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Drug

Colistimethate sodium

Established medicine
ResearchOngoing clinical research
RxNorm48305
3
Active clinical trials
10
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Label change: COLISTIMETHATE SODIUM (ANDA201365)

Regulatory2026-09-14FDA

Colistin Methanesulfonate Sodium Inhalation for Prophylaxis of Ventilator-Associated Pneumonia (CIVAP): A Prospective, Multicentre, Double-Blind, Randomized, Placebo-Controlled Trial

Clinical trial2026-09-01Primary completion · ClinicalTrials.gov

Label change: COLISTIMETHATE SODIUM (ANDA065364)

Regulatory2026-08-19FDA

Nebulised Colistimethate Sodium to Prevent Pediatric Ventilator-associated Pneumonia: The COLIPED Investigation

Clinical trial2026-02-24Results expected Q4 2028 · ClinicalTrials.gov

Comparative Study of Clinical Outcomes and Safety Between Colistin and Tigecycline for Multi-Drug Resistant Gram Negative Bacteria

Clinical trial2025-05-30Primary completion · ClinicalTrials.gov

Label change: COLISTIMETHATE SODIUM (ANDA201365)

Regulatory2021-03-26FDA

Label change: COLISTIMETHATE SODIUM (ANDA201365)

Regulatory2021-03-26FDA

Label change: COLISTIMETHATE SODIUM (ANDA065364)

Regulatory2021-03-19FDA

Effect of Different Colistin Doses on Clinical Outcome of Pediatric Cancer Patients With Gram Negative Infections

Clinical trial2019-03-01Completed · ClinicalTrials.gov

A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Estimate the Efficacy and Safety of Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Colistimethate Sodium + Imipenem/Cilastatin in Subjects With Imipenem-Resistant Bacterial Infection

Clinical trial2018-10-19Results posted · ClinicalTrials.gov

A Randomized Clinical Study of the Decolonization of MDR Gram-negative Bacteria in Patients With Haematological Malignancies

Clinical trial2017-12-01Completed · ClinicalTrials.gov

A Phase 1, Open-Label Study of the Safety, Tolerability and Pharmacokinetics of Aerosolized Colistimethate Sodium After Multiple Doses Administered Separately or in Combination With Intravenous Colistimethate Sodium in Healthy Adults

Clinical trial2017-05-04Terminated · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Colistimethate sodium
RxNorm CUI
48305
Regulatory jurisdictions
emafda

Regulatory timeline

10 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2012-02-13 → 2014-02-19)
Earliest approval
2008-04-17
Latest approval
2014-02-19
Authorities
FDA · EMA
Total events
10
fdaU.S. Food and Drug Administration· 9 events
2026-09-14Label change
Label change: COLISTIMETHATE SODIUM (ANDA201365)
Evidence ↗
2026-08-19Label change
Label change: COLISTIMETHATE SODIUM (ANDA065364)
Evidence ↗
2021-03-26Label change
Label change: COLISTIMETHATE SODIUM (ANDA201365)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2012-02-13ApprovalMulti-authority
Approval: Colobreathe (EMA)
Indication: Colobreathe is indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged six years and older.… Show full indication

Colobreathe is indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged six years and older. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

9 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
9
registered trials across all phases
LATEST COMPLETION 2019
3
Active studies
2
Recruiting
6
Late-stage (III+)
4
Completed
2
Discontinued
PHASE DISTRIBUTIONn = 9
Phase 12Phase 21Phase 2 / 31Phase 31Phase 43Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Comparative Study of Clinical Outcomes and Safety Between Colistin and Tigecycline for Multi-Drug Resistant Gram Negative Bacteria

Active, not recruitingPH IVBeni-Suef Universityn=1322025

Effect of Different Colistin Doses on Clinical Outcome of Pediatric Cancer Patients With Gram Negative Infections

CompletedPH IVNational Cancer Institute, Egyptn=702019

A Randomized Clinical Study of the Decolonization of MDR Gram-negative Bacteria in Patients With Haematological Malignancies

CompletedPH IVMinsk Scientific-Practical Center for Surgery, Transplantation and Hematologyn=622017

Nebulised Colistimethate Sodium to Prevent Pediatric Ventilator-associated Pneumonia: The COLIPED Investigation

Not yet recruitingPH II/IIIUniversity Hospital Fattouma Bourguiban=4002028

A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Estimate the Efficacy and Safety of Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Colistimethate Sodium + Imipenem/Cilastatin in Subjects With Imipenem-Resistant Bacterial Infection

CompletedPH IIIMerck Sharp & Dohme LLCn=502017

Recent completions

Trials that read out recently, adding to the completed evidence base.

Effect of Different Colistin Doses on Clinical Outcome of Pediatric Cancer Patients With Gram Negative Infections

CompletedPH IVNational Cancer Institute, Egyptn=702019

A Randomized Clinical Study of the Decolonization of MDR Gram-negative Bacteria in Patients With Haematological Malignancies

CompletedPH IVMinsk Scientific-Practical Center for Surgery, Transplantation and Hematologyn=622017

A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Estimate the Efficacy and Safety of Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Colistimethate Sodium + Imipenem/Cilastatin in Subjects With Imipenem-Resistant Bacterial Infection

CompletedPH IIIMerck Sharp & Dohme LLCn=502017

Phase I Study of Colistin Methanesulfonate Sodium (CMS-Na) -A Randomized, Double Blind, Placebo Controlled, Single and Repeat Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of CMS-Na in Healthy Japanese Male Subjects -

CompletedPH IGlaxoSmithKlinen=222010
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.