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Also known as Retpamulin Ointment, 1%
Retpamulin, 1% · 1 trial · 1 indication
Follow-up is defined as 7-9 days post-therapy: Day 12-14 for retapamulin; Day 17-19 for linezolid. Clinical success at follow-up was defined as the resolution of clinically meaningful signs and symptoms of infection recorded at baseline, including a pus/exudate skin infection rating scale (SIRS) score of "0." The SIRS is used by the investigator to evaluate infected lesions. Scores on the SIRS range from 0 (absent) to 6 (severe).
| Arm | Type | Description |
|---|---|---|
| Retapamulin | EXPERIMENTAL | - |
| Linezolid | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Retpamulin Ointment, 1% | DRUG | Topical retapamulin (SB-275833) ointment, 1% (w/w), and placebo ointment, will be provided as approximately 10 grams of an off-white smooth ointment in collapsible aluminum tubes with reverse-taper puncture-tip caps. Retapamulin or placebo ointment will be applied twice daily for 5 days. |
| Linezolid | DRUG | Adult and adolescent (=\>12 years of age) subjects will receive one 600mg linezolid tablet (overencapsulated), or one placebo capsule, twice daily for 10 days. Pediatric subjects aged 5-11 years will receive 10mg/kg body weight of a 100mg/5mL oral linezolid suspension, or placebo suspension, twice daily for 10 days. Pediatric subjects \<5 years of age will receive 10mg/kg of a 100mg/5mL oral linezolid suspension, or placebo suspension, three times daily for 10 days. |
Inclusion Criteria: * 2 months of age or older * diagnosis of secondarily-infected traumatic lesion (SITL) or impetigo (bullous or non-bullous) * negative urine pregnancy test (females of childbearing potential) * total skin infection rating scale (SIRS) score of at least 8, which must include a pu...
Retpamulin, 1% is an investigational topical small molecule being developed for bacterial skin infections. It is being studied in conditions including impetigo and secondarily infected traumatic lesions, which are skin infections that can be caused by methicillin-resistant Staphylococcus aureus (MRSA).
Retpamulin, 1% is being developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program evaluating this topical antibacterial candidate for bacterial skin infections.
Retpamulin, 1% is in Phase 3 development. It is an investigational product and is not approved; the Phase 3 trial evaluating it has been completed. The program includes one completed Phase 3 study with 410 enrolled participants.
Retpamulin, 1% has been studied in the Phase 3 trial NCT00852540, titled Retapamulin Versus Linezolid in the Treatment of SITL and Impetigo Due to MRSA. The trial was completed, enrolled 410 participants, was randomized, double blind, and active controlled, and was conducted in the United States.
Yes. Retpamulin, 1% is also known as Retpamulin Ointment, 1%. Both names refer to the same topical 1% formulation being developed by GSK for bacterial skin infections, so searches using either name point to the same product.