Colistimethate
As of the edition of 20 October 2026, Colistimethate is a drug: marketed, first approved in 1982 (US); no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2015
- Kind
- Unknown
- Brand name
- Coly-Mycin M
- First approved
- 1 January 1982 (US)
- Approvals on record
- 6 in 6 regions
- Holder of the most recent approval
- GSK; 6 holders in all
- Registered trials
- 20, 4 stopped early
- Disease areas
- Infections; Lungs and airways; Digestive system; Inherited and neonatal; Cancer; Nervous system
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 5 | 2 | 2 | 0 |
| Phase 1 | 6 | 5 | 0 | 1 |
| Phase 2 | 1 | 0 | 0 | 0 |
| Phase 3 | 5 | 1 | 0 | 3 |
| Phase 4 | 3 | 3 | 0 | 0 |
| All trials | 20 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| GSK | Applicant and Lead sponsor of trials | 2010 to now |
| Essential Pharma | Applicant | 2012 to now |
| Ph Health | Acquired holder | 2025 to now |
| Pfizer | Earlier holder |