At a glance
- Colistin (polymyxin E) is an FDA-approved drug, marketed as Coly-mycin, Colistimethate (first approval: May 17, 1962).
- PubMed lists 13,176 publications mentioning it, including 169 randomized controlled trials and 1,517 animal-only studies.
- ClinicalTrials.gov lists 132 registered studies testing it (28 active).
- FDA's adverse event system (FAERS) holds 5,262 reports mentioning it; 4,790 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
| Application | Product | Status | First approval | Sponsor |
|---|---|---|---|---|
| NDA050356 | COLY-MYCIN S | Approved, marketed | May 17, 1962 | PH HEALTH |
| NDA050108 | COLY-MYCIN M | Approved, discontinued | June 4, 1970 | PH HEALTH |
| ANDA064216 | COLISTIMETHATE SODIUM | Approved, discontinued | February 26, 1999 | PHARMOBEDIENT |
| ANDA065177 | COLISTIMETHATE SODIUM | Approved, discontinued | March 19, 2004 | NEXUS |
| ANDA065364 | COLISTIMETHATE SODIUM | Approved, marketed | April 17, 2008 | FRESENIUS KABI USA |
| ANDA202359 | COLISTIMETHATE SODIUM | Approved, marketed | September 28, 2012 | AVET LIFESCIENCES |
| ANDA201365 | COLISTIMETHATE SODIUM | Approved, marketed | February 19, 2014 | SAGENT PHARMS INC |
| ANDA205356 | COLISTIMETHATE SODIUM | Approved, marketed | May 29, 2015 | XELLIA PHARMS APS |
| NDA050355 | COLY-MYCIN S | Approved, discontinued | — | PARKE DAVIS |
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- Farm management factors associated with antimicrobial resistance in dairy herds: Insights from a bulk tank milk study.
- Occurrence of carbapenemase genes and phenotypic colistin resistance in wastewater from Kütahya, Türkiye.
- Optimizing colistin dosing in acute-on-chronic liver failure patients with sepsis due to multidrug-resistant gram-negative pathogens.
- The persistence and transmission of mcr-mediated colistin resistance in E. coli from pigs, farmers, and farm environments after colistin withdrawal in Thailand.
- MCR-Mediated Colistin Resistance Across the One Health Continuum in South Asia: A Systematic Review and Meta-Analysis.
- Resensitization of colistin-resistant bacteria by the combination of colistin and L-arginine.
- Extensively Drug-Resistant Pseudomonas aeruginosa Keratitis After Photorefractive Keratectomy Because of Contaminated Eye Drops: Experience With Colistin-Based Therapy.
- Sulbactam/Durlobactam for CRAB Bacteremia and Pneumonia in a Critically Ill Patient in China: A Case Report.
- Reptiles in the One Health ecology of antimicrobial resistance, with insights into zoonotic pathogens: reservoirs, transmission pathways, and public health implications.
- Antimicrobial susceptibility and virulence phenotypes of Escherichia coli isolated from bovine milk and feces in Brazil.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 132
- Active
- 28
- With posted results
- 10
Conditions studied
Show 40 more studies
All 132 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 5,262
- Serious
- 4,790
- With death outcome
- 1,231
Most reported reactions
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
FDA prescribing information
Official US prescribing information. Dosing sections are intentionally not shown.
- Coly-Mycin M
- Colistimethate
- Colistimethate
- COLISTIMETHATE SODIUM
- Colistimethate
- Cortisporin TC
- Colistimethate
Source: DailyMed / openFDA
Change history
No changes since monitoring began on October 30, 2026.