CLINICAL TRIALS PROFILE FOR PREDNISOLONE

505(b)(2) Clinical Trials for PREDNISOLONE

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 Indication	NCT05283954 ↗	Use of a Combined Regimen of Fluoxetine, Prednisolone and Ivermectin in the Treatment of Mild COVID-19 to Prevent Disease Progression Progression in Papua New Guinea	Not yet recruiting	Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia	Phase 2/Phase 3	2022-05-01	The Fluo-Pred-Iver clinical trial will test the efficacy of a combined regimen of Fluoxetine, Prednisolone and Ivermectin (Fluo-Pred-Iver), as treatment for ambulatory patients with mild COVID-19. The overarching idea of the work proposed herein is to investigate the use of Fluo-Pred-Iver to treat COVID-19, conducting a randomized controlled clinical trial to evaluate a new indication for these widely available drugs. It is estimated to include 954 participants.
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
New Combination	NCT00373815 ↗	Everolimus in Combination With Cyclosporine A and Prednisolone for the Treatment of Graft Versus Host Disease	Terminated	University Hospital Tuebingen	Phase 1	2006-09-01	The present protocol is a dose-finding and toxicity study in preparation of a randomised study comparing current standard treatment CSA/prednisolone with the new combination CSA/prednisolone/everolimus.

All Clinical Trials for PREDNISOLONE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001409 ↗	Genetically Modified Lymphocytes to Treat HIV-Infected Identical Twins - Study Modifications	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1994-09-01	Certain patients enrolled in NIH protocol 94-I-0206 at the Clinical Center may be eligible to participate in one or more of the following new options: - Donor/recipient extension phase - Both the recipient (HIV-infected twin) and donor (non-infected twin) will participate in this extension of the CD4-zeta gene therapy study. It will evaluate the safety and activity of infusing gene-modified CD4+ cells as well as the modified CD8+ cells. - Corticosteroid administration - A corticosteroid, such as prednisone, hydrocortisone or prednisolone, will be added to the interleukin-2 (IL-2) regimen for preventing or treating side effects of IL-2 such as fever and other flu-like symptoms. - Extended follow-up - A more intensive follow-up will be scheduled for patients with substantial numbers of lymphocytes that harbor the CD4-zeta gene. Every 3 months, participants will have blood tests and specialized tests of CD4 counts, HIV-1 viral load and numbers of circulating cells containing the CD4-zeta gene every 3 months> the frequency of follow-up visits may be reduced as time goes by. - IL-2 continuation - Participants will continue to receive periodic treatment with IL-2 to see how long the genetically modified cells persist in the bloodstream and to evaluate the long-term response to IL-2. - Home treatment with interleukin-2 - Participants may receive future IL-2 treatment cycles at home. Home treatment involves less frequent data and safety monitoring and no medical evaluations at the Clinical Center except at the beginning of each cycle.
NCT00000138 ↗	Herpetic Eye Disease Study (HEDS) I	Unknown status	National Eye Institute (NEI)	Phase 3	1989-05-01	To evaluate the efficacy of topical corticosteroids in treating herpes simplex stromal keratitis in conjunction with topical trifluridine. To evaluate the efficacy of oral acyclovir in treating herpes simplex stromal keratitis in patients receiving concomitant topical corticosteroids and trifluridine. To evaluate the efficacy of oral acyclovir in treating herpes simplex iridocyclitis in conjunction with treatment with topical corticosteroids and trifluridine.
NCT00000730 ↗	Comparison of Three Treatments for Pneumocystis Pneumonia in AIDS Patients	Terminated	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	This study compares three different therapies for treatment of refractory Pneumocystis carinii pneumonia (PCP) in patients with AIDS. "Refractory" means that the patient has failed to respond to at least 4 days of treatment with either of two standard therapies: (1) sulfamethoxazole/trimethoprim (SMX/TMP) or (2) pentamidine (PEN). This study compares therapy with trimetrexate (TMTX) and leucovorin (LCV) to standard therapy and standard therapy plus high-dose steroids (methylprednisolone). The purpose is to find better and safer forms of treatment for PCP in AIDS patients. There is at present no scientific information about the best treatment for an AIDS patient with PCP who is not improving while receiving the standard therapies (SMX/TMP or PEN). New drug treatments are available, including steroid therapy and TMTX, but there is no information proving that these new treatments work better than the standard therapies.

Clinical Trial Conditions for PREDNISOLONE

Condition Name

Condition Name for PREDNISOLONE
Intervention	Trials
Lymphoma	33
Asthma	21
Prostate Cancer	19

Condition MeSH

Condition MeSH for PREDNISOLONE
Intervention	Trials
Lymphoma	104
Prostatic Neoplasms	45
Leukemia	39

Clinical Trial Locations for PREDNISOLONE

Trials by Country

+

−

Trials by Country for PREDNISOLONE
Location	Trials
United Kingdom	253
Canada	126
Germany	124
Japan	115
Australia	94

Trials by US State

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−

Trials by US State for PREDNISOLONE
Location	Trials
California	66
New York	57
Texas	50
Ohio	43
Massachusetts	41

Clinical Trial Progress for PREDNISOLONE

Clinical Trial Phase

Clinical Trial Phase for PREDNISOLONE
Clinical Trial Phase	Trials
Phase 4	181
Phase 3	192
Phase 2/Phase 3	46

Clinical Trial Status

Clinical Trial Status for PREDNISOLONE
Clinical Trial Phase	Trials
Completed	330
Recruiting	142
Unknown status	112

Clinical Trial Sponsors for PREDNISOLONE

Sponsor Name

Sponsor Name for PREDNISOLONE
Sponsor	Trials
GlaxoSmithKline	22
Hoffmann-La Roche	17
AstraZeneca	13

Sponsor Type

Sponsor Type for PREDNISOLONE
Sponsor	Trials
Other	1040
Industry	293
NIH	31

Clinical Trials, Market Analysis, and Projections for Prednisolone

Introduction to Prednisolone

Prednisolone is a synthetic glucocorticoid widely used in the treatment of various inflammatory and autoimmune conditions, including asthma, allergies, and rheumatoid arthritis. Its efficacy and broad application make it a significant player in the pharmaceutical market.

Current Clinical Trials: Focus on Polymyalgia Rheumatica (PMR)

Sparrow Pharmaceuticals' Clofutriben and Prednisolone Trial

One of the notable ongoing clinical trials involves the combination of prednisolone with clofutriben, an 11β-Hydroxysteroid Dehydrogenase Type 1 (HSD-1) inhibitor, for the treatment of polymyalgia rheumatica (PMR). Sparrow Pharmaceuticals is conducting this Phase 2 clinical trial, which has shown promising results.

• Trial Design and Outcomes: The trial includes patients with PMR who are administered prednisolone in combination with clofutriben. Key findings indicate that the combination of prednisolone with clofutriben reduces or prevents the side effects of prednisolone while maintaining its therapeutic efficacy. Specifically, no PMR relapses occurred when prednisolone was co-administered with clofutriben, and the combination showed less glucocorticoid toxicity compared to prednisolone alone[1][4].

• Expansion and Future Directions: Encouraged by these results, Sparrow Pharmaceuticals has expanded the trial to include a fifth cohort, further exploring the potential of clofutriben to optimize the effects of prednisolone in PMR patients[1][4].

Market Analysis of Prednisolone

Global Market Size and Growth

The global prednisolone market is experiencing significant growth driven by several key factors.

• Current Market Size: As of 2023, the global prednisolone market size was estimated to be around USD 0.16 billion[5].
• Projected Growth: The market is projected to reach USD 0.34 billion by 2032, growing at a Compound Annual Growth Rate (CAGR) of 8.14%[5].

Growth Drivers

Several factors are driving the growth of the prednisolone market:

• Increasing Prevalence of Chronic Diseases: The rising incidence of chronic diseases such as asthma, allergies, and autoimmune disorders is a primary driver. These conditions necessitate effective treatment options, leading to higher demand for prednisolone[2][5].
• Advancements in Drug Formulations: Innovations in drug formulations, including extended-release and combination therapies, are enhancing the efficacy of prednisolone. New delivery systems like inhalers and injectables are also improving patient compliance and therapeutic outcomes[2].
• Strategic Partnerships and Mergers: Collaborations between pharmaceutical companies and research institutions are fostering innovation, while mergers and acquisitions are helping companies consolidate resources and expand their market presence[2].

Regional Market Analysis

• North America: This region is expected to hold a significant share of the prednisone (and by extension, prednisolone) market, driven by the high prevalence of asthma and other respiratory conditions. The region's advanced healthcare infrastructure and high investment in research also contribute to its market dominance[3].
• Asia Pacific: The APAC region is anticipated to experience notable growth due to the increasing prevalence of diseases such as chronic kidney disease and the lack of physical activity, which contributes to a higher incidence of various health conditions[3].

Market Trends and Innovations

New Product Launches

Pharmaceutical companies are continually introducing new formulations of prednisolone to cater to diverse patient needs. Recent launches include innovative delivery systems that enhance patient compliance and therapeutic outcomes[2].

Personalized Medicine

The focus on personalized medicine is expected to shape the future of the prednisolone market. Tailored treatment approaches based on individual patient profiles are likely to improve treatment outcomes and drive market growth[2].

Challenges and Side Effects

While prednisolone is effective, its long-term use can lead to significant side effects, including weight gain, increased appetite, and mood changes. More serious complications can arise from prolonged glucocorticoid therapy, such as glucocorticoid toxicity. The use of HSD-1 inhibitors like clofutriben aims to mitigate these side effects while maintaining therapeutic efficacy[1][4].

Key Players in the Prednisolone Market

Several companies are dominant in the prednisolone market:

• Shandong Taihua Bio &Tech
• Mahima Life Sciences
• Sanofi
• Wuhan DKY Technology
• Xianju Pharma

These companies are involved in various aspects of prednisolone production, from research and development to manufacturing and distribution[5].

Future Outlook

The future of the prednisolone market appears promising, driven by ongoing research, technological advancements, and a focus on personalized medicine. As healthcare providers strive for better treatment outcomes, the demand for prednisolone is anticipated to rise.

"The data suggest that by using an HSD-1 inhibitor like clofutriben, we may be able to improve the balance between the therapeutic benefits and side effects of glucocorticoid therapy in patients with PMR," said Dr. David Katz, Chief Scientific Officer at Sparrow Pharmaceuticals[4].

Key Takeaways

• Clinical Trials: Ongoing Phase 2 trials combining prednisolone with clofutriben show promising results in reducing side effects while maintaining efficacy for PMR treatment.
• Market Growth: The global prednisolone market is projected to grow at a CAGR of 8.14% to reach USD 0.34 billion by 2032.
• Growth Drivers: Increasing prevalence of chronic diseases, advancements in drug formulations, and strategic partnerships are key drivers.
• Regional Analysis: North America and Asia Pacific are significant regions driving market growth.
• Innovations: New product launches and a focus on personalized medicine are shaping the market.

FAQs

What is the current market size of the global prednisolone market?

The global prednisolone market size was estimated to be around USD 0.16 billion in 2023[5].

What is the projected growth rate of the global prednisolone market?

The global prednisolone market is expected to exhibit a CAGR of 8.14% until 2032[5].

What are the primary growth drivers of the prednisolone market?

The primary growth drivers include the increasing prevalence of chronic diseases, advancements in drug formulations, and greater awareness among patients[2][5].

Which regions are expected to dominate the prednisolone market?

North America and the Asia Pacific region are expected to hold significant shares of the market due to various health and economic factors[3].

What are the common side effects of long-term prednisolone use?

Common side effects include weight gain, increased appetite, and mood changes. Long-term use can lead to more serious complications such as glucocorticoid toxicity[2].

Sources

1. Business Wire: Sparrow Pharmaceuticals to Present Two Abstracts at ACR Convergence 2024 and Expand Phase 2 Clinical Trial of Clofutriben with Prednisolone for Polymyalgia Rheumatica to Fifth Cohort.
2. Market Research Intellect: Prednisolone Market Size And Projection - Market Research Intellect.
3. Research Nester: Prednisone Market Size & Share, Growth Forecasts 2036.
4. Biospace: Sparrow Pharmaceuticals Presented New Data on Clofutriben and Prednisolone for Polymyalgia Rheumatica Treatment at DGRh Kongress 2024.
5. Business Research Insights: Prednisolone Market Growth, Size, Share and Forecast [2032].