MedPath

Ziprasidone

Generic Name
Ziprasidone
Brand Names
Geodon, Zeldox
Drug Type
Small Molecule
Chemical Formula
C21H21ClN4OS
CAS Number
146939-27-7
Unique Ingredient Identifier
6UKA5VEJ6X

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
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.

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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