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Colistimethate sodium (CMS)
Colistimethate sodium (CMS) is a Polymyxin antibiotic Small molecule drug developed by Merck Sharp & Dohme LLC. It is currently in Phase 3 development for Multidrug-resistant gram-negative bacterial infections, Cystic fibrosis-associated Pseudomonas aeruginosa infections.
Colistimethate sodium is a prodrug that is hydrolyzed to colistin, which disrupts bacterial cell membranes by binding to lipopolysaccharides and causing cell lysis.
Colistimethate sodium is a prodrug that is hydrolyzed to colistin, which disrupts bacterial cell membranes by binding to lipopolysaccharides and causing cell lysis. Used for Multidrug-resistant gram-negative bacterial infections, Cystic fibrosis-associated Pseudomonas aeruginosa infections.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline. -
Big-pharma sponsor
+3.0pp
Merck Sharp & Dohme LLC is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Colistimethate sodium (CMS) |
|---|---|
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | Polymyxin antibiotic |
| Target | Bacterial lipopolysaccharide (LPS) |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Colistimethate sodium (CMS) is the inactive methane sulfonate salt of colistin that is converted to active colistin in vivo. Colistin is a polymyxin antibiotic that acts as a cationic detergent, binding to the lipopolysaccharide layer of gram-negative bacteria and disrupting membrane integrity, leading to bacterial cell death. It is primarily used against multidrug-resistant gram-negative organisms.
Approved indications
- Multidrug-resistant gram-negative bacterial infections
- Cystic fibrosis-associated Pseudomonas aeruginosa infections
Common side effects
- Nephrotoxicity
- Neurotoxicity
- Bronchospasm
- Injection site reactions
Key clinical trials
- Nebulised Colistimethate Sodium to Prevent Pediatric Ventilator-associated Pneumonia (PHASE2, PHASE3)
- Colistin Methanesulfonate Sodium Inhalation for Prophylaxis of Ventilator-Associated Pneumonia (CIVAP): A Prospective, Multicentre, Double-Blind, Randomized, Placebo-Controlled Trial (NA)
- Comparing Tigecycline Vs. Colistimethate in CNS Infections
- Pharmacokinetics of Colistin in Critically Ill Patients With Extracorporeal Membrane Oxygenation (PHASE4)
- Trial in Non-cystic Fibrosis Bronchiectasis Patients With Chronic Lung Infections Treated With Colistimethate Sodium. (PHASE3)
- Efficacy and Safety of Inhaled CMS in Bronchiectasis Subjects With Chronic P. Aeruginosa Infection. (PROMIS-I) (PHASE3)
- Evaluation of Pharmacokinetic and Pharmacodynamic Properties of Intravenous Colistimethate Sodium
- Efficacy and Safety of Imipenem+Cilastatin/Relebactam (MK-7655A) Versus Colistimethate Sodium+Imipenem+Cilastatin in Imipenem-Resistant Bacterial Infection (MK-7655A-013) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Colistimethate sodium (CMS) CI brief — competitive landscape report
- Colistimethate sodium (CMS) updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI
Frequently asked questions about Colistimethate sodium (CMS)
What is Colistimethate sodium (CMS)?
How does Colistimethate sodium (CMS) work?
What is Colistimethate sodium (CMS) used for?
Who makes Colistimethate sodium (CMS)?
What drug class is Colistimethate sodium (CMS) in?
What development phase is Colistimethate sodium (CMS) in?
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What does Colistimethate sodium (CMS) target?
Related
- Drug class: All Polymyxin antibiotic drugs
- Target: All drugs targeting Bacterial lipopolysaccharide (LPS)
- Manufacturer: Merck Sharp & Dohme LLC — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Multidrug-resistant gram-negative bacterial infections
- Indication: Drugs for Cystic fibrosis-associated Pseudomonas aeruginosa infections
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing