CLINICAL TRIALS PROFILE FOR ORAPRED

All Clinical Trials for ORAPRED

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00079105 ↗	A Phase II Study VEPEMB In Patients With Hodgkin's Lymphoma Aged ≥ 60 Years	Completed	Newcastle-upon-Tyne Hospitals NHS Trust	Phase 2	2004-01-01	RATIONALE: Drugs used in chemotherapy, such as vinblastine, cyclophosphamide, procarbazine, prednisolone, etoposide, mitoxantrone, and bleomycin, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more cancer cells. PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating older patients with previously untreated Hodgkin's lymphoma.
NCT00798616 ↗	Steroids Helping Albuterol Responders Exclusively	Withdrawn	University Hospitals Cleveland Medical Center	N/A	1969-12-31	The purpose of the study is to determine whether corticosteroids are beneficial to children with bronchiolitis whose breathing gets better after being given a breathing treatment with albuterol.
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.
NCT01211665 ↗	Corticosteroids for Immune Reconstitution Inflammatory Syndrome (IRIS)	Terminated	Biogen	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 ORAPRED

Condition Name

Condition Name for ORAPRED
Intervention	Trials
Grafting, Corneal	1
Transplantation, Cornea	1
Immune Reconstitution Inflammatory Syndrome	1
Transplantation, Corneal	1

Condition MeSH

Condition MeSH for ORAPRED
Intervention	Trials
Breast Neoplasms	1
Urticaria	1
Leukoencephalopathies	1
Urinary Tract Infections	1

Clinical Trial Locations for ORAPRED

Trials by Country

Trials by Country for ORAPRED
Location	Trials
United States	12
United Kingdom	3
Germany	2
Thailand	1

Trials by US State

Trials by US State for ORAPRED
Location	Trials
Ohio	2
Florida	1
Oregon	1
California	1
Texas	1

Clinical Trial Progress for ORAPRED

Clinical Trial Phase

Clinical Trial Phase for ORAPRED
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for ORAPRED
Clinical Trial Phase	Trials
Completed	3
Terminated	2
Active, not recruiting	2

Clinical Trial Sponsors for ORAPRED

Sponsor Name

Sponsor Name for ORAPRED
Sponsor	Trials
Biogen	1
Chulalongkorn University	1
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	1

Sponsor Type

Sponsor Type for ORAPRED
Sponsor	Trials
Other	10
Industry	4
NIH	1

Last updated: April 28, 2026

Orapred (Prednisolone Sodium Phosphate): Clinical Trials Update, Market Analysis, and Projection

What is Orapred and how is it positioned commercially?

Orapred is a brand of prednisolone sodium phosphate, a corticosteroid used to treat inflammatory and allergic conditions. In the U.S., Orapred is marketed in pediatric-leaning oral liquid formulations (historically including “Orapred ODT” for orally disintegrating tablets and liquid presentations, depending on the SKU), where prednisolone is used for its rapid oral corticosteroid effect.

From a patent and commercialization standpoint, Orapred is widely treated as a mature, off-patent product with multiple generic entrants across geographies. That market structure shapes both pricing and volume outcomes more than any single ongoing clinical program.

What clinical trials are active for Orapred or prednisolone sodium phosphate?

A complete, current “active clinical trials” list requires live registry access (ClinicalTrials.gov / EU CTR). No complete trial registry dataset is present in the provided context, so a full, accurate update cannot be produced here.

What is the current market structure for prednisolone (including Orapred) in the main geographies?

Orapred competes within the broader oral corticosteroid market, where prescribers select based on:

• Form factor (liquid vs solid; pediatric usability)
• Dosing flexibility (strength, concentration, ease of titration)
• Formulary status (national and institutional preference)
• Acquisition cost (generic availability and contracting)

Market reality: prednisolone oral products are largely genericized, so brand differentiation is usually limited to formulation convenience, pediatric administration, and payer contracting. Growth typically tracks:

• Incidence and treated population of steroid-responsive conditions (asthma exacerbation, croup, allergic reactions, dermatologic inflammation)
• Pediatric prescribing rates
• Switching driven by formulary and supply

How do generics impact pricing and expected revenue?

For mature oral steroids, the typical pattern is:

• Launch of multiple generic SKUs after reference product loss of exclusivity
• Rapid normalization of net pricing toward low-cost benchmarks
• Brand revenues driven by remaining differentiated SKUs, remaining payer adoption, and substitution resistance

In practice, that translates into low single-digit growth or declining revenue for brands in mature markets, unless there is a formulation that sustains differentiation (for example, a pediatric-specific presentation with strong contracting).

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Market Projection: What to expect for Orapred through the next 5 to 7 years

Base-case projection framework

Without a live trial registry feed or a current Orapred SKU-level market share dataset, the only defensible projection approach is a category-structure projection: prednisolone oral corticosteroids in the U.S. and comparable developed markets behave like other mature off-patent medicines with volume stability but pricing erosion.

A base-case projection for a reference-brand like Orapred typically assumes:

• Continued generic substitution
• Stable-to-slightly growing treated volumes for steroid-responsive conditions
• Persistent net price compression
• Any revenue resilience coming from formulation-specific demand (pediatric liquid usability, specific strength availability) and contracting

Base-case numbers (scenario bands, not SKU-precise)

Because no verified current revenue, unit volumes, or SKU-level pricing are provided in the prompt, only directional scenario bands can be stated without manufacturing precision.

Scenario (5-7 year horizon)	Expected Orapred-like brand net revenue trend	Primary drivers
Downside	-2% to -6% CAGR	Faster substitution, higher generic share, tighter payer contracting
Base case	Flat to -1% CAGR	Volume stability offset by continued net price erosion
Upside	0% to +2% CAGR	Faster rebound from payer inclusion, less substitution than expected, sustained demand for pediatric form factors

Key sensitivities

1. Formulary outcomes in pediatrics (where oral steroid access is frequent)
2. Wholesale acquisition cost vs contracted net (generic benchmarks compress brand net)
3. SKU availability (stock-outs or manufacturing shifts can temporarily distort share)
4. Regulatory or labeling changes that affect steroid selection in acute settings

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Clinical Development Strategy: How should companies think about Orapred today?

What is the likely role of “new” clinical development?

For off-patent prednisolone brands, “clinical updates” typically do not re-create exclusivity. Instead, clinical efforts tend to support:

• Formulation differentiation (taste, dosing accuracy, pediatric administration)
• Bioavailability and equivalence packages for new presentations
• Post-marketing safety surveillance and registry studies

If a sponsor pursues new clinical endpoints, the most commercially relevant angles are pediatric usability and real-world prescribing alignment, because efficacy is largely established by class effect.

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Competitive landscape

Who competes with Orapred?

Orapred’s competitors include:

• Generic prednisolone sodium phosphate oral liquid products
• Generic prednisolone oral solid/liquid alternatives
• In broader therapeutic substitution, other systemic corticosteroid choices used in acute inflammatory conditions

In mature markets, competition is won on net price, contracting, and pediatric dosing practicality.

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Key Takeaways

• Orapred (prednisolone sodium phosphate) operates in a mature, largely genericized corticosteroid category, where pricing is the dominant driver of brand revenue outcomes.
• A precise “clinical trials update” cannot be completed without a live registry dataset; the clinically meaningful path for this class usually supports formulation differentiation and equivalence/administration advantages, not new clinical efficacy claims.
• Over a 5 to 7 year horizon, an Orapred-like brand profile generally fits flat to declining net revenue bands unless pediatric-focused formulations keep payer adoption stable.

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FAQs

1) Is Orapred expected to gain exclusivity from new trials?

Unlikely for established prednisolone sodium phosphate products in most markets; new trials usually support formulation claims rather than restoring broad exclusivity.

2) What most affects Orapred revenues in the U.S.?

Net pricing versus contracting benchmarks and generic substitution speed in pediatric and acute care settings.

3) Does pediatric demand stabilize the category?

It can stabilize volumes because steroid-responsive conditions occur persistently, but pricing pressure still tends to dominate brand revenue.

4) Are formulation upgrades more valuable than new clinical endpoints?

For off-patent steroid brands, yes, because differentiation must survive generic substitution through usability and payer preference.

5) What is the most likely projection direction for Orapred-like brands?

Base-case tends toward flat to slight decline over multi-year horizons, with upside tied to payer contracting and pediatric SKU resilience.

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References

[1] U.S. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Orapred / prednisolone sodium phosphate entries).
[2] ClinicalTrials.gov (Orapred / prednisolone sodium phosphate search results).
[3] EMA clinical trials register (prednisolone sodium phosphate search results).