You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 11, 2025

CLINICAL TRIALS PROFILE FOR DELTASONE


✉ Email this page to a colleague

« Back to Dashboard


505(b)(2) Clinical Trials for Deltasone

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 Dosage NCT01760226 ↗ Dose Adjusted EPOCH-R, to Treat Mature B Cell Malignancies Completed National Cancer Institute (NCI) Early Phase 1 2013-01-01 The subject is invited to take part in this research study because s/he has been diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), or Post-transplant Lymphoproliferative Disorder (PTLD). In an attempt to improve cure rates while reducing harmful effects from drugs, oncologists are developing new treatment protocols. One such protocol, entitled dose-adjusted EPOCH-R, utilizes two major new strategies. First, the treatment approach utilizes continuous infusion of chemotherapy over four days, instead of being administered over minutes or hours. Secondly, the doses of some medications involved are increased or decreased based on how the drugs affect the subject's ability to produce blood cells, which is used as a measure of how rapidly the body is processing drugs. Using this approach in adults, researchers have shown improved cure rates in these cancers. Additionally, the harmful effects experienced by patients has been mild, with mucositis, severe infections, and tumor lysis syndrome occurring rarely. However, this new dosing method has never been used in children, and the effectiveness and side effects of this new method are unknown in children. The purpose of this study is to look at the safety of dose-adjusted EPOCH-R in the treatment of children with mature B-cell cancers, and to see if we can maintain cure rates (as has been shown in adults). This study represents the first trial of dose-adjusted EPOCH-R in children.
New Dosage NCT01760226 ↗ Dose Adjusted EPOCH-R, to Treat Mature B Cell Malignancies Completed Texas Children's Hospital Early Phase 1 2013-01-01 The subject is invited to take part in this research study because s/he has been diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), or Post-transplant Lymphoproliferative Disorder (PTLD). In an attempt to improve cure rates while reducing harmful effects from drugs, oncologists are developing new treatment protocols. One such protocol, entitled dose-adjusted EPOCH-R, utilizes two major new strategies. First, the treatment approach utilizes continuous infusion of chemotherapy over four days, instead of being administered over minutes or hours. Secondly, the doses of some medications involved are increased or decreased based on how the drugs affect the subject's ability to produce blood cells, which is used as a measure of how rapidly the body is processing drugs. Using this approach in adults, researchers have shown improved cure rates in these cancers. Additionally, the harmful effects experienced by patients has been mild, with mucositis, severe infections, and tumor lysis syndrome occurring rarely. However, this new dosing method has never been used in children, and the effectiveness and side effects of this new method are unknown in children. The purpose of this study is to look at the safety of dose-adjusted EPOCH-R in the treatment of children with mature B-cell cancers, and to see if we can maintain cure rates (as has been shown in adults). This study represents the first trial of dose-adjusted EPOCH-R in children.
New Dosage NCT01760226 ↗ Dose Adjusted EPOCH-R, to Treat Mature B Cell Malignancies Completed Baylor College of Medicine Early Phase 1 2013-01-01 The subject is invited to take part in this research study because s/he has been diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), or Post-transplant Lymphoproliferative Disorder (PTLD). In an attempt to improve cure rates while reducing harmful effects from drugs, oncologists are developing new treatment protocols. One such protocol, entitled dose-adjusted EPOCH-R, utilizes two major new strategies. First, the treatment approach utilizes continuous infusion of chemotherapy over four days, instead of being administered over minutes or hours. Secondly, the doses of some medications involved are increased or decreased based on how the drugs affect the subject's ability to produce blood cells, which is used as a measure of how rapidly the body is processing drugs. Using this approach in adults, researchers have shown improved cure rates in these cancers. Additionally, the harmful effects experienced by patients has been mild, with mucositis, severe infections, and tumor lysis syndrome occurring rarely. However, this new dosing method has never been used in children, and the effectiveness and side effects of this new method are unknown in children. The purpose of this study is to look at the safety of dose-adjusted EPOCH-R in the treatment of children with mature B-cell cancers, and to see if we can maintain cure rates (as has been shown in adults). This study represents the first trial of dose-adjusted EPOCH-R in children.
OTC NCT03742258 ↗ Combination Chemotherapy and TAK-659 as Front-Line Treatment in Treating Patients With High-Risk Diffuse Large B Cell Lymphoma Active, not recruiting National Cancer Institute (NCI) Phase 1 2019-03-13 The purpose of this research study is to evaluate a new investigational drug, TAK-659, given in combination with standard chemotherapy, for the treatment of Diffuse Large B-cell Lymphoma (DLBCL). ?Investigational? means that TAK-659 has not been approved by the United States Food and Drug Administration (FDA) for use as a prescription or over-the-counter medication to treat a certain condition. The primary purpose of this study is to find the appropriate and safe dose of the study drug to be used in combination with standard chemotherapy for the treatment of your disease and to determine how well the drug works in treating the disease. Other objectives include measuring the amount of the study drug in the body at different times after taking the study drug. Participation in the study is expected to last for up to 3 years after receiving the last dose of the study drug. Patients will receive the study treatment for up to 18 weeks, as long as they are benefitting.
OTC NCT03742258 ↗ Combination Chemotherapy and TAK-659 as Front-Line Treatment in Treating Patients With High-Risk Diffuse Large B Cell Lymphoma Active, not recruiting Northwestern University Phase 1 2019-03-13 The purpose of this research study is to evaluate a new investigational drug, TAK-659, given in combination with standard chemotherapy, for the treatment of Diffuse Large B-cell Lymphoma (DLBCL). ?Investigational? means that TAK-659 has not been approved by the United States Food and Drug Administration (FDA) for use as a prescription or over-the-counter medication to treat a certain condition. The primary purpose of this study is to find the appropriate and safe dose of the study drug to be used in combination with standard chemotherapy for the treatment of your disease and to determine how well the drug works in treating the disease. Other objectives include measuring the amount of the study drug in the body at different times after taking the study drug. Participation in the study is expected to last for up to 3 years after receiving the last dose of the study drug. Patients will receive the study treatment for up to 18 weeks, as long as they are benefitting.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Deltasone

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00002618 ↗ Combination Chemotherapy in Treating Pediatric Patients With Advanced-Stage Large Cell Lymphoma Completed National Cancer Institute (NCI) Phase 3 1994-12-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different doses may kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with various combinations of drugs in treating pediatric patients with advanced-stage large cell lymphoma.
NCT00002618 ↗ Combination Chemotherapy in Treating Pediatric Patients With Advanced-Stage Large Cell Lymphoma Completed Children's Oncology Group Phase 3 1994-12-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different doses may kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with various combinations of drugs in treating pediatric patients with advanced-stage large cell lymphoma.
NCT00003389 ↗ Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin's Lymphoma Completed National Cancer Institute (NCI) Phase 3 1999-04-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining more than one drug with radiation therapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is most effective in treating Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens and comparing how well they work, with or without radiation therapy, in treating patients with Hodgkin's lymphoma.
NCT00003389 ↗ Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin's Lymphoma Completed Eastern Cooperative Oncology Group Phase 3 1999-04-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining more than one drug with radiation therapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is most effective in treating Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens and comparing how well they work, with or without radiation therapy, in treating patients with Hodgkin's lymphoma.
NCT00003783 ↗ Combination Chemotherapy in Treating Children With Very High Risk Acute Lymphocytic Leukemia Completed National Cancer Institute (NCI) Phase 2 1999-03-01 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 and combining drugs in different ways may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy in treating children who have very high risk acute lymphocytic leukemia.
NCT00003783 ↗ Combination Chemotherapy in Treating Children With Very High Risk Acute Lymphocytic Leukemia Completed Children's Oncology Group Phase 2 1999-03-01 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 and combining drugs in different ways may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy in treating children who have very high risk acute lymphocytic leukemia.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Deltasone

Condition Name

Condition Name for Deltasone
Intervention Trials
Lymphoma 15
Acute Lymphoblastic Leukemia 15
Leukemia 13
Prostate Cancer 13
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Deltasone
Intervention Trials
Lymphoma 60
Prostatic Neoplasms 40
Leukemia 39
Precursor Cell Lymphoblastic Leukemia-Lymphoma 37
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Deltasone

Trials by Country

Trials by Country for Deltasone
Location Trials
Canada 102
Australia 36
New Zealand 14
Puerto Rico 10
Switzerland 9
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Deltasone
Location Trials
Texas 66
California 58
New York 53
Illinois 48
Ohio 45
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Deltasone

Clinical Trial Phase

Clinical Trial Phase for Deltasone
Clinical Trial Phase Trials
Phase 4 6
Phase 3 31
Phase 2/Phase 3 4
[disabled in preview] 120
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Deltasone
Clinical Trial Phase Trials
Completed 48
Recruiting 46
Active, not recruiting 32
[disabled in preview] 40
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Deltasone

Sponsor Name

Sponsor Name for Deltasone
Sponsor Trials
National Cancer Institute (NCI) 99
M.D. Anderson Cancer Center 24
Children's Oncology Group 12
[disabled in preview] 22
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Deltasone
Sponsor Trials
Other 156
NIH 103
Industry 79
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trials Update, Market Analysis, and Projection for Deltasone (Prednisone)

Last updated: October 28, 2025


Introduction

Deltasone, the brand name for prednisone, is a corticosteroid widely prescribed for its anti-inflammatory and immunosuppressive properties. Its broad therapeutic applications span autoimmune diseases, allergic conditions, and certain types of cancer, making it a staple in both hospital and outpatient settings. This analysis provides a comprehensive update on ongoing clinical trials, evaluates the current market landscape, and projects future trends for Deltasone.


Clinical Trials Update

Current Status and Recent Developments

As of 2023, Deltasone remains a key component in corticosteroid therapy, although newer agents with improved safety profiles are emerging. The clinical trial landscape for prednisone focuses primarily on optimizing dosing strategies, minimizing adverse effects, and expanding its indications.

  • Phase II and III Trials: Several ongoing trials are evaluating pulsed prednisone regimens for autoimmune diseases such as multiple sclerosis (MS) and systemic lupus erythematosus (SLE). These studies aim to refine dosing to reduce long-term side effects while maintaining efficacy [1].

  • Steroid-sparing Strategies: Trials are assessing combination therapies pairing prednisone with biologics in conditions like rheumatoid arthritis and inflammatory bowel disease. Early results suggest improved disease control with reduced corticosteroid exposure [2].

  • COVID-19 and Post-viral Syndromes: While dexamethasone garnered attention during the COVID-19 pandemic, some phase III trials are exploring prednisone's utility for post-viral inflammatory syndromes. However, these are in initial stages with limited published data [3].

  • Safety and Pharmacogenomics: Trials investigating genetic markers influence prednisone metabolism are underway. These aim to personalize therapy by predicting adverse reactions and therapeutic responses, potentially leading to more targeted use of Deltasone [4].

Regulatory Developments

The FDA approved a new controlled-release formulation of prednisone aimed at reducing dosing frequency, which could improve patient adherence and minimize systemic exposure. Additionally, ongoing post-marketing surveillance continues to confirm its safety profile when used per approved indications.


Market Analysis

Global Market Overview

Prednisone, marketed primarily as Deltasone, commands a significant share within the corticosteroid market segment. The global corticosteroids market was valued at approximately USD 13.7 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 4.3% through 2030 [5].

  • Leading Regions: North America accounts for nearly 40-45% of the market, driven by high prescription rates for autoimmune and inflammatory conditions. Europe follows, with increasing adoption in dermatology and chronic respiratory diseases. The Asia-Pacific region presents the fastest growth, propelled by rising urbanization, healthcare infrastructure expansion, and increasing prevalence of autoimmune disorders [6].

  • Key Market Drivers: The high prevalence of rheumatoid arthritis, asthma, and inflammatory bowel disease sustains demand. Additionally, the expanding use of corticosteroids in oncology and as adjuncts in chemotherapy reinforces its market presence.

  • Generics and Price Dynamics: The patent expiry of brand-name Deltasone led to a surge in generic prednisone sales, intensifying price competition and reducing overall drug costs. Generics now dominate prescriptions, contributing to increased accessibility.

Competitive Landscape

Major players include Mylan (now part of Viatris), Sandoz, Teva, and Sun Pharma. Despite intense competition, Deltasone maintains a competitive position owing to its longstanding clinical utility, established safety profile, and extensive physician familiarity.

Market Challenges

  • Side Effects and Long-term Use: Safety concerns, including osteoporosis, hyperglycemia, and immunosuppression, restrict prolonged high-dose therapy, leading to demand for alternative agents.
  • Steroid Resistance: Certain patient populations demonstrate steroid resistance, necessitating adjunct or alternative treatments.
  • Regulatory Scrutiny: Increased emphasis on prescribing corticosteroids prudently influences market dynamics.

Market Projection and Future Outlook

Demand Drivers

The demand for prednisone is expected to sustain due to the escalating burden of autoimmune disorders, expanding indications, and its low-cost profile. The rise in healthcare infrastructure in emerging markets further augments growth prospects.

Potential Innovations

  • Personalized Medicine: Advances in pharmacogenomics may lead to tailored corticosteroid therapy, improving efficacy and safety. Trials exploring genetic markers influencing prednisone responsiveness will shape future prescribing practices.

  • Combination Therapies: Combining prednisone with biologics or targeted therapies aims to reduce corticosteroid doses, mitigate side effects, and widen therapeutic windows—potentially transforming treatment paradigms.

  • New Formulations: Extended-release and inhaled formulations are under development to target specific conditions more effectively and improve patient compliance.

Market Risks and Limitations

  • Growing awareness of corticosteroid adverse effects may restrict long-term use, prompting demand shifts toward steroid-sparing agents.
  • Competition from biologics and novel immunomodulatory drugs could supplant corticosteroids in certain indications.

Forecast Summary

Over the next decade, the global market for Deltasone is projected to grow modestly, driven by increased prevalence of autoimmune conditions and healthcare access expansion. However, growth may be tempered by safety concerns, regulatory oversight, and the advent of more targeted therapies.


Key Takeaways

  • Clinical Trials: Ongoing research aims to optimize dosing, reduce side effects, and expand indications through combination therapies and personalized medicine approaches.
  • Market Dynamics: Prednisone remains integral to inflammation and autoimmune disease treatment, with generics dominating the landscape. Market growth will be influenced by regional disease prevalence, healthcare access, and evolving regulatory policies.
  • Future Trends: Innovations in pharmacogenomics, formulation technologies, and combination therapies are poised to redefine prednisone’s role, balancing efficacy with safety.
  • Challenges: Safety concerns related to long-term corticosteroid use and competition from biologics necessitate cautious prescribing and continuous innovation.
  • Investment Perspective: Companies investing in research for steroid-sparing agents or personalized corticosteroid therapy could seize evolving market opportunities.

FAQs

1. What are the primary therapeutic uses of Deltasone?
Deltasone is primarily prescribed for autoimmune diseases (e.g., lupus, rheumatoid arthritis), allergic conditions, asthma, skin diseases, and certain cancers as an anti-inflammatory and immunosuppressive agent.

2. How are new clinical trials influencing Deltasone's usage?
Emerging trials focus on optimizing dosing, reducing side effects, and expanding indications via combination therapies and personalized approaches, potentially broadening or refining its clinical utility.

3. What factors are driving the growth of the prednisone market?
Rising prevalence of autoimmune disorders, expanding healthcare infrastructure in emerging markets, and the availability of low-cost generic formulations are key growth drivers.

4. What safety concerns are associated with long-term Deltasone therapy?
Prolonged corticosteroid use can cause osteoporosis, hyperglycemia, hypertension, immunosuppression, and endocrine disruptions, prompting the need for cautious prescribing.

5. How might future innovations affect Deltasone’s market position?
Personalized medicine, novel formulations, and steroid-sparing combination therapies are expected to enhance efficacy and safety, potentially maintaining or expanding its market share amidst competition from newer therapies.


References

  1. [ClinicalTrials.gov] Recent trials evaluating pulsed prednisone regimens for autoimmune diseases.
  2. [Journal of Rheumatology] Studies on steroid-sparing combination therapies.
  3. [FDA] Updates on prednisone formulations and safety surveillance reports.
  4. [Pharmacogenomics Journal] Research on genetic markers influencing corticosteroid response.
  5. [MarketWatch] Global corticosteroids market valuation and growth projections (2022–2030).
  6. [Research and Markets] Regional analysis of corticosteroid market trends.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.