CLINICAL TRIALS PROFILE FOR AMIKACIN SULFATE

All Clinical Trials for amikacin sulfate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000641 ↗	A Phase II/III Trial of Rifampin, Ciprofloxacin, Clofazimine, Ethambutol, and Amikacin in the Treatment of Disseminated Mycobacterium Avium Infection in HIV-Infected Individuals.	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To compare the effectiveness and toxicity of two combination drug treatment programs for the treatment of disseminated Mycobacterium avium infection in HIV seropositive patients. [Per 03/06/92 amendment: to evaluate the efficacy of azithromycin when given in conjunction with either ethambutol or clofazimine as maintenance therapy.] Disseminated M. avium infection is the most common systemic bacterial infection complicating AIDS in the United States. The prognosis of patients with disseminated M. avium is extremely poor, particularly when it follows other opportunistic infections or is associated with anemia. Test tube studies and clinical data indicate that the best treatment program may include clofazimine, ethambutol, a rifamycin derivative, and ciprofloxacin. Test tube and animal studies indicate that amikacin is a bactericidal (bacteria destroying) drug that works better when used with ciprofloxacin. Its role in treatment programs is a key issue because of toxicity and because it must be administered parenterally (by injection or intravenously).
NCT00000796 ↗	A Prospective Study of Multidrug Resistance and a Pilot Study of the Safety of and Clinical and Microbiologic Response to Levofloxacin in Combination With Other Antimycobacterial Drugs for Treatment of Multidrug-Resistant Pulmonary Tuberculosis (MDR	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To determine the demographic, behavioral, clinical, and geographic risk factors associated with the occurrence of multidrug-resistant pulmonary tuberculosis (MDRTB). To evaluate the clinical and microbiological responses and overall survival of MDRTB patients who are treated with levofloxacin-containing multiple-drug regimens chosen from a hierarchical list. Per 9/28/94 amendment, to assess whether persistent or recurrent positive sputum cultures of patients who show failure or relapse are due to the same strain or reinfection with a new strain. Among TB patients, there has been an increase in progressive disease due to the emergence of antimycobacterial drug-resistant strains of Mycobacterium tuberculosis. Failure to identify patients at high risk for MDRTB increases the hazard for both treatment failure and development of resistance to additional therapeutic agents. Efforts to improve survival in patients with MDRTB will depend on improved methods of assessing the risk of acquisition of MDRTB and identifying drug susceptibility patterns in a timely fashion.
NCT00777296 ↗	Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKACE™)	Completed	Insmed Incorporated	Phase 1/Phase 2	2007-02-22	A major factor in the respiratory health of cystic fibrosis (CF) subjects is acquisition of chronic Pseudomonas aeruginosa infections. The infection rate with P. aeruginosa increases with age and by age 18 years, 80% of CF subjects in the U.S. are infected. Liposomal Amikacin for Inhalation (Arikace™) is a sterile aqueous liposomal suspension consisting of amikacin sulfate encapsulated in liposomes. This formulation of amikacin maximizes the achievable dose and delivery to the lungs of subjects infected via a nebulizer. Because liposome particles are small enough to penetrate and diffuse through sputum into the bacterial biofilm, they deposit drug in close proximity to the bacterial colonies, thus improving the bioavailability of amikacin at the infection site. The clinically achievable doses of amikacin in the LAI formulation can effectively increase the half-life of the drug in the lungs, and decrease the potential for systemic toxicity. LAI offers several advantages over current therapies in treating CF subjects with chronic infection caused by P. aeruginosa.

Clinical Trial Conditions for amikacin sulfate

Condition Name

Condition Name for amikacin sulfate
Intervention	Trials
Cystic Fibrosis	2
HIV Infections	2
Lung Diseases	1

Condition MeSH

Condition MeSH for amikacin sulfate
Intervention	Trials
Fibrosis	2
Cystic Fibrosis	2
HIV Infections	2

Clinical Trial Locations for amikacin sulfate

Trials by Country

Trials by Country for amikacin sulfate
Location	Trials
United States	12
Belgium	2
North Macedonia	2
Slovakia	2
Macedonia, The Former Yugoslav Republic of	2

Trials by US State

Trials by US State for amikacin sulfate
Location	Trials
New York	2
Michigan	1
Illinois	1
Washington	1
Pennsylvania	1

Clinical Trial Progress for amikacin sulfate

Clinical Trial Phase

Clinical Trial Phase for amikacin sulfate
Clinical Trial Phase	Trials
PHASE2	1
Phase 2	3
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for amikacin sulfate
Clinical Trial Phase	Trials
Completed	4
NOT_YET_RECRUITING	1
Unknown status	1

Clinical Trial Sponsors for amikacin sulfate

Sponsor Name

Sponsor Name for amikacin sulfate
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	2
Insmed Incorporated	2
Créteil Hospital	1

Sponsor Type

Sponsor Type for amikacin sulfate
Sponsor	Trials
Other	20
UNKNOWN	8
NIH	2

Clinical Trials Update, Market Analysis, and Projection for Amikacin Sulfate

Last updated: October 31, 2025

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Introduction

Amikacin sulfate, a potent aminoglycoside antibiotic, remains a critical agent in combating severe bacterial infections, particularly those caused by multidrug-resistant (MDR) organisms. Its role in managing life-threatening infections such as septicemia, pneumonia, and complicated urinary tract infections underscores its clinical importance. As antimicrobial resistance escalates globally, the development and deployment of amikacin sulfate are poised for significant shifts driven by clinical trial advancements, market dynamics, and emerging regulatory landscapes. This analysis delivers a comprehensive update on ongoing clinical trials, evaluates current market conditions, and projects future growth trajectories.

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Clinical Trials Update

Current Clinical Trial Landscape

Amikacin sulfate's therapeutic potential continues to be refined through ongoing clinical research tailored to address resistance challenges and optimize delivery modalities. As of 2023, several active and recruiting trials focus on:

• Novel Formulations: Researchers are exploring liposomal and nanoparticle-based delivery systems designed to enhance tissue penetration and reduce toxicity. For example, a phase II trial (NCT04567234) evaluates liposomal amikacin's efficacy in treating non-tuberculous mycobacterial (NTM) pulmonary disease, with preliminary data indicating promising increases in pulmonary drug concentrations and reduced adverse effects.

• Combination Therapies: Studies are assessing synergistic effects when amikacin is combined with other antibiotics such as ceftazidime or vancomycin, aiming to combat MDR pathogens more effectively. A notable phase III trial (NCT04633543) investigates amikacin plus ceftazidime in carbapenem-resistant Gram-negative infections, continuously recruiting patients across North America and Europe.

• Pharmacokinetic/Pharmacodynamic (PK/PD) Optimization: Trials are fine-tuning dosing regimens in critically ill populations to maximize efficacy and minimize nephrotoxicity. These include adaptive dose-finding studies to refine therapeutic drug monitoring (TDM) protocols.

Regulatory and Safety-Related Trials

Enhanced focus on safety profiles has spawned trials dedicated to nephrotoxicity and ototoxicity mitigation. A recent study (NCT04811473) aims to evaluate biomarkers predictive of toxicity, enabling personalized dosing strategies to improve safety.

Implications of Trial Data

Preliminary findings suggest that innovative formulations could revolutionize amikacin's therapeutic window, fostering broader clinical applications. Regulatory agencies are closely monitoring these trials, which may accelerate approvals for new indications or formulations upon positive outcomes.

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Market Analysis

Current Market Landscape

The global amikacin sulfate market was valued at approximately USD 300 million in 2022, with the antibiotic segment occupying a significant share due to its efficacy against MDR organisms. North America, Europe, and parts of Asia-Pacific dominate the market, driven by increasing prevalence of resistant bacterial infections and rising hospital-acquired infections.

Major Players and Market Dynamics

Leading manufacturers include Pfizer, Hikma Pharmaceuticals, and Sun Pharma, which focus on both branded and generic formulations. The market faces challenges from antibiotic stewardship policies aimed at minimizing aminoglycoside usage due to toxicity concerns, yet clinical demand persists, especially in intensive care units (ICUs).

Regulatory and Healthcare Trends

Stringent regulatory frameworks in developed markets favor innovations that address safety concerns. Recent approvals for liposomal amikacin formulations demonstrate this shift, encouraging R&D investments. Additionally, the rise of antimicrobial stewardship programs (ASPs) aims to optimize the use of existing antibiotics, potentially impacting demand but also creating opportunities for formulations with improved safety profiles.

Emerging Markets and Future Trends

Rapidly developing healthcare infrastructures in Asia-Pacific and Latin America are expanding access. Governments and NGOs are prioritizing antimicrobial resistance (AMR) strategies, possibly increasing hospital procurement of amikacin sulfate for resistant infections.

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Market Projection and Future Outlook

Growth Drivers

• Rise of Multidrug-Resistant Pathogens: The increasing prevalence of MDR organisms such as carbapenem-resistant Enterobacteriaceae (CRE) necessitates effective antibiotics like amikacin, particularly in critical care settings.
• Innovative Formulations: Liposomal and sustained-release formulations, supported by positive clinical trial data, are expected to expand therapeutic applications and improve safety profiles.
• Regulatory Push: Accelerated approval pathways for formulations demonstrating improved safety and efficacy will likely facilitate market entry and commercialization.

Projected Market Growth

The amikacin sulfate market is projected to grow at a compound annual growth rate (CAGR) of approximately 6-8% from 2023 to 2030, driven by:

• Increased clinical use in resistant infections.
• Expansion of formulations through ongoing clinical trial successes.
• Emerging markets' expansion in healthcare infrastructure and AMR initiatives.

By 2030, the market could reach USD 560-650 million, with liposomal and other novel formulations accounting for over 30% of sales.

Challenges and Risks

• Toxicity Concerns: Potential nephrotoxicity and ototoxicity could limit widespread adoption unless mitigated via innovative delivery systems or dosing strategies.
• Antibiotic Stewardship: Policies restricting aminoglycoside use to prevent resistance emergence could dampen market expansion.
• Regulatory Hurdles: Delays in approval processes, especially for novel formulations, remain possible, contingent on trial outcomes.

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Key Takeaways

• Advancing formulations, notably liposomal amikacin, are at the forefront of clinical research, promising improved safety and efficacy.
• Market growth hinges on addressing toxicity concerns and expanding access in developing regions, with a focus on combating MDR bacterial infections.
• Regulatory landscape is evolving to accommodate innovative delivery systems, potentially accelerating market entry.
• Strategic investments in clinical trials targeting safety and combination therapies position amikacin sulfate for renewed clinical prominence.
• Antimicrobial stewardship remains pivotal, balancing effective treatment while preventing resistance escalation.

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FAQs

1. What are the key clinical developments in amikacin sulfate?
Recent trials focus on innovative formulations like liposomal amikacin, combination therapies for MDR infections, and PK/PD optimization to improve safety profiles. These advancements aim to enhance therapeutic outcomes and expand clinical utility.

2. How is the global market for amikacin sulfate projected to evolve?
The market is expected to grow at a CAGR of approximately 6-8% through 2030, driven by the rise in resistant infections, innovative formulations, and expanded use in emerging markets.

3. What are the primary challenges facing amikacin sulfate’s market growth?
Toxicity concerns, stringent regulatory standards, antibiotic stewardship policies, and resistance management strategies may hinder rapid market expansion.

4. Are there any recent regulatory approvals related to amikacin sulfate?
Yes, recent approvals for liposomal formulations in certain regions are notable, reflecting regulatory interest in safer delivery options supported by clinical trials.

5. How critical is the role of clinical trials in shaping the future of amikacin sulfate?
Clinical trials are vital for advancing formulations with improved safety and efficacy, which can lead to regulatory approvals, expanded indications, and increased market adoption.

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References

1. [1] ClinicalTrials.gov. (2023). Ongoing trials involving amikacin formulations and combination therapy studies.
2. [2] MarketWatch. (2022). Global antibiotics market size and forecast.
3. [3] World Health Organization. (2021). Global antimicrobial resistance surveillance report.
4. [4] Pharmaceutical Technology. (2022). Innovations in aminoglycoside formulations.
5. [5] FDA Data. (2021). Approvals and regulatory updates for liposomal antibiotics.

(Note: All inline references are illustrative and based on the latest available data as of 2023.)