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Last Updated: May 16, 2025

CLINICAL TRIALS PROFILE FOR GENTAMICIN SULFATE


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All Clinical Trials for Gentamicin Sulfate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00671528 ↗ Safety and Efficacy of Quadriderme® in the Treatment of Impetiginous Eczema (Study P05134AM4) Terminated Merck Sharp & Dohme Corp. Phase 4 2009-07-01 This is a parallel-group, randomized, active-controlled, double-blind, Phase 4 trial comparing three creams in the treatment of impetiginous eczema: - Arm A: QUADRIDERME® cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate) - Arm B: Combination of betamethasone diproprionate cream and gentamicin sulfate cream - Arm C: Betamethasone diproprionate cream At 7 sites, in Portugal, a total of 207 subjects will be randomized using a 1:1:1 randomization ratio to receive one of the three possible treatments for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days. Assessments will be made of level of improvement of the target area in each treatment group, number of days for total remission, and safety profile. Note: This study was terminated early due to lack of recruitment (only 3 of the 207 planned participants were enrolled). Statistical analyses were not performed. Further, 7 sites were planned, but only 4 sites were approved out of which 3 sites were initiated.
NCT01878643 ↗ Reduction of Bacterial Resistance With Inhaled Antibiotics in the Intensive Care Unit Completed Stony Brook University Early Phase 1 2001-12-01 The purpose of this study was : - to determine the effect of inhaled antibiotics on airway bacteria in ventilated patients - to determine the effect of inhaled antibiotics on respiratory infection
NCT02036528 ↗ Safety and Efficacy of Gentamicin Topical Gel (AppliGel-G) for Treatment of Mild to Moderately Infected Diabetic Foot Ulcers Terminated Royer Biomedical, Inc. Phase 1/Phase 2 2014-01-01 The purpose of this study is to determine whether AppliGel-G (Gentamicin topical gel) plus oral Ciprofloxacin / Doxycycline are safe and effective in the treatment of mild to moderately infected foot ulcers in diabetic patients.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Gentamicin Sulfate

Condition Name

Condition Name for Gentamicin Sulfate
Intervention Trials
Recessive Dystrophic Epidermolysis Bullosa 2
Spinal Cord Injuries 2
Neurogenic Bladder 2
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Condition MeSH

Condition MeSH for Gentamicin Sulfate
Intervention Trials
Epidermolysis Bullosa 4
Infections 3
Infection 3
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Clinical Trial Locations for Gentamicin Sulfate

Trials by Country

Trials by Country for Gentamicin Sulfate
Location Trials
United States 13
Kenya 1
China 1
Norway 1
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Trials by US State

Trials by US State for Gentamicin Sulfate
Location Trials
California 4
Michigan 2
Kentucky 1
Utah 1
Maryland 1
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Clinical Trial Progress for Gentamicin Sulfate

Clinical Trial Phase

Clinical Trial Phase for Gentamicin Sulfate
Clinical Trial Phase Trials
Phase 4 1
Phase 3 1
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Gentamicin Sulfate
Clinical Trial Phase Trials
Recruiting 5
Terminated 2
Completed 2
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Clinical Trial Sponsors for Gentamicin Sulfate

Sponsor Name

Sponsor Name for Gentamicin Sulfate
Sponsor Trials
University of Southern California 3
Stony Brook University 1
Medical Research Council 1
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Sponsor Type

Sponsor Type for Gentamicin Sulfate
Sponsor Trials
Other 20
Industry 2
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Gentamicin Sulfate: Clinical Trials, Market Analysis, and Projections

Introduction

Gentamicin sulfate, an aminoglycoside antibiotic, has been a cornerstone in the treatment of serious bacterial infections for decades. Here, we delve into the current state of clinical trials, market analysis, and future projections for this essential drug.

Clinical Trials Update

Gentamicin sulfate is continuously being evaluated in various clinical trials to expand its therapeutic applications and improve its safety profile.

  • Ongoing Trials: As of the latest data, there are multiple clinical trials associated with gentamicin sulfate. For instance, a trial listed as NCT06712641 is focused on neural regeneration research, highlighting the drug's potential in new therapeutic areas[1].
  • Phase 3 and Phase 4 Trials: Several Phase 3 trials are underway, including those combining gentamicin with other antibiotics like fluoroquinolones, cephalosporins, ampicillin, and clindamycin to treat a range of infections. Phase 4 trials, such as those involving heparin lock solutions, also indicate ongoing research into its efficacy and safety in different clinical settings[1].

Mechanism and Indications

Gentamicin sulfate works by inhibiting the 30S subunit of bacterial ribosomes, thereby preventing protein synthesis and leading to bacterial cell death.

  • Indications: It is indicated for serious infections caused by susceptible strains of bacteria, including Pseudomonas aeruginosa, Proteus species, Escherichia coli, and Staphylococcus species. It is effective in treating bacterial neonatal sepsis, septicemia, and infections of the central nervous system, urinary tract, respiratory tract, gastrointestinal tract, skin, bone, and soft tissue[4].

Market Analysis

The market for gentamicin sulfate is experiencing significant growth driven by several factors.

Market Size and Growth

  • The global gentamicin sulfate market is projected to grow at a remarkable CAGR from 2024 to 2031. This growth is attributed to increasing demand from the downstream sector, particularly in the pharmaceutical, nutraceutical, and healthcare industries[2][3][5].

Segmentation

  • The market is segmented based on type (e.g., 99% purity, 98% purity, 95% purity) and application (e.g., gentamicin sulfate eye drops, tablets, injections, granules, sustained-release tablets). Geographical regions such as North America, Europe, Asia-Pacific, South America, and the Middle East & Africa are also key segments[2][3].

Regional Demand

  • In Europe, particularly in Germany, there has been a moderate surge in inquiries for gentamicin sulfate since January 2023, driven by increased domestic consumption rates. Similar trends are observed in the United States and China, where production activities have resumed to meet the growing demand for antibiotics[5].

Market Dynamics

  • The market is influenced by drivers such as increasing antibiotic resistance, rising infections, and advancements in healthcare. However, restraints like potential toxicity and the need for susceptibility testing also play a role. Opportunities include expanding into new therapeutic areas and improving formulations to reduce side effects[2][3].

Projections and Future Outlook

Revenue Growth

  • The global gentamicin sulfate market is expected to achieve substantial revenue growth during the forecast period from 2024 to 2031. This is supported by the increasing demand for effective antibiotics and the ongoing research into new applications[2][3].

Application Trends

  • The hospital segment is anticipated to expand significantly, retaining its position throughout the forecast period. Key applications such as gentamicin sulfate ophthalmic ointment are also expected to grow, driven by their effectiveness in treating bacterial infections in the eye[3].

Competitive Landscape

  • Companies like Akorn and Pacific Pharma are focusing on strategy building and expanding their product portfolios to strengthen their market presence. This competitive landscape is expected to drive innovation and improve the availability of gentamicin sulfate products[3].

Key Factors Influencing Market Growth

End-User Demand

  • The consistent increase in end-user demand from the downstream sector, particularly in pharmaceutical and healthcare industries, is a significant driver of market growth[5].

Trade Activities

  • Ease in trade activities from export nations has also contributed to the upswing in gentamicin sulfate prices and demand[5].

Environmental Factors

  • Changes in environmental conditions, such as temperature fluctuations, have encouraged the growth and spread of various antibiotic-resistant infections, further boosting demand for gentamicin sulfate[5].

Conclusion

Gentamicin sulfate remains a vital antibiotic in the treatment of serious bacterial infections. With ongoing clinical trials exploring new therapeutic areas and a robust market analysis indicating significant growth, the future outlook for gentamicin sulfate is optimistic.

Key Takeaways

  • Clinical Trials: Ongoing trials are expanding the therapeutic applications of gentamicin sulfate.
  • Market Growth: The global market is projected to grow at a remarkable CAGR from 2024 to 2031.
  • Segmentation: The market is segmented by type, application, and geographical region.
  • Regional Demand: Europe, the United States, and China are key regions driving demand.
  • Market Dynamics: Increasing antibiotic resistance and healthcare advancements are key drivers.

FAQs

What is the mechanism of action of gentamicin sulfate?

Gentamicin sulfate inhibits the 30S subunit of bacterial ribosomes, preventing protein synthesis and leading to bacterial cell death[1][4].

What are the common indications for gentamicin sulfate?

Gentamicin sulfate is indicated for serious infections caused by susceptible strains of bacteria, including bacterial neonatal sepsis, septicemia, and infections of various body systems[4].

What is the current market trend for gentamicin sulfate?

The market is experiencing significant growth driven by increasing demand from the downstream sector and ease in trade activities from export nations[2][3][5].

Which regions are driving the demand for gentamicin sulfate?

Key regions include North America, Europe, Asia-Pacific, South America, and the Middle East & Africa, with notable demand in Germany, the United States, and China[2][3][5].

What are the potential restraints on the gentamicin sulfate market?

Potential toxicity and the need for susceptibility testing are significant restraints on the market[2][3].

Sources

  1. Synapse: Gentamicin Sulfate - Drug Targets, Indications, Patents.
  2. Market Research Intellect: Global Gentamycin Sulfate Market Size, Trends and Projections.
  3. Cognitive Market Research: Global Gentamicin Sulfate Ophthalmic Ointment Market Report 2024.
  4. Drugs.com: Gentamicin Sulfate: Package Insert / Prescribing Info.
  5. ChemAnalyst: Gentamicin Sulphate Market Follows an Upswing Trend Across the Globe.
Last updated: 2025-01-01

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