Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [14C]-darigabat, CVL-865, PF-06372865
darigabat · 3 trials · 2 indications
| Name | Type | Description |
|---|---|---|
| [14C]-darigabat | DRUG | Oral capsule |
| Darigabat | DRUG | Oral tablet |
| Carbamazepine | DRUG | Oral tablets |
Darigabat is an investigational small molecule developed by AbbVie Inc. (ticker ABBV). It is a GABAA receptor agonist that has been studied in Phase 1 clinical trials in healthy participants. Its therapeutic indications have not been disclosed, and it remains in early clinical development.
Darigabat targets GABAA receptor subunits, specifically GABRA1, GABRB2, GABRG2, GABRB3, GABRA4, and GABRG3. It acts as an agonist at these targets. This receptor activity is the basis for its classification as a small molecule GABAA receptor agonist in clinical development.
Darigabat is developed by AbbVie Inc., which trades under the ticker ABBV. AbbVie is the sponsor of the clinical trials evaluating darigabat, including the Phase 1 studies conducted in healthy participants.
Darigabat is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. All three of its recorded trials are Phase 1 studies, and all three are completed, with no active trials currently listed.
Darigabat has been evaluated in three completed Phase 1 trials. NCT06435923 assessed absorption, metabolism, excretion, and mass balance of [14C]-darigabat in healthy male participants. NCT05824143 evaluated the effect of carbamazepine on darigabat pharmacokinetics. NCT05123079 assessed relative bioavailability and food effect of darigabat tablet formulations.
Yes, [14C]-darigabat is an alternative name for darigabat. The [14C] label denotes a carbon-14 radiolabeled form used in a mass balance and metabolism trial, NCT06435923, which studied absorption, metabolism, excretion, and mass balance after a single oral dose in healthy male participants.