ZIPRASIDONE MESYLATE · STERISCIENCE
Ziprasidone mesylate is an atypical antipsychotic indicated for the treatment of schizophrenia and bipolar disorder in adult patients. It is utilized as a monotherapy for the acute treatment of manic or mixed episodes and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. The intramuscular formulation is specifically indicated for the rapid control of acute agitation in patients with schizophrenia. Because the drug has a greater capacity to prolong the QT/QTc interval than several other antipsychotics, prescribers are advised to consider alternative treatments first.
How ZIPRASIDONE MESYLATE Works
The therapeutic effects of ziprasidone mesylate are mediated through its activity as an antagonist at specific neurotransmitter receptors. The drug works by blocking dopamine type 2 (D2) and serotonin type 2 (5HT2) receptors in the brain. This combined antagonism of dopamine and serotonin pathways is the mechanism by which the medication manages the symptoms of schizophrenia and bipolar episodes.
Details
- Status
- Prescription
- First Approved
- 2019-12-26
- Routes
- INTRAMUSCULAR
- Dosage Forms
- POWDER
ZIPRASIDONE MESYLATE Approval History
What ZIPRASIDONE MESYLATE Treats
3 indicationsZIPRASIDONE MESYLATE is approved for 3 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Schizophrenia
- Bipolar Disorder
- Agitation
ZIPRASIDONE MESYLATE Boxed Warning
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Ziprasidone mesylate for injection is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1) ]. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. Elderly patients ...
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Ziprasidone mesylate for injection is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1) ]. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Ziprasidone mesylate for injection is not approved for the treatment of patients with dementia-related psychosis ( 5.1 )
ZIPRASIDONE MESYLATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ZIPRASIDONE MESYLATE FDA Label Details
Indications & Usage
Ziprasidone mesylate for injection is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. Ziprasidone mesylate for injection intramuscular is indicated for acute agitation in schizophrenic patients. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone's greater capacity to prolong the QT/QTc interval compared to several other antipsychot...
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Ziprasidone mesylate for injection is not approved for the treatment of patients with dementia-related...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.