NDAORALCAPSULE
Approved
Feb 2001
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
GEODON (ziprasidone) by Viatris (2) is 2 (d 2 ) and serotonin type 2 (5ht 2 ) antagonism. First approved in 2001.
Drug data last refreshed 10h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GEODON (ziprasidone) is an atypical antipsychotic that antagonizes dopamine D2 and serotonin 5HT2A receptors. It is indicated for schizophrenia, bipolar disorder, and schizoaffective disorder as an oral capsule. Ziprasidone is a foundational agent in the atypical antipsychotic class, though now facing significant competitive pressure from newer mechanisms.
LOE Approaching
With loss of exclusivity approaching and moderate competitive pressure (30%), GEODON brand teams are consolidating focus and likely operating with lean staffing models.
Mechanism of Action
2 (D 2 ) and serotonin type 2 (5HT 2 ) antagonism.
Pharmacologic Class:
Atypical Antipsychotic
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
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
The Efficacy And Safety Of Intramuscular Ziprasidone For Three Days In Patients With Psychotic Agitation
Started Oct 2016
1,000 enrolled
Schizophrenia
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
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
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
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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.