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Last Updated: April 2, 2025

CLINICAL TRIALS PROFILE FOR DEXAMETHASONE SODIUM PHOSPHATE


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All Clinical Trials for DEXAMETHASONE SODIUM PHOSPHATE

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00266838 ↗ Prevention of Docetaxel Induced Dacryostenosis Completed Universitaire Ziekenhuizen Leuven Phase 1 2006-07-01 The antineoplastic agent Docetaxel (Taxotere®) is approved for the treatment of patients with metastatic and locally advanced breast cancer and other malignancies. There are 2 frequently used schedules of treatment with Docetaxel. Docetaxel can be administered every 3 weeks or in a weekly regimen. The efficacy seems to be similar but the toxicity profile changes. In the standard 3-weekly Docetaxel regimen the dose-limiting side effect is myelosuppression, while in the weekly regimen there is only a mild myelosuppression. On the other hand, weekly Docetaxel has a side effect that is rare in the 3-weekly schedule: epiphora (= tearing eye) caused by dacryostenosis. The underlying mechanism of dacryostenosis induced by weekly Docetaxel is fibrosis of the lacrimal puncta and canaliculi. Docetaxel has been reported to be secreted in the lacrimal tears. Direct contact between Docetaxel containing tears and the epithelial lining causes chronic inflammation of the mucosa and ultimately fibrosis of the most narrow part of the lacrimal outflow system i.e. the lacrimal puncta and canaliculi. A surgical treatment is possible for dacryostenosis. In case of subtotal stenosis of the lacrimal canaliculi, silicone intubation of the canaliculi is performed in order to prevent further closure. In the case of complete stenosis, placement of a permanent pyrex glass tube of Jones is required. To our knowledge, there is no primary prevention for Docetaxel induced dacryostenosis. The rationale of this randomized double blind interventional study is to investigate the efficacy of corticosteroid versus artificial tears topical eye treatment in patients on a weekly Docetaxel regimen in prevention of dacryostenosis. The dacryotoxic agent Docetaxel in the lacrimal tears will be washed away by the repetitive use of eye drops. In addition, eye drops containing corticosteroids have an anti-inflammatory effect and may further prevent the formation of fibrosis. A new treatment protocol will be investigated. Two different commercially available eye drops will be compared: dexamethasone sodium phosphate (Maxidex®, Alcon) in one eye of the patient and artificial tears (Lacrystat®, Viatris) in the other eye of the same patient. The study period will start with topical eye treatment from day 1 of cycle 1 and will continue during the administration of chemotherapy, with a final analysis at 26 weeks.
NCT00122278 ↗ Headache in the Emergency Department (ED) - A Multi-Center Research Network to Optimize the ED Treatment of Migraines Completed Montefiore Medical Center Phase 3 2005-07-01 Migraines are a specific type of headache that frequently recur and are very painful. Although there are many medications that are effective against migraines, none of these medications cure 100% of migraines. Another problem with migraines is that although many times they get better after intravenous (IV) treatment in the emergency room (ER), about 1/3 of the time migraines recur the next day. The purpose of this research project is to see if adding a medication called dexamethasone to standard ER therapy will help patients get better quicker and stay pain-free more often than if they receive placebo.
NCT00258245 ↗ Arsenic Trioxide and Ascorbic Acid Combined With Bortezomib, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma or Plasma Cell Leukemia Completed National Cancer Institute (NCI) Phase 1 2005-05-01 RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Ascorbic acid may help arsenic trioxide work better by making cancer cells more sensitive to the drug. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Thalidomide may stop the growth of cancer cells by stopping blood flow to the cancer. Giving arsenic trioxide and ascorbic acid together with bortezomib, thalidomide, and dexamethasone may stop the growth of and kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of arsenic trioxide when given together with ascorbic acid, bortezomib, thalidomide, and dexamethasone in treating patients with relapsed or refractory multiple myeloma or plasma cell leukemia.
NCT00258245 ↗ Arsenic Trioxide and Ascorbic Acid Combined With Bortezomib, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma or Plasma Cell Leukemia Completed Barbara Ann Karmanos Cancer Institute Phase 1 2005-05-01 RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Ascorbic acid may help arsenic trioxide work better by making cancer cells more sensitive to the drug. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Thalidomide may stop the growth of cancer cells by stopping blood flow to the cancer. Giving arsenic trioxide and ascorbic acid together with bortezomib, thalidomide, and dexamethasone may stop the growth of and kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of arsenic trioxide when given together with ascorbic acid, bortezomib, thalidomide, and dexamethasone in treating patients with relapsed or refractory multiple myeloma or plasma cell leukemia.
NCT00293384 ↗ Aprepitant, Granisetron, & Dexamethasone in Preventing Nausea & Vomiting in Pts. Receiving Cyclophosphamide Before a Stem Cell Transplant Completed National Cancer Institute (NCI) N/A 2004-10-01 RATIONALE: Antiemetic drugs, such as aprepitant, granisetron, and dexamethasone, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy. PURPOSE: This clinical trial is studying how well giving aprepitant together with granisetron and dexamethasone works in preventing nausea and vomiting in patients receiving cyclophosphamide before undergoing an autologous stem cell transplant.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 5 of 5 entries

Clinical Trial Conditions for DEXAMETHASONE SODIUM PHOSPHATE

Condition Name

4322000.511.522.533.54Postoperative PainMultiple MyelomaLymphomaKnee Arthroplasty[disabled in preview]
Condition Name for DEXAMETHASONE SODIUM PHOSPHATE
Intervention Trials
Postoperative Pain 4
Multiple Myeloma 3
Lymphoma 2
Knee Arthroplasty 2
[disabled in preview] 0
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Condition MeSH

7665001234567Multiple MyelomaNeoplasms, Plasma CellLeukemiaPain, Postoperative[disabled in preview]
Condition MeSH for DEXAMETHASONE SODIUM PHOSPHATE
Intervention Trials
Multiple Myeloma 7
Neoplasms, Plasma Cell 6
Leukemia 6
Pain, Postoperative 5
[disabled in preview] 0
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Clinical Trial Locations for DEXAMETHASONE SODIUM PHOSPHATE

Trials by Country

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Trials by Country for DEXAMETHASONE SODIUM PHOSPHATE
Location Trials
United States 182
Canada 8
Australia 7
India 7
China 4
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Trials by US State

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Trials by US State for DEXAMETHASONE SODIUM PHOSPHATE
Location Trials
New York 11
Pennsylvania 10
California 10
Texas 9
Massachusetts 8
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Clinical Trial Progress for DEXAMETHASONE SODIUM PHOSPHATE

Clinical Trial Phase

28.9%20.0%48.9%0024681012141618202224Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for DEXAMETHASONE SODIUM PHOSPHATE
Clinical Trial Phase Trials
Phase 4 13
Phase 3 9
Phase 2/Phase 3 1
[disabled in preview] 22
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Clinical Trial Status

45.0%21.7%11.7%21.7%06810121416182022242628CompletedRecruitingNot yet recruiting[disabled in preview]
Clinical Trial Status for DEXAMETHASONE SODIUM PHOSPHATE
Clinical Trial Phase Trials
Completed 27
Recruiting 13
Not yet recruiting 7
[disabled in preview] 13
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Clinical Trial Sponsors for DEXAMETHASONE SODIUM PHOSPHATE

Sponsor Name

trials01234567National Cancer Institute (NCI)ErydelMercator MedSystems, Inc.[disabled in preview]
Sponsor Name for DEXAMETHASONE SODIUM PHOSPHATE
Sponsor Trials
National Cancer Institute (NCI) 7
Erydel 4
Mercator MedSystems, Inc. 3
[disabled in preview] 6
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Sponsor Type

66.3%25.3%8.4%00102030405060OtherIndustryNIH[disabled in preview]
Sponsor Type for DEXAMETHASONE SODIUM PHOSPHATE
Sponsor Trials
Other 63
Industry 24
NIH 8
[disabled in preview] 0
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Dexamethasone Sodium Phosphate: Clinical Trials, Market Analysis, and Projections

Introduction to Dexamethasone Sodium Phosphate

Dexamethasone sodium phosphate is a corticosteroid with widespread therapeutic applications, including the treatment of inflammatory diseases, allergic reactions, and autoimmune disorders. Its anti-inflammatory and immunosuppressant properties make it a versatile drug in modern medicine.

Clinical Trials Update

EryDex for Ataxia

One of the notable clinical trials involving dexamethasone sodium phosphate is the Phase 3 trial for EryDex, a treatment for Ataxia-Telangiectasia (A-T). EryDex, developed by Quince Therapeutics, involves the ex-vivo encapsulation of dexamethasone sodium phosphate into patients' red blood cells, allowing for a controlled, slow release of the drug over several weeks. The FDA has lifted its clinical hold on the investigational new drug application (IND) for EryDex, paving the way for the NEAT study, a double-blinded, placebo-controlled trial expected to enroll 86 patients aged 6 to 9 years, with an additional 20 patients aged 10 years or older[1].

Dexamethasone Sodium Phosphate SR for Osteoarthritis

Taiwan Liposome is conducting a Phase III clinical trial for Dexamethasone sodium phosphate SR, a sustained-release formulation aimed at treating osteoarthritis pain. This trial is significant as it assesses the drug's phase transition success rate and likelihood of approval, with GlobalData indicating a 37% phase transition success rate for Phase III drugs in this indication[4].

Market Analysis

Market Size and Growth

The global dexamethasone market is projected to experience robust growth over the next decade. According to Fact.MR, the market is expected to surpass $46.9 billion by 2031, driven by the increasing prevalence of diseases such as allergic disorders, skin conditions, cancer, and breathing disorders[3].

Market Segmentation

The dexamethasone sodium phosphate injection market is segmented by end-user, application, and geography.

End-User Segmentation

The market is primarily divided into hospitals and clinics. Hospitals represent a significant segment due to their advanced facilities for administering injectable medications, catering to patients in emergency care, surgical recovery, and intensive care units[5].

Application Segmentation

The primary application segments include inflammatory diseases, allergic reactions, and autoimmune disorders. Inflammatory diseases, such as rheumatoid arthritis and lupus, drive a significant portion of the market due to the widespread use of dexamethasone as an anti-inflammatory agent[5].

Geographical Segmentation

The market is classified by geography, with North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa being key regions. North America and Europe are characterized by advanced healthcare infrastructure and a high prevalence of chronic diseases, while the Asia-Pacific region is witnessing a surge in demand driven by rising health expenditures and increasing incidences of respiratory diseases[5].

Market Projections

Revenue Forecast

The dexamethasone sodium phosphate injection market size was valued at USD 121.21 million in 2023 and is projected to reach USD 200.21 million by 2031, growing at a CAGR of 5.8% during the forecast period 2024-2031[5].

Key Drivers

  • Increasing Prevalence of Diseases: The growing incidence of chronic diseases such as chronic obstructive lung diseases and arthritis is driving the demand for dexamethasone.
  • COVID-19 Pandemic: The pandemic significantly bolstered the sales of dexamethasone products, with the drug being prescribed for treating severe and critical COVID-19 cases[3].
  • Government Support: Government involvement in tackling rising cases of diseases like COVID-19 and cancer has positively impacted the demand for dexamethasone.
  • Expansion of Pharmaceutical Sector: The growth of the pharmaceutical sector offers lucrative opportunities for dexamethasone manufacturers[3].

Key Restraints

  • Development of Vaccines: The development of vaccines, particularly for COVID-19, may decrease the demand for dexamethasone products.
  • Side Effects: The side effects associated with dexamethasone are a significant restraint on the market's growth[3].

Regional Market Dynamics

North America and Europe

These regions are characterized by advanced healthcare infrastructure and a high prevalence of chronic diseases, driving the demand for effective anti-inflammatory treatments. The presence of key players and extensive research activities contribute to innovations in therapeutic applications[5].

Asia Pacific

The region is witnessing a surge in demand driven by rising health expenditures and increasing incidences of respiratory diseases in countries such as China and India[5].

Latin America and Middle East & Africa

These regions are gradually emerging due to increasing healthcare investments and urbanization, leading to a rise in the prevalence of conditions necessitating dexamethasone treatment[5].

Key Takeaways

  • Robust Market Growth: The dexamethasone market is expected to witness strong growth, driven by increasing disease prevalence and government support.
  • Clinical Trials: Ongoing clinical trials, such as those for EryDex and Dexamethasone sodium phosphate SR, are pivotal for expanding therapeutic applications.
  • Geographical Variations: Regional dynamics, including healthcare infrastructure and disease prevalence, significantly influence market demand.
  • Market Segmentation: The market is segmented by end-user, application, and geography, each with distinct drivers and restraints.

FAQs

What is the current status of the EryDex clinical trial?

The FDA has lifted its clinical hold on the IND for EryDex, allowing Quince Therapeutics to proceed with the Phase 3 NEAT study, which is expected to begin patient enrollment in the second quarter of 2024[1].

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

The COVID-19 pandemic significantly increased the demand for dexamethasone, with the drug being prescribed for treating severe and critical COVID-19 cases. This led to a surge in sales, particularly in the injectable segment[3].

What are the primary applications of dexamethasone sodium phosphate?

The primary applications include inflammatory diseases, allergic reactions, and autoimmune disorders. Inflammatory diseases represent a significant portion of the market due to the widespread use of dexamethasone as an anti-inflammatory agent[5].

Which regions are expected to drive the growth of the dexamethasone market?

North America and Europe are expected to drive growth due to their advanced healthcare infrastructure and high prevalence of chronic diseases. The Asia-Pacific region is also witnessing a surge in demand driven by rising health expenditures and increasing incidences of respiratory diseases[5].

What are the key restraints on the dexamethasone market?

The development of vaccines, particularly for COVID-19, and the side effects associated with dexamethasone are significant restraints on the market's growth[3].

Sources

  1. FDA Lifts Hold on IND for Phase 3 Trial of Ataxia Agent EryDex - Neurology Live
  2. Global Dexamethasone Sodium Phosphate Preparation Market Size - Market Research Intellect
  3. Dexamethasone Injectables to Remain Top Choice for Addressing Rising Cases of Inflammatory Conditions - BioSpace
  4. Dexamethasone sodium phosphate SR by Taiwan Liposome for Osteoarthritis Pain - Pharmaceutical Technology
  5. Dexamethasone Sodium Phosphate Injection Market Size - Verified Market Research

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