Last Updated: August 8, 2026

CLINICAL TRIALS PROFILE FOR PRELONE


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505(b)(2) Clinical Trials for PRELONE

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 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
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for PRELONE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00900445 ↗ Studying Body Mass Index in Younger Patients Who Are Receiving Treatment for High-Risk Acute Lymphoblastic Leukemia Withdrawn National Cancer Institute (NCI) 2008-03-24 This clinical trial is studying body mass index in younger patients receiving prednisone/prednisolone, vincristine, daunorubicin, and pegaspargase for high-risk acute lymphoblastic leukemia. Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about the affect of body mass index on the way anticancer drugs work in the body. It may also help doctors predict how patients will respond to treatment
NCT00900445 ↗ Studying Body Mass Index in Younger Patients Who Are Receiving Treatment for High-Risk Acute Lymphoblastic Leukemia Withdrawn Children's Oncology Group 2008-03-24 This clinical trial is studying body mass index in younger patients receiving prednisone/prednisolone, vincristine, daunorubicin, and pegaspargase for high-risk acute lymphoblastic leukemia. Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about the affect of body mass index on the way anticancer drugs work in the body. It may also help doctors predict how patients will respond to treatment
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.
NCT01391793 ↗ Corticosteroids for Children With Febrile Urinary Tract Infections Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 3 2011-09-01 In this study the investigators will determine whether corticosteroids given at the time of urinary tract infection help prevent permanent damage to the kidneys.
NCT01391793 ↗ Corticosteroids for Children With Febrile Urinary Tract Infections Completed Nader Shaikh Phase 3 2011-09-01 In this study the investigators will determine whether corticosteroids given at the time of urinary tract infection help prevent permanent damage to the kidneys.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for PRELONE

Condition Name

Condition Name for PRELONE
Intervention Trials
B Acute Lymphoblastic Leukemia 5
Mixed Phenotype Acute Leukemia 3
B Lymphoblastic Lymphoma 2
Blasts More Than 25 Percent of Bone Marrow Nucleated Cells 2
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Condition MeSH

Condition MeSH for PRELONE
Intervention Trials
Precursor Cell Lymphoblastic Leukemia-Lymphoma 8
Leukemia, Lymphoid 8
Leukemia 8
Lymphoma 4
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Clinical Trial Locations for PRELONE

Trials by Country

Trials by Country for PRELONE
Location Trials
United States 240
Canada 30
Australia 15
New Zealand 6
Puerto Rico 4
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Trials by US State

Trials by US State for PRELONE
Location Trials
Pennsylvania 7
Ohio 7
Utah 6
Texas 6
Tennessee 6
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Clinical Trial Progress for PRELONE

Clinical Trial Phase

Clinical Trial Phase for PRELONE
Clinical Trial Phase Trials
Phase 4 1
Phase 3 7
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for PRELONE
Clinical Trial Phase Trials
Not yet recruiting 4
Recruiting 4
Withdrawn 1
[disabled in preview] 3
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Clinical Trial Sponsors for PRELONE

Sponsor Name

Sponsor Name for PRELONE
Sponsor Trials
National Cancer Institute (NCI) 9
Children's Oncology Group 5
Elan Pharmaceuticals 1
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Sponsor Type

Sponsor Type for PRELONE
Sponsor Trials
NIH 10
Other 9
Industry 2
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Prelone clinical trials update, market analysis, and projection (2026) for prednisolone oral solution

Last updated: July 28, 2026

Prelone (prednisolone) is a corticosteroid oral product marketed for inflammatory and allergic conditions. There is no reliably citable, drug-specific clinical-trial and commercial-release dataset in the provided context to support an accurate trials update, current market size, revenue forecast, or label-driven utilization outlook for “Prelone” specifically as a branded product versus generic prednisolone oral solutions.

Because the necessary source-linked facts (clinicaltrials.gov entries tied to “Prelone” by sponsor, NCT number, phase, start/completion dates; FDA status and Orange Book listings tied to the specific brand/manufacturer; and audited revenue or third-party sales series tied to Prelone) are not present here, a complete and accurate analysis cannot be produced.

What clinical trials are recruiting for Prelone (prednisolone) oral solution?

No Prelone-specific trial record set is available in the provided context to enumerate NCT numbers, phase, endpoints, or recruitment status.

What are the main trial designs for prednisolone oral products in asthma/allergy indications?

No prednisolone trial details tied to Prelone are present.

Which sponsors run prednisolone oral solution studies relevant to Prelone?

No sponsor-linked studies are provided.

What is the latest clinical trials update for prednisolone oral corticosteroid therapy?

No updateable, source-anchored clinical timeline is provided for Prelone or for prednisolone oral solutions under the Prelone brand.

When did the most recent prednisolone oral studies complete?

No completion dates or study status facts are available.

Are there ongoing bioequivalence or formulation studies for Prelone?

No formulation/bioequivalence items are provided.

How big is the Prelone (prednisolone) market and where does demand come from?

No branded-sales series or market segmentation data is provided that isolates Prelone from generic prednisolone oral solutions.

What indications drive corticosteroid oral utilization?

No label-linked utilization drivers for Prelone are provided.

How sensitive is demand to steroid stewardship and guideline shifts?

No sourcing is provided.

What is the revenue projection for Prelone through 2030?

A revenue forecast requires at minimum: (1) current branded unit and revenue base; (2) projected share versus authorized generics; (3) pricing and reimbursement assumptions; and (4) patent/exclusivity and entry timelines for the exact Prelone NDA/ANDA product. None of these elements are available in the provided context.

When does Prelone lose exclusivity or what patents expire for prednisolone oral solution?

No Orange Book patent listing set or exclusivity/method-of-use identifiers tied to the Prelone product are provided, so an exclusivity or expiration schedule cannot be stated accurately.

How many patents cover the Prelone prednisolone oral formulation?

No patent counts are available.

What Orange Book status does Prelone have (listed patents and exclusivities)?

No listing status is provided.

Are there Paragraph IV challenges to Prelone (prednisolone) oral solution?

No FDA “Paragraph IV” litigation or notice facts tied to Prelone are provided.

Which companies are challenging Prelone?

No challenger names are available.

What settlement agreements affect generic entry timing?

No settlements or consent decrees are provided.

What generic entry risks exist for Prelone?

No barriers are provided for the specific Prelone NDA/brand, including: patent claim scopes, formulation/manufacturing constraints, REMS requirements (if any), or data exclusivity status.

What formulation patents could block generic prednisolone oral solutions?

No formulation patent set is available.

Are there risks from manufacturing or stability constraints for prednisolone liquid?

No product-specific manufacturing IP facts are available.

How does Prelone compare with other branded prednisolone oral products?

No comparative brand roster tied to “Prelone” and no relative market share, pricing, or product-line differences are available.

What delivery-system differences matter (solution vs suspension vs tablets)?

No Prelone product-form factor details are included here.

How do price and rebate dynamics compare across branded prednisolone liquids?

No pricing data is available.

What is the regulatory status of Prelone with FDA (NDA/ANDA, labeling, approvals)?

No FDA regulatory record set is provided for Prelone’s NDA/ANDA number, approval history, labeling dates, or current supplement status.

Is Prelone approved under an NDA with listed patents, or is it a legacy brand?

No NDA/ANDA classification is provided.

What is the current label status and dosing regimen in FDA labeling?

No label text or dose schedule facts are provided.

Key Takeaways

  • Prelone analysis cannot be completed as requested because no source-linked Prelone-specific clinical trial, FDA/Orange Book, patent, or branded commercial dataset is provided.
  • A defensible clinical-trials update, market sizing, and revenue projection require product-specific identifiers (NDA/ANDA, manufacturer, Orange Book listings) and audit-grade sales or third-party series tied to the Prelone brand, none of which are included here.

FAQs

  1. What is the FDA Orange Book listing status for Prelone (prednisolone) oral solution?
  2. Are there any active NCT clinical trials that include Prelone as the investigational product?
  3. What prednisolone oral formulation patents could be asserted against generic entrants?
  4. What Paragraph IV notice history exists for branded prednisolone oral solutions?
  5. How does reimbursement coverage for pediatric oral corticosteroids affect branded prednisolone demand?

References

  1. (No citations available from the provided context.)

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