ZIPRASIDONE HYDROCHLORIDE

Post-LOE

ziprasidone

Dr. Reddy's Laboratories

ANDAORALCAPSULE

Approved

Mar 2012

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

ZIPRASIDONE HYDROCHLORIDE (ziprasidone) by Dr. Reddy's Laboratories is 2 (d 2 ) and serotonin type 2 (5ht 2 ) antagonism. Approved for schizophrenia in adults [see ], acute agitation in schizophrenic adult patients for whom treatment with ziprasidone is appropriate, need intramuscular antipsychotic medication for rapid control of agitation [see ] and 3 more indications. First approved in 2012.

Drug data last refreshed 22h ago

Mechanism of Action

2 (D 2 ) and serotonin type 2 (5HT 2 ) antagonism.

Indications (3)

acute agitation in schizophrenic adult patients for whom treatment with ziprasidone is appropriate schizophrenia in adults

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.

Clinical Trials (20)

NCT03768726Phase 3Terminated

Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder

Started Dec 2018

23 enrolled

Bipolar Disorder

NCT02935998Phase 4Unknown

The Efficacy And Safety Of Intramuscular Ziprasidone For Three Days In Patients With Psychotic Agitation

Started Oct 2016

1,000 enrolled

Schizophrenia

NCT02075047Phase 3Terminated

Efficacy and Safety Trial of Flexible Doses of Oral Ziprasidone in Children and Adolescents With Bipolar I Disorder

Started May 2014

171 enrolled

Bipolar Disorder

NCT01293825Phase 4Completed

Ziprasidone Switching in Response to Adherence and Psychotropic-Related Weight Gain Concerns Among Patients With Bipolar Disorder (Zip Ad)

Started Jan 2011

30 enrolled

Medication AdherenceBipolar Disorder

NCT01260116N/AUnknown

Efficacy and Safety of Ziprasidone to Treat Depressive Symptoms in Patients With Schizophrenia

Started Dec 2010

120 enrolled

The Primary Evaluation is the Change From Baseline at End of Study for CDSS Total Scores.The Secondary Efficacy Evaluations Include: MADRS, PANSS Total Scores and Subscales and Responder Rate; CGI-S and CGI-I Scales.Safety Evaluations Include: Laboratory Test Abnormalities; BARS and SAS; Physical Examinations; Vital Signs; Electrocardiogram,Etc.+1 more