Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Trametinib pediatric formulation · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| GSK1120212 tablet | EXPERIMENTAL | GSK1120212 tablet |
| GSK1120212 powder for oral solution | EXPERIMENTAL | GSK1120212 powder for oral solution |
| Name | Type | Description |
|---|---|---|
| Trametinib tablet | DRUG | 2 mg, orally, on Day 1 of the dosing period |
| Trametinib pediatric formulation | DRUG | 2 mg, orally, on Day 1 of the dosing period |
Inclusion Criteria: * Male or female, 18 years of age or older, at the time of signing the informed consent. * Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. * Able to swallow and retain oral medication. * His...
Top 2 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/GEH200521 |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
Trametinib pediatric formulation is a powder for suspension (PfOS) oral version of trametinib developed by GSK plc for use in cancer. It is a small molecule designed for pediatric dosing, studied in a Phase 1 relative bioavailability trial. It is an investigational formulation rather than a marketed product.
Trametinib pediatric formulation targets MAP2K1 and MAP2K2, also known as MEK1 and MEK2. It acts as an inhibitor of these kinases, which sit in the MAPK signaling pathway. The same molecular target underlies the approved adult trametinib product, and this pediatric powder for suspension delivers the same active agent.
GSK plc, which trades under the ticker GSK, is the developer of the trametinib pediatric powder for suspension formulation. The company sponsored the Phase 1 relative bioavailability study of the formulation in the United States.
Trametinib pediatric formulation is in Phase 1 development. It is investigational and has not been approved by the FDA for pediatric use. The single registered trial of this formulation is a completed Phase 1 relative bioavailability study.
Trametinib pediatric formulation was studied in one completed Phase 1 trial, NCT01647659, titled Relative Bioavailability for Pediatric Powder for Suspension (PfOS) Formulation. The trial enrolled 18 participants with cancer in the United States, used a controlled and randomized design, and included participants aged 18 years and older.
Trametinib pediatric formulation is a powder for suspension version of trametinib, the same active small molecule, prepared for pediatric dosing. It shares the MAP2K1 and MAP2K2 target with the standard trametinib product but is a distinct oral formulation studied separately in a Phase 1 bioavailability trial.