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Research Report

Published: May 15, 2025

Darigabat (CVL-865, PF-06372865): A Comprehensive Profile of an Investigational GABAA Receptor Modulator

1. Introduction to Darigabat

1.1. Overview and Background

Darigabat is an investigational small molecule pharmaceutical agent currently undergoing clinical evaluation for its potential therapeutic applications in a range of neurological and psychiatric conditions.[1] It is classified as a GABAergic medication, operating specifically as a positive allosteric modulator (PAM) of the gamma-aminobutyric acid type A (GABAA) receptor.[1] The development of Darigabat is centered on the hypothesis that it can deliver the established therapeutic benefits of GABAergic modulation, such as anxiolytic and anticonvulsant actions, while offering an improved side-effect profile. A key objective is the minimization of sedation, a common limiting side effect of older, non-selective GABAergic compounds like benzodiazepines. This anticipated improvement is attributed to Darigabat's selective interaction with specific subtypes of the GABAA receptor.[2]

1.2. Chemical Identity and Synonyms

The officially recognized generic name for this investigational compound is Darigabat.[1] Throughout its research and development phases, Darigabat has been identified by several internal developmental code names. The most prominent of these are CVL-865, utilized by Cerevel Therapeutics, and PF-06372865 (sometimes cited as PF-6372865), used during its initial development by Pfizer.[1] The International Nonproprietary Name (INN) "darigabat" was formally adopted for the compound previously designated CVL-865.[6]

1.3. Therapeutic Class

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Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study to Evaluate Efficacy, Safety, and Tolerability of Darigabat in Participants With Panic Disorder	2023/07/12	NCT05941442	Phase 2	Completed	AbbVie
Open-label Trial to Evaluate the Effect Carbamazepine on Darigabat Pharmacokinetics in Healthy Adult Participants	2023/04/21	NCT05824143	Phase 1	Completed	Cerevel Therapeutics, LLC
Relative Bioavailability and Food Effect Following Single Oral Dose of Darigabat Tablet Formulations in Healthy Participants	2021/11/17	NCT05123079	Phase 1	Completed	Cerevel Therapeutics, LLC
An Open-label Extension Trial of CVL-865 as Adjunctive Therapy in the Treatment of Focal Onset Seizures	2020/12/29	NCT04686786	Phase 2	Completed	AbbVie
A Trial of the Efficacy and Safety of CVL-865 as Adjunctive Therapy in the Treatment of Focal Onset Seizures	2020/01/28	NCT04244175	Phase 2	Completed	AbbVie
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Repeat Doses of PF-06372865 in Healthy Subjects	2017/11/24	NCT03351751	Phase 1	Completed	Pfizer
PF-06372865 in Subjects With Photosensitive Epilepsy	2015/09/30	NCT02564029	Phase 2	Completed	Pfizer
An Open-label, Two-period, Fixed-sequence Study to Evaluate Multiple-dose Itraconazole Effect on The Single-dose PK of PF-06372865 in Healthy Subjects	2015/06/19	NCT02475746	Phase 1	Withdrawn	Pfizer
PF-06372865 In Subjects With Chronic Low Back Pain	2014/10/13	NCT02262754	Phase 2	Completed	Pfizer
Food Effect Study for PF-06372865	2014/08/15	NCT02217787	Phase 1	Completed	Pfizer

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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