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Icalcaprant - Cerevel Therapeutics

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Drug Profile

Icalcaprant - Cerevel Therapeutics

Alternative Names: ABBV-1354; CVL-354; Kappa opiate antagonist - Cerevel therapeutics

Latest Information Update: 05 Mar 2026

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At a glance

  • Originator Pfizer
  • Developer Cerevel Therapeutics
  • Class Antidepressants; Drug withdrawal therapies; Small molecules
  • Mechanism of Action Opioid kappa receptor antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes
  • Available For Licensing Yes

Highest Development Phases

  • Phase II Bipolar depression; Major depressive disorder
  • Phase I Opioid-related disorders
  • No development reported Substance-related disorders

Most Recent Events

  • 03 Feb 2026 Phase-II clinical trials in Bipolar depression (Treatment-experienced) in USA (PO) (NCT06696755)
  • 18 Dec 2025 Phase-II clinical trials in Major depressive disorder in USA (PO) (NCT07276997)
  • 11 Dec 2025 AbbVie plans a phase II trial for Major depressive disorder (PO, Capsule), in January 2026 (NCT07276997)

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