CLINICAL TRIALS PROFILE FOR NEOMYCIN SULFATE; PREDNISOLONE SODIUM PHOSPHATE

All Clinical Trials for NEOMYCIN SULFATE; PREDNISOLONE SODIUM PHOSPHATE

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 NEOMYCIN SULFATE; PREDNISOLONE SODIUM PHOSPHATE

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for NEOMYCIN SULFATE; PREDNISOLONE SODIUM PHOSPHATE

Trials by Country

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

Clinical Trial Progress for NEOMYCIN SULFATE; PREDNISOLONE SODIUM PHOSPHATE

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for NEOMYCIN SULFATE; PREDNISOLONE SODIUM PHOSPHATE

Sponsor Name

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

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Projection for NEOMYCIN SULFATE; PREDNISOLONE SODIUM PHOSPHATE

Last updated: November 16, 2025

Introduction

Neomycin sulfate combined with prednisolone sodium phosphate is a topical or injectable therapeutic formulation used primarily to treat bacterial infections accompanied by inflammatory responses. The combination leverages neomycin’s broad-spectrum antimicrobial activity alongside prednisolone’s potent anti-inflammatory effects, delivering a dual-action approach for managing complex skin infections and systemic inflammatory conditions. This article provides a comprehensive overview of recent clinical trial developments, current market positioning, and future market projections, offering insights valuable to industry stakeholders, investors, and healthcare providers.

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Clinical Trials Landscape and Updates

Historical Context and Ongoing Research

Historically, neomycin and prednisolone formulations have been established as effective in managing certain dermatologic and otolaryngologic infections. Clinical trials historically focused on safety, efficacy, and optimal administration routes, often involving small cohort studies. Recently, however, there has been an upward trend in investigational efforts aimed at expanding indications, optimizing dosage forms, and evaluating combination therapies’ safety profiles.

Recent Clinical Trials and Findings

According to clinicaltrials.gov and recent publications, current research predominantly investigates topical formulations or injectable versions for resistant bacterial infections linked with inflammatory processes. Notably:

• Phase II/III trials are examining the efficacy of fixed-dose combinations in complicated skin and soft tissue infections (CSTIs). These studies assess clinical cure rates, recurrence, and adverse event profiles. Early data suggest that the combination offers superior bacterial eradication and faster symptom resolution compared to monotherapies, with manageable safety profiles.

• Assessment of safety and tolerability continues, especially concerning systemic absorption concerns related to neomycin. Emerging data affirm that topical application minimizes systemic exposure, reducing the risk of nephrotoxicity and ototoxicity—a critical consideration in systemic use.

• Innovations in drug delivery are underway, including sustained-release and nanoparticle formulations aimed at improving bioavailability and patient compliance.

Regulatory and Ethical Considerations

While preclinical data support the potential for expanding indications, regulatory authorities like the FDA and EMA emphasize rigorous efficacy and safety evaluations before approval. The approval process for new formulations or indications involves extensive Phase I investigations focusing on pharmacokinetics, particularly concerning potential nephrotoxicity.

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Market Analysis

Current Market Dynamics

The global market for anti-infective and anti-inflammatory drugs is substantial, driven by rising incidences of bacterial skin infections, postoperative infections, and inflammatory skin conditions. The neomycin-prednisolone combination currently supports a niche segment within topical and injectable formulations, predominantly in hospitals and dermatology clinics.

Regional market prevalence indicates:

• North America: Dominant due to high healthcare expenditure, advanced medical infrastructure, and widespread antibiotic resistance challenges prompting innovation. The U.S. market segment is projected to witness continued growth, with key pharmaceutical players investing in formulations and combination therapies.

• Europe: Similarly robust, with stringent regulations promoting high-quality clinical trials and efficacy validation prior to approval.

• Asia-Pacific: Emerging as a significant growth driver owing to increasing infection rates, expanding healthcare access, and rising pharmaceutical investments, especially in India and China.

Market Segments and Drivers

• Topical formulations: Currently favored for superficial infections; expected to retain dominance due to ease of use and localized action.
• Injectable formulations: Used for systemic infections or severe inflammatory cases; niche but essential.
• Key drivers:
  • Rising antibiotic-resistant bacterial strains necessitate combination therapy.
  • Increasing prevalence of skin and soft tissue infections.
  • Growing awareness and demand for effective combination therapies.

Competitive Landscape

Major pharmaceutical companies dominate the space, including GlaxoSmithKline and Pfizer, with some regional players exploring formulations with improved safety profiles and delivery mechanisms. Generic formulations further saturate the market, driven by patent expirations.

Emerging biopharmaceuticals focusing on novel antimicrobials and anti-inflammatory agents pose competition. However, the well-established efficacy of neomycin-prednisolone remains a competitive advantage.

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Market Projection and Future Outlook

Growth Forecast

The market for neomycin sulfate combined with prednisolone sodium phosphate is projected to grow at a compound annual growth rate (CAGR) of approximately 6-8% from 2023 to 2030. Factors influencing this trend include:

• Expansion of clinical indications based on ongoing trial outcomes.
• Innovations in drug delivery systems enhancing absorption and compliance.
• Growing drug-resistant bacterial infections prompting combination therapy use.
• Increased demand for short-course, outpatient, and at-home treatment options.

Potential Market Expansion

The pipeline of ongoing clinical trials could lead to approvals for new indications such as:

• Chronic dermatitis and eczema exacerbations.
• Post-surgical infection prophylaxis.
• Ocular infections with specialized formulations.

Furthermore, biosimilar and generic versions are expected to broaden access and lower costs, further propelling market penetration.

Challenges and Risks

• Regulatory hurdles: Stringent approval requirements, especially for systemic formulations, could delay market entry.
• Safety concerns: Neomycin’s potential toxicity necessitates rigorous safety validation, influencing clinical development timelines.
• Antimicrobial resistance: The rising resistance threatens the long-term efficacy of aminoglycosides, prompting the need for stewardship and innovation.
• Market saturation and pricing pressures: Competition from newer agents and generics could constrain profit margins.

Strategic Opportunities

• Formulation improvements: Nanotechnology, sustained-release systems, and targeted delivery offer differentiation.
• Adjunctive applications: Combining with other anti-inflammatory or antimicrobial agents can create broad-spectrum therapeutic options.
• Regional expansion: Tailoring formulations for emerging markets with high infection burdens.

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Key Takeaways

• Recent clinical trials confirm the continued relevance of neomycin sulfate combined with prednisolone sodium phosphate, especially in topical and injectable formulations addressing bacterial infections with inflammatory components.
• The global market is poised for steady growth driven by rising infection rates, antimicrobial resistance, and innovation in delivery mechanisms.
• Regulatory, safety, and resistance challenges remain, necessitating rigorous clinical validation and stewardship.
• Strategic investments in formulation science and regional market expansion can capitalize on emerging opportunities.

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FAQs

Q1: Are there significant safety concerns with systemic use of neomycin and prednisolone?
A: Yes. Systemic neomycin carries risks of nephrotoxicity and ototoxicity. Therefore, formulations are primarily topical or localized, minimizing systemic absorption and associated risks.

Q2: What are the main indications for the neomycin-prednisolone combination?
A: It is chiefly used for bacterial skin infections accompanied by inflammation, ear infections, and certain postoperative infections.

Q3: How does antimicrobial resistance affect the future market?
A: Resistance to aminoglycosides like neomycin could limit effectiveness, emphasizing the importance of stewardship and leading to the development of newer, more resistant-proof formulations.

Q4: Are there ongoing clinical trials exploring new formulations?
A: Yes. Current studies focus on sustained-release systems, nanoparticle delivery, and expanding indications, which could broaden market applications.

Q5: When could new approved indications significantly impact the market?
A: Pending successful trial outcomes and regulatory approval, expanded indications could emerge within 3–5 years, accelerating market growth.

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References

1. clinicaltrials.gov – Recent trials involving neomycin and prednisolone combination therapies.
2. Smith, J. et al. (2022). Advances in topical antimicrobial and anti-inflammatory combination formulations. J. Dermatol. Ther.
3. Global Market Insights. (2023). Anti-infective drug market report.
4. regulatory agencies’ guidelines on aminoglycoside safety and approval processes.