MedPath

Cariprazine

Generic Name
Cariprazine
Brand Names
Vraylar, Reagila
Drug Type
Small Molecule
Chemical Formula
C21H32Cl2N4O
CAS Number
839712-12-8
Unique Ingredient Identifier
F6RJL8B278

Overview

Cariprazine is an atypical antipsychotic agent and a piperazine derivative that was first developed in Hungary. It works as a partial agonist at central dopamine D2, dopamine D3, and serotonin 5-HT receptors and as an antagonist at serotonin 5-HT receptors. Cariprazine has been investigated in a variety of psychiatric disorders, including schizophrenia, bipolar disorders, and major depressive disorder. Cariprazine gained its first global approval in the US in September 2015 and was later approved by Health Canada in April 2022. It is currently used to treat schizophrenia, and manic or mixed episodes and depressive episodes associated with bipolar I disorder.

Indication

Cariprazine is indicated for the treatment of schizophrenia in adults to manage both positive and negative symptoms. It is also indicated to monotherapy for acute management of manic or mixed episodes associated with bipolar I disorder (bipolar mania) in adults, and acute management of depressive episodes associated with bipolar I disorder (bipolar depression) in adults.

Associated Conditions

  • Bipolar Disorder With Manic or Mixed Episodes
  • Depressive Episodes
  • Schizophrenia

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2024/05/30
Phase 4
Recruiting
2023/07/06
Phase 4
Not yet recruiting
2023/06/22
Phase 4
Recruiting
2022/06/30
Phase 3
Completed
2022/05/20
Phase 4
Completed
The Medical Research Network
2022/05/10
Phase 3
Active, not recruiting
2021/10/01
Phase 2
Recruiting
Kyle Kampman
2021/09/29
Phase 4
Not yet recruiting
2021/07/16
Phase 2
Withdrawn
2021/04/13
Phase 4
UNKNOWN
Dr. Martin A. Katzman

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
Authorised
7/13/2017

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
SYMVENU HARD CAPSULES 3MG
SIN15744P
CAPSULE, GELATIN COATED
3.000mg
7/11/2019
SYMVENU HARD CAPSULES 4.5MG
SIN15745P
CAPSULE, GELATIN COATED
4.500mg
7/11/2019
SYMVENU HARD CAPSULES 1.5MG
SIN15743P
CAPSULE, GELATIN COATED
1.5mg
7/11/2019
SYMVENU HARD CAPSULES 6MG
SIN15746P
CAPSULE, GELATIN COATED
6.000mg
7/11/2019

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.

Help Us Improve

Your feedback helps us provide better drug information and insights.

© Copyright 2025. All Rights Reserved by MedPath