CLINICAL TRIALS PROFILE FOR PRELONE

505(b)(2) Clinical Trials for Prelone

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	NCT01884428 ↗	Study of Combination of PIGEV Before Autologous Stem Cell Transplant in Patients With Hodgkin's Lymphoma	Unknown status	Armando Santoro, MD	Phase 1	2011-07-01	study to assess maximum tolerated dose (MTD), safety, tolerability and activity of IGEV (Ifosfamide, Gemcitabine,Vinorelbine, Prednisolone) + Panobinostat new combination in order to determine the recommended phase II dose

All Clinical Trials for Prelone

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00900445 ↗	Studying Body Mass Index in Younger Patients Who Are Receiving Treatment for High-Risk Acute Lymphoblastic Leukemia	Withdrawn	National Cancer Institute (NCI)		2008-03-24	This clinical trial is studying body mass index in younger patients receiving prednisone/prednisolone, vincristine, daunorubicin, and pegaspargase for high-risk acute lymphoblastic leukemia. Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about the affect of body mass index on the way anticancer drugs work in the body. It may also help doctors predict how patients will respond to treatment
NCT00900445 ↗	Studying Body Mass Index in Younger Patients Who Are Receiving Treatment for High-Risk Acute Lymphoblastic Leukemia	Withdrawn	Children's Oncology Group		2008-03-24	This clinical trial is studying body mass index in younger patients receiving prednisone/prednisolone, vincristine, daunorubicin, and pegaspargase for high-risk acute lymphoblastic leukemia. Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about the affect of body mass index on the way anticancer drugs work in the body. It may also help doctors predict how patients will respond to treatment
NCT01211665 ↗	Corticosteroids for Immune Reconstitution Inflammatory Syndrome (IRIS)	Terminated	Elan Pharmaceuticals	Phase 4	2010-09-01	The objectives of this study are to explore the effects of administering high-dose corticosteroids to participants who developed progressive multifocal leukoencephalopathy (PML) while on natalizumab as measured by time-course change in functional status based on Karnofsky Performance Status Index through 6 months following the completion of plasma exchange (PLEX; or equivalent), survival at 6 months following the completion of PLEX (or equivalent), and incidence and severity of adverse events (AEs) and serious adverse events (SAEs); to characterize the evolution of immune reconstitution inflammatory syndrome (IRIS) as measured by time course changes in Global Clinical Impression of Improvement (GCI-I), Symbol Digit Modalities Test (SDMT), brain magnetic resonance imaging (MRI), magnetoencephalography (MEG), chemokines, cytokines, C-reactive protein (CRP), John Cunningham virus (JCV) load and cell count in cerebrospinal fluid (CSF); and to characterize the time course elimination of serum natalizumab concentrations in the study population following the last PLEX (or equivalent) procedure.

Clinical Trial Conditions for Prelone

Condition Name

Condition Name for Prelone
Intervention	Trials
B Acute Lymphoblastic Leukemia	5
Mixed Phenotype Acute Leukemia	3
Acute Lymphoblastic Leukemia	2

Condition MeSH

Condition MeSH for Prelone
Intervention	Trials
Precursor Cell Lymphoblastic Leukemia-Lymphoma	8
Leukemia, Lymphoid	8
Leukemia	8

Clinical Trial Locations for Prelone

Trials by Country

Trials by Country for Prelone
Location	Trials
United States	240
Canada	30
Australia	15
New Zealand	6
Puerto Rico	4

Trials by US State

Trials by US State for Prelone
Location	Trials
Pennsylvania	7
Ohio	7
Utah	6
Texas	6
Tennessee	6

Clinical Trial Progress for Prelone

Clinical Trial Phase

Clinical Trial Phase for Prelone
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	7
Phase 2	2

Clinical Trial Status

Clinical Trial Status for Prelone
Clinical Trial Phase	Trials
Not yet recruiting	4
Recruiting	4
Active, not recruiting	1

Clinical Trial Sponsors for Prelone

Sponsor Name

Sponsor Name for Prelone
Sponsor	Trials
National Cancer Institute (NCI)	9
Children's Oncology Group	5
Elan Pharmaceuticals	1

Sponsor Type

Sponsor Type for Prelone
Sponsor	Trials
NIH	10
Other	9
Industry	2

Clinical Trials, Market Analysis, and Projections for Prednisone (PRELONE)

Introduction

Prednisone, marketed under the brand name PRELONE among others, is a synthetic corticosteroid widely used in various medical conditions, including inflammatory diseases, autoimmune disorders, and certain types of cancer. Here, we will delve into the current clinical trials, market analysis, and projections for prednisone.

Current Clinical Trials Involving Prednisone

Combination Therapies in Cancer

Prednisone is often used in combination with other drugs in cancer treatment. For instance, the Phase 3 PROpel trial investigated the efficacy and safety of LYNPARZA (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC). This trial demonstrated significant improvements in radiographic progression-free survival (rPFS) and overall survival (OS)[1].

Other Therapeutic Areas

In addition to cancer, prednisone is being studied in various other conditions. For example, the REPLENISH study is a multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of secukinumab in combination with prednisone for the treatment of polymyalgia rheumatica (PMR) in adult participants who have recently relapsed. This study aims to assess the safety and efficacy of this combination over a 52-week period[4].

Market Analysis

Current Market Position

Prednisone is a well-established drug with a long history of use across multiple therapeutic areas. It is widely prescribed due to its broad anti-inflammatory and immunosuppressive properties. The market for corticosteroids, including prednisone, is substantial and diverse, with applications in rheumatology, dermatology, respiratory diseases, and oncology.

Market Drivers

The demand for prednisone is driven by its versatility and the prevalence of conditions it treats. The increasing incidence of chronic inflammatory diseases and the ongoing need for effective treatments in cancer care contribute to the sustained demand for prednisone.

Market Projections

While specific market projections for prednisone alone are not readily available, the broader corticosteroid market is expected to grow due to the increasing incidence of diseases it treats. For instance, the growth in the non-small cell lung cancer (NSCLC) market, where prednisone is often used in combination therapies, is projected to rise significantly. By 2025, the NSCLC market is expected to reach $26.8 billion, driven by the incorporation of premium-priced therapies, including those that may be used in combination with prednisone[2].

Competitive Landscape

Combination Therapies

Prednisone is frequently used in combination with other drugs to enhance therapeutic outcomes. In the context of mCRPC, the combination of LYNPARZA with abiraterone and prednisone or prednisolone has shown promising results, indicating a competitive edge in this therapeutic area[1].

Generic and Branded Competition

Prednisone is available in both generic and branded forms, which affects its market dynamics. The generic version is widely available and often preferred due to its lower cost, while branded versions like PRELONE may offer specific formulations or dosing regimens that differentiate them from generic alternatives.

Future Outlook

Emerging Trends

The future outlook for prednisone involves its continued use in combination therapies, particularly in oncology. The trend towards precision medicine and targeted therapies may see prednisone being used in more tailored treatment regimens to minimize side effects and maximize efficacy.

Regulatory Environment

Regulatory updates and approvals play a crucial role in the market dynamics of prednisone. For example, the ongoing regulatory review for the use of LYNPARZA in combination with abiraterone and prednisone or prednisolone for mCRPC highlights the importance of regulatory approvals in expanding the therapeutic indications for prednisone[1].

Key Takeaways

• Clinical Trials: Prednisone is being evaluated in various clinical trials, including combination therapies for mCRPC and PMR.
• Market Analysis: The market for prednisone is driven by its broad therapeutic applications and the increasing incidence of diseases it treats.
• Market Projections: The corticosteroid market, including prednisone, is expected to grow, particularly in the context of rising demand for treatments in oncology and other chronic inflammatory diseases.
• Competitive Landscape: Prednisone is used in combination with other drugs, and its market is influenced by both generic and branded competition.
• Future Outlook: The future involves continued use in combination therapies and potential advancements in precision medicine.

FAQs

What is the current status of the PROpel trial involving prednisone?

The PROpel trial has demonstrated significant improvements in radiographic progression-free survival (rPFS) and overall survival (OS) for patients with mCRPC treated with LYNPARZA in combination with abiraterone and prednisone or prednisolone[1].

How is prednisone used in the treatment of polymyalgia rheumatica (PMR)?

Prednisone is being studied in combination with secukinumab in the REPLENISH trial to evaluate its efficacy and safety in treating PMR in adult participants who have recently relapsed[4].

What are the market projections for the corticosteroid market, including prednisone?

The broader corticosteroid market is expected to grow, with the NSCLC market, where prednisone is often used, projected to reach $26.8 billion by 2025[2].

Is prednisone available in generic and branded forms?

Yes, prednisone is available in both generic and branded forms, such as PRELONE, which can affect its market dynamics due to differences in cost and formulation.

What emerging trends might impact the future use of prednisone?

The trend towards precision medicine and targeted therapies may see prednisone being used in more tailored treatment regimens to minimize side effects and maximize efficacy.

Sources

1. Merck and AstraZeneca Provide Update on US Regulatory Review of LYNPARZA (Olaparib) for Use in Combination with Abiraterone and Prednisone or Prednisolone for the Treatment of Metastatic Castration-Resistant Prostate Cancer (mCRPC). Merck.
2. NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025. GlobalData.
3. Prelude Therapeutics Reports First Quarter 2024 Financial Results. Prelude Therapeutics.
4. REPLENISH - UF Health. UF Health.