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 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.

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.

Clinical Trial Conditions for prednisolone

Condition Name

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

Condition MeSH

Condition MeSH for prednisolone
Intervention	Trials
Lymphoma	105
Prostatic Neoplasms	47
Leukemia	39
Precursor Cell Lymphoblastic Leukemia-Lymphoma	39

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

Trials by US State

Trials by US State for prednisolone
Location	Trials
California	76
New York	63
Texas	58
Ohio	49
Florida	48

Clinical Trial Progress for prednisolone

Clinical Trial Phase

Clinical Trial Phase for prednisolone
Clinical Trial Phase	Trials
PHASE4	19
PHASE3	12
PHASE2	23

Clinical Trial Status

Clinical Trial Status for prednisolone
Clinical Trial Phase	Trials
Completed	335
RECRUITING	175
Unknown status	112

Clinical Trial Sponsors for prednisolone

Sponsor Name

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

Sponsor Type

Sponsor Type for prednisolone
Sponsor	Trials
Other	1108
Industry	319
NIH	32

Prednisolone Market Analysis and Financial Projection

Last updated: April 27, 2026

Prednisolone: Clinical-Development Update, Market Readout, and Forward Projections

What is prednisolone’s current clinical and regulatory status?

Prednisolone is an established systemic corticosteroid marketed worldwide across multiple formulations (oral tablets, oral solution, delayed-release and enteric-coated products in some markets, injectable forms, and ophthalmic/other steroid uses in separate product lines). The market is dominated by generics and long-standing branded legacy products in certain territories. Against that backdrop, late-stage “new drug” clinical activity for prednisolone itself is limited and typically centers on:

• Formulation differentiation (release profile, taste masking, pediatric dosing convenience, and switching from one dosage form to another).
• Bioequivalence (BE) studies that support generic or follow-on product approvals rather than novel mechanism trials.
• Safety/usage optimization research (dose-sparing, regimen comparisons, and adherence) more than discovery-grade efficacy trials.

Clinical-trial “signal” for prednisolone in global registries is therefore expected to skew toward:

• Small- to medium-size interventional BE and pharmacokinetic studies
• Observational and outcomes studies in defined patient populations (often tied to guideline-relevant indications)

No new, mechanism-shifting pivotal phase-program is required to sustain market access because prednisolone already meets the critical regulatory standard for steroid efficacy and class-based safety. Commercial dynamics thus hinge less on “pipeline breakthroughs” and more on supply, price, and formulation positioning.

Which indications drive utilization and how does that shape clinical trial mix?

Prednisolone is used across a wide indication panel where corticosteroid therapy is standard. Utilization concentrates in:

• Inflammatory and autoimmune disorders (broad adult use with pediatric demand tied to guideline-led use cases)
• Allergic conditions and acute flare management
• Respiratory inflammatory disease where oral steroids remain an escalation option (outside inhaled steroid optimization)
• Hematology and oncology supportive care where steroid schedules form part of multi-drug regimens
• Gastrointestinal inflammatory disease in steroid-responsive disease settings

This indication breadth is a key reason clinical trials and post-approval research remain persistent even when the drug is old: clinicians run regimen- and population-specific studies while manufacturers run BE and formulation studies to compete on access and cost.

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What does the prednisolone market look like today?

Market structure: low innovation, high volume

Prednisolone’s commercial footprint follows classic off-patent specialty generics economics:

• Large number of suppliers across geographies
• Price compression driven by multi-source competition
• Formulation-level competition (different release profiles, taste/handling improvements, and line extensions)
• Tender and reimbursed-indication purchasing as major demand channels in many markets

Because corticosteroids are staple therapies, procurement behavior is rule-driven: hospital formularies, national reimbursement schedules, and tender cycles dominate purchasing rather than product novelty.

Demand drivers

The biggest demand drivers are durable:

• Persistent prevalence of chronic inflammatory disease and intermittent exacerbations
• Guideline-based steroid use in flare management
• Multi-indication hospital use for emergency and inpatient care
• Pediatric care demand for palatable, dose-flexible formulations when available

Supply-side risk is also a market driver. Steroid APIs and finished-dose manufacturing are mature, but production disruptions can swing availability and pricing temporarily, especially in markets with fewer local fill-finish suppliers.

Competitive landscape

Competition breaks into two layers:

1. Generic prednisolone tablets/solutions (price-led competition)
2. Differentiated formulations (where manufacturers can defend pricing margins via BE-supported claims and patient usability)

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How should investors and R&D leaders project prednisolone forward?

Base-case market trajectory

For an off-patent, multi-supplier product, the forward view typically looks like this:

• Volumes remain stable to modestly growing with overall disease burden and population growth
• Revenue grows slower than volume due to price pressure and tender-driven cost cuts
• Formulation upgrades (newer tablets/solutions, pediatric-friendly presentations) can create incremental share shifts but do not reset the pricing floor

Scenario framework

A practical projection uses three levers: (1) pricing, (2) volume, and (3) share capture via formulation.

Scenario	Pricing	Volume	Share	Net effect on revenue
Downside	Tender-driven price declines accelerate	Stable	Limited share gains for incumbents	Revenue contraction
Base case	Price stabilizes after periodic tender cycles	Modest growth	Gradual share shifts by formulation	Low single-digit revenue growth (or flat)
Upside	Supply constraints or regional shortages	Moderate growth	Differentiated formulations win formulary access	Mid single-digit revenue growth

Key commercialization math (what to watch)

For business planning, the move is to track:

• National formulary decisions and tender outcomes (quarterly/half-yearly cycles in many health systems)
• Switching rates between strengths and dosage forms (tablet vs solution, delayed vs immediate release where offered)
• Inventory-driven buying ahead of tender deadlines
• API and fill-finish capacity changes affecting availability and price

What about pipeline “risk” and “opportunity”?

With prednisolone, the “pipeline risk” is not clinical failure risk. It is:

• Regulatory and commercial commoditization (rapid generic entry following local approvals)
• Price erosion as more suppliers qualify
• Substitution toward alternative steroids in certain therapeutic algorithms (where prescribers prefer other agents based on side effect profile or dosing convenience)

The “opportunity” is:

• Formulation line extensions that improve dosing experience and adherence
• Regional supply leadership (continuity of supply can create share lock-in with hospital networks)
• Pediatric presentation optimization that aligns with pediatric prescribing habits and dosing precision

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Clinical trial update: where activity is concentrated

Trial types that keep showing up for prednisolone

Even without new mechanism breakthroughs, the trial ecosystem tends to keep moving via:

• BE studies for tablets and solutions across strengths and manufacturers
• PK studies supporting switches between dosage forms and/or strengths
• Comparative regimen research in specific patient populations in defined clinical contexts
• Real-world evidence studies that quantify outcomes and safety in routine use

Implication for “update” reporting

A credible clinical-trial update for prednisolone is therefore best expressed as:

• Activity volume (number of trials and new postings by year)
• Trial type mix (BE vs interventional efficacy vs observational)
• Geography (where manufacturers are filing, where studies are recruiting)

Because prednisolone is not driven by blockbuster innovation, the “update” is mainly a barometer of manufacturing competition and access timing.

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Key Takeaways

• Prednisolone is a mature, off-patent systemic steroid with stable clinical relevance across inflammatory, allergic, hematology, and other guideline-driven indications.
• Clinical-trial activity is dominated by BE, PK, and population-specific regimen or outcomes research, not novel pivotal mechanism studies.
• Market performance is shaped by tender pricing, multi-supplier competition, and formulation-level differentiation, not by pipeline milestones.
• Base-case projections favor stable or modestly growing volumes with slower revenue growth due to price pressure; upside depends on localized supply constraints and formulary share capture; downside follows accelerating tender price declines.

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FAQs

1) Is prednisolone still seeing phase 3 innovation-level trials?

Most new trial activity is BE, PK, and regimen/outcomes work rather than de novo phase 3 mechanism discovery.

2) What keeps prednisolone trials running if the drug is old?

Clinical practice remains steroid-based in many diseases, and manufacturers keep filing for access via new presentations and generic competition.

3) How do market projections differ from pipeline biotech forecasting?

Prednisolone forecasting hinges on pricing, tender cycles, and supply continuity rather than clinical readouts.

4) Which business lever affects prednisolone revenue most?

Tender-driven pricing and formulary uptake of differentiated presentations (where available) usually dominate.

5) What indicators best predict near-term pricing moves?

Tender outcomes by region, supplier count changes, and any disruptions in API or fill-finish supply.

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References

[1] ClinicalTrials.gov. (n.d.). Search results for prednisolone. https://clinicaltrials.gov/
[2] EMA. (n.d.). European public assessment reports and medicine information: prednisolone. https://www.ema.europa.eu/
[3] FDA. (n.d.). Drugs@FDA: prednisolone product information. https://www.accessdata.fda.gov/scripts/cder/daf/