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Last Updated: March 21, 2025

CLINICAL TRIALS PROFILE FOR PREDNISOLONE ACETATE


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All Clinical Trials for Prednisolone Acetate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00134992 ↗ A Study to Compare Ocular Safety and Tolerability of Prednisolone Acetate 0.5% Eye Drops Versus Vehicle in Healthy Volunteers Completed Novartis Phase 4 2004-08-01 The objective of this trial was to confirm the tolerability of prednisolone acetate 0.5% eye drops by testing the hypothesis that the ocular safety and tolerability of prednisolone acetate 0.5% eye drops are equivalent to vehicle. Thus healthy volunteers have been selected and have been treated by using a crossover design.
NCT00170729 ↗ A Study to Compare Ocular Safety and Tolerability of Eye Drops Containing Prednisolone Acetate in Patients With Intraocular Inflammation After Cataract Surgery Completed Novartis Phase 4 2004-08-17 The primary objective was to demonstrate that two days of treatment with 0.5% prednisolone acetate eye-drops after cataract surgery are superior to vehicle in reducing the flare in the anterior chamber of the operated eye.
NCT00198523 ↗ A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte Completed Bausch & Lomb Incorporated Phase 3 2005-07-01 The purpose of this study is to demonstrate the bioequivalence of the combination test agent, prednisolone acetate 1.0% and tobramycin 0.3% ophthalmic suspension compared to PredForte (prednisolone acetate 1.0%) ophthalmic suspension. Bioequivalence will be measured by comparing aqueous humor concentrations of prednisolone acetate.
NCT00229918 ↗ PST/Laser v. Laser Alone for CSME Unknown status Edward Hines Jr. VA Hospital Phase 2 2005-09-01 Prospective randomized clinical trial comparing Laser Alone v. Laser and posterior sub-tenon injection of triamcinolone acetonide for primary and refractory clinically significant macular edema.
NCT00238563 ↗ Post-Operative Sub-Tenon Kenalog in Glaucoma Filtering Surgery Withdrawn Stanford University N/A 1969-12-31 Determine efficacy of sub tenon kenalog injections for post-operative management of trabeculectomy procedures.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Prednisolone Acetate

Condition Name

Condition Name for Prednisolone Acetate
Intervention Trials
Cataract 15
Glaucoma 5
Prostate Cancer 5
Prostatic Neoplasms 4
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Condition MeSH

Condition MeSH for Prednisolone Acetate
Intervention Trials
Cataract 30
Inflammation 22
Prostatic Neoplasms 16
Macular Edema 10
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Clinical Trial Locations for Prednisolone Acetate

Trials by Country

Trials by Country for Prednisolone Acetate
Location Trials
United States 222
Japan 31
Germany 23
China 22
Italy 21
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Trials by US State

Trials by US State for Prednisolone Acetate
Location Trials
New York 22
California 18
Massachusetts 12
Florida 11
Texas 11
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Clinical Trial Progress for Prednisolone Acetate

Clinical Trial Phase

Clinical Trial Phase for Prednisolone Acetate
Clinical Trial Phase Trials
Phase 4 48
Phase 3 21
Phase 2/Phase 3 7
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Clinical Trial Status

Clinical Trial Status for Prednisolone Acetate
Clinical Trial Phase Trials
Completed 49
Recruiting 27
Unknown status 7
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Clinical Trial Sponsors for Prednisolone Acetate

Sponsor Name

Sponsor Name for Prednisolone Acetate
Sponsor Trials
Ocular Therapeutix, Inc. 12
Janssen Research & Development, LLC 6
Alcon Research 5
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Sponsor Type

Sponsor Type for Prednisolone Acetate
Sponsor Trials
Other 76
Industry 62
U.S. Fed 1
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Clinical Trials, Market Analysis, and Projections for Prednisolone Acetate

Introduction to Prednisolone Acetate

Prednisolone acetate is a corticosteroid used in various medical applications, including the treatment of hypersensitivity diseases, autoimmune diseases, and other inflammatory conditions. Here, we will delve into recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Historical Context and Efficacy

Numerous clinical trials have documented the efficacy of prednisolone and its analogs in low doses. Studies from the 1980s and 1990s, as well as those conducted since 2000, have shown that low-dose prednisolone (typically 5-10 mg/day) is effective in improving function and maintaining status in patients with conditions like rheumatoid arthritis (RA)[3].

For example, the Utrecht Study and the Barfot Study demonstrated that low doses of prednisolone can retard radiographic progression in RA patients. The CAMERA-II study further showed that adding 10 mg of prednisone to a 'treat-to-target' strategy with methotrexate provided incremental benefits in slowing radiographic progression[3].

Current and Ongoing Trials

While specific recent trials on prednisolone acetate itself may be less frequent, ongoing studies comparing different formulations and treatments can provide insights into its efficacy. For instance, a clinical trial registered in the EU Clinical Trials Register compares the safety and efficacy of clobetasol propionate ophthalmic nanoemulsion 0.05% with prednisolone acetate 1% in treating ocular inflammation. This trial, though not exclusively focused on prednisolone acetate, helps in understanding the comparative efficacy and safety profiles of corticosteroids[4].

Market Analysis

Global Market Size and Forecast

The global prednisolone acetate market is expected to grow at a compound annual growth rate (CAGR) of 3 to 5% from 2024 to 2031. The market size is estimated to increase from its current valuation, with the forecast period indicating a steady growth trajectory[5].

Segmentation by Application and Product

The market is segmented based on application (hypersensitivity diseases, autoimmune diseases, and others) and product types (prednisolone acetate tablets, liquids, and emulsifiable pastes). This segmentation helps in understanding the demand across different end-use industries and geographical regions.

  • Hypersensitivity Diseases: This segment includes treatments for allergic reactions and other hypersensitivity conditions.
  • Autoimmune Diseases: This segment covers treatments for conditions like rheumatoid arthritis, lupus, and others.
  • Others: This includes various other inflammatory and immune-related conditions.

Geographical Analysis

The market is analyzed across major regions such as North America, Europe, Asia-Pacific, South America, and the Middle East & Africa. Each region's market size, revenue share, and growth rate are evaluated to provide a comprehensive understanding of the global market dynamics[5].

Key Players and Market Dynamics

Major Companies

Key companies profiled in the market analysis include Sanofi, Symbiotec Pharma, Xianju Pharma, Wuhan Dky Technology, and others. These companies play a significant role in the production and distribution of prednisolone acetate products globally[5].

Market Trends and Drivers

The growth of the prednisolone acetate market is driven by several factors, including:

  • Increasing prevalence of autoimmune and hypersensitivity diseases.
  • Advancements in pharmaceutical formulations and delivery systems.
  • Growing demand for effective and safe corticosteroid treatments.
  • Expanding healthcare infrastructure in emerging markets.

Challenges and Restraints

Despite the growth potential, the market faces challenges such as:

  • Side effects associated with long-term corticosteroid use.
  • Regulatory hurdles and stringent approval processes.
  • Competition from alternative treatments and generic drugs.

Future Projections

Market Size and Revenue

By 2031, the global prednisolone acetate market is expected to reach a significant valuation, driven by the increasing demand for corticosteroid treatments. The market size is projected to grow steadily, with a CAGR of 3 to 5% during the forecast period[5].

Emerging Opportunities

Emerging markets, particularly in Asia-Pacific and Latin America, are expected to offer significant growth opportunities due to their large patient populations and improving healthcare infrastructure.

Technological Advancements

Advancements in pharmaceutical technology, such as the development of new formulations and delivery systems, are likely to enhance the efficacy and safety of prednisolone acetate, further driving market growth.

Key Takeaways

  • Efficacy in Clinical Trials: Prednisolone acetate has been shown to be effective in low doses for treating various inflammatory and autoimmune conditions.
  • Market Growth: The global market is projected to grow at a CAGR of 3 to 5% from 2024 to 2031.
  • Segmentation: The market is segmented by application, product type, and geographical region.
  • Key Players: Major pharmaceutical companies are driving the market through innovation and distribution.
  • Future Projections: Emerging markets and technological advancements are expected to drive future growth.

FAQs

What are the common applications of prednisolone acetate?

Prednisolone acetate is commonly used to treat hypersensitivity diseases, autoimmune diseases such as rheumatoid arthritis, and other inflammatory conditions.

What is the expected CAGR of the global prednisolone acetate market?

The global prednisolone acetate market is expected to grow at a CAGR of 3 to 5% from 2024 to 2031.

Which regions are expected to drive the growth of the prednisolone acetate market?

Emerging markets in Asia-Pacific and Latin America are expected to drive significant growth due to their large patient populations and improving healthcare infrastructure.

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

Common side effects include anemia, hypertension, bruising, and purpura, with the incidence of some side effects increasing with the duration of treatment[3].

Which companies are major players in the prednisolone acetate market?

Key companies include Sanofi, Symbiotec Pharma, Xianju Pharma, Wuhan Dky Technology, and others[5].

Sources

  1. Janssen Pharmaceutical Companies of Johnson & Johnson, "Janssen Presents Updated Data Demonstrating Improved Outcomes from the Use of Niraparib in Combination with Abiraterone Acetate Plus Prednisone as a First-Line Therapy in Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer," February 16, 2023.
  2. Cognitive Market Research, "Global Prednisolone Acetate Market Report 2024 Edition," 2024.
  3. Karger, "Clinical Trials Documenting the Efficacy of Low-Dose Prednisone," September 25, 2014.
  4. EU Clinical Trials Register, "Clinical trial to assess the safety and efficacy of Clobetasol propionate ophthalmic nanoemulsion 0.05% compared to Prednisolone acetate, 1%," October 5, 2022.
  5. Market Research Intellect, "Global Prednisolone Acetate Market Size And Forcast," December 2024.

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