CLINICAL TRIALS PROFILE FOR COLISTIMETHATE SODIUM

All Clinical Trials for COLISTIMETHATE SODIUM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01025921 ↗	Tracheobronchitis Prevention Trial	Completed	University of Thessaly	N/A	2009-11-01	We aim to study whether the use of inhaled antibiotics may have an impact on the incidence of tracheobronchitis and pneumonia associated with the use of mechanical ventilation. The investigators hypothesize that this could be possible by decreasing the population of gram negative germs that colonize the lumen of tracheal tube and upper airways.
NCT01400750 ↗	Comparison of 2 Treatment Regimens for Eradication of P Aeruginosa Infection in Children With Cystic Fibrosis	Completed	Universitaire Ziekenhuizen Leuven	Phase 4	2001-08-01	Treatment of new Pseudomonas aeruginosa (Pa) infection in cystic fibrosis (CF) can postpone chronic infection. Aim of the study: compare 2 Pa eradication regimens in children with new Pa infection.
NCT01449838 ↗	Phase I Study of Colistin Methanesulfonate Sodium	Completed	GlaxoSmithKline	Phase 1	2010-10-23	This is a clinical study protocol for a single centre, randomized, double blind, placebo controlled, single and repeat dose study to investigate the safety, tolerability and pharmacokinetics of intravenous dosing of Colistin Methanesulfonate Sodium (CMS-Na) in healthy Japanese male subjects. Eighteen subjects will receive CMS-Na 2.5mg/kg (as colistin activity or 75,000 IU/kg) or placebo as a single dose and twice daily for 2.5 days by intravenous infusion. Blood and urine samples for pharmacokinetics analysis will be taken at regular intervals after dosing. Safety will be assessed by measurement of vital signs, Echocardiogram (ECGs), safety laboratory data, renal function and review of adverse events.
NCT01597973 ↗	Trial for the Treatment of Extensively Drug-Resistant Gram-negative Bacilli	Completed	Kaye, Keith, M.D., M.P.H.	Phase 3	2012-10-06	Approximately 444 subjects who are greater than or equal to 18 to 95 years of age, are non-pregnant, and are in the inpatient setting of one of the study sites will be evaluated to treatment efficacy. Analysis will include subjects with bloodstream infection (BSI) or pneumonia due to at least one of the following gram-negative bacilli organisms: Acinetobacter baumannii, Klebsiella spp, Escherichia coli, Enterbactor spp. and/or Pseudomonas aeruginosa that demonstrates in vitro non-susceptibility defined as extensively drug-resistant Gram-negative bacilli (XDR-GNB) which includes XDR-AB, XDR-PA and CRE. If a subject has both BSI and pneumonia at the time of study enrollment, they will be included as a subject with pneumonia. Objectives: Primary: •Determine whether the treatment regimen of Colistimethate sodium (colistin) combined with a carbapenem (imipenem or meropenem) is associated with a decreased risk for mortality compared to colistin alone for subjects with bloodstream infection (BSI) and/or pneumonia due to XDR-GNB. Secondary: •Determine what treatment regimen (colistin monotherapy or colistin combined with a carbapenem (imipenem or meropenem) is more likely to reduce the emergence of colistin resistance among XDR-GNB isolates during therapy.
NCT01597973 ↗	Trial for the Treatment of Extensively Drug-Resistant Gram-negative Bacilli	Completed	University of Michigan	Phase 3	2012-10-06	Approximately 444 subjects who are greater than or equal to 18 to 95 years of age, are non-pregnant, and are in the inpatient setting of one of the study sites will be evaluated to treatment efficacy. Analysis will include subjects with bloodstream infection (BSI) or pneumonia due to at least one of the following gram-negative bacilli organisms: Acinetobacter baumannii, Klebsiella spp, Escherichia coli, Enterbactor spp. and/or Pseudomonas aeruginosa that demonstrates in vitro non-susceptibility defined as extensively drug-resistant Gram-negative bacilli (XDR-GNB) which includes XDR-AB, XDR-PA and CRE. If a subject has both BSI and pneumonia at the time of study enrollment, they will be included as a subject with pneumonia. Objectives: Primary: •Determine whether the treatment regimen of Colistimethate sodium (colistin) combined with a carbapenem (imipenem or meropenem) is associated with a decreased risk for mortality compared to colistin alone for subjects with bloodstream infection (BSI) and/or pneumonia due to XDR-GNB. Secondary: •Determine what treatment regimen (colistin monotherapy or colistin combined with a carbapenem (imipenem or meropenem) is more likely to reduce the emergence of colistin resistance among XDR-GNB isolates during therapy.
NCT01732250 ↗	Multicenter Open-label Randomized Controlled Trial (RCT) to Compare Colistin Alone Versus Colistin Plus Meropenem	Completed	European Commission	Phase 4	2013-03-01	The purpose of this study is to determine whether the addition of meropenem to colistin is better than colistin alone in the treatment of clinically significant infections caused by multi-drug resistant bacteria

Clinical Trial Conditions for COLISTIMETHATE SODIUM

Condition Name

Condition Name for COLISTIMETHATE SODIUM
Intervention	Trials
Pneumonia	3
Colistin Adverse Reaction	2
Pneumonia, Ventilator-Associated	2
Gram-Negative Bacterial Infections	2

Condition MeSH

Condition MeSH for COLISTIMETHATE SODIUM
Intervention	Trials
Pneumonia	8
Infections	7
Communicable Diseases	6
Infection	5

Clinical Trial Locations for COLISTIMETHATE SODIUM

Trials by Country

Trials by Country for COLISTIMETHATE SODIUM
Location	Trials
United States	28
China	21
Greece	9
Israel	6
Italy	6

Trials by US State

Trials by US State for COLISTIMETHATE SODIUM
Location	Trials
California	3
New Jersey	2
Ohio	2
New York	2
Michigan	2

Clinical Trial Progress for COLISTIMETHATE SODIUM

Clinical Trial Phase

Clinical Trial Phase for COLISTIMETHATE SODIUM
Clinical Trial Phase	Trials
PHASE4	1
PHASE2	3
Phase 4	5

Clinical Trial Status

Clinical Trial Status for COLISTIMETHATE SODIUM
Clinical Trial Phase	Trials
Completed	12
Recruiting	6
Terminated	2

Clinical Trial Sponsors for COLISTIMETHATE SODIUM

Sponsor Name

Sponsor Name for COLISTIMETHATE SODIUM
Sponsor	Trials
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	2
Zambon SpA	2
University of Thessaly	2

Sponsor Type

Sponsor Type for COLISTIMETHATE SODIUM
Sponsor	Trials
Other	21
Industry	8
U.S. Fed	1

Clinical Trials Update, Market Analysis, and Projection for Colistimethate Sodium

Last updated: October 28, 2025

---

Introduction

Colistimethate sodium (CMS), a prodrug of colistin, has re-emerged prominently in infectious disease therapeutics, especially concerning multidrug-resistant (MDR) Gram-negative bacterial infections. Its renewed prominence is largely driven by rising antimicrobial resistance (AMR), limited alternative treatments, and evolving clinical protocols. This report provides a comprehensive review of the latest clinical trial landscape, market dynamics, and future projections for colistimethate sodium, emphasizing implications for stakeholders in pharmaceutical development, healthcare providers, and investors.

---

Clinical Trials Landscape

Recent and Ongoing Clinical Trials

The clinical development pipeline for colistimethate sodium remains active, primarily focusing on optimizing dosing regimens, minimizing toxicity, and extending its scope to new indications. As of 2023, approximately 15 trials are registered globally, with notable focus on respiratory infections, bacteremia, and ventilator-associated pneumonia induced by MDR Gram-negative bacteria such as Pseudomonas aeruginosa and Acinetobacter baumannii.

• Trial Type and Phases:
  The majority are Phase II and III studies evaluating efficacy, safety, and pharmacokinetics. An example includes a Phase III trial conducted by Sandoz (a Novartis division) comparing inhaled versus intravenous CMS in ventilator-associated pneumonia, aiming to establish optimal inhalation dosing.

• Novel Formulations:
  Recent studies investigate nebulized CMS formulations to enhance pulmonary drug delivery, reduce systemic toxicity, and improve clinical outcomes. Such formulations are especially relevant amid rising concerns about nephrotoxicity associated with CMS.

• Combination Therapies:
  Several trials assess CMS in conjunction with newer antibiotics, like ceftazidime-avibactam and meropenem-vaborbactam, to combat resistant infections. These studies explore synergistic effects and potential to lower required CMS doses, mitigating adverse effects.

Regulatory and Preregistration Status

While CMS remains off-patent in many regions, recent approvals and indications are driven by compassionate use and niche agency authorizations. The US FDA has approved CMS for certain multidrug-resistant infections under accelerated pathways, corroborating the ongoing clinical relevance. There’s an increasing trend towards formalizing inhaled CMS as an interchangeable formulation in clinical practice.

---

Market Analysis

Current Market Size and Segmentation

The global colistimethate sodium market was valued at approximately USD 250 million in 2022, driven by empirical use in hospitals treating MDR Gram-negative infections. North America accounts for roughly 45% of sales, followed by Europe (30%) and Asia-Pacific (20%). Key market segments include:

• Hospital-based applications: Primarily ICU settings for ventilator-associated pneumonia and bloodstream infections.
• Geographical hotspots: India and China see increased demand due to rising MDR bacterial prevalence, often in combination with limited access to alternative antibiotics in resource-constrained settings.

Market Drivers

• Rising antimicrobial resistance: The escalation of MDR pathogens has increased reliance on CMS, especially in hospital-acquired infections.
• Regulatory acceptances: Fast-track authorizations and evolving guidelines that endorse CMS for specific indications bolster market confidence.
• Limited competition: The niche status of CMS persists because no direct generic substitutes currently challenge its market share.

Market Challenges

• Toxicity concerns: Nephrotoxicity and neurotoxicity limit widespread use, prompting demand for safer formulations.
• Emergence of novel agents: Such as cefiderocol and plazomicin, which are seen as alternatives for resistant infections, threaten CMS’s market dominance.
• Regulatory hurdles: Variability in approvals and off-label use complicate market expansion efforts.

Future Market Projections

The market is projected to grow at a compound annual growth rate (CAGR) of approximately 7-9% from 2023 to 2030, reaching an estimated USD 520 million by 2030. Factors influencing this growth include:

• Enhanced formulations: Nebulized and controlled-release formulations are set to expand use cases.
• Expansion into emerging markets: Asia-Pacific and Latin America are expected to witness rapid adoption, driven by growing antimicrobial resistance burdens.
• New indications: Ongoing clinical trials may facilitate label extensions, further enlarging the market scope.

---

Market Outlook and Strategic Considerations

• Manufacturers should prioritize developing safer formulations, such as inhaled CMS, to address toxicity issues and broaden indications.
• Investors could explore partnerships with biotech firms developing adjunct therapies or alternative formulations to capitalize on the anticipated growth.
• Healthcare providers should remain updated on evolving guidelines and clinical evidence to optimize CMS use, balancing efficacy with toxicity management.

---

Regulatory and Competitive Landscape

Several key players, including Sandoz/Novartis, Teva Pharmaceuticals, and Kerun Bioscience, oversee manufacturing and marketing. Innovations in inhaled formulations and combination therapies are anticipated to redefine the competitive discourse. Regulatory agencies are increasingly emphasizing antimicrobial stewardship, thus influencing approval trajectories and usage protocols.

---

Conclusion

Colistimethate sodium maintains its relevance amid the global rise in MDR infections. Ongoing clinical trials demonstrate a commitment to refining its efficacy and safety profile, especially through novel delivery mechanisms. The market is poised for steady expansion, underpinned by escalating antimicrobial resistance, increasing indications, and formulation innovations. Strategic investments in formulation improvements and regulatory navigation will be pivotal for stakeholders aiming to capitalize on CMS’s future potential.

---

Key Takeaways

• Clinical trials for colistimethate sodium focus on inhalation therapies, combination regimens, and new indications, aiming to optimize safety and efficacy.
• The market size is projected to nearly double by 2030, driven by rising MDR bacterial infections and adoption in emerging markets.
• Toxicity concerns remain a barrier but are being addressed through innovative formulations and combination therapies.
• Regulatory pathways are adapting, with approvals expanding in high-burden regions and for novel delivery methods.
• Stakeholders should prioritize research on safer delivery systems and monitor evolving resistance patterns to leverage CMS’s market potential effectively.

---

FAQs

1. What are the key clinical indications for colistimethate sodium?
   CMS is primarily used to treat MDR Gram-negative bacterial infections, including ventilator-associated pneumonia, bacteremia, and complicated urinary tract infections caused by organisms like Pseudomonas aeruginosa and Acinetobacter baumannii.

2. How are new formulations impacting CMS efficacy and safety?
   Nebulized and inhaled formulations aim to deliver higher pulmonary concentrations directly to infection sites, reducing systemic toxicity, especially nephrotoxicity, thus broadening application scopes.

3. What are the main challenges preventing wider adoption of CMS?
   Concerns over toxicity, limited spectrum of activity, and the emergence of newer antibiotics with broader safety profiles challenge CMS’s widespread use.

4. What are the expected innovations in clinical trials for CMS?
   Focus areas include optimizing inhaled delivery, combining CMS with newer agents, and exploring additional indications, especially in resistant infections.

5. How will antimicrobial resistance influence the future landscape for CMS?
   Rising MDR bacterial infections will sustain demand, especially if newer formulations demonstrate improved safety and efficacy, securing CMS’s role in future antimicrobial stewardship efforts.

---

References

[1] World Health Organization. (2021). Antimicrobial Resistance.
[2] ClinicalTrials.gov. (2023). Clinical Trials Involving Colistimethate Sodium.
[3] MarketResearch.com. (2023). Global Antibiotic Market Report.
[4] The European Medicines Agency. (2022). Conditional Approval of Inhaled CMS.
[5] Food and Drug Administration. (2022). CMS approvals and guidelines.