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2021/07/16 | Phase 2 | Withdrawn | |||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. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
REAGILA cariprazine (as hydrochloride) 6 mg hard capsule blister pack | 325476 | Medicine | A | 11/18/2020 | |
REAGILA cariprazine (as hydrochloride) 3 mg hard capsule blister pack | 325478 | Medicine | A | 11/18/2020 | |
REAGILA cariprazine (as hydrochloride) 1.5 mg hard capsule blister pack | 325477 | Medicine | A | 11/18/2020 | |
REAGILA cariprazine (as hydrochloride) 4.5 mg hard capsule blister pack | 325479 | Medicine | A | 11/18/2020 |
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