Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Experimental paracetamol
Experimental paracetamol formulation · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Experimental paracetamol formulation | EXPERIMENTAL | experimental formulation |
| paracetamol marketed formulation | ACTIVE_COMPARATOR | Paracetamol marketed formulation |
| Name | Type | Description |
|---|---|---|
| Experimental paracetamol | DRUG | experimental paracetamol with caffeine |
| Paracetamol marketed formulation | DRUG | marketed formulation containing caffeine |
Inclusion Criteria: * Healthy volunteer Exclusion Criteria: \-
The experimental paracetamol formulation is an investigational small molecule developed by GSK plc for tension-type headache. It is a reformulated version of paracetamol studied in a Phase 1 pharmacokinetic trial. It is not an approved product and remains in clinical development.
It is being studied for tension-type headache. The only listed trial enrolled healthy adult volunteers aged 18 and older in the United States, so the work to date has focused on how the formulation behaves in the body rather than on treating patients with headache.
GSK plc, which trades under the ticker GSK, is the developer of the experimental paracetamol formulation. The company sponsored the Phase 1 pharmacokinetic study of the asset in tension-type headache.
The experimental paracetamol formulation is in Phase 1. It is investigational and has not been approved by the FDA. One Phase 1 trial has been completed, and no trials are currently active.
One trial has studied the experimental paracetamol formulation: NCT01476176, titled A Pharmacokinetic Study of an Experimental Paracetamol Formulation. It was a completed Phase 1 study with 30 enrolled participants, randomized, double blind, and active controlled, conducted in the United States.
Yes. Experimental paracetamol is another name for the experimental paracetamol formulation, the GSK plc asset studied in the Phase 1 pharmacokinetic trial NCT01476176 for tension-type headache. Searches using either name refer to the same investigational product.