Drugs / Darigabat
Darigabat
Trials 17
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 111 trials · 1 met primary | ||||||
| Phase 1 | NCT06435923 | May → Jul 2024 | — | Cerevel Therapeutics, LLC | Completed | No outcome recorded |
| Phase 1 | NCT05824143 | Apr → Jul 2023 | — | Cerevel Therapeutics, LLC | Completed | No outcome recorded |
| Phase 1 | NCT05123079 | Nov 2021 | — | Cerevel Therapeutics, LLC | Completed | No outcome recorded |
| Phase 1 | NCT04592536 | Oct 2020 → Nov 2021 | panic disorder | Cerevel Therapeutics, LLC | Completed | Met primary |
| Phase 1 | NCT03351751 | Nov 2017 → Feb 2018 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02475746 | Jul → Aug 2015 | — | Pfizer | Withdrawn | No outcome recorded |
| Phase 1 | NCT02217787 | Sep 2014 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02238717 | Sep → Nov 2014 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02138500 | May → Aug 2014 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02070289 | Mar → Jul 2014 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01951144 | Oct 2013 → Jul 2014 | — | Pfizer | Completed | No outcome recorded |
| Phase 26 trials · 1 met primary · 4 missed | ||||||
| Phase 2 | NCT05941442 | Jul 2023 → Mar 2025 | panic disorder | AbbVie | Terminated | Missed primary Stop: Enrollment |
| Phase 2 | NCT04686786 | Dec 2020 → Dec 2024 | epilepsy | AbbVie | Terminated | No outcome recorded |
| Phase 2 | NCT04244175 | Jan 2020 → May 2024 | epilepsy | AbbVie | Completed | Missed primary |
| Phase 2 | NCT02564029 | Dec 2015 → Jan 2017 | photosensitive epilepsy | Pfizer | Completed | Met primary |
| Phase 2 | NCT02310568 | Nov 2014 → Oct 2015 | generalized anxiety disorder | Pfizer | Terminated | Missed primary Stop: Enrollment |
| Phase 2 | NCT02262754 | Oct 2014 → Aug 2015 | chronic pain syndrome | Pfizer | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2022-03-31 | AbbVie | Results Cerevel Therapeutics Announces Upcoming Presentations at AAN 2022 abbvie.com ↗
In an oral presentation, Cerevel will discuss preclinical data for darigabat that demonstrates robust antiepileptic activity in a model of drug-resistant focal seizures |
| 2022-02-15 | AbbVie | Results Cerevel Therapeutics Announces Positive Topline Results for Darigabat in Phase 1 Clinical Trial in Acute Anxiety abbvie.com ↗
Both the 7.5 mg twice-daily and the 25 mg twice-daily doses of darigabat demonstrated clinically meaningful and statistically significant anxiolytic activity compared with placebo in this proof-of-principle trial. |
| 2019-12-08 | AbbVie | Results Cerevel Therapeutics Announces Phase 1 Results for CVL-865, a Novel α2/3/5-subtype GABAA Positive Allosteric Modulator in Development to Treat Epilepsy abbvie.com ↗
announced today results of a Phase 1 dose-escalation clinical trial1 evaluating the safety, tolerability and pharmacokinetics of multiple repeated doses of CVL-865 (formerly PF-06372865) in healthy volunteers. |
| 2019-04-09 | AbbVie | Results Cerevel Therapeutics Announces Publication of Phase 2a Study Results in Neurology on Its Most Advanced Investigational Epilepsy Treatment abbvie.com ↗
today announced the publication of results from a Phase 2a study1 in Neurology demonstrating the anticonvulsant activity of CVL-865 (formerly PF-06372865), a novel α2/3/5-subtype selective GABAA positive allosteric modulator, in patients with photosensitive epilepsy (seizures triggered by visual stimuli). |
All press releases naming this drug 7 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Darigabat | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05123079 ↗ |
| Known as | CVL-865 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04592536 ↗ |
| Known as | PF-06372865 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02262754 ↗ |
| Modality | Small molecule | — CHEMBL3647536 ↗ |
| Route | Oral | “single oral doses of PF-06372865” NCT01951144 ↗ |