolerability of the combination therapy are closely monitored using the National Cancer Institute (NCI) Common Toxicity Criteria Version 5.0[1].

Key Takeaways

• Clinical Trials: Prednisone is being used in combination therapies in clinical trials, such as the phase II trial for mCRPC, to enhance treatment efficacy.
• Market Growth: The prednisone market is projected to grow significantly, driven by the increasing prevalence of skin diseases, asthma, and other conditions.
• Mechanism of Action: Prednisone acts as a glucocorticoid agonist, reducing inflammation and immune responses.
• Safety and Tolerability: Careful management is required due to potential adverse effects such as HPA axis suppression and increased infection susceptibility.

FAQs

What is the primary use of prednisone in clinical trials?

Prednisone is used in clinical trials to reduce inflammation and lower the body's immune response, thereby helping to mitigate the side effects of other treatments.

What is the projected market size of prednisone by 2036?

The prednisone market is estimated to cross USD 9 billion by 2036, expanding at a CAGR of around 5% from 2024 to 2036[2].

What are the main growth drivers for the prednisone market?

The main growth drivers include the increasing prevalence of skin diseases, rising prevalence of asthma, and growing investments in the healthcare sector[2].

What are the common adverse effects of prednisone?

Common adverse effects include hypothalamic-pituitary-adrenal axis suppression and increased susceptibility to infections[4].

In which regions is the prednisone market expected to grow significantly?

The prednisone market is expected to grow significantly in North America and the Asia Pacific region due to various health-related factors[2].

Sources

1. CareAcross: CJNJ-67652000 and Prednisone for Treatment of Metastatic Castration-Resistant Prostate Cancer and SPOP Gene Mutations. [NCT05689021].
2. Research Nester: Prednisone Market Size & Share, Growth Forecasts 2036.
3. PubMed: Corticosteroid Use in Randomized Clinical Trials of Biologics and Small Molecules for Inflammatory Bowel Disease.
4. DrugBank: Prednisone: Uses, Interactions, Mechanism of Action.
5. PharmaCompass: Prednisone Intensol | Drug Information, Uses, Side Effects, Chemistry.