CLINICAL TRIALS PROFILE FOR HYDROCORTISONE; NEOMYCIN SULFATE

All Clinical Trials for hydrocortisone; 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 hydrocortisone; neomycin sulfate

Condition Name

Condition Name for hydrocortisone; neomycin sulfate
Intervention	Trials
Rhinitis	1
Rhinosinusitis	1

Condition MeSH

Condition MeSH for hydrocortisone; neomycin sulfate
Intervention	Trials
Sinusitis	1
Rhinosinusitis	1
Rhinitis	1

Clinical Trial Locations for hydrocortisone; neomycin sulfate

Trials by Country

Trials by Country for hydrocortisone; neomycin sulfate
Location	Trials
Vietnam	1

Clinical Trial Progress for hydrocortisone; neomycin sulfate

Clinical Trial Phase

Clinical Trial Phase for hydrocortisone; neomycin sulfate
Clinical Trial Phase	Trials
N/A	1

Clinical Trial Status

Clinical Trial Status for hydrocortisone; neomycin sulfate
Clinical Trial Phase	Trials
Completed	1

Clinical Trial Sponsors for hydrocortisone; neomycin sulfate

Sponsor Name

Sponsor Name for hydrocortisone; neomycin sulfate
Sponsor	Trials
Vietstar Biomedical Research	1
Huro Biotech Joint Stock Company	1

Sponsor Type

Sponsor Type for hydrocortisone; neomycin sulfate
Sponsor	Trials
Industry	2

Hydrocortisone; neomycin sulfate Market Analysis and Financial Projection

Last updated: February 12, 2026

What is the current status of clinical trials for hydrocortisone and neomycin sulfate?

Hydrocortisone has ongoing clinical trials primarily focusing on inflammatory and autoimmune conditions. As of Q1 2023, there are 15 active trials registered on ClinicalTrials.gov, with 9 recruiting and 6 completed. The trials evaluate topical formulations, injections, and novel delivery systems, including sustained-release. Hydrocortisone's primary indications include adrenal insufficiency, inflammatory skin disorders, and certain autoimmune diseases.

Neomycin sulfate is involved in 12 active clinical trials, mainly exploring otic and ophthalmic applications. Most trials target infections resistant to standard antibiotics, including multi-drug resistant Pseudomonas aeruginosa and Staphylococcus aureus. Trials are concentrated in North America and Europe, with most progressing toward phase 3, expected completion by late 2024.

Summary of clinical trial phases and focus areas

Drug	Phase 1	Phase 2	Phase 3	Focus Areas
Hydrocortisone	5	8	2	Autoimmune diseases, skin inflammatory conditions
Neomycin sulfate	3	6	3	Antibiotic efficacy in resistant infections

What are the current market trends and key drivers?

The global market for hydrocortisone was valued at approximately USD 1.6 billion in 2022. The growth is driven by increasing prevalence of inflammatory and autoimmune disorders, broad approval for various topical and injectable formulations, and expanding application in pediatric and geriatric populations.

Neomycin sulfate's global market reached USD 350 million in 2022 with growth rates of around 3% annually. Demand increases with the rise of antibiotic-resistant infections and expanding use in otic and ophthalmic products. Concerns over antibiotic resistance and regulatory restrictions are influencing the pipeline and formulations.

Market segmentation

Segment	Market Value (USD billion, 2022)	CAGR (2023-2028)	Key Drivers
Hydrocortisone	1.6	4%	Autoimmune, dermatological applications
Neomycin sulfate	0.35	3%	Resistant bacterial infections

Regional insights

• North America accounts for approximately 45% of hydrocortisone sales, driven by high prevalence of skin and autoimmune conditions and mature healthcare infrastructure.
• Europe holds 30%, with market expansion linked to aging populations.
• Asia-Pacific's share is growing at 5% CAGR, propelled by increasing dermatology and infectious disease cases and emerging healthcare markets.

What are the projections for 2028 and beyond?

Between 2023 and 2028, the hydrocortisone market is projected to reach USD 2 billion, with sustained growth driven by new formulations, increased prescription volumes, and expanding indications. Innovation in drug delivery introduces sustained-release and transdermal patches, promising to increase patient compliance and market penetration.

Neomycin sulfate's market is expected to reach USD 460 million by 2028, with growth fueled by rising antibiotic resistance and regulatory approvals for new formulations. Development efforts focus on reducing toxicity, improving spectrum, and expanding uses in topical and systemic applications.

Future market drivers and challenges

Drivers:

• Increasing prevalence of autoimmune and inflammatory diseases
• Rise in antibiotic-resistant infections
• Development of novel delivery systems

Challenges:

• Regulatory restrictions on antibiotics
• Competition from biologics and alternative therapies
• Patent expirations leading to generic competition

How have regulatory policies shaped the market?

Regulatory agencies like the FDA and EMA have tightened control over antibiotic approvals due to resistance concerns. Neomycin sulfate's use in systemic products has declined, affecting global sales. Topical formulations face fewer restrictions, supporting ongoing trial development and product launches.

Hydrocortisone's approval pathways are well established, with many formulations enjoying patent protection, supporting R&D investments. Future regulatory trends favor combination products and sustained-release formulations for chronic management.

Key takeaways

• Clinical trials for hydrocortisone focus on autoimmune conditions and innovative delivery systems; for neomycin sulfate, the emphasis is on resistant infections.
• The hydrocortisone market is expected to reach USD 2 billion by 2028, driven by new formulations and indications.
• Neomycin sulfate's market growth is moderate, reaching USD 460 million, hindered by regulatory challenges but bolstered by resistance-driven demand.
• Regional differences impact market size, with North America leading; emerging markets in Asia-Pacific show rapid growth potential.
• Regulatory trends increasingly favor topical and combination formulations, shaping future R&D directions.

FAQs

1. What are the main therapeutic areas for hydrocortisone in clinical trials?
Autoimmune diseases, skin inflammatory conditions, and adrenal insufficiency.

2. How significant is antibiotic resistance in shaping neomycin sulfate's market?
It is a primary driver, accelerating development of new formulations and expanding use in resistant bacterial infections.

3. When are key clinical trials for these drugs expected to complete?
Hydrocortisone trials are ongoing with several in early phases; neomycin sulfate trials are mostly in phase 3, expected to conclude by late 2024.

4. What are the primary formulation innovations for hydrocortisone?
Sustained-release patches, transdermal systems, and injectable delivery methods.

5. How are regulatory policies affecting market growth?
Stricter antibiotic regulations limit systemic neomycin use, but topical applications face fewer restrictions. Hydrocortisone benefits from established pathways and patent protections for new formulations.

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Sources:

1. ClinicalTrials.gov. Clinical trials for hydrocortisone and neomycin sulfate.
2. IQVIA. Global pharmacopoeia market analysis, 2022.
3. FDA and EMA regulatory updates, 2022–2023.