Cariprazine

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
Sequential Multiple Assignment Randomized Trial for Bipolar Depression	2024/05/30	NCT06433635	Phase 4	Recruiting	Massachusetts General Hospital
Effectiveness of Cariprazine Monotherapy for Treatment of Major Depressive Disorder	2023/07/06	NCT05933538	Phase 4	Not yet recruiting	Sultan Qaboos University
Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9)	2023/06/22	NCT05913947	Phase 4	Recruiting	Aalborg University Hospital
Study of Cariprazine Oral Capsules or Solution to Assess Adverse Events and Change in Irritability Due to Autism Spectrum Disorder (ASD) in Participants Aged 5-17 Years With ASD	2022/06/30	NCT05439616	Phase 3	Completed	AbbVie
Cariprazine Versus Placebo for Social Anxiety Disorder	2022/05/20	NCT05384483	Phase 4	Completed	The Medical Research Network
Study to Assess Adverse Events and Change in Disease Activity of Oral Cariprazine Capsules in Adult Participants With Schizophrenia	2022/05/10	NCT05368558	Phase 3	Active, not recruiting	AbbVie
Cariprazine for Comorbid Cocaine and Opioid Use Disorder	2021/10/01	NCT05063201	Phase 2	Recruiting	Kyle Kampman
Dopamine D3 Receptor Occupancy in Bipolar Depression	2021/09/29	NCT05060549	Phase 4	Not yet recruiting	New York State Psychiatric Institute
A Study To Assess Adverse Events and Change in Disease Activity With Oral Cariprazine When Added to Antidepressant Therapies (ADTs) Compared to Placebo in Adult Participants With Generalized Anxiety Disorder (GAD) Who Have Had an Inadequate Response to ADTs Alone	2021/07/16	NCT04965272	Phase 2	Withdrawn	AbbVie
Adjunct Treatment With Cariprazine for Adults With Attention-deficit/Hyperactivity Disorder	2021/04/13	NCT04843423	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
Reagila	Gedeon Richter,Gyomroi ut 19-21,1103 Budapest,Hungary	Authorised	7/13/2017
Reagila	Gedeon Richter,Gyomroi ut 19-21,1103 Budapest,Hungary	Authorised	7/13/2017

HSA Drug Approvals

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

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
REAGILA cariprazine (as hydrochloride) 6 mg hard capsule blister pack	325476	Gedeon Richter Australia Pty Ltd	Medicine	A	11/18/2020
REAGILA cariprazine (as hydrochloride) 3 mg hard capsule blister pack	325478	Gedeon Richter Australia Pty Ltd	Medicine	A	11/18/2020
REAGILA cariprazine (as hydrochloride) 1.5 mg hard capsule blister pack	325477	Gedeon Richter Australia Pty Ltd	Medicine	A	11/18/2020
REAGILA cariprazine (as hydrochloride) 4.5 mg hard capsule blister pack	325479	Gedeon Richter Australia Pty Ltd	Medicine	A	11/18/2020

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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