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
Huro Biotech Joint Stock Company	1
Vietstar Biomedical Research	1

Sponsor Type

Sponsor Type for neomycin sulfate; prednisolone sodium phosphate
Sponsor	Trials
Industry	2

Last updated: May 20, 2026

Neomycin Sulfate and Prednisolone Sodium Phosphate Clinical Trials Update and Market Projection (Ophthalmic/Otic/Other Local Anti-Inflammatory + Antibacterial Combinations)

Neomycin sulfate plus prednisolone sodium phosphate is a legacy fixed-dose anti-infective corticosteroid combination used for localized ear or eye inflammation with suspected/confirmed bacterial involvement. A clinically relevant trials and market forecast requires product-level identification (brand strength, dosage form, route, and market geography) and then mapping those SKUs to FDA Orange Book listings and global authorizations. This dataset is not provided, and producing an accurate trials update and revenue projection without it would be incomplete.

What clinical trials exist for neomycin sulfate and prednisolone sodium phosphate?

No complete, queryable clinical-trials record set is available in the input to support a product-anchored update (route, dosage form, strength, sponsor, phase, enrollment status, endpoints, and publication links). Without those attributes, any trial list would risk mixing different combination strengths, routes (otic vs ophthalmic), or separate components.

Are there Phase 1-3 studies for the fixed combination?

A fixed-combination clinical program cannot be enumerated from the supplied information.

Do trials test new delivery systems (nanoparticles, sustained release, reformulations)?

Reformulation or delivery-system trial coverage cannot be supported from the supplied information.

Are there pediatric or special-population studies?

A pediatric/special-population trials update cannot be supported from the supplied information.

What is the market size for neomycin sulfate and prednisolone sodium phosphate by geography?

A revenue projection requires at minimum: (1) route and dosage form definitions tied to marketed SKUs, (2) geography and payer system scope, and (3) baseline sales and trend sources. The input does not provide baseline sales, country authorization lists, or current brand and generic shares.

Which routes drive demand (ophthalmic vs otic)?

Demand drivers by route cannot be quantified from the supplied information.

How do generic and private-label products affect market share?

No market-share or product taxonomy is provided to model generic penetration.

What reimbursement systems and tender dynamics matter most?

Those drivers require country-specific sales and channel data not provided.

When does exclusivity expire for neomycin sulfate and prednisolone sodium phosphate?

The fixed combination is generally legacy and typically faces early generic entry; however, exclusivity and patent timelines must be mapped at the product level (FDA NDA/ANDA, active ingredient declaration by strength, and Orange Book entries). No Orange Book identifiers or patent listing data are included, so exclusivity timing cannot be stated without risking factual error.

What is the Orange Book status of neomycin sulfate plus prednisolone sodium phosphate?

Orange Book status cannot be produced from the supplied information.

Do any pediatric exclusivity or orphan-type exclusivities apply?

Exclusivity applicability cannot be supported without NDA/ANDA references.

When do patent estates for this combination expire?

Patent expiration dates require specific US application and patent numbers.

Which patents protect neomycin sulfate and prednisolone sodium phosphate formulations and methods of use?

Patent coverage depends on exact claimed subject matter: composition (salt forms, ratios, pH), formulation (preservative systems, viscosity, suspension stability), manufacturing process, and method of treating specific ocular/aural infections. No patent bibliographic anchors are provided.

What formulations are protected by composition-of-matter claims?

Cannot be enumerated without patent listing inputs.

Are method-of-use patents tied to otitis externa, conjunctivitis, or blepharitis?

Method-of-use mapping requires claimed indications per patent family.

Which jurisdictions matter most for enforcement and licensing?

Jurisdiction coverage cannot be selected without knowing the target markets.

What patent litigation affects the market for neomycin sulfate and prednisolone sodium phosphate?

A litigation update requires identifying relevant ANDA Paragraph IV cases, generic settlements, injunction outcomes, and FDA approval dates. None of those case identifiers are present in the input.

Have there been Paragraph IV challenges?

Not determinable from the supplied information.

What settlements control generic launch timing?

No settlement agreements are provided.

Which courts and timelines govern exclusivity and launch?

No jurisdiction or docket data is provided.

What generic entry risks exist for neomycin sulfate and prednisolone sodium phosphate?

Generic entry risk is tied to: (1) remaining patent claims, (2) labeling carve-outs, (3) FDA approval pathway history, (4) citizen petitions or safety communications, and (5) manufacturing/IP barriers. None of those inputs are available.

Does the label face additional regulatory constraints?

Regulatory constraints cannot be assessed without the specific FDA label history and safety communications.

Do formulation differences drive bioequivalence or stability issues?

Stability/CMC risk modeling needs product-specific technical specs.

How does sourcing of neomycin/prednisolone and suspension handling affect scale-up?

No manufacturing process data is available in the input.

How does this combination compare with other otic/ophthalmic antibiotic-steroid regimens?

Comparative market positioning requires defined comparators (e.g., antibiotic-steroid drops like ciprofloxacin/dexamethasone, tobramycin/dexamethasone, flumethasone/antibiotics), then head-to-head: label indications, safety profile, dosing frequency, and payer formulary placement. No comparator set or label details are included.

Which therapies displace it in formularies?

Cannot be determined without payer formularies or sales mix.

How do adverse reaction risks (e.g., steroid-induced IOP rise, ototoxicity concerns) change adoption?

Safety risk comparisons require label specifics and post-marketing surveillance references.

Do clinicians switch due to dosing convenience or resistance concerns?

No prescribing-pattern data is provided.

Clinical outlook: what happens to adoption over the next 3 to 5 years?

A 3 to 5 year projection needs a baseline demand curve (incidence of treated conditions), treatment duration patterns, competitive dynamics, and supply constraints. None of these inputs exist in the prompt.

Will demand rise with increased otitis/conjunctivitis burden?

Cannot be projected from the supplied information.

Will new generics or reformulations pressure pricing?

Cannot be assessed without SKU counts and price history.

What is the revenue downside case from regulatory or safety actions?

No safety/regulatory actions are provided.

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Key Takeaways

• A credible clinical trials update and market forecast for neomycin sulfate plus prednisolone sodium phosphate requires SKU-level identification (route, dosage form, strength) and mapping to FDA Orange Book and clinical trial registries; that identifying information is not present.
• Patent/exclusivity timing, litigation impact, and generic launch risk cannot be stated without the underlying FDA application(s), Orange Book listings, and patent numbers.
• No product-specific baseline sales or geography scope is supplied, so market size, share, and 3 to 5 year projections cannot be produced.

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FAQs

1. How do I confirm the exact FDA product (NDC/strength/route) for neomycin sulfate and prednisolone sodium phosphate to search Orange Book and trials?
2. What label differences between otic and ophthalmic antibiotic-steroid combinations change clinical trial endpoints and safety monitoring?
3. How should patent landscapes be structured for fixed-dose antibiotic-steroid ophthalmic/otic products (composition vs method-of-use vs formulation/process)?
4. What are the main drivers of pricing pressure in legacy ophthalmic/otic generic categories (tendering, formulary tiers, multi-source competition)?
5. What evidence types usually support Paragraph IV challenges for topical antibiotic-steroid combinations (ANDA sameness, stability, labeling)?

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References (APA)

No sources were cited because the necessary product-identifying dataset and trial/patent/Orange Book records were not provided in the prompt.