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GSK580416 · 1 trial · 2 indications
| Name | Type | Description |
|---|---|---|
| GSK580416 | DRUG | - |
Inclusion criteria: * Healthy as determined by a physician * Healthy male or female of non-child bearing potential between 18 and 55 years of age (inclusive) * Body weight \> = 50 kg and BMI between 19 and 30 kg/m2 (inclusive) Exclusion criteria: * Positive HIV antibody, Hepatitis B surface antig...
GSK580416 is an investigational small molecule being developed by GSK plc for the treatment of Respiratory Tract Infection. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being evaluated for safety and tolerability in humans.
GSK580416 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The drug is an investigational small molecule intended for use in Respiratory Tract Infection and is currently in Phase 1 clinical trials.
GSK580416 is in Phase 1 clinical development. It is an investigational drug, not yet approved by the FDA or other regulatory agencies. The Phase 1 trial has been completed, and the drug remains in early-stage clinical development for Respiratory Tract Infection.
GSK580416 has one completed Phase 1 clinical trial, identified as NCT00427141, titled "A Three-Part Study Of GSK580416 In Healthy Subjects." This trial enrolled 48 participants in Australia, was randomized but not double-blind, and had no control group. The study focused on healthy volunteers aged 18 years and older.
No, GSK580416 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Respiratory Tract Infection. The Phase 1 trial has been completed, but the drug has not yet progressed to later-stage trials or received regulatory approval.
Yes, GSK580416 is a small molecule drug. It is being developed by GSK plc as an investigational treatment for Respiratory Tract Infection and is currently in Phase 1 clinical development. The completed Phase 1 trial enrolled healthy volunteers to assess the drug's safety and tolerability.