CLINICAL TRIALS PROFILE FOR HEXADROL

All Clinical Trials for Hexadrol

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004228 ↗	Combination Chemotx in Treating Children or Adolescents With Newly Diagnosed Stg III or Stg IV Lymphoblastic Lymphoma	Completed	National Cancer Institute (NCI)	Phase 3	2000-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of combination chemotherapy is most effective for lymphoblastic lymphoma. PURPOSE: This randomized phase III trial is studying different regimens of combination chemotherapy to compare how well they work in treating children or adolescents with newly diagnosed stage III or stage IV lymphoblastic lymphoma.
NCT00004228 ↗	Combination Chemotx in Treating Children or Adolescents With Newly Diagnosed Stg III or Stg IV Lymphoblastic Lymphoma	Completed	Children's Oncology Group	Phase 3	2000-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of combination chemotherapy is most effective for lymphoblastic lymphoma. PURPOSE: This randomized phase III trial is studying different regimens of combination chemotherapy to compare how well they work in treating children or adolescents with newly diagnosed stage III or stage IV lymphoblastic lymphoma.
NCT00025259 ↗	Chemotherapy With or Without Additional Chemotherapy and/or Radiation Therapy in Treating Children With Newly Diagnosed Hodgkin's Disease	Completed	National Cancer Institute (NCI)	Phase 3	2002-09-01	This randomized phase III trial is studying different chemotherapy regimens given with or without radiation therapy to compare how well they work in treating children with newly diagnosed Hodgkin's disease. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known if chemotherapy is more effective with or without additional chemotherapy and/or radiation therapy in treating Hodgkin's disease.
NCT00025259 ↗	Chemotherapy With or Without Additional Chemotherapy and/or Radiation Therapy in Treating Children With Newly Diagnosed Hodgkin's Disease	Completed	Children's Oncology Group	Phase 3	2002-09-01	This randomized phase III trial is studying different chemotherapy regimens given with or without radiation therapy to compare how well they work in treating children with newly diagnosed Hodgkin's disease. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known if chemotherapy is more effective with or without additional chemotherapy and/or radiation therapy in treating Hodgkin's disease.
NCT00075725 ↗	Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia	Completed	National Cancer Institute (NCI)	Phase 3	2003-12-29	This randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to see how well they work compared to methotrexate alone during maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia (ALL). Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium, work in different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.

Clinical Trial Conditions for Hexadrol

Condition Name

Condition Name for Hexadrol
Intervention	Trials
Recurrent Plasma Cell Myeloma	36
Refractory Plasma Cell Myeloma	30
Acute Lymphoblastic Leukemia	20
Plasma Cell Myeloma	16

Condition MeSH

Condition MeSH for Hexadrol
Intervention	Trials
Multiple Myeloma	75
Neoplasms, Plasma Cell	73
Leukemia	47
Precursor Cell Lymphoblastic Leukemia-Lymphoma	43

Clinical Trial Locations for Hexadrol

Trials by Country

Trials by Country for Hexadrol
Location	Trials
Canada	141
Australia	64
New Zealand	28
Puerto Rico	15
Brazil	10

Trials by US State

Trials by US State for Hexadrol
Location	Trials
Minnesota	66
Texas	64
California	54
Michigan	52
Florida	48

Clinical Trial Progress for Hexadrol

Clinical Trial Phase

Clinical Trial Phase for Hexadrol
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	27
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for Hexadrol
Clinical Trial Phase	Trials
Recruiting	55
Completed	35
Active, not recruiting	34

Clinical Trial Sponsors for Hexadrol

Sponsor Name

Sponsor Name for Hexadrol
Sponsor	Trials
National Cancer Institute (NCI)	132
M.D. Anderson Cancer Center	30
Mayo Clinic	24

Sponsor Type

Sponsor Type for Hexadrol
Sponsor	Trials
Other	160
NIH	133
Industry	56

HEXADROL: Clinical Trials, Market Analysis, and Projections

Introduction

HEXADROL, a brand name for dexamethasone acetate, is a corticosteroid medication known for its anti-inflammatory properties. Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials and Efficacy

COVID-19 and RECOVERY Trial

One of the most significant recent clinical trials involving dexamethasone was the RECOVERY (Randomised Evaluation of COVid-19 thERapY) trial. This trial, conducted in the UK, demonstrated that dexamethasone significantly reduces the risk of death among patients with severe respiratory complications due to COVID-19. The trial showed that dexamethasone reduced deaths by one-third in ventilated patients and by one-fifth in patients receiving oxygen only[1].

Other Clinical Uses

Dexamethasone acetate, marketed as HEXADROL, has been used in various clinical settings beyond COVID-19. It is effective in speeding the resolution of acute exacerbations of multiple sclerosis and is used to treat inflammatory ocular conditions, skin allergic reactions, and to decrease swelling associated with cancer of the spine and brain[2][4].

Market Analysis

Global Market Trends

The global dexamethasone acetate market is expected to see significant growth due to several factors. The increasing use of dexamethasone acetate in cancer patients, particularly in injection form, and its availability in various forms are key drivers. The market is also driven by the growing prevalence of inflammatory conditions and the drug's anti-inflammatory properties[2].

Market Size and Forecast

The dexamethasone acetate market is forecasted to grow substantially from 2020 to 2025. The market size is expected to increase due to the drug's widespread use and the expanding need for corticosteroid medications. The report provides granular level information about the market size, regional market share, and historic and forecast data[2].

Key Players

The market includes key players such as Purdue Pharma, LGM Pharma, and Alfa Aesar. These companies play a crucial role in the production and distribution of dexamethasone acetate, contributing to the market's growth and competitiveness[2].

Market Drivers and Restraints

Drivers

• Growing Prevalence of Inflammatory Conditions: The increasing incidence of inflammatory diseases is a major driver for the dexamethasone acetate market.
• Availability and Affordability: Dexamethasone acetate is widely available and affordable, making it a preferred choice for many medical conditions.
• Diverse Applications: The drug's use in various medical conditions, including cancer, multiple sclerosis, and COVID-19, expands its market potential[2].

Restraints

• Side Effects and Dosage Adjustments: Corticosteroids like dexamethasone acetate can have significant side effects, requiring careful dosage adjustments and monitoring. This can be a restraint in some cases[4].
• Regulatory Changes: Changes in regulatory frameworks or the discontinuation of certain products (as seen with Organon's discontinuation of HEXADROL distribution) can impact market dynamics[5].

Projections

Market Growth

The dexamethasone acetate market is projected to grow significantly over the next few years. The market is expected to reach USD XX million by 2026, registering a CAGR of xx% during the forecast period 2020-2026. This growth is driven by the increasing demand for corticosteroid medications and the drug's proven efficacy in various clinical settings[2].

Regional Analysis

The market will see growth across various regions, with a detailed analysis provided for each region's market size, share, and forecast. The report outlines the market's performance in different regions, helping businesses understand the global landscape and make informed decisions[2].

Conclusion

Dexamethasone acetate, marketed as HEXADROL, has demonstrated significant clinical efficacy, particularly in the context of the COVID-19 pandemic. The market for this drug is poised for substantial growth due to its widespread use, affordability, and diverse applications. However, it is crucial to consider the potential side effects and the need for careful dosage adjustments.

Key Takeaways

• Clinical Efficacy: Dexamethasone acetate has shown significant efficacy in reducing mortality in COVID-19 patients and in treating other inflammatory conditions.
• Market Growth: The global dexamethasone acetate market is expected to grow substantially from 2020 to 2026.
• Diverse Applications: The drug is used in various medical conditions, including cancer, multiple sclerosis, and COVID-19.
• Regulatory and Safety Considerations: Careful monitoring and dosage adjustments are necessary due to potential side effects.

FAQs

What is HEXADROL used for?

HEXADROL, or dexamethasone acetate, is used to treat various inflammatory conditions, including COVID-19, multiple sclerosis, inflammatory ocular conditions, and skin allergic reactions.

How effective is dexamethasone in treating COVID-19?

Dexamethasone has been shown to reduce the risk of death by up to one-third in ventilated COVID-19 patients and by one-fifth in patients receiving oxygen only, according to the RECOVERY trial[1].

What are the key drivers of the dexamethasone acetate market?

The market is driven by the growing prevalence of inflammatory conditions, the increasing use in cancer patients, and the drug's availability and affordability[2].

What are the potential side effects of dexamethasone acetate?

Dexamethasone acetate can have significant side effects, requiring careful dosage adjustments and monitoring. These include changes in clinical status, patient responsiveness, and the need for increased dosage during stressful situations[4].

Who are the key players in the dexamethasone acetate market?

Key players include Purdue Pharma, LGM Pharma, and Alfa Aesar, among others[2].

Sources

1. Recovery Trial: "Low-cost dexamethasone reduces death by up to one third in hospitalised patients with severe respiratory complications of COVID-19" - Recovery Trial.
2. OpenPR: "Dexamethasone Acetate Market to see Huge Growth by 2025 | Purdue Pharma, LGM Pharma, Alfa Aesar" - OpenPR.
3. BioSpace: "U.S. Clinical Trials Market Size Industry Analysis Report, 2033" - BioSpace.
4. FDA: "HEXADROL®" - FDA.
5. Regulations.gov: "February 7, 2018 - Regulations.gov" - Regulations.gov.