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
Rhinitis	1
Sinusitis	1
Rhinosinusitis	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
Vietstar Biomedical Research	1
Huro Biotech Joint Stock Company	1

Sponsor Type

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

Last updated: April 24, 2026

Dexamethasone Sodium Phosphate / Neomycin Sulfate: Clinical Trial Update, Market View, and Forward Projections

What is the current clinical development footprint for dexamethasone sodium phosphate / neomycin sulfate?

As a fixed-combination topical regimen (dexamethasone sodium phosphate plus neomycin sulfate), the clinical evidence base is dominated by historical studies and standard-of-care use rather than large, registrational-grade late-stage development. In practice, “new trial” activity tends to cluster around:

• formulation changes (particle size, vehicle, preservative system),
• line extensions (indications, anatomic sites),
• bioequivalence work rather than new efficacy proof,
• and post-marketing or safety requalification in specific jurisdictions.

A complete, current “clinical trials update” requires a live registry scan across ClinicalTrials.gov and major regional databases, but no such trial-identifying dataset was provided in the input. Under the operating constraints, no partial or inferential trial claims are included.

Clinical conclusion: No definitive, up-to-date trial-by-trial status, enrollment, endpoints, or reads can be stated from the information provided.

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How does the market for dexamethasone + neomycin topical therapy look today?

The commercial market for this fixed combination is driven by demand for anti-inflammatory corticosteroid action (dexamethasone) plus topical antibacterial coverage (neomycin). It is used in ophthalmic, otic, and some dermatologic contexts depending on local labeling and product form.

Market structure (practical view):

• Product reality: This combination typically sells as generic and branded legacy products with multiple manufacturers and frequent substitution where permitted.
• Demand drivers: post-procedural inflammation, bacterial-susceptible infections, mixed inflammatory and infectious indications where labels support the combination.
• Price dynamics: most markets exhibit erosion toward low-cost generics; branded premium use persists mainly where patents, exclusivities, or supply constraints exist.

Commercial implication: In mature topical combinations with broad generic availability, growth tends to track volume (population, visit rates, procedure volumes) more than unit pricing.

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What is the near-term market projection for dexamethasone sodium phosphate / neomycin sulfate?

A forward projection depends on whether a market is:

• constrained by ongoing formulary access and substitution,
• limited by antibiotic stewardship rules or resistance-related restrictions,
• or affected by regulatory labeling changes (for example, restrictions around ototoxicity risk, contact sensitization, or use in contraindicated ear conditions).

No jurisdiction-level labeling changes, competitive pipeline events, or registry-confirmed trial milestones were provided in the input, so a quantified projection (CAGR, TAM expansion, category growth by indication) cannot be produced without making unsupported assumptions.

Projection conclusion: No defensible numeric forecast is provided because the input does not include the required market sizing baseline, geographies, or competitive/regulatory triggers.

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Where do investors and R&D teams usually see leverage in this combination?

Even in a generic-heavy topical combination space, leverage exists when development targets a measurable differentiator:

1. Regulatory pathway execution
   • Bioequivalence and approval speed can create near-term share, especially where supply disruptions or tender cycles exist.
2. Formulation and delivery
   • improved penetration (otic) or retention (ophthalmic) and tolerability improvements can shift utilization within clinician preference bounds.
3. Labeling precision
   • narrowing to well-supported indications or re-aligning with current clinical practice can reduce reimbursement friction.

No specific, current product strategy or filing events were supplied, so the above is limited to typical levers rather than a statement about any particular sponsor’s plan.

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What competitive and patent context matters for forecasting?

For dexamethasone/antibiotic combination products, the competitive landscape typically features:

• multiple generic approvals and multi-source supply,
• limited remaining exclusivity at the combination level in many markets,
• and risk that any “new” product is forced into generic or line-extension lanes unless it changes actives, dose, or delivery enough for a non-generic pathway.

A precise competitive and exclusivity map requires:

• list of current approved products by geography,
• expiration dates by manufacturer,
• and any relevant patents for formulation or method of use.

No such dataset was provided; therefore, no expiration schedule or competitive share estimate can be produced under the constraints.

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Market Decision Table

Dimension	What determines outcome	What the current input enables	What is not included
Clinical pipeline	Late-stage readouts, label expansions, safety signals	No registry-confirmed trial facts can be cited	Trial status, endpoints, enrollment, reads
Category growth	Procedure volume and substitution dynamics	Qualitative maturity is implied	TAM size, volume growth, pricing trends
Forecast quality	Exclusivity, competitive intensity, tender behavior	No numerics	Patent/exclusivity and product list by country
Regulatory risk	Label restrictions, safety policy changes	No jurisdiction-specific changes	Agency actions and timeline

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Key Takeaways

• Clinical trials: No up-to-date, registry-backed trial update can be issued from the provided input.
• Market: The combination sits in a typically mature topical landscape with generic competition and demand tied more to volume than price.
• Projections: No defensible quantitative market forecast can be produced without a baseline market sizing dataset, geography scope, and competitive/regulatory event inputs.

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FAQs

1) Is dexamethasone sodium phosphate plus neomycin sulfate still actively developed?

No specific current development activity can be confirmed from the input provided, and no registry-backed trial update is deliverable here.

2) What typically drives demand for this combination?

Demand generally tracks use cases where clinicians apply an anti-inflammatory plus topical antibiotic regimen under local labeling.

3) Why is market forecasting harder for this combination than for novel drugs?

Markets for legacy topical combinations are heavily shaped by generic substitution, procurement cycles, and label-level constraints, which require product- and jurisdiction-specific data to quantify.

4) What types of product changes create the most commercial value in this category?

Formulation/delivery improvements, faster regulatory execution via bioequivalence lanes, and label alignment that reduces reimbursement friction.

5) What would change a forecast materially?

A new regulatory action (label expansion or restriction), a competitive supply event, or an exclusivity shift tied to a specific product/manufacturer would materially move projections, but none are provided in the input.

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References

No sources were provided in the input, and no live registry or market dataset was included to support citations.