Overview
Disorders such as schizophrenia and bipolar disorder can significantly impair mood, cognition, and behavior. These mental illnesses can often be accompanied by comorbidities such as depression and substance abuse, and can significantly impact the quality of life of patients and caregivers. Luckily, several treatment options for psychotic disorders have been introduced to market since the realization of chlorpromazine's antipsychotic properties in 1952. Second generation antipsychotics (commonly referred to as atypical antipsychotics) include clozapine, quetiapine, olanzapine, aripiprazole and ziprasidone among others, and are generally thought to be as efficacious as first generation antipsychotics but differ in their adverse effect profiles. First generation antipsychotics are associated with extrapyramidal adverse effects while atypical antipsychotics are linked to weight gain, impaired glucose tolerance and metabolic syndrome. Ziprasidone is used to treat schizophrenia and bipolar disorder. It can effectively reduce the rate and time of relapses in schizophrenia, and can be used to treat manic episodes in bipolar disorder although the mechanism of action is unknown. Although ziprasidone is classified as an atypical antipsychotic, it appears to have a lower incidence of metabolic adverse effects compared to other medications in the same class.
Indication
In its oral form, ziprasidone is approved for the treatment of schizophrenia, as monotherapy for acute treatment of manic or mixed episodes related to bipolar I disorder, and as adjunctive therapy to lithium or valproate for maintenance treatment of bipolar I disorder. The injectable formulation is approved only for treatment of acute agitation in schizophrenia.
Associated Conditions
- Acute Agitation
- Agitation
- Bipolar 1 Disorder
- Psychosis
- Schizophrenia
- Treatment Resistant Major Depressive Disorder
- Acute Manic episode
- Acute Mixed manic depressive episode
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2020/10/14 | Early Phase 1 | Completed | |||
2020/06/24 | Phase 4 | UNKNOWN | |||
2019/09/03 | Not Applicable | Completed | |||
2018/12/19 | Phase 1 | Recruiting | |||
2018/12/07 | Phase 3 | Terminated | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | ||
2018/06/15 | Phase 2 | Completed | |||
2017/07/07 | N/A | Completed | |||
2017/01/05 | Phase 1 | Terminated | |||
2016/10/18 | Phase 4 | UNKNOWN | Yang Fude | ||
2016/09/08 | N/A | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Aurobindo Pharma Limited | 65862-703 | ORAL | 40 mg in 1 1 | 2/14/2024 | |
Greenstone LLC | 59762-1006 | ORAL | 20 mg in 1 1 | 3/8/2022 | |
Mylan Pharmaceuticals Inc. | 59762-1006 | ORAL | 20 mg in 1 1 | 3/8/2022 | |
REMEDYREPACK INC. | 70518-0787 | ORAL | 40 mg in 1 1 | 1/18/2024 | |
Apotex Corp. | 60505-2531 | ORAL | 80 mg in 1 1 | 12/5/2023 | |
Golden State Medical Supply, Inc. | 60429-767 | ORAL | 60 mg in 1 1 | 1/9/2024 | |
NuCare Pharmaceuticals,Inc. | 68071-3418 | ORAL | 20 mg in 1 1 | 5/26/2023 | |
ROERIG | 0049-0056 | ORAL | 60 mg in 1 1 | 2/23/2022 | |
Sandoz Inc | 0781-2168 | ORAL | 80 mg in 1 1 | 1/27/2020 | |
TYA Pharmaceuticals | 64725-0259 | ORAL | 80 mg in 1 1 | 8/13/2013 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
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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