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Last Updated: March 30, 2025

CLINICAL TRIALS PROFILE FOR DEXAMETHASONE


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505(b)(2) Clinical Trials for DEXAMETHASONE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial TypeTrial IDTitleStatusSponsorPhaseStart DateSummary
New Combination NCT00116961 ↗ Velcade, Doxil, and Dexamethasone (VDd) as First Line Therapy for Multiple Myeloma Completed University of Michigan Cancer Center Phase 2 2005-06-01 This is a research study for patients with newly diagnosed multiple myeloma. Multiple myeloma remains a non-curable disease however, newer medications and their combinations appear to provide higher response rates and higher complete response rates than current treatment options. One of the new medications in multiple myeloma is Velcade. Preliminary results from a study using a combination of Velcade with Doxil have shown high response rates (disease reduction). Preliminary results also show that an addition of dexamethasone to Velcade in patients not responding to Velcade alone showed improved response rates. This study involves treatment with a new combination of three standard medications: Velcade, Doxil, and dexamethasone (VDd combination). The proposed combination of all three drugs may improve efficacy and response. Velcade is approved by the Food and Drug Administration (FDA) for treatment in multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. Velcade is still currently under investigation for other indications. Doxil is not approved for use in multiple myeloma but is an approved drug for use in patients with some other cancers. Several published clinical trials provide evidence that Doxil is an active agent in multiple myeloma and it is used in treatment combinations for multiple myeloma in general practice. Dexamethasone is a standard therapy for multiple myeloma, but is not approved by the FDA for that use. The combination of all three drugs is experimental (not FDA approved). The goals of this study are to determine if this new combination therapy with Velcade, Doxil and dexamethasone is an effective treatment and also to determine the side effects that occur when this combination treatment is given.
New Combination NCT00116961 ↗ Velcade, Doxil, and Dexamethasone (VDd) as First Line Therapy for Multiple Myeloma Completed University of Michigan Rogel Cancer Center Phase 2 2005-06-01 This is a research study for patients with newly diagnosed multiple myeloma. Multiple myeloma remains a non-curable disease however, newer medications and their combinations appear to provide higher response rates and higher complete response rates than current treatment options. One of the new medications in multiple myeloma is Velcade. Preliminary results from a study using a combination of Velcade with Doxil have shown high response rates (disease reduction). Preliminary results also show that an addition of dexamethasone to Velcade in patients not responding to Velcade alone showed improved response rates. This study involves treatment with a new combination of three standard medications: Velcade, Doxil, and dexamethasone (VDd combination). The proposed combination of all three drugs may improve efficacy and response. Velcade is approved by the Food and Drug Administration (FDA) for treatment in multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. Velcade is still currently under investigation for other indications. Doxil is not approved for use in multiple myeloma but is an approved drug for use in patients with some other cancers. Several published clinical trials provide evidence that Doxil is an active agent in multiple myeloma and it is used in treatment combinations for multiple myeloma in general practice. Dexamethasone is a standard therapy for multiple myeloma, but is not approved by the FDA for that use. The combination of all three drugs is experimental (not FDA approved). The goals of this study are to determine if this new combination therapy with Velcade, Doxil and dexamethasone is an effective treatment and also to determine the side effects that occur when this combination treatment is given.
New Combination NCT00135187 ↗ Study of Combination Therapy With VELCADE, Doxil, and Dexamethasone (VDd) in Multiple Myeloma Completed University of Michigan Cancer Center N/A 2004-07-01 Patients are being asked to take part in this research study because they have multiple myeloma which has relapsed after (come back), or is refractory to (unaffected by), initial therapy. For patients who have relapsed or are refractory to therapy, there is no agreed upon standard treatment. Treatment options include chemotherapy and, for some patients, bone marrow transplants. None of the available treatments are curative and investigators are continually looking for more effective treatments. This study involves treatment with a new combination of standard drugs: VELCADE, Doxil, and Dexamethasone. Preliminary results from a study using a combination of VELCADE with Doxil showed high response rates (disease reduction). Two other studies showed that an addition of Dexamethasone to VELCADE in patients not responding to VELCADE alone improved response rate. The proposed combination of all three drugs may improve efficacy and response. VELCADE is approved by the Food and Drug Administration (FDA) for use in multiple myeloma. Doxil is not approved for use in multiple myeloma but is an approved drug for use in patients with some other cancers. Several published clinical trials provide evidence that Doxil is an active agent in multiple myeloma and it is used in treatment combinations for multiple myeloma in general practice. Dexamethasone is approved for use in multiple myeloma. The combination of all three drugs is experimental (not FDA approved). The goals of this study are to determine if this new combination therapy with VELCADE, Doxil and Dexamethasone is an effective treatment, and also to determine the side effects that occur when this combination treatment is given.
>Trial Type>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 3 of 3 entries

All Clinical Trials for DEXAMETHASONE

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00000621 ↗ Feasibility of Retinoic Acid Treatment in Emphysema (FORTE) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 2 1999-09-01 To conduct feasibility studies on the use of retinoids in the treatment of emphysema. Specific objectives are to identify optimal patient populations, retinoids, doses, dosing schedules, routes of administration, and outcome measures preparatory to conducting a larger, controlled, clinical trial on the efficacy of retinoid therapy in the management of emphysema.
NCT00000563 ↗ Prevention of Neonatal Respiratory Distress Syndrome With Antenatal Steroid Administration Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1976-06-01 To determine the effect of corticosteroids, administered 24 to 48 hours before parturition, on the incidence of neonatal respiratory distress syndrome (RDS) and to determine whether the therapy has any adverse short- or long-term (up to 36 months) effects on the infant. Secondarily, to determine whether the therapy has any adverse short-term effects on the mother and to determine whether morbidity rates for neonatal respiratory distress syndrome as well as total and cause-specific infant mortality rates differ between mothers who received antenatal steroids and those who received conventional medical care.
NCT00000658 ↗ A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkin's Lymphoma Completed Schering-Plough Phase 3 1969-12-31 To determine the impact of dose intensity on tumor response and survival in patients with HIV-associated non-Hodgkin's lymphoma (NHL). HIV-infected patients are at increased risk for developing intermediate and high-grade NHL. While combination chemotherapy for aggressive B-cell NHL in the absence of immunodeficiency is highly effective, the outcome of therapy for patients with AIDS-associated NHL has been disappointing. Treatment is frequently complicated by the occurrence of multiple opportunistic infections, as well as the presence of poor bone marrow reserve, making the administration of standard doses of chemotherapy difficult. A recent study was completed using a low-dose modification of the standard mBACOD (cyclophosphamide, doxorubicin, vincristine, bleomycin, dexamethasone, methotrexate ) treatment. A 46 percent response rate was observed in patients treated with this combination of chemotherapeutic agents, with a number of durable remissions and reduced toxicity when compared to previous experience with more standard treatments. A subsequent study showed similar effectiveness using a lower dose of methotrexate administered on day 15. It is hoped that the use of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) will improve bone marrow function and allow for administration of a higher dose of chemotherapy.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 3 of 3 entries

Clinical Trial Conditions for DEXAMETHASONE

Condition Name

636938900100200300400500600Multiple MyelomaLeukemiaLymphoma[disabled in preview]
Condition Name for DEXAMETHASONE
Intervention Trials
Multiple Myeloma 636
Leukemia 93
Lymphoma 89
[disabled in preview] 0
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Condition MeSH

919883290001002003004005006007008009001000Multiple MyelomaNeoplasms, Plasma CellLymphoma[disabled in preview]
Condition MeSH for DEXAMETHASONE
Intervention Trials
Multiple Myeloma 919
Neoplasms, Plasma Cell 883
Lymphoma 290
[disabled in preview] 0
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Clinical Trial Locations for DEXAMETHASONE

Trials by Country

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Trials by Country for DEXAMETHASONE
Location Trials
Canada 806
Russian Federation 96
India 89
Sweden 88
Switzerland 87
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Trials by US State

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Trials by US State for DEXAMETHASONE
Location Trials
New York 458
Texas 452
California 429
Massachusetts 327
Florida 314
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Clinical Trial Progress for DEXAMETHASONE

Clinical Trial Phase

44.2%49.3%6.5%00100200300400500600700Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for DEXAMETHASONE
Clinical Trial Phase Trials
Phase 4 572
Phase 3 639
Phase 2/Phase 3 84
[disabled in preview] 0
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Clinical Trial Status

58.5%27.6%13.9%00200400600800100012001400CompletedRecruitingNot yet recruiting[disabled in preview]
Clinical Trial Status for DEXAMETHASONE
Clinical Trial Phase Trials
Completed 1411
Recruiting 667
Not yet recruiting 336
[disabled in preview] 0
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Clinical Trial Sponsors for DEXAMETHASONE

Sponsor Name

trials050100150200250300350National Cancer Institute (NCI)M.D. Anderson Cancer CenterCelgene Corporation[disabled in preview]
Sponsor Name for DEXAMETHASONE
Sponsor Trials
National Cancer Institute (NCI) 324
M.D. Anderson Cancer Center 133
Celgene Corporation 121
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Sponsor Type

67.7%26.0%6.3%0050010001500200025003000350040004500OtherIndustryNIH[disabled in preview]
Sponsor Type for DEXAMETHASONE
Sponsor Trials
Other 4185
Industry 1606
NIH 390
[disabled in preview] 0
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Dexamethasone: Clinical Trials, Market Analysis, and Projections

Introduction to Dexamethasone

Dexamethasone is a potent synthetic adrenal corticosteroid widely used for its anti-inflammatory and immunosuppressant properties. It is employed in the treatment of various inflammatory conditions, including allergic disorders, skin diseases, adrenal problems, arthritis, severe allergies, asthma, blood or bone marrow problems, and multiple sclerosis flare-ups.

Clinical Trials Involving Dexamethasone

Multiple Myeloma Trials

Dexamethasone is a key component in several clinical trials focused on multiple myeloma, a type of blood cancer.

  • AMN001 Trial: This trial, conducted by the Asian Myeloma Network, investigated the efficacy and toxicity of pomalidomide and dexamethasone in patients with relapsed multiple myeloma. The trial recruited 146 patients across several Asian countries and demonstrated the feasibility of large-scale clinical trials in this region[1].

  • AMN002 Trial: This ongoing trial combines carfilzomib with thalidomide and dexamethasone in patients with relapsed and/or refractory multiple myeloma. Supported by Amgen, this trial has commenced in Singapore[1].

  • Lenalidomide, Bortezomib, and Dexamethasone Trial: Conducted at UCSF, this trial evaluates the combination of lenalidomide, bortezomib, and dexamethasone, with or without autologous stem cell transplantation, for newly diagnosed multiple myeloma patients. The objective is to determine if high-dose therapy is still necessary in the initial management of multiple myeloma[4].

COVID-19 and Other Applications

Dexamethasone gained significant attention during the COVID-19 pandemic due to its efficacy in treating critically ill patients.

  • COVID-19 Treatment: The rapid increase in the use of dexamethasone as a lifesaving treatment for COVID-19 patients has been a significant factor in the growth of the dexamethasone market. Its emergency use authorization for COVID-19 has further boosted its demand[3].

Market Analysis of Dexamethasone

Global Market Size and Growth

The global dexamethasone market is projected to experience substantial growth over the coming years.

  • Forecasted Growth: The market is expected to grow at a compound annual growth rate (CAGR) of 6.65% from 2021 to 2028, reaching a market size of USD 4,634.01 million by 2028[3].

  • Regional Analysis: The market is segmented into major regions including North America, Europe, Asia-Pacific, Middle East & Africa, and Latin America. Each region's revenue share and current trends are analyzed to provide a comprehensive understanding of the market[2][3].

Market Segments

The dexamethasone market is segmented based on several key factors:

  • Formulation Type: The market includes various formulations such as liquid, tablets, solution for injection, and others. Understanding these segments helps in identifying the most lucrative types in the near future[3].

  • Patient Type: The market is segmented into adult, pediatric, and geriatric patient types, each with different needs and growth prospects[3].

  • Application: Dexamethasone is used for anti-inflammatory and immunosuppressant effects, respiratory distress syndrome, COVID-19, and other conditions. The demand for dexamethasone varies across these applications[3].

  • End Users: The market includes hospitals, clinics, pharmacy & drug stores, and online pharmacies as key end users. Each segment has its own growth dynamics and market opportunities[3].

Drivers and Restraints

Drivers

  • Increasing Prevalence of Inflammatory Conditions: The rising incidence of various inflammatory diseases and viral outbreaks is driving the demand for dexamethasone[3].
  • COVID-19 Pandemic: The emergency use authorization and effectiveness of dexamethasone in treating critically ill COVID-19 patients have significantly boosted its market growth[3].
  • Research and Development: Robust investment in R&D is contributing to the growth of the dexamethasone market[3].

Restraints

  • Side Effects: The various side effects associated with the use of dexamethasone are expected to impede market growth. These side effects can deter some patients and healthcare providers from using the drug[3].
  • Preventive Measures: The development of vaccines and other preventive measures could challenge the growth of the dexamethasone market in the long term[3].

Projections and Future Outlook

Market Trends

  • Geographical Trends: The Asia-Pacific region is expected to show significant growth due to increasing awareness and the high incidence of inflammatory conditions. This region offers substantial market opportunities for dexamethasone[2][3].

  • Technological Advancements: Advances in pharmaceutical technology and the development of new formulations are likely to enhance the market growth of dexamethasone[5].

Market Opportunities

  • Emerging Markets: Countries in the Middle East, Africa, and Latin America present untapped opportunities for the dexamethasone market due to their growing healthcare needs and increasing access to pharmaceuticals[2][3].

  • New Applications: The potential for dexamethasone to be used in new therapeutic areas, such as additional inflammatory conditions and autoimmune diseases, offers significant growth opportunities[3].

Key Takeaways

  • Clinical Trials: Dexamethasone is a crucial component in several clinical trials for multiple myeloma and other conditions, highlighting its ongoing importance in medical research.
  • Market Growth: The global dexamethasone market is projected to grow significantly, driven by increasing demand for anti-inflammatory and immunosuppressant treatments.
  • Regional Dynamics: The market is segmented by region, with the Asia-Pacific region showing promising growth prospects.
  • Drivers and Restraints: The market is influenced by factors such as the COVID-19 pandemic, R&D investments, and the potential side effects of the drug.

FAQs

What are the primary applications of dexamethasone?

Dexamethasone is primarily used for its anti-inflammatory and immunosuppressant effects, treating conditions such as allergic disorders, skin diseases, adrenal problems, arthritis, and multiple sclerosis flare-ups.

How has the COVID-19 pandemic impacted the dexamethasone market?

The COVID-19 pandemic has significantly boosted the demand for dexamethasone due to its efficacy in treating critically ill patients, leading to emergency use authorization and increased market growth.

What are the key segments of the dexamethasone market?

The market is segmented by formulation type (liquid, tablets, solution for injection), patient type (adult, pediatric, geriatric), application (anti-inflammatory, immunosuppressant, COVID-19), and end users (hospitals, clinics, pharmacies).

What are the major drivers of the dexamethasone market growth?

The major drivers include the increasing prevalence of inflammatory conditions, robust R&D investments, and the emergency use authorization for COVID-19 treatment.

What are the potential restraints on the dexamethasone market?

The potential restraints include the side effects associated with dexamethasone use and the development of preventive measures such as vaccines.

Sources

  1. Myeloma Clinical Trials in Asia - Myeloma.org
  2. Dexamethasone Market Report 2024 (Global Edition) - Cognitivemarketresearch.com
  3. Global Dexamethasone Market – Industry Trends and Forecast to 2028 - Databridgemarketresearch.com
  4. Lenalidomide, Bortezomib, Dexamethasone vs High-Dose Melphalan and Autologous Stem Cell Transplantation for Newly Diagnosed Multiple Myeloma - Clinicaltrials.ucsf.edu
  5. Global Dexamethasone API Market Insights, Forecast to 2030 - Marketresearchreports.com

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