CLINICAL TRIALS PROFILE FOR DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE

All Clinical Trials for DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05999955 ↗	Safety and Efficacy of DSM 32444 Postbiotic in the Treatment of Acute Rhinosinusitis	Completed	Vietstar Biomedical Research	N/A	2022-12-29	Rhinitis is a type of upper respiratory infection with a common nasal pathology especially in Southeast Asia, which is characterized by the presence of one or more of the following symptoms: itchy nose, sneezing, runny nose, and nasal congestion. Other symptoms occasionally experienced include headache, excessive pain reaction, cough, fever. Rhinitis can be idiopathic or due to a variety of causes, including allergens, medications, endocrine/metabolic, infectious, inflammatory, and abnormal nasal structures. The treatment of acute rhinosinusitis and allergic rhinitis in hospitals is currently carried out according to the general professional guidance of the Vietnam Ministry of Health. Most patients are prescribed corticosteroids, antihistamines, and antibiotics for immediate decongestion and anti-inflammatory effects. Current concerns about antimicrobial resistance (AMR) as well as side effects of corticosteroids and antihistamines have led to an urgent need for a naturebased next generation therapeutic approach that is safe, effective and helps in addressing the issues of AMR. The goal of this interventional study is to evaluate the safety and efficacy of postbiotic nasal spray using inert bioparticles of Bacillus subtilis DSM32444 in treatment of acute rhinosinusitis; and to compare the efficacy against Neomycin/Dexamethasone//Xylometazoline administered as a nasal spray as an adjunct to Amoxicillin/Clavulanate standard treatment in patients with acute rhinosinusitis. Patients with acute rhinosinusitis who give consent to participate in the study will be randomly assigned in a 1:1 ratio to one of two groups using postbiotic of Bacillus subtilis DSM32444 nasal spray ("Sperovid") or Neomycin/ Dexamethasone nasal spray for a period of 10 days. Investigators will compare whether the nasal spray using postbiotic Bacillus subtilis DSM32444 has similar efficacy as compared to Neomycin/Dexamethasone/Xylometazoline nasal spray as an adjuvant therapy along with the standard Amoxicillin/Clavulanate regimen in patients with acute rhinosinusitis based on time to improvement of rhinosinusitis symptoms.
NCT05999955 ↗	Safety and Efficacy of DSM 32444 Postbiotic in the Treatment of Acute Rhinosinusitis	Completed	Huro Biotech Joint Stock Company	N/A	2022-12-29	Rhinitis is a type of upper respiratory infection with a common nasal pathology especially in Southeast Asia, which is characterized by the presence of one or more of the following symptoms: itchy nose, sneezing, runny nose, and nasal congestion. Other symptoms occasionally experienced include headache, excessive pain reaction, cough, fever. Rhinitis can be idiopathic or due to a variety of causes, including allergens, medications, endocrine/metabolic, infectious, inflammatory, and abnormal nasal structures. The treatment of acute rhinosinusitis and allergic rhinitis in hospitals is currently carried out according to the general professional guidance of the Vietnam Ministry of Health. Most patients are prescribed corticosteroids, antihistamines, and antibiotics for immediate decongestion and anti-inflammatory effects. Current concerns about antimicrobial resistance (AMR) as well as side effects of corticosteroids and antihistamines have led to an urgent need for a naturebased next generation therapeutic approach that is safe, effective and helps in addressing the issues of AMR. The goal of this interventional study is to evaluate the safety and efficacy of postbiotic nasal spray using inert bioparticles of Bacillus subtilis DSM32444 in treatment of acute rhinosinusitis; and to compare the efficacy against Neomycin/Dexamethasone//Xylometazoline administered as a nasal spray as an adjunct to Amoxicillin/Clavulanate standard treatment in patients with acute rhinosinusitis. Patients with acute rhinosinusitis who give consent to participate in the study will be randomly assigned in a 1:1 ratio to one of two groups using postbiotic of Bacillus subtilis DSM32444 nasal spray ("Sperovid") or Neomycin/ Dexamethasone nasal spray for a period of 10 days. Investigators will compare whether the nasal spray using postbiotic Bacillus subtilis DSM32444 has similar efficacy as compared to Neomycin/Dexamethasone/Xylometazoline nasal spray as an adjuvant therapy along with the standard Amoxicillin/Clavulanate regimen in patients with acute rhinosinusitis based on time to improvement of rhinosinusitis symptoms.

Clinical Trial Conditions for DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE

Condition Name

Condition Name for DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE
Intervention	Trials
Rhinitis	1
Rhinosinusitis	1

Condition MeSH

Condition MeSH for DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE
Intervention	Trials
Sinusitis	1
Rhinosinusitis	1
Rhinitis	1

Clinical Trial Locations for DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE

Trials by Country

Trials by Country for DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE
Location	Trials
Vietnam	1

Clinical Trial Progress for DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE

Clinical Trial Phase

Clinical Trial Phase for DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE
Clinical Trial Phase	Trials
N/A	1

Clinical Trial Status

Clinical Trial Status for DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE
Clinical Trial Phase	Trials
Completed	1

Clinical Trial Sponsors for DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE

Sponsor Name

Sponsor Name for DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE
Sponsor	Trials
Huro Biotech Joint Stock Company	1
Vietstar Biomedical Research	1

Sponsor Type

Sponsor Type for DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE
Sponsor	Trials
Industry	2

Clinical Trials Update, Market Analysis, and Projection for Dexamethasone Sodium Phosphate and Neomycin Sulfate

Last updated: November 3, 2025

Introduction

Dexamethasone Sodium Phosphate and Neomycin Sulfate are widely used pharmaceuticals with significant clinical and commercial relevance. Dexamethasone, a potent corticosteroid, is employed primarily for its anti-inflammatory and immunosuppressive properties, while Neomycin, an aminoglycoside antibiotic, targets bacterial infections. Their combination offers therapeutic advantages in various infections and inflammatory conditions. This report synthesizes the latest developments in clinical trials, evaluates current market dynamics, and projects future market trajectories.

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Clinical Trials Landscape

Current Status of Clinical Trials

As of Q1 2023, the clinical trial landscape for Dexamethasone Sodium Phosphate and Neomycin Sulfate remains dynamic. Several trials are exploring expanded indications, novel formulations, and combination therapies.

• Dexamethasone Sodium Phosphate: Trials focus on its use in inflammatory and respiratory diseases, notably COVID-19-related cytokine storms. The RECOVERY trial in the UK previously established dexamethasone’s mortality benefit in hospitalized COVID-19 patients, solidifying its role in viral pneumonitis management [1]. Ongoing studies are examining its application in conditions such as autoimmune disorders, arthritis, and dermatological inflammatory diseases.

• Neomycin Sulfate: Clinical investigations primarily center around topical formulations for skin and ear infections, aside from systemic use which is less prevalent due to toxicity concerns. Notably, trials are assessing its efficacy in combination with other antibiotics to combat resistant bacterial strains.

• Combination Therapy Trials: No prominent recent trials explicitly target combined dexamethasone and neomycin therapy. However, their co-prescription in clinical practice suggests investigational and off-label use with ongoing observational studies.

Innovative Formulations and Delivery Systems

Advancements in drug delivery aim to enhance efficacy and reduce toxicity:

• Liposomal encapsulation of dexamethasone to improve targeted delivery in inflammatory tissues.
• Novel topical formulations of Neomycin with sustained-release properties to minimize dosing frequency.

Regulatory and Labeling Developments

Regulatory agencies, such as the FDA and EMA, continue to monitor safety profiles, especially regarding neomycin-related ototoxicity and nephrotoxicity. Recent updates highlight stricter labeling requirements and post-marketing surveillance, influencing clinical trial designs.

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Market Overview

Global Market Size and Historical Trends

The combined market for Dexamethasone Sodium Phosphate and Neomycin Sulfate has experienced robust growth driven by increased infection rates, chronic inflammatory disease prevalence, and the COVID-19 pandemic.

• Market Valuation (2022): Estimated at USD 2.5 billion, with Dexamethasone accounting for approximately 70% of this share due to its broader therapeutic indications and patent expirations in certain regions [2].

• Market Drivers:

  • Rising incidence of respiratory infections, autoimmune conditions, and skin diseases.
  • Pandemic-induced demand for corticosteroids in COVID-19 management [3].
  • Growing adoption of combination therapies to combat resistant bacterial strains.

Regional Market Dynamics

• North America: Dominates market share (>40%) owing to high healthcare expenditure, strong R&D investments, and widespread clinical adoption.
• Europe: Significant market presence, with expanding use in autoimmune and respiratory conditions.
• Asia-Pacific: Fastest growth rate (~8% CAGR from 2022-2028), fueled by rising prevalence of infectious diseases and increasing healthcare infrastructure development, notably in China and India.

Competitive Landscape

Major players include Pfizer, GSK, Novartis, and Teva Pharmaceuticals, competing through branded products and generics. The patent cliff for dexamethasone has accelerated generic entry, intensifying price competition.

Market Challenges

• Safety Concerns: Ototoxicity and nephrotoxicity risks with neomycin limit its systemic use, leading to decreased market share in systemic antibiotics.
• Regulatory Scrutiny: Post-market safety alerts impact demand and formulations.
• Emergence of Resistance: Antibiotic resistance trends necessitate continuous innovation.

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Market Projection (2023-2030)

Forecast Overview

The combined market for Dexamethasone Sodium Phosphate and Neomycin Sulfate is projected to grow at a compounded annual growth rate (CAGR) of approximately 6-7% over the next seven years. The total market is anticipated to reach USD 4.2 billion by 2030, driven predominantly by dexamethasone’s expanding indications and improved formulations.

Key Market Drivers

• COVID-19 Legacy: Continued use of corticosteroids in managing post-COVID complications sustains demand.

• Expanding Therapeutic Applications: Research into new indications like severe allergic reactions, certain cancers, and multidrug-resistant infections.

• Innovations in Drug Delivery: Extended-release topical and injectable formulations will improve patient compliance and efficacy, encouraging broader adoption.

Potential Market Constraints

• Safety and Toxicity Issues: Ongoing concerns about neomycin's adverse effects may restrict systemic application, focusing growth on topical or localized treatments.
• Market Saturation: In mature markets with widespread generic availability, growth may slow unless new patented formulations or combinations emerge.

Emerging Opportunities

• Development of liposomal and nanoparticle formulations to improve safety profiles.
• Exploring alternative antibiotics with similar spectrum but fewer adverse effects.

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Conclusion

Dexamethasone Sodium Phosphate and Neomycin Sulfate are fundamental components in infectious and inflammatory disease management. The clinical trial landscape supports expanding the therapeutic breadth of dexamethasone, especially post-pandemic, while safety concerns temper neomycin’s systemic use. Market growth prospects remain promising, with innovations in formulations and expanding indications serving as primary catalysts.

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Key Takeaways

• Clinical validation of dexamethasone’s efficacy in COVID-19 and autoimmune conditions sustains its market dominance.
• Neomycin’s market is shrinking systemically due to toxicity concerns, but topical applications continue robust growth.
• The global market is projected to reach USD 4.2 billion by 2030, with high-growth regions including Asia-Pacific.
• Innovative formulations, such as liposomal and sustained-release systems, will be critical in ongoing product differentiation.
• Safety concerns and regulatory scrutiny will shape future R&D priorities and commercialization strategies.

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FAQs

1. What are recent breakthrough clinical trials involving dexamethasone?
   Recent trials have focused on its role in managing severe COVID-19 symptoms, autoimmune diseases, and certain cancers, emphasizing its anti-inflammatory and immunosuppressive capacities [1].

2. Are there new formulations of neomycin that mitigate its toxicity?
   Yes, research explores liposomal and topical sustained-release formulations to reduce systemic absorption and toxicity risks, expanding its usability in dermatological and localized infections.

3. How has the COVID-19 pandemic impacted the demand for dexamethasone?
   The pandemic significantly increased demand due to its proven efficacy in reducing mortality in severe COVID-19 cases, leading to supply chain adjustments and accelerated clinical research.

4. What are the main challenges facing the market for these drugs?
   Safety concerns, especially with neomycin, generic market saturation, regulatory restrictions, and antibiotic resistance constitute the primary challenges.

5. What future innovations could enhance the market for dexamethasone and neomycin?
   Development of targeted delivery systems, combination therapies with fewer side effects, and novel formulations with enhanced stability and patient compliance are key innovation areas.

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References

[1] RECOVERY Collaborative Group. "Dexamethasone in Hospitalized Patients with Covid-19." New England Journal of Medicine, 2021.
[2] MarketWatch. "Global Corticosteroids and Antibiotics Market Size, Share & Trends." 2022.
[3] WHO. "Dexamethasone Use in COVID-19 Treatment Guidelines." 2021.