CLINICAL TRIALS PROFILE FOR DECADRON-LA

505(b)(2) Clinical Trials for DECADRON-LA

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
OTC	NCT03995004 ↗	The Effect of Melatonin on Postoperative Pain Reduction After Orthognathic Surgery	Recruiting	The University of Hong Kong	Phase 1	2021-10-01	Orthognathic surgery is a procedure performed to correct dentofacial deformities. It involves osteotomy at the facial skeleton. Considerable pain is expected in the early recovery period. Melatonin is a hormone that is produced naturally by the body. Synthetic Melatonin is available over the counter for the management of sleeping disorder and jetlag. Clinically, Melatonin can also be used to reduce pain and analgesic consumption in patients undergoing surgery. Dexamethasone is a type of steroid. It can suppress the inflammatory response. It is an anti-inflammatory, anti-allergic drug. It is commonly used in head and neck and oral surgery for its anti-inflammatory effect to reduce swelling. This study aims evaluate the efficacy of oral melatonin in the pain reduction following orthognathic surgery. This is a double-blinded randomized controlled trial. We will recruit 87 patients who are scheduled for double-jaw orthognathic surgery to participate in this three-year study. The study lasts for 2 weeks. Participant will be randomly allocated by computer to one of the three groups. (1) Group D will receive dexamethasone only; (2) Group M will receive melatonin only; and (3) Group DM both melatonin and dexamethasone. Postoperative pain level and perioperative plasma levels of inflammatory markers and anti-oxidizing enzymes will be recorded and compared among the study groups.

All Clinical Trials for DECADRON-LA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002744 ↗	Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Lymphoblastic Leukemia	Completed	National Cancer Institute (NCI)	Phase 3	1996-05-01	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 giving them in different ways may kill more cancer cells. It is not yet known which regimen of combination chemotherapy is more effective for acute lymphoblastic leukemia PURPOSE: Randomized phase III trial to compare different regimens of combination chemotherapy in treating children who have newly diagnosed acute lymphoblastic leukemia.
NCT00002744 ↗	Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Lymphoblastic Leukemia	Completed	Children's Oncology Group	Phase 3	1996-05-01	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 giving them in different ways may kill more cancer cells. It is not yet known which regimen of combination chemotherapy is more effective for acute lymphoblastic leukemia PURPOSE: Randomized phase III trial to compare different regimens of combination chemotherapy in treating children who have newly diagnosed acute lymphoblastic leukemia.
NCT00002798 ↗	Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Children With Acute Myelogenous Leukemia or Myelodysplastic Syndrome	Completed	National Cancer Institute (NCI)	Phase 3	1996-08-01	Randomized phase III trial to compare the effectiveness of different chemotherapy regimens with or without bone marrow transplantation in treating children who have acute myelogenous leukemia or myelodysplastic syndrome. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known which treatment regimen is more effective for acute myelogenous leukemia or myelodysplastic syndrome

Clinical Trial Conditions for DECADRON-LA

Condition Name

Condition Name for DECADRON-LA
Intervention	Trials
Multiple Myeloma	94
Recurrent Plasma Cell Myeloma	37
Leukemia	33

Condition MeSH

Condition MeSH for DECADRON-LA
Intervention	Trials
Multiple Myeloma	201
Neoplasms, Plasma Cell	193
Leukemia	89

Clinical Trial Locations for DECADRON-LA

Trials by Country

Trials by Country for DECADRON-LA
Location	Trials
Canada	216
Australia	90
New Zealand	29
Puerto Rico	21
China	21

Trials by US State

Trials by US State for DECADRON-LA
Location	Trials
Texas	146
California	113
New York	99
Massachusetts	97
Minnesota	94

Clinical Trial Progress for DECADRON-LA

Clinical Trial Phase

Clinical Trial Phase for DECADRON-LA
Clinical Trial Phase	Trials
Phase 4	41
Phase 3	76
Phase 2/Phase 3	9

Clinical Trial Status

Clinical Trial Status for DECADRON-LA
Clinical Trial Phase	Trials
Completed	209
Recruiting	86
Active, not recruiting	69

Clinical Trial Sponsors for DECADRON-LA

Sponsor Name

Sponsor Name for DECADRON-LA
Sponsor	Trials
National Cancer Institute (NCI)	188
M.D. Anderson Cancer Center	84
Mayo Clinic	33

Sponsor Type

Sponsor Type for DECADRON-LA
Sponsor	Trials
Other	563
Industry	259
NIH	191

Dexamethasone: A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Introduction

Dexamethasone, known by its trade name Decadron among others, has been a cornerstone in the treatment of various inflammatory and immune-related conditions for decades. Its recent prominence in the management of COVID-19 has significantly impacted its market and clinical relevance. Here, we delve into the latest clinical trials, market analysis, and future projections for dexamethasone.

Clinical Trials and Efficacy in COVID-19

Oxford University RECOVERY Trial

One of the most pivotal clinical trials involving dexamethasone was the RECOVERY Trial conducted by Oxford University. This trial demonstrated that dexamethasone can be lifesaving for patients who are critically ill with COVID-19. For patients on ventilators, the treatment reduced mortality by about one third, and for those requiring only oxygen, mortality was cut by about one fifth[1][5].

COVID-19 Dexamethasone (CoDEX) Trial

The CoDEX randomized clinical trial, conducted in Brazil, further reinforced the efficacy of dexamethasone in patients with moderate to severe Acute Respiratory Distress Syndrome (ARDS) due to COVID-19. The trial showed that patients treated with dexamethasone had more ventilator-free days and improved clinical outcomes compared to those receiving standard care alone[4].

Market Analysis and Projections

Global Market Size and Growth

The global dexamethasone market is expected to experience significant growth, driven largely by its role in treating COVID-19 and other inflammatory conditions. According to market research, the dexamethasone market is projected to reach USD 4,634.01 million by 2028, growing at a Compound Annual Growth Rate (CAGR) of 6.65% from 2021 to 2028[2].

Segmentation and Key Markets

The market is segmented based on formulation type (liquid, tablet, solution for injection), patient type (adult, pediatric, geriatric), application (anti-inflammatory and immunosuppressant effects, respiratory distress syndrome, COVID-19), and end users (hospitals, clinics, pharmacy & drug stores, online pharmacies). The North America region currently leads the market due to the high prevalence of COVID-19 and other diseases, while the Asia-Pacific region is expected to expand significantly due to the rising prevalence of viral disease outbreaks and the strong presence of major manufacturers[2].

Drivers and Restraints

The growth of the dexamethasone market is driven by several factors, including the rapid increase in its use as a lifesaving treatment for critically ill COVID-19 patients, robust investment in research and development, and increasing awareness about its benefits. However, the market also faces challenges such as the various side effects associated with dexamethasone and the potential impact of preventive measures like vaccines on its demand[2].

End Users and Distribution Channels

Hospitals and Clinics

Hospitals and clinics are among the primary end users of dexamethasone, particularly in the context of treating severe COVID-19 cases. The drug's efficacy in reducing mortality and improving patient outcomes has made it a staple in intensive care units (ICUs)[1][4].

Pharmacy and Drug Stores

Pharmacy and drug stores, including online pharmacies, also play a crucial role in the distribution of dexamethasone. The drug's availability in various formulations (liquid, tablet, solution for injection) makes it accessible through different channels[2].

Regulatory Approvals and Guidelines

WHO and EMA Endorsements

The World Health Organization (WHO) and the European Medicines Agency (EMA) have endorsed the use of dexamethasone in treating COVID-19. The WHO welcomed the preliminary results from the RECOVERY Trial and updated its clinical guidance to reflect the use of dexamethasone in critically ill patients. The EMA endorsed its use in adults and adolescents requiring supplemental oxygen therapy[1][5].

Future Projections and Trends

Continued Research and Development

The ongoing research into the use of dexamethasone and other corticosteroids is expected to further solidify its position in the treatment of COVID-19 and other inflammatory conditions. Large randomized control trials will continue to provide actionable evidence, driving updates in clinical guidelines and market growth[1].

Market Expansion

The dexamethasone market is anticipated to expand significantly in the Asia-Pacific region, driven by the rising prevalence of viral disease outbreaks and the strong presence of major manufacturers. The North America region will also continue to be a key market due to the high prevalence of diseases and robust investment in healthcare research[2].

Challenges and Opportunities

Side Effects and Safety Concerns

Despite its efficacy, dexamethasone is associated with various side effects, which could impede market growth. However, the benefits in critically ill patients often outweigh these risks, and ongoing research aims to optimize its use while minimizing adverse effects[2].

Preventive Measures and Vaccines

The development and distribution of vaccines could potentially challenge the growth of the dexamethasone market. However, the drug's established role in treating severe cases and its affordability make it a valuable asset in the fight against COVID-19 and other diseases[2].

Key Takeaways

• Clinical Efficacy: Dexamethasone has been shown to reduce mortality in critically ill COVID-19 patients, particularly those on ventilators or requiring oxygen.
• Market Growth: The global dexamethasone market is projected to reach USD 4,634.01 million by 2028, growing at a CAGR of 6.65%.
• Regulatory Endorsements: The WHO and EMA have endorsed the use of dexamethasone in treating COVID-19.
• Future Trends: Continued research, market expansion in the Asia-Pacific region, and the drug's affordability are expected to drive its growth.
• Challenges: Side effects and the impact of preventive measures like vaccines are potential restraints on market growth.

FAQs

What are the key findings from the RECOVERY Trial regarding dexamethasone?

The RECOVERY Trial showed that dexamethasone can reduce mortality by about one third in COVID-19 patients on ventilators and by about one fifth in those requiring only oxygen[1][5].

How is the global dexamethasone market expected to grow?

The global dexamethasone market is expected to reach USD 4,634.01 million by 2028, growing at a CAGR of 6.65% from 2021 to 2028[2].

What are the primary end users of dexamethasone?

Hospitals and clinics are among the primary end users, particularly in the context of treating severe COVID-19 cases[1][4].

What regulatory approvals has dexamethasone received?

The WHO and EMA have endorsed the use of dexamethasone in treating COVID-19, with the EMA specifying its use in adults and adolescents requiring supplemental oxygen therapy[1][5].

What are the potential challenges to the growth of the dexamethasone market?

The various side effects associated with dexamethasone and the potential impact of preventive measures like vaccines are potential challenges to market growth[2].

How does dexamethasone compare to other corticosteroids in treating COVID-19?

Dexamethasone has shown the largest reduction in mortality compared to other corticosteroids in treating COVID-19, with a 36% reduction compared to placebo[5].

Sources

1. World Health Organization. "WHO welcomes preliminary results about dexamethasone use in treating critically ill COVID-19 patients." June 16, 2020.
2. Data Bridge Market Research. "Global Dexamethasone Market – Industry Trends and Forecast to 2028."
3. BioSpace. "U.S. Clinical Trials Market Size Industry Analysis Report, 2033." April 26, 2024.
4. JAMA Network. "Effect of Dexamethasone on Days Alive and Ventilator-Free in Patients With COVID-19 and Moderate to Severe ARDS." September 2, 2020.
5. Wikipedia. "Dexamethasone."