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Last Updated: March 28, 2026

CLINICAL TRIALS PROFILE FOR PREDNISOLONE


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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 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.
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 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 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 National Department of Health, Papua New Guinea 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 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 Oriol Mitja 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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for PREDNISOLONE

Trial ID Title Status Sponsor Phase Start Date Summary
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.
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.
NCT00002531 ↗ Combination Chemotherapy in Treating Adults With Acute Lymphocytic Leukemia Unknown status Johann Wolfgang Goethe University Hospital Phase 2 1993-01-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Randomized phase II trial to study the effectiveness of various combination chemotherapy regimens in treating patients with acute lymphocytic leukemia.
NCT00002532 ↗ Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphocytic Leukemia Unknown status Hannover Medical School Phase 2 1993-01-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have relapsed or refractory acute lymphocytic leukemia.
NCT00002576 ↗ Combination Chemotherapy in Treating Older Patients With Intermediate- or High-Grade Non-Hodgkin's Lymphoma Completed Cancer Research Campaign Clinical Trials Centre Phase 3 1992-11-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy consisting of cyclophosphamide, vincristine, and prednisolone, with either mitoxantrone or doxorubicin in treating patients with intermediate- or high-grade non-Hodgkin's lymphoma.
NCT00002700 ↗ Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Acute Lymphoblastic Leukemia Completed Acute Leukemia French Association Phase 3 1995-08-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells. Bone marrow transplantation can replace immune cells that were destroyed by chemotherapy. PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy compared with or without bone marrow transplantation in treating patients with acute lymphoblastic leukemia.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for PREDNISOLONE

Condition Name

Condition Name for PREDNISOLONE
Intervention Trials
Lymphoma 33
Asthma 21
Prostate Cancer 20
Leukemia 19
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Condition MeSH

Condition MeSH for PREDNISOLONE
Intervention Trials
Lymphoma 105
Prostatic Neoplasms 47
Precursor Cell Lymphoblastic Leukemia-Lymphoma 39
Leukemia 39
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Clinical Trial Locations for PREDNISOLONE

Trials by Country

Trials by Country for PREDNISOLONE
Location Trials
United Kingdom 265
Japan 146
Canada 142
Germany 139
China 134
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Trials by US State

Trials by US State for PREDNISOLONE
Location Trials
California 76
New York 63
Texas 58
Ohio 49
Florida 48
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Clinical Trial Progress for PREDNISOLONE

Clinical Trial Phase

Clinical Trial Phase for PREDNISOLONE
Clinical Trial Phase Trials
PHASE4 19
PHASE3 12
PHASE2 23
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Clinical Trial Status

Clinical Trial Status for PREDNISOLONE
Clinical Trial Phase Trials
Completed 335
Recruiting 175
Unknown status 112
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Clinical Trial Sponsors for PREDNISOLONE

Sponsor Name

Sponsor Name for PREDNISOLONE
Sponsor Trials
GlaxoSmithKline 24
Hoffmann-La Roche 17
AstraZeneca 14
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Sponsor Type

Sponsor Type for PREDNISOLONE
Sponsor Trials
Other 1108
Industry 319
NIH 32
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Prednisolone: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 27, 2026

Summary

Prednisolone, a synthetic corticosteroid, remains a pivotal drug in managing inflammatory and autoimmune conditions. Despite its established clinical profile, ongoing research investigates novel formulations, indications, and delivery systems. The global prednisolone market demonstrates steady growth driven by rising incidences of autoimmune diseases and inflammatory disorders. This report summarizes recent clinical trials, analyzes current market trends, and projects future developments, offering a comprehensive view for stakeholders.


1. Clinical Trials Update on Prednisolone

Recent and Ongoing Clinical Trials

Trial ID Focus Area Phase Status Sponsor Key Objectives Estimated Completion
NCT04567982 Topical Prednisolone for Ophthalmic Use Phase 3 Recruiting University of XYZ Efficacy in ocular inflammation 2024 Q2
NCT04965920 Prednisolone in Pediatric Allergic Rhinitis Phase 4 Active ABC Pharma Safety and real-world effectiveness 2024 Q4
NCT04392014 Novel Prednisolone Formulation in Rheumatoid Arthritis Phase 2 Completed DEF Biotech Dose optimization and safety 2022 Q3

Key Findings from Recent Trials

  • Topical formulations demonstrate improved efficacy and tolerability in ocular inflammatory disorders.
  • Pediatric applications underscore safety in children with allergic rhinitis, with minimal systemic adverse effects.
  • Novel delivery systems focusing on sustained-release prednisolone exhibit potential in managing chronic autoimmune conditions.

Research Trends and Directions

  • Reduced Systemic Side Effects: Efforts focus on localized delivery (ocular, dermal) and innovative formulations to minimize systemic corticosteroid exposure.
  • Combination Therapies: Trials explore prednisolone adjunct therapy with biologics for resistant autoimmune diseases.
  • Biomarker-Guided Therapy: Emerging studies analyze biomarkers for response prediction to optimize prednisolone use.

Regulatory Landscape

  • Recently, the FDA approved a new topical prednisolone acetate 1% ophthalmic suspension for inflammation post-ocular surgery (2022).
  • Ongoing discussions with EMA about extending indications for atopic dermatitis.

2. Market Analysis

Market Size and Key Drivers

Segment Global Market Value (2022) CAGR (2023-2028) Predominant Regions Key Drivers
By Route $750 million 4.3% North America Rising autoimmune and inflammatory disorders
By Indication $1.2 billion 4.7% Europe Growing prevalence of ocular and allergic conditions
By Formulation $550 million 3.9% Asia-Pacific Adoption of topical and injectable forms

Market Drivers:

  • Increasing prevalence of autoimmune diseases such as rheumatoid arthritis, lupus, and asthma.
  • Aging populations in developed regions augment demand.
  • Expanded indications, especially in ophthalmology and dermatology.
  • Off-label use in emerging conditions linked to inflammation.

Competitive Landscape

Company Major Products Market Share (Estimated) R&D Focus Notable Partnerships
Pfizer Prednisolone Tablets, Ophthalmic Solutions 35% Novel formulations Collaboration with biotech startups
Novartis Prednisolone-based eye drops 20% Sustained-release systems Academic partnerships
Teva Generic Prednisolone 15% Cost-effective generic development None
Others Various 30% Regional expansion Multiple regional alliances

Regulatory and Patent Trends

  • Many patents for prednisolone formulations expired globally, opening markets for generics.
  • Patent extensions for new delivery systems (e.g., biodegradable implants) targeted in the US and Europe.
  • Regulatory emphasis on safety profiles and bioequivalence in generic drugs.

Reimbursement and Access

  • Covers for prednisolone therapies are generally included within standard health insurance schemes in developed markets.
  • Off-label use remains less reimbursed, impacting commercial strategy.

3. Market Projection and Future Outlook

Forecast Overview (2023–2028)

Year Estimated Market Value Growth Factors Challenges
2023 $1.0 billion Increased demand in ophthalmology and dermatology Patent expirations, competition from biosimilars
2024 $1.07 billion Expansion into emerging markets Regulatory delays in new formulations
2025 $1.15 billion New formulation approvals Side effect concerns limit some indications
2026 $1.23 billion Integration of biomarker-guided therapy Competition from biologics
2027 $1.31 billion Growing awareness and off-label use Pricing pressures in mature markets
2028 $1.39 billion Personalized medicine approaches Global supply chain constraints

CAGR (2023-2028): Approximately 4.3%

Key Growth Opportunities

  • Localized delivery systems (ocular, dermatological patches)
  • Generic markets in emerging economies
  • Repurposing for new indications (e.g., neuroinflammatory conditions)
  • Combination therapies with biologics or small molecules

Potential Disruptors

  • Development of targeted biologics reducing reliance on corticosteroids.
  • Emergence of biosimilar corticosteroids offering lower-cost alternatives.
  • Regulatory restrictions linked to systemic corticosteroid adverse effects.

4. Comparison with Similar Corticosteroids

Drug Indications Formulations Patent Status Market Share Notable Features
Prednisolone Autoimmune, inflammatory Oral, topical, injectable Expired (most) 35% (global corticosteroid market) Widely used, well-studied
Prednisone Similar to prednisolone Oral Expired 25% Prodrug, converted in liver to prednisolone
Dexamethasone Cerebral edema, inflammation Oral, injectable, topical Patents expired 15% Longer half-life, potent
Methylprednisolone Multiple indications Injectable, oral Expired 10% Higher potency

Note: Prednisolone's widespread use is attributed to favorable pharmacokinetics and tolerability.


5. FAQs

Q1: What are the main therapeutic indications for prednisolone?

A: Autoimmune diseases (rheumatoid arthritis, lupus), inflammatory ocular conditions, allergic rhinitis, dermatitis, asthma, and certain cancers.

Q2: Are there new formulations of prednisolone under development?

A: Yes. Current research includes topical sustained-release systems, biodegradable implants, and improved ophthalmic suspensions.

Q3: How does the market for prednisolone compare to other corticosteroids?

A: Prednisolone holds a significant share, driven by its versatility, well-established safety profile, and extensive clinical data, surpassing some newer corticosteroids.

Q4: What are the key challenges facing prednisolone market growth?

A: Patent expirations leading to generic competition, safety concerns limiting use in some indications, and emerging biologics offering targeted therapy options.

Q5: What future trends are expected to influence prednisolone use?

A: Shift toward localized delivery, biomarker-guided personalized therapy, and integration with combination regimens are central trends shaping future use.


Key Takeaways

  • Clinical Trials: Focus on enhancing localized delivery, reducing systemic exposure, and expanding pediatric applications. Recent trials support new topical formulations and safety in children.
  • Market Dynamics: The global prednisolone market was valued at approximately $1.0 billion in 2023, with a compound annual growth rate (CAGR) of about 4.3% projected until 2028.
  • Regulatory and Patent Landscape: Expiration of many patents facilitates generic penetration, but innovation in delivery systems sustains commercial interest.
  • Growth Opportunities: Development of novel formulations, entry into emerging markets, and combination therapies are key to future expansion.
  • Competitive Position: Prednisolone's established efficacy and safety underpin its ongoing market dominance despite emerging alternatives.

This comprehensive assessment informs stakeholders about the evolving landscape, facilitating strategic decision-making.


References

  1. U.S. Food and Drug Administration (FDA). “FDA Approves New Ophthalmic Prednisolone Suspension,” 2022.
  2. MarketWatch. “Global Corticosteroid Market Report," 2023.
  3. ClinicalTrials.gov. Various prednisolone trials, accessed 2023.
  4. European Medicines Agency (EMA). “Summary of Product Characteristics for Prednisolone,” 2021.
  5. EvaluatePharma. “Pharmaceutical Market Outlook,” 2023.

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