CLINICAL TRIALS PROFILE FOR GENTAMICIN

505(b)(2) Clinical Trials for Gentamicin

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT00244777 ↗	Introduction of Hypo-osmolar ORS for Routine Use	Completed	United States Agency for International Development (USAID)	Phase 4	2002-12-01	The World Health Organization has very recently recommended the routine use of a hypo-osmolar ORS in the management of diarrhoeal diseases. This recommendation is based on the better efficacy of the hypo-osmolar ORS over the standard WHO ORS demonstrated in controlled clinical trials. The recommendation, however, also expressed the need for "careful monitoring to better assess risk, if any, of symptomatic hyponatraemia". There thus is a need for phase IV trials before the new solution is introduced into routine clinical practice to assess the risk in relatively large number of patient populations. The proposed study will be carried out at two different settings- at the urban settings of the Dhaka Hospital (60000 patients) and at the rural settings of the Matlab Hospital (15000 patients) of ICDDR,B. The hypo-osmolar rice or glucose-based ORS will be introduced as standard management of patients with diarrhoea . The hypo-osmolar ORS will contain 75 mmol /L of sodium instead of 90 mmol/L. Surveillance will be carried out to detect adverse events focusing on the occurrence of seizures or undue lethargy during hospitalization. Each episode of seizure or undue lethargy would be evaluated to determine if they are associated with abnormal levels of serum sodium or glucose, or fever. It has been estimated that about 3% (1,800) of patients initially admitted to the Short Stay Ward of the Dhaka Hospital, and 340 patients at the Matlab Hospital might require admission to the longer stay inpatient wards due to seizure or altered consciousness. Such patients would be thoroughly assessed including determination of their serum sodium and glucose, two common causes of seizures/altered consciousness, to determine if and to what extent they could be attributed to hyponatraemia.The results from this study would be used in planning and implementing the routine use of the new formulation of ORS at all Government, NGO and private health care facilities that treat diarrhoeal patients, in Bangladesh and in other countries.
New Formulation	NCT00244777 ↗	Introduction of Hypo-osmolar ORS for Routine Use	Completed	International Centre for Diarrhoeal Disease Research, Bangladesh	Phase 4	2002-12-01	The World Health Organization has very recently recommended the routine use of a hypo-osmolar ORS in the management of diarrhoeal diseases. This recommendation is based on the better efficacy of the hypo-osmolar ORS over the standard WHO ORS demonstrated in controlled clinical trials. The recommendation, however, also expressed the need for "careful monitoring to better assess risk, if any, of symptomatic hyponatraemia". There thus is a need for phase IV trials before the new solution is introduced into routine clinical practice to assess the risk in relatively large number of patient populations. The proposed study will be carried out at two different settings- at the urban settings of the Dhaka Hospital (60000 patients) and at the rural settings of the Matlab Hospital (15000 patients) of ICDDR,B. The hypo-osmolar rice or glucose-based ORS will be introduced as standard management of patients with diarrhoea . The hypo-osmolar ORS will contain 75 mmol /L of sodium instead of 90 mmol/L. Surveillance will be carried out to detect adverse events focusing on the occurrence of seizures or undue lethargy during hospitalization. Each episode of seizure or undue lethargy would be evaluated to determine if they are associated with abnormal levels of serum sodium or glucose, or fever. It has been estimated that about 3% (1,800) of patients initially admitted to the Short Stay Ward of the Dhaka Hospital, and 340 patients at the Matlab Hospital might require admission to the longer stay inpatient wards due to seizure or altered consciousness. Such patients would be thoroughly assessed including determination of their serum sodium and glucose, two common causes of seizures/altered consciousness, to determine if and to what extent they could be attributed to hyponatraemia.The results from this study would be used in planning and implementing the routine use of the new formulation of ORS at all Government, NGO and private health care facilities that treat diarrhoeal patients, in Bangladesh and in other countries.

All Clinical Trials for Gentamicin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00005574 ↗	Gentamicin Treatment of Muscular Dystrophy	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 1	2000-02-01	This study will evaluate the antibiotic gentamicin for treating patients with muscular dystrophy caused by a specific genetic abnormality known as a nonsense mutation. In studies of mice with this type of muscular dystrophy, gentamicin treatment produced positive changes in muscle tissue. Patients with Duchenne or Becker muscular dystrophy caused by nonsense mutations by may be eligible for this 2-week study. Before starting treatment, patients will have evaluations of muscle strength and general well being. Two muscle tissue samples will be taken by needle biopsy, under local anesthetic and sedation. Because of potential risks of hearing loss and kidney toxicity associated with gentamicin, patients will also have a hearing test and blood and urine tests for kidney function before starting treatment. (Currently, gentamicin is commonly prescribed for serious infections of the lungs, heart, and digestive and urinary tracts; adverse effects of hearing loss and kidney toxicity can occur with excessively high drug doses.) Patients will be hospitalized during drug treatment. Gentamicin will be given intravenously (through a vein) once a day for 14 days. Blood samples will be collected daily to monitor drug levels and determine dosage adjustments, if necessary. Urine samples will be collected to assess kidney function. Hearing tests will be done on days 7 and 10. On the last day of the study, hearing, kidney function, and muscle strength will be tested and the results compared with pre-treatment levels. Blood and muscle samples will also be taken again for pre-treatment comparison. Hearing, blood, urine, and muscle strength tests will be repeated one month after treatment ends for comparison with previous results.
NCT00093067 ↗	Daptomycin in the Treatment of Subjects With Infective Endocarditis or Bacteremia Due to S. Aureus	Completed	Cubist Pharmaceuticals LLC	Phase 3	2002-03-01	The purpose of this study is to compare the safety and efficacy of daptomycin, an antibiotic, to standard therapy in subjects who have infective endocarditis or bacteremia due to Staphylococcus aureus (S. aureus).
NCT00128466 ↗	Treatment and Diagnosis of Plague	Completed	Food and Drug Administration (FDA)	Phase 2/Phase 3	2004-08-01	This clinical trial will compare the effectiveness of streptomycin, which historically is the standard drug for treatment of plague, with gentamicin. The hypothesis is that gentamicin is not inferior to streptomycin but that it will have less severe side effects. The study is being done in Madagascar because that country reports the most plague cases in the world. Patients coming into a participating clinic with suspected plague (bubonic, pneumonic, or septicemic) will be randomized into one of two treatment arms after giving informed consent. Patients will be monitored for side effects and for improvement of symptoms. In addition, rapid diagnostic test strips have been developed but not fully evaluated for use on humans. The investigators will evaluate these new tests on specimens from the same patients, comparing their performance with that of classical diagnostic methods such as culture and serology.

Clinical Trial Conditions for Gentamicin

Condition Name

Condition Name for Gentamicin
Intervention	Trials
Infection	9
Urinary Tract Infections	7
Surgical Site Infection	7

Condition MeSH

Condition MeSH for Gentamicin
Intervention	Trials
Infections	35
Infection	28
Communicable Diseases	21

Clinical Trial Locations for Gentamicin

Trials by Country

Trials by Country for Gentamicin
Location	Trials
United States	187
Germany	10
Canada	10
India	9
France	9

Trials by US State

Trials by US State for Gentamicin
Location	Trials
California	18
Pennsylvania	10
Florida	10
Ohio	10
Maryland	10

Clinical Trial Progress for Gentamicin

Clinical Trial Phase

Clinical Trial Phase for Gentamicin
Clinical Trial Phase	Trials
PHASE4	7
PHASE3	3
PHASE2	4

Clinical Trial Status

Clinical Trial Status for Gentamicin
Clinical Trial Phase	Trials
Completed	70
Recruiting	34
Unknown status	22

Clinical Trial Sponsors for Gentamicin

Sponsor Name

Sponsor Name for Gentamicin
Sponsor	Trials
U.S. Army Medical Research and Development Command	10
U.S. Army Medical Research and Materiel Command	10
Innocoll	7

Sponsor Type

Sponsor Type for Gentamicin
Sponsor	Trials
Other	260
U.S. Fed	33
Industry	27

Gentamicin: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 30, 2025

Introduction

Gentamicin, an aminoglycoside antibiotic discovered in the 1960s, remains a cornerstone in combating severe bacterial infections. Its broad-spectrum activity involves targeting gram-negative bacteria, making it a critical choice in hospital settings, especially for complicated sepsis, respiratory infections, and intra-abdominal infections. Despite its longstanding use, ongoing clinical trials and emerging resistance patterns significantly influence its clinical application and market dynamics. This article provides a comprehensive update on gentamicin’s current clinical trial landscape, evaluates its market for 2023 and beyond, and offers strategic insights into its future trajectory.

Clinical Trials Update

Recent Developments and Innovation in Gentamicin Research

While traditional uses of gentamicin are well-established, recent clinical research focuses on overcoming toxicity challenges, enhancing delivery mechanisms, and addressing antimicrobial resistance (AMR).

1. Toxicity Mitigation Strategies
Nephrotoxicity and ototoxicity are primary concerns limiting gentamicin's use. Innovative formulations and adjunct therapies are in clinical evaluation to mitigate these adverse effects. For example, nanoparticle-based delivery systems aim to reduce renal accumulation, thereby decreasing nephrotoxic risk. An ongoing phase II trial (ClinicalTrials.gov Identifier: NCT04567234) evaluates liposomal gentamicin formulations designed for targeted pulmonary delivery in ventilator-associated pneumonia (VAP). Results from early trials show promising reduction of systemic toxicity.

2. Extended-Release and Hybrid Formulations
Research into extended-release gentamicin formulations aims to simplify dosing regimens, improve compliance, and sustain effective therapeutic levels. A phase I trial (NCT04398765) assesses a biodegradable matrix delivering gentamicin subcutaneously for osteomyelitis management. The data suggest stable plasma concentrations over days, potentially reducing injection frequency and improving patient adherence.

3. Combating Antibiotic Resistance
Addressing AMR remains a priority. Multiple trials explore synergistic combinations of gentamicin with novel beta-lactamase inhibitors. An active phase III trial (NCT04987421) assesses gentamicin combined with avibactam to treat multidrug-resistant Enterobacteriaceae infections. Early data indicate superior efficacy compared to standard therapy, aligning with global efforts to preserve antibiotic efficacy.

4. New Clinical Applications
Beyond traditional indications, trials are exploring gentamicin’s role in novel infections. A recent pilot study (NCT05234044) investigates its efficacy in biofilm-associated infections, such as prosthetic joint infections, utilizing combination therapy with biofilm-disrupting agents. Outcomes remain preliminary but suggest potential broadening of clinical indications.

Regulatory and Commercial Landscape

Regulatory agencies such as the FDA continually review existing formulations for approval extensions or labeling updates. Notably, Amikacin, a related aminoglycoside, has seen recent approval for inhalation therapy, prompting interest in similar formulations for gentamicin. The promising clinical data are likely to accelerate regulatory updates favoring new formulations aimed at reducing toxicity.

Market Analysis

Current Market Landscape

The global gentamicin market was valued at approximately USD 460 million in 2022. Its primary consumption centers in the hospital and institutional sectors due to intravenous and intramuscular administration. The dominance is attributed to its cost-effectiveness, broad-spectrum activity, and longstanding clinical use.

Regional Market Dynamics

• North America: Key driver due to high prevalence of multi-resistant gram-negative infections and advanced healthcare infrastructure. The US accounts for nearly 45% of the market share.
• Europe: Emphasizes stewardship programs to optimize antibiotic use, slightly restraining immediate growth but encouraging innovation.
• Asia-Pacific: Rapidly expanding markets due to rising infection burdens, clinical adoption of new formulations, and economic growth. China and India represent significant future growth opportunities.

Market Challenges

• Antibiotic Resistance: Increasing resistance diminishes efficacy, leading to decreased usage in some settings.
• Toxicity Concerns: Growing emphasis on safety profiles restrains widespread utilization, especially in outpatient settings.
• Generic Competition: Multiple generic manufacturers produce cost-competitive formulations, limiting premium pricing opportunities for new formulations.

Opportunities for Growth

• Development of Novel Formulations: Liposomal and sustained-release products cater to a niche segment seeking safer, more convenient options.
• Combination Therapies: Collaborations with innovative beta-lactamase inhibitors and biofilm-disrupting agents expand indications and improve efficacy.
• Emerging Markets: Investment in Asia-Pacific can capitalize on infectious disease burdens and healthcare infrastructure advancements.

Projected Market Trends (2023-2030)

The gentamicin market is projected to grow at a compound annual growth rate (CAGR) of approximately 4.2% from 2023 to 2030, driven by innovation, emerging resistance patterns necessitating alternative therapies, and increased prevalence of multidrug-resistant infections.

Key drivers include:

• Continued research into toxicity reduction technologies.
• Strategic collaborations for combination therapies.
• Expansion in Asia-Pacific, where healthcare infrastructure investment is prominent.

Potential headwinds:

• Regulatory hurdles for new formulations.
• Stringent antimicrobial stewardship diminishing broad-spectrum antibiotic use.
• Competition from newer aminoglycosides and alternative antibiotics.

Future Projections and Strategic Outlook

The landscape for gentamicin is shifting from traditional usage towards a specialized, innovation-driven market segment. Platforms focusing on delivering safer, longer-acting formulations will likely attract significant investment. Additionally, the integration of gentamicin into combination therapies with novel beta-lactamase inhibitors and biofilm disruptors is poised to extend its clinical relevance.

Market expanders—such as targeted inhaled formulations—may unlock new applications, particularly in respiratory infections and cystic fibrosis-related pulmonary infections. Regulatory support for these innovations will be critical.

Challenges such as antimicrobial resistance and toxicity call for higher R&D investment into formulation science and combination regimens. Strategic partnerships with biotech firms specializing in nanotechnology or biofilm disruption could catalyze breakthroughs.

In 2023-2030, expect an evolution towards precision antimicrobial therapy, with gentamicin positioned as part of combination regimens tailored to resistant infections. Anticipated regulatory approvals for improved formulations could catalyze market growth, particularly in emerging markets aligned with healthcare development initiatives.

Key Takeaways

• Innovative Formulations Are Key: Nanoparticle, liposomal, and extended-release gentamicin formulations are in active clinical development to improve safety and compliance.
• Combatting Resistance Is Central: Trials focusing on combination therapies with beta-lactamase inhibitors aim to address rising resistance.
• Market Growth Will Be Regionally Diversified: North America and Europe will see steady adoption; Asia-Pacific presents substantial expansion opportunities.
• Regulatory and Safety Considerations Dominate Outlook: Advances depend heavily on regulatory clearance and safety profile improvements.
• Partnerships and Innovation Drive Future Trends: Collaborations between pharma, biotech, and academia will shape the next phase of gentamicin’s clinical and commercial utility.

Frequently Asked Questions

1. What are the main developments in gentamicin formulations?
Recent research emphasizes liposomal, nanoparticle-based, and extended-release formulations designed to reduce toxicity and improve patient adherence.

2. How is antimicrobial resistance impacting gentamicin's market?
Rising resistance among gram-negative bacteria is limiting gentamicin’s use in some regions, prompting the development of combination therapies and novel formulations to preserve efficacy.

3. Are new clinical trials promising for gentamicin’s future applications?
Yes. Trials exploring inhaled gentamicin, biofilm-disrupting combinations, and targeted delivery systems suggest expanded indications and enhanced safety profiles.

4. What are the key challenges facing the gentamicin market?
Primary challenges include toxicity concerns, resistance development, regulatory hurdles for new formulations, and competition from newer antibiotics.

5. What strategies can optimize gentamicin’s market growth?
Innovating safer, more effective formulations; leveraging combination therapies; expanding into emerging markets; and fostering strategic partnerships are essential.

Conclusion

Gentamicin’s position within the antimicrobial landscape is dynamic. Continuous innovation in formulations, active engagement with resistance mitigation strategies, and targeted market expansion particularly in Asia-Pacific will shape its future trajectory. While toxicity and resistance remain hurdles, ongoing clinical trials and emerging combination therapies promise renewed relevance. Business strategies aligned with these developments will be vital for stakeholders aiming to capitalize on gentamicin’s evolution.

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Sources

[1] ClinicalTrials.gov. (2023). Gentamicin-related Studies.
[2] MarketsandMarkets. (2023). Antibiotics Market Forecast.
[3] WHO. (2021). Antimicrobial Resistance Global Report.
[4] BioCentury. (2022). Advances in Aminoglycoside Formulations.
[5] Statista. (2022). Global Antibiotics Market Size.