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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 being developed by AbbVie Inc. (ABBV). It is currently in Phase 1 clinical development. The drug has been studied in healthy participants across multiple early-stage trials, with a total of three completed studies involving 33 participants.
Darigabat is being studied for use in healthy participants, meaning it is not yet being tested for a specific disease or condition. The ongoing clinical trials focus on understanding the drug's pharmacokinetics, such as its absorption, metabolism, and excretion, as well as its bioavailability and potential food effects.
Darigabat is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. AbbVie is responsible for the clinical development and manufacturing of this investigational small molecule drug.
Darigabat is in Phase 1 clinical development. All three of its clinical trials are Phase 1 studies and have been completed. The drug remains investigational and is not yet approved for any medical use.
Darigabat has been studied in three completed Phase 1 trials: NCT05123079, which evaluated relative bioavailability and food effects of tablet formulations; NCT05824143, which assessed the effect of carbamazepine on Darigabat pharmacokinetics; and NCT06435923, which examined absorption, metabolism, and excretion of a radiolabeled form of the drug.
No, Darigabat is not FDA approved. It is an investigational drug currently in Phase 1 clinical trials. The studies completed so far have focused on healthy participants to evaluate the drug's safety and pharmacokinetics, but it has not yet been submitted for regulatory approval.