CLINICAL TRIALS PROFILE FOR DEXAMETHASONE SODIUM PHOSPHATE

All Clinical Trials for DEXAMETHASONE SODIUM PHOSPHATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
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.
NCT00293384 ↗	Aprepitant, Granisetron, & Dexamethasone in Preventing Nausea & Vomiting in Pts. Receiving Cyclophosphamide Before a Stem Cell Transplant	Completed	Barbara Ann Karmanos Cancer Institute	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.
NCT00335140 ↗	Rituximab and Combination Chemotherapy in Treating Patients With Primary Central Nervous System Lymphoma	Terminated	National Cancer Institute (NCI)	Phase 2	2006-12-01	RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as methotrexate, leucovorin, vincristine, procarbazine, dexamethasone, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with primary central nervous system (CNS) lymphoma.

Clinical Trial Conditions for DEXAMETHASONE SODIUM PHOSPHATE

Condition Name

Condition Name for DEXAMETHASONE SODIUM PHOSPHATE
Intervention	Trials
Postoperative Pain	4
Multiple Myeloma	3
Acute Lymphoblastic Leukemia	2
Non-Infectious Anterior Uveitis	2

Condition MeSH

Condition MeSH for DEXAMETHASONE SODIUM PHOSPHATE
Intervention	Trials
Multiple Myeloma	7
Pain, Postoperative	6
Neoplasms, Plasma Cell	6
Leukemia	6

Clinical Trial Locations for DEXAMETHASONE SODIUM PHOSPHATE

Trials by Country

Trials by Country for DEXAMETHASONE SODIUM PHOSPHATE
Location	Trials
United States	187
Canada	8
India	7
Australia	7
China	6

Trials by US State

Trials by US State for DEXAMETHASONE SODIUM PHOSPHATE
Location	Trials
California	11
New York	11
Texas	10
Pennsylvania	10
Ohio	9

Clinical Trial Progress for DEXAMETHASONE SODIUM PHOSPHATE

Clinical Trial Phase

Clinical Trial Phase for DEXAMETHASONE SODIUM PHOSPHATE
Clinical Trial Phase	Trials
PHASE3	2
PHASE1	1
Phase 4	13

Clinical Trial Status

Clinical Trial Status for DEXAMETHASONE SODIUM PHOSPHATE
Clinical Trial Phase	Trials
Completed	27
Recruiting	16
Terminated	7

Clinical Trial Sponsors for DEXAMETHASONE SODIUM PHOSPHATE

Sponsor Name

Sponsor Name for DEXAMETHASONE SODIUM PHOSPHATE
Sponsor	Trials
National Cancer Institute (NCI)	7
Erydel	4
Yangzhou University	3

Sponsor Type

Sponsor Type for DEXAMETHASONE SODIUM PHOSPHATE
Sponsor	Trials
Other	67
Industry	26
NIH	8

Dexamethasone Sodium Phosphate: Clinical Trials, Market Analysis, and Future Projections

Last updated: October 28, 2025

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Introduction

Dexamethasone Sodium Phosphate (DSP), a synthetic glucocorticoid, has long-standing applications in anti-inflammatory, immunosuppressive, and endocrine therapy contexts. Its rapid absorption and potent efficacy make it a key ingredient in various therapeutic areas, notably in treating severe COVID-19 cases, allergic reactions, and certain cancers. This report offers a comprehensive review of ongoing clinical trials, market dynamics, and future growth projections for DSP, facilitating strategic decision-making for industry stakeholders.

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Clinical Trials Landscape

Current Clinical Trial Status

Recent analyses reveal several active and recruiting clinical trials assessing DSP's therapeutic efficacy across numerous indications. Notably, the focus on COVID-19 treatment has waned post-pandemic, but trials investigating its use in oncology, autoimmune diseases, and inflammatory conditions remain robust.

• COVID-19 Management: Multiple studies[1] have confirmed Dexa's role in decreasing mortality rates among severely ill patients. The RECOVERY trial notably established dexamethasone’s survival benefit, paving the way for its inclusion in standard COVID-19 treatment protocols globally.

• Oncology Applications: Trials exploring DSP in managing chemotherapy-induced nausea and immune modulation in hematological malignancies are ongoing[2]. The drug’s ability to suppress cytokine storms and inflammatory responses underpins these investigations.

• Autoimmune and Inflammatory Diseases: Numerous Phase II and III trials evaluate DSP’s efficacy in conditions such as multiple sclerosis, rheumatoid arthritis, and vasculitis, with promising preliminary outcomes[3].

Regulatory and Approval Status

DSP formulations are broadly approved across major regulatory territories. The U.S. Food and Drug Administration (FDA) classifies dexamethasone as an essential medicine, with several injectable and oral formulations approved. Emerging trials are focusing on novel delivery systems, such as nanoparticle-based formulations, to improve bioavailability and reduce systemic side effects.

Innovative Developments in Formulation and Delivery

Research presented at recent pharmaceutical conferences highlights advancements like liposomal DSP, aiming to achieve targeted delivery with minimized systemic exposure. Such nanocarrier systems are Currently in early-phase clinical evaluation, promising enhanced therapeutic index[4].

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Market Analysis

Market Overview and Key Drivers

The DSP market reflects broader trends in corticosteroid demand driven by expanding indications, aging populations, and the ongoing burden of inflammatory diseases. The global corticosteroids market was valued at approximately USD 2.5 billion in 2022 and is expected to grow at a CAGR around 4.5% through 2030[5].

Key drivers include:

• COVID-19 Pandemic: Unprecedented utilization of dexamethasone, especially in hospitalized treatments, generated short-term market growth.

• Rising Incidence of Chronic Diseases: Increasing prevalence of autoimmune disorders, rheumatoid arthritis, and inflammatory respiratory diseases fuels demand.

• Product Innovation: Development of sustained-release formulations and combination therapies enhances clinical benefits and broadens application scope.

Regional Market Dynamics

• North America: Dominates the DSP market owing to high healthcare expenditure, rapid adoption of novel therapies, and extensive clinical research infrastructure[6].

• Europe: Rapid growth attributable to aging demographics and favorable regulatory support for biosimilar corticosteroids.

• Asia-Pacific: Fastest growth anticipated, driven by improving healthcare access, rising chronic disease burden, and ongoing clinical trial activities in emerging economies.

Competitive Landscape

Major players include Pfizer (Deltasone), Teva Pharmaceuticals, Mylan, and Lupin, with numerous generics available, which have significantly reduced costs and increased access. Innovative formulations by biotech firms are increasingly capturing market share among niche patient populations.

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Market Projections

Growth Outlook (2023-2030)

• Market Expansion: The corticosteroid segment, with DSP as a core compound, projected to reach USD 4.1 billion by 2030[5].

• Segmental Contributions:

  • Infectious Diseases: Expected to remain significant due to ongoing applications in viral and bacterial infections.

  • Oncology and Autoimmune Diseases: Anticipated to see a compounded annual growth rate (CAGR) of approximately 5% given increased clinical trial success and regulatory approvals.

• Emerging Opportunities:

  • Personalized Medicine: Tailored corticosteroid therapy guided by pharmacogenomics to optimize efficacy and minimize side effects.

  • Nanotechnology and Drug Delivery: Innovations in targeted delivery could redefine DSP's clinical utility, prompting new formulations entering pipelines.

Market Challenges

• Side Effect Profile: Long-term corticosteroid use's adverse effects, including osteoporosis and adrenal suppression, may limit application scope.

• Regulatory Hurdles: Stringent approval pathways for new formulations or combination therapies can delay market entry.

• Generic Competition: Price erosion driven by generics affects profitability for manufacturers.

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Strategic Implications

Stakeholders should emphasize R&D into novel DSP formulations, especially targeted and sustained-release systems, to bolster therapeutic outcomes and competitive positioning. Collaborations with biotech firms for advanced delivery technologies and expanding into emerging markets represent promising avenues for growth.

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Key Takeaways

• Robust Clinical Pipeline: DSP enjoys active clinical trial activity across diverse indications, notably in oncology and autoimmune diseases, indicating steady future potential.

• Market Expansion: The global corticosteroids market, with DSP at its core, is poised for moderate but sustained growth driven by increasing disease prevalence and innovation.

• Innovation as a Growth Driver: Formulation advancements, including nanotechnologies and personalized therapies, are critical for extending DSP’s clinical utility and market share.

• Regulatory Evolution: Ongoing approvals and clearances for new DSP formulations will underpin market expansion, particularly in underserved regions.

• Competitive Dynamics: Price competition from generics necessitates differentiation via formulation innovation and targeted therapies.

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FAQs

1. What are the primary therapeutic uses of Dexamethasone Sodium Phosphate?
DSP is primarily used for its anti-inflammatory and immunosuppressive properties. It treats conditions like severe allergic reactions, respiratory illnesses (including COVID-19), certain cancers, and autoimmune disorders.

2. Are there ongoing clinical trials exploring new indications for DSP?
Yes. Beyond COVID-19, trials are investigating DSP’s role in autoimmune diseases, oncology, and targeted drug delivery systems. Researchers are also exploring its use in managing cytokine storms and as part of combination therapies.

3. How does the market for DSP compare regionally?
North America leads due to high healthcare spending and clinical research activity, followed by Europe and the Asia-Pacific, where rapid population growth and increasing disease prevalence expand market opportunities.

4. What are the key challenges facing DSP market growth?
Challenges include managing side effects, regulatory hurdles for novel formulations, price competition from generics, and evolving healthcare policies.

5. What future innovations could influence DSP's market trajectory?
Advances in nanotechnology, personalized medicine, sustained-release formulations, and combination therapies are expected to enhance DSP’s therapeutic utility and market appeal.

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Conclusion

Dexamethasone Sodium Phosphate remains a pivotal corticosteroid with expanding clinical applications. Its ongoing clinical trials and pipeline innovations position it well for sustained market relevance. Stakeholders investing in DSP should focus on formulation innovation, expanding indications, and strategic regional penetration to capitalize on its growth trajectory through 2030. Continuous monitoring of clinical developments and regulatory landscapes will be vital for informed decision-making within this dynamic pharmaceutical segment.

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Sources:
[1] RECOVERY Collaborative Group, “Dexamethasone in Hospitalized Patients with Covid-19,” The New England Journal of Medicine, 2021.
[2] Oncology drug development reports, recent clinical trial repositories.
[3] ClinicalTrials.gov, ongoing autoimmune disease trials involving DSP.
[4] Recent pharmaceutical nanotechnology publications, conferences.
[5] MarketWatch, “Global Corticosteroids Market Size and Forecast,” 2023.
[6] IQVIA, “Healthcare Market Insights,” 2022.