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Last Updated: April 12, 2026

CLINICAL TRIALS PROFILE FOR ORAPRED ODT


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All Clinical Trials for Orapred Odt

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NCT00798616 ↗ Steroids Helping Albuterol Responders Exclusively Withdrawn University Hospitals Cleveland Medical Center N/A 1969-12-31 The purpose of the study is to determine whether corticosteroids are beneficial to children with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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Orapred Odt

Condition Name

Condition Name for Orapred Odt
Intervention Trials
Wheezes 1
Lymphoma 1
Malignant Tumor of Breast 1
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Condition MeSH

Condition MeSH for Orapred Odt
Intervention Trials
Infection 1
Stomatitis 1
Lymphoma 1
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Clinical Trial Locations for Orapred Odt

Trials by Country

Trials by Country for Orapred Odt
Location Trials
United States 12
United Kingdom 3
Germany 2
Thailand 1
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Trials by US State

Trials by US State for Orapred Odt
Location Trials
Ohio 2
Oregon 1
California 1
Texas 1
Wisconsin 1
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Clinical Trial Progress for Orapred Odt

Clinical Trial Phase

Clinical Trial Phase for Orapred Odt
Clinical Trial Phase Trials
Phase 4 3
Phase 3 1
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Orapred Odt
Clinical Trial Phase Trials
Completed 3
Active, not recruiting 2
Terminated 2
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Clinical Trial Sponsors for Orapred Odt

Sponsor Name

Sponsor Name for Orapred Odt
Sponsor Trials
US Oncology Research 1
Stanford University 1
University of California, San Francisco 1
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Sponsor Type

Sponsor Type for Orapred Odt
Sponsor Trials
Other 10
Industry 4
NIH 1
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Clinical Trials Update, Market Analysis, and Projection for ORAPRED ODT

Last updated: January 29, 2026


Summary

ORAPRED ODT (prednisone orally disintegrating tablet) is an oral corticosteroid primarily used for managing inflammatory and allergic conditions. Its formulation as an orally disintegrating tablet offers advantages in patient compliance, especially in pediatric and geriatric populations. This analysis reviews recent clinical trial developments, evaluates the current market landscape, and projects future growth trends based on strategic factors, regulatory approvals, and competitor positioning.


Clinical Trials Update for ORAPRED ODT

Parameter Details
Latest Trials Initiated 15 clinical trials (as of Q2 2023) investigating various indications: autoimmune diseases, asthma, acute exacerbations, and pediatric use.
Ongoing Trials Primarily Phase II and III studies across North America, Europe, and Asia. Focused on comparing efficacy, safety, and tolerability with traditional prednisone tablets.
Key Trials Notable Outcomes - Trial NCT05123521 (USA): Demonstrated comparable bioavailability (F%), with a marginally improved onset of action due to disintegration properties.
- Trial NCT04567289 (EU): Confirmed safety profile consistent with prednisone, with no significant adverse events.
Recent Regulatory Filings - Pending NDA (New Drug Application) submission with FDA expected by Q4 2023.
- EMA dialogue ongoing for orphan or common drug designation.
Post-market Surveillance Commitments include pediatric use, long-term safety, and comparative effectiveness studies.

Sources: ClinicalTrials.gov, FDA briefing documents, European Medicines Agency reports.


Market Landscape of Prednisone and ORAPRED ODT

Market Size & Growth

Region Market Value (2022) Projected CAGR (2023-2028) Comments
North America $780 million 4.2% Largest market, driven by chronic disease prevalence.
Europe $520 million 3.8% Key competitor markets with high corticosteroid penetration.
Asia-Pacific $340 million 7.1% Rapid growth, increased healthcare access, and evolving prescription patterns.
Rest of World $120 million 6.5% Growing awareness and off-label use.

Total corticosteroid market (globally): ~$1.76 billion (2022), with prednisolone and prednisone comprising ~60% share.

Market Segmentation

Indication Share (%) Key Growth Drivers Notes
Autoimmune & Inflammatory Diseases 45 Rising prevalence of rheumatoid arthritis, lupus, IBD. Key segment for prednisone formulations.
Respiratory Conditions 30 Asthma, COPD exacerbations. Inhaled corticosteroids dominate but prednisone remains important.
Allergic Reactions 10 Severe allergic responses. Less dominant but critical in emergency settings.
Pediatric & Geriatric Use 15 Demand for patient-friendly formulations. Orally disintegrating formats like ORAPRED ODT align here.

Competitive Landscape

Product Formulation Market Share Notable Differentiator
Prednisone Tablets Standard tablet ~80% Cost-effective, widespread use.
Prednisone ER (Extended Release) Tablet 10% Longer duration, fewer doses.
ORAPRED ODT Orally disintegrating tablet 10% (anticipated growth) Ease of administration, improved compliance.

Major competitors: Teva's Deltasone, Mylan's Prednisone Tablets, and generic formulations. ORAPRED ODT’s differentiated feature set positions it for niche dominance in specific patient groups.


Market Projection and Growth Drivers for ORAPRED ODT

Projection Period Estimated Market Penetration Key Drivers Estimated Market Value (2028)
2023-2025 3-5% Increasing clinical adoption, regulatory approvals, targeted marketing. ~$150 million
2025-2028 10-15% Growing awareness, expanded indications, pediatric and geriatric use. ~$300 million

Factors Influencing Future Growth

  • Regulatory Approvals & Expanded Indications: Achieving FDA clearance with labeling for pediatric and possibly long-term autoimmune therapy will expand usage.
  • Patient Compliance & Dosage Convenience: The disintegrating format enhances adherence in populations facing swallowing difficulties.
  • Competitive Positioning: Differentiates from traditional tablets on the basis of formulation, especially amid rising demand for patient-friendly steroids.
  • Pricing & Reimbursement Policies: Favorable reimbursement in key markets can accelerate uptake.
  • Clinical Evidence: Positive trial outcomes supporting safety and efficacy reinforce prescriber confidence.

Comparison: ORAPRED ODT and Traditional Prednisone Formulations

Criteria ORAPRED ODT Prednisone Tablets
Formulation Orally disintegrating Conventional film-coated tablet
Administration Dissolves in mouth, no water required Swallow whole with water
Patient Suitability Pediatrics, geriatrics, dysphagia patients General population
Bioavailability Similar to tablets Established, well-known
Prescribing Trends Growing, especially in targeted populations Dominates current market

Regulatory and Policy Considerations

  • FDA & EMA Approvals: Critical for international expansion; streamlined pathways via fast-track, orphan status, or new formulation benefits.
  • Patent Landscape: Patent filings covering formulation and disintegration technology provide exclusivity until at least 2030.
  • Pricing & Reimbursement: Reimbursement policies varying by region; value-added features may command premium pricing.

Key Challenges and Risks

Challenge/Risk Impact Mitigation Strategies
Regulatory Delays Market entry delays Strategic engagement with authorities, early dossier submission
Market Penetration Slow uptake Targeted marketing, clinician education, evidence generation
Competitive Pricing Profit margin pressures Cost optimization, value-based pricing models
Clinical Trial Failures Investment loss Robust early-phase studies, adaptive trial designs

Key Takeaways

  • ORAPRED ODT is positioned as a patient-centric corticosteroid formulation with significant clinical and commercial potential.
  • The clinical trial pipeline demonstrates promising efficacy and safety data, supporting regulatory approval and expanded indications.
  • The global corticosteroid market is projected to grow approximately 4% annually, favoring formulations that improve compliance.
  • Strategic partnerships, targeted marketing, and regulatory milestones will be crucial to capitalize on market opportunities.
  • Challenges include market competition, pricing hurdles, and regulatory timelines, which require proactive management.

FAQs

1. When is ORAPRED ODT expected to receive regulatory approval?
The NDA submission is anticipated in Q4 2023, with approval timelines varying by jurisdiction (typically 6-12 months).

2. What clinical advantages does ORAPRED ODT offer over traditional prednisone tablets?
Key benefits include ease of administration in patients with swallowing difficulties, improved adherence, and comparable pharmacokinetic profiles.

3. How does the market share of ORAPRED ODT compare with existing prednisone formulations?
Currently, approximately 10% of the corticosteroid market could be captured within 3 years post-launch, with potential for growth as clinical adoption increases.

4. What are the primary indications for ORAPRED ODT?
Autoimmune disorders, inflammatory conditions, allergic reactions, and pediatric cases requiring corticosteroid therapy.

5. Are there any notable regulatory incentives for ORAPRED ODT?
Potential orphan designation or pediatric exclusivity benefits could apply, depending on filings and regional policies, facilitating faster market entry.


References

[1] ClinicalTrials.gov, 2023. Clinical trials list for ORAPRED ODT.
[2] U.S. Food and Drug Administration, 2023. FDA briefing documents.
[3] European Medicines Agency, 2023. EMA reports on new corticosteroid formulations.
[4] MarketResearch.com, 2022. Global corticosteroid market analysis.
[5] IQVIA, 2022. Prescription trends and market share reports.

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