Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Colistimethate sodium
Colistimethate · 1 trial · 1 indication
Maximum drug concentration (Cmax), Time of occurrence of Cmax (tmax), Terminal phase half-life(t1/2), Area under the concentration-time curve: AUC(0-inf), AUC(0-12), AUC(0-last), Clearance (CL), Fraction of urinary excretion (fe), Accumulation ratio (Ro and Rs).
Vital signs, ECGs, clinical laboratory test and adverse events.
Urinary β2-microglobulin, N-acetyl-β-D-glucosaminidase and creatinine clearance (CLcr).
Vital signs, ECGs, clinical laboratory test and adverse events.
Vital signs, ECGs, clinical laboratory test and adverse events.
| Arm | Type | Description |
|---|---|---|
| Saline | PLACEBO_COMPARATOR | Subjects were administered single dose or twice daily for 2.5 days repeat dose of placebo by the intravenous route. |
| Colistimethate sodium | EXPERIMENTAL | 2.5 milligrams (mg)/kilogram (kg) of CMS-NA (as colistin activity or 75,000 International Unit/kg) was administered as single dose or twice daily for 2.5 days repeat dose by the intravenous route. |
| Name | Type | Description |
|---|---|---|
| Colistimethate sodium | DRUG | active |
| Saline | DRUG | placebo |
\<Inclusion Criteria\> A subject will be eligible for inclusion in this study only if all of the following criteria apply: 1. Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardia...
Colistimethate is an antibacterial agent studied for the treatment of Pseudomonas infections. It is being developed by GSK plc under the ticker GSK and sits in the infectious disease therapeutic area. The clinical program has focused on Pseudomonas infections, a category of bacterial infection that can be difficult to treat.
Colistimethate is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program for this small molecule antibacterial agent. The company has advanced the compound into Phase 1 testing in the infectious disease therapeutic area.
Colistimethate is in Phase 1 clinical development. It is an investigational small molecule antibacterial being studied for Pseudomonas infections, and it has not been established as an approved therapy based on the development stage reported here. The program includes one completed Phase 1 trial.
Colistimethate has been evaluated in one completed Phase 1 trial, NCT01449838, titled Phase I Study of Colistin Methanesulfonate Sodium. That trial enrolled 22 healthy male volunteers aged 20 years and older in Australia. It was randomized, double blind, and placebo controlled, and it has completed.
Yes, colistimethate and colistimethate sodium refer to the same agent. Colistimethate sodium is the alternative name used for this compound, which GSK plc is developing as a small molecule antibacterial for Pseudomonas infections. Searches using either name point to the same Phase 1 development program.