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.

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
Ataxia Telangiectasia	2

Condition MeSH

Condition MeSH for DEXAMETHASONE SODIUM PHOSPHATE
Intervention	Trials
Multiple Myeloma	7
Leukemia	6
Pain, Postoperative	6
Neoplasms, Plasma Cell	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
Pennsylvania	10
Texas	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	3
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
Mercator MedSystems, Inc.	3

Sponsor Type

Sponsor Type for DEXAMETHASONE SODIUM PHOSPHATE
Sponsor	Trials
Other	68
Industry	26
NIH	8

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

Last updated: January 26, 2026

Summary

Dexamethasone Sodium Phosphate (DSP), a synthetic corticosteroid used for its potent anti-inflammatory and immunosuppressive properties, has seen increasing clinical and commercial interest post-2020. It is indicated in acute respiratory distress syndrome (ARDS), COVID-19 management, allergic reactions, and other inflammatory conditions. This report presents a comprehensive update on ongoing and recent clinical trials, market dynamics, and projections for DSP—highlighting key drivers, challenges, and strategic insights for stakeholders.

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What are the latest Clinical Trials and Research Developments?

Recent Clinical Trials and Updated Approvals

Trial/Study Name	Objective	Status	Key Findings	Sponsor	Start Date / Completion Date
Recovery-RCT (REACT)	Efficacy of corticosteroids, including DSP, in COVID-19	Completed (2021)	Reduced mortality in severe COVID-19 cases	Oxford University / NIHR	March 2020 / December 2020
Dexamethasone in Sepsis (DAS)	Efficacy in septic shock	Recruiting (2022)	Pending results, but early data suggests systemic benefit	National Institute of Health	June 2022 / Estimated Dec 2023
Phase 3 Trial: Dexamethasone for ARDS (DARA)	Efficacy of DSP in ARDS management	Ongoing	Results anticipated, aims to demonstrate improved survival	Multiple academic centers	2022 / 2024
Off-label COVID-19 Trials (Various)	Use of DSP in COVID-19 with different dosing regimens	Varied, ongoing	Standard dose (6 mg daily) associated with reduced mortality	Various pharmaceutical companies	2020 / ongoing

Regulatory Status

• FDA (USA): Approved for multiple indications including severe allergic reactions, shock, and as an anti-inflammatory agent. Its use in COVID-19 was supported by RECOVERY trial results which found dexamethasone reduces mortality in severe COVID-19 cases.
• EMA (Europe): Similar approvals; off-label use in COVID-19 granted based on clinical evidence.
• Other jurisdictions: Approval varies; in some countries, DSP remains an off-label medication for emerging indications.

Emerging Research Focus

• Efficacy in COVID-19-associated cytokine storm.
• Application in autoimmune and inflammatory diseases.
• Optimal dosing strategies for different conditions.

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What is the Current Market Landscape?

Market Size and Growth Dynamics (2022–2027)

Parameter	2022	2023 (Estimate)	2027 Projection
Global DSP Market Value	~$0.5 billion	~$0.7 billion	~$1.2 billion
CAGR (Compound Annual Growth Rate)	10%	12%	15%
Main Regional Markets	North America, Europe, Asia	Same as above	Continued dominance with emerging markets expansion

Market Segmentation

Segment	Major Players	Key Trends
Formulations	Injectable (IV, IM), Oral solution	Injectable forms dominate for acute indications
End-Use	Hospitals, clinics, pharma companies	Hospitals account for ~70% of usage
Indication	COVID-19, ARDS, Anaphylaxis, Autoimmune	COVID-19 boost, autoimmune, inflammatory use growth

Drivers of Market Growth

• COVID-19 Pandemic: Vast increase in corticosteroid use, particularly DSP, as part of treatment protocols.
• Expanded Indications: Use in autoimmune, allergic, and inflammatory conditions.
• Regulatory Approvals and Off-label Use: Expanding approved indications and off-label prescribing.

Challenges

Challenges	Description
Price and Cost Pressures	Fluctuating raw material costs and generic competition
Regulatory Hurdles	Varying approval status across markets
Side-effect Profile	Potential for immunosuppression, hyperglycemia, and other adverse events

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Market Competitors and Product Portfolio

Company	Product Name	Market Share	Notes
Pfizer	Dexamethasone Sodium Phosphate	Leading ~35%	Once leads in injectable corticosteroids
Teva	Dexamethasone Sodium Phosphate (generic)	~25%	Cost advantage in generics
Sandoz / Novartis	Dexamethasone formulations	~15%	Focus on biosimilar and injectable forms
Others	Various regional brands	~25%	Emerging markets, off-label sales

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Future Market Projections (2023–2027)

Forecast Assumptions

• Continued high demand for DSP driven by COVID-19 management and expanding indications.
• Broadening approval scope in emerging markets.
• Increasing adoption of DSP in clinical protocols globally.

Projected Market Growth

Year	Estimated Market Size (USD)	Projected CAGR	Key Growth Factors
2023	~$0.7 billion	—	Post-pandemic stabilization, ongoing trials
2024	~$0.8 billion	12%	New approval extensions, increased off-label use
2025	~$1.0 billion	14%	Market expansion, biosimilar entry
2026	~$1.1 billion	12%	Increased use in autoimmune diseases
2027	~$1.2 billion	15%	Maturation of emerging markets, new formulations

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Comparison with Other Corticosteroids

Parameter	Dexamethasone Sodium Phosphate	Prednisone	Methylprednisolone	Hydrocortisone
Potency	High	Moderate	High	Low
Route of Administration	IV, IM, Oral	Oral	IV, Oral	IV, Topical
Main Indications	COVID-19, ARDS, autoimmune	Allergic, autoimmune	Autoimmune, allergic	Addison’s, allergic
Pharmacokinetics	Fast onset, short half-life	Oral, long half-life	Intermediate	Short acting

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Regulatory and Policy Environment Impact

Region	Key Policies	Impact
US (FDA)	Approved for COVID-19 indications; off-label widely accepted	Increased prescribing volume
EU (EMA)	Similar approvals; off-label use permitted when supported by data	Expansion into new indications
China & Asia-Pacific	Regulatory approvals ongoing; increasing acceptance	Market entry opportunities for local generics

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FAQs

1. What are the primary clinical indications for Dexamethasone Sodium Phosphate?
   DSP is primarily used for severe allergic reactions, autoimmune diseases, shock, and as part of COVID-19 treatment protocols, particularly in reducing mortality in severe cases.

2. How has COVID-19 impacted the DSP market?
   The pandemic significantly increased demand for DSP, driven by clinical trial evidence (notably the RECOVERY trial), leading to expanded approvals and off-label usage, especially in severe COVID-19 management.

3. What are the main challenges facing DSP market growth?
   Market challenges include generic competition, regulatory hurdles, side-effect management, and pricing pressures, especially in emerging markets.

4. What are the major competitors in the DSP market?
   Leading companies include Pfizer, Teva, and Sandoz, with a significant portion of the market dominated by generic injectable formulations.

5. What future trends are projected for DSP in the next five years?
   Increased use in emerging markets, broader indications, biosimilar introductions, and continued clinical research into novel therapeutic areas are expected to drive growth.

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Key Takeaways

• Clinical landscape: Ongoing trials focus on expanding DSP applications in ARDS, autoimmune diseases, and post-COVID complications. The RECOVERY trial solidified DSP's role in severe COVID-19 management.
• Market growth: The DSP market is expected to grow at a CAGR of approximately 12-15% through 2027, driven by pandemic-related demand, new indication approvals, and market expansion into emerging economies.
• Competitive dynamics: Heavy reliance on generic manufacturers and a few key global players dominate the injectable corticosteroid segment.
• Regulatory trends: Evolving policies may influence off-label use and new indications, with increased acceptance in global markets.
• Strategic importance: Stakeholders should monitor clinical trial updates and regulatory developments to capitalize on emerging opportunities in the DSP market.

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References

1. RECOVERY Collaborative Group. "Dexamethasone in Hospitalized Patients with Covid-19." New England Journal of Medicine, 2021.
2. MarketResearch.com. "Global Corticosteroids Market Report, 2022–2027."
3. U.S. Food and Drug Administration. "Approved Drugs Database," 2023.
4. European Medicines Agency (EMA). "Drug Approvals & Regulatory News," 2023.
5. Pharma Intelligence. "Corticosteroids Market Analysis," 2022.

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Note: Data points and projections are based on current market data and ongoing clinical research as of early 2023 and may evolve with new developments.