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

Sponsor Type

Sponsor Type for hydrocortisone; neomycin sulfate
Sponsor	Trials
Industry	2

Clinical Trials Update, Market Analysis, and Projection for Hydrocortisone and Neomycin Sulfate

Last updated: November 8, 2025

Introduction

Hydrocortisone and neomycin sulfate are notable pharmaceuticals with a longstanding history in dermatology, infectious disease management, and various other therapeutic areas. Hydrocortisone, a corticosteroid, reduces inflammation, while neomycin sulfate, an aminoglycoside antibiotic, targets bacterial infections. An increasing number of clinical trials and innovative formulations suggest evolving landscape opportunities for these drugs amid a complex and competitive healthcare market. This analysis provides an in-depth update on clinical trials, evaluates current market dynamics, and forecasts future trends for hydrocortisone and neomycin sulfate.

Clinical Trials Update

Hydrocortisone: Ongoing and Recent Trials

Hydrocortisone remains a cornerstone in managing inflammatory and autoimmune conditions such as eczema, psoriasis, and adrenal insufficiency. Recent clinical research emphasizes novel formulations and delivery methods. Notably:

• Topical Hydrocortisone Formulations: Multiple trials focus on enhanced transdermal delivery systems aiming to increase bioavailability and reduce systemic absorption (NCT04531245). These include nanoemulsions, liposomal encapsulations, and hydrogels, which aim to optimize therapeutic outcomes while minimizing side effects.

• Intravenous and Injectable Forms: Studies like NCT04478945 explore hydrocortisone’s use in septic shock and COVID-19-related cytokine storms, emphasizing dosage optimization and safety profiling.

• Combination Therapies: Clinical investigations assess hydrocortisone co-administration with immunomodulators to treat complex autoimmune conditions—either to enhance efficacy or reduce steroid dosages. For instance, trials are examining the combination in managing rheumatoid arthritis and inflammatory bowel disease.

Neomycin Sulfate: Emerging and Noteworthy Trials

Neomycin sulfate continues to be evaluated primarily for its antiseptic and bacterial sterilization capabilities. Recent developments include:

• Oral and Topical Formulations: Trials (e.g., NCT04651278) investigate novel topical formulations, including nanocarrier-based ointments designed for multidrug-resistant bacterial infections, notably in wound care and skin infections.

• Preoperative and Bowel Preparation Applications: Several ongoing studies assess optimized dosing protocols for bowel sterilization pre-surgery, aiming to minimize adverse effects such as nephrotoxicity and ototoxicity (NCT04589362).

• Combination Antibiotic Strategies: Trials are testing neomycin in combination with other antibiotics like bacitracin or polymyxin B for synergistic activity against resistant bacterial strains, especially Gram-negative bacteria.

Regulatory and Approval Updates

While both drugs are FDA-approved and have established indications, recent clinical trials serve to expand their use cases, improve formulations, and address resistance challenges. For example, the FDA has recently approved a novel hydrocortisone topical formulation with enhanced skin penetration (FDA, 2022), and similar advances are expected for neomycin-based therapies.

Market Analysis

Current Market Landscape

The combined global market for hydrocortisone and neomycin sulfate is substantial, driven by their extensive use in dermatology, infectious diseases, and pre/post-operative care. According to market research, the global corticosteroid market was valued at approximately USD 6.4 billion in 2021, with hydrocortisone representing a significant segment (Market Data Forecast, 2022). The antibiotics market, including aminoglycosides like neomycin, was valued at USD 14.2 billion in 2021, with growth fueled by rising antibiotic resistance and need for effective bacterial infection management.

Key Market Drivers

• Growing Incidence of Dermatological Disorders: Rising prevalence of eczema, psoriasis, and contact dermatitis sustains demand for topical hydrocortisone, especially in chronic management (WHO, 2023).
• Antibiotic Resistance Challenge: Increasing bacterial resistance heightens demand for effective antibiotics like neomycin, including combination therapies targeting multidrug-resistant organisms.
• Novel Formulations and Delivery Systems: Innovations, including nanocarriers and sustained-release formulations, improve treatment adherence, efficacy, and safety, thus expanding market potential.
• Regulatory Approvals and Expanding Indications: New approvals and expanded indications foster market growth; for example, topical hydrocortisone's approval for pediatric and sensitive skin applications.

Regional Dynamics

• North America: Dominates the market due to a robust pharmaceutical infrastructure, high disease prevalence, and favorable regulatory policies.
• Europe: Exhibits strong growth driven by aging populations and expanding dermatological and bacterial infection treatment needs.
• Asia-Pacific: Anticipated to register the highest CAGR (~7%) through 2028, reflecting increasing healthcare expenditure, rising prevalence of skin disorders, and improving healthcare infrastructure, notably in China and India.

Market Challenges and Limitations

• Side Effects and Toxicity: Both drugs, especially when misused or overused, pose risks such as skin atrophy (hydrocortisone) and nephrotoxicity (neomycin).
• Antimicrobial Resistance (AMR): The rise of resistant bacterial strains threatens the efficacy of neomycin, prompting regulatory and clinical shifts towards combination therapy and stewardship programs.
• Generic Competition: The commoditization of hydrocortisone and neomycin in developed markets suppresses pricing, impacting profitability but expanding access.

Market Projection and Future Outlook

Forecast Overview (2023-2030)

• Hydrocortisone Market: Expected to grow at a CAGR of approximately 4-6%, reaching an estimated USD 9.3 billion to USD 10.6 billion by 2030. Innovations in topical delivery and expanded indications, including infant and sensitive skin formulations, underpin growth. The developing global awareness of dermatological health sustains demand.

• Neomycin Sulfate Market: Projected to expand at a CAGR of 5-8%, potentially reaching USD 20 billion by 2030, driven by novel formulations, combination therapies, and ongoing efforts to combat AMR. The rise in wound care applications and surgical prophylaxis further contributes to market expansion.

Emerging Opportunities

• Gene and RNA-based Delivery Systems: Integrating hydrocortisone and neomycin into advanced biotechnological platforms could revolutionize targeted therapy, reducing systemic toxicity.
• Biosimilars and Generics: Market entry of biosimilars and generics will stabilize prices, improve accessibility, and drive volume sales.
• Regulatory Approvals for New Indications: Expanding approved uses—such as for COVID-19-related inflammatory responses or multidrug-resistant bacterial infections—may boost revenues.

Risks and Considerations

• Regulatory Rigor: Stringent drug approval processes, especially for new formulations, may delay market entry.
• Supply Chain Constraints: Global manufacturing disruptions could affect drug availability.
• Resistance and Side Effects: Continued resistance or adverse events could restrain growth, emphasizing the need for innovation and stewardship.

Key Takeaways

• Clinical Trials Indicate Rising Innovation: Both hydrocortisone and neomycin are subjects of ongoing research focusing on enhanced formulations, novel delivery systems, and expanded indications, signaling sustained R&D investments.

• Market Growth Remains Robust: Driven by dermatological, infectious, and perioperative needs, the combined markets are poised for steady expansion through 2030, with Asia-Pacific leading growth.

• Innovation and Regulatory Developments Drive Opportunities: Advances in nanotechnology, combination therapies, and expanded approvals will generate demand, especially for complex or resistant infections and sensitive dermatological conditions.

• Challenges Persist: Antimicrobial resistance, side effect profiles, and market commoditization pose ongoing hurdles requiring strategic management, innovation, and stewardship programs.

• Strategic Focus for Stakeholders: Investment in novel formulations, targeted delivery systems, and clinical trials to demonstrate efficacy and safety remain critical for competitive advantage and market penetration.

FAQs

1. What are the recent advancements in hydrocortisone formulations?
Recent efforts focus on nanoemulsions, liposomal encapsulations, and hydrogels that improve skin penetration, reduce systemic absorption, and enhance anti-inflammatory efficacy, as shown in ongoing clinical trials (e.g., NCT04531245).

2. How is antibiotic resistance influencing the use of neomycin sulfate?
Rising resistance among Gram-negative bacteria has prompted innovation in combination therapies and novel drug delivery systems to sustain neomycin’s efficacy and expand its applications despite mounting resistance concerns.

3. What are the primary therapeutic areas driving market demand for these drugs?
Dermatology (eczema, psoriasis), infectious diseases (wound care, bacterial infections), and perioperative prophylaxis are the main segments propelling market growth for hydrocortisone and neomycin sulfate.

4. Are there any regulatory shifts impacting these drugs?
Yes. The FDA recently approved a hydrocortisone topical formulation with improved skin penetration (FDA, 2022). Ongoing clinical trials may lead to expanded indications and new approval pathways, particularly for resistant infections.

5. What is the outlook for biosimilars or generics for these drugs?
The commoditization trend for hydrocortisone and neomycin sulfate is expected to persist, leading to increased availability of biosimilars and generics, which will improve accessibility and sustain market growth, especially in developing regions.

Sources

[1] Market Data Forecast. (2022). Corticosteroids Market Size, Share & Trends Analysis Report.
[2] WHO. (2023). The Global Burden of Skin Diseases.
[3] FDA. (2022). Approval of New Hydrocortisone Formulation.
[4] ClinicalTrials.gov. (Various identifiers as cited).