Drugs / Icalcaprant
last change Feb 2026 re-read 2 minutes ago

Icalcaprant

also known as CVL-354 · ABBV-1354

Small molecule

Developed for
bipolar I disorder · bipolar II disorder · major depressive disorder
Investigated by
AbbVie · Cerevel Therapeutics, LLC · National Institute on Drug Abuse (NIDA)

Trials 7 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 15 trials
Phase 1 NCT07219017 Oct → Dec 2025 AbbVie Completed No outcome recorded
Phase 1 NCT06722417 Nov 2024 → Jan 2025 AbbVie Completed No outcome recorded
Phase 1 NCT06722430 Nov 2024 → Jan 2025 AbbVie Completed No outcome recorded
Phase 1 NCT05547542 Mar 2023 → Jul 2024 substance-related disorder Cerevel Therapeutics, LLC Completed No outcome recorded
Phase 1 NCT05138653 Oct 2021 → Jan 2023 Cerevel Therapeutics, LLC Completed No outcome recorded
Phase 22 trials
Phase 2 NCT06696755 Feb 2026 → Nov 2027 expected bipolar I disorder, bipolar II disorder AbbVie Recruiting No outcome recorded
Phase 2 NCT07276997 Dec 2025 → Sep 2027 expected major depressive disorder AbbVie Recruiting No outcome recorded

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 8 sources stand behind the page.

FieldValueCited text
Known as Icalcaprant “Mass Balance Study of [14C] ABBV-1354 (Icalcaprant) in Healthy Male Subjects Following Single Oral Dose Administration” NCT07219017
4

NCT06722430

NCT07276997

NCT06722417

NCT06696755

Known as ABBV-1354 ClinicalTrials.gov intervention name — accepted as the source's own label NCT07219017
Known as CVL-354 ClinicalTrials.gov intervention name — accepted as the source's own label NCT05138653
1

NCT05547542

Modality Small molecule CHEMBL5314519
Route Oral oral dose of CVL-354 10 mg” NCT05138653