drug
as of 2026-07-01Ziprasidone
Ziprasidone 80-160 mg/dZiprasidone 160 mg/dziprasidoneziprasidone (Geodon)ziprasidone-sertraline combinationonly ziprasidoneZiprasidone oral capsulesZiprasidone HCL (oral)
MeSH C092292UNII 6UKA5VEJ6XRxCUI 284548, 284549, 284550, 285127, 313776, 313777FDA_ApplNo NDA020825SPL_set_id 8326928a-2cb6-4f7f-9712-03a425a14c37FDA_sponsor VIATRISOrangeBook_Appl A077560, A077561, A077562, A077565, A090348, A202395, A204117, A204375
at a glance
small molecule · Atypical Antipsychotic [EPC]
US-approved (2001) as Geodon
65 trials in the graph
Synthesized from structured facts only — each point cited above.
Mechanism & identity
Modality
small molecule
FDA class
Atypical Antipsychotic [EPC]
Mechanism of action
12.1 Mechanism of Action The mechanism of action of ziprasidone in the treatment of the listed indications could be mediated through a combination of dopamine type 2 (D 2 ) and serotonin type 2 (5HT 2 ) antagonism.
Indications
Labeled
Bipolar maniaAgitationSchizophreniaBipolar depression
Investigational (via trials)
SchizophreniaAcute Exacerbation of PsychosisAffective Disorders, PsychoticManic-Depressive PsychosisType 2 Diabetes MellitusDepressionObsessive-Compulsive DisorderPsychosomatic DisordersHealthyPsychosisDeliriumDiabetes MellitusSchizophrenia Spectrum and Other Psychotic DisordersAgitationFirst Episode PsychosisPsychotic Mood Disorder
Adverse-event signal
FAERS spontaneous · within-drug share
Weight Metabolic15.0%
top term: WEIGHT INCREASED
Eps Akathisia10.0%
top term: DYSKINESIA
Sedation5.3%
top term: SOMNOLENCE
Mortality4.0%
top term: SUICIDE ATTEMPT
Gi3.7%
top term: NAUSEA
Qt Cardiac1.7%
top term: ELECTROCARDIOGRAM QT PROLONGED
Anticholinergic1.3%
top term: VISION BLURRED
Prolactin1.0%
top term: BLOOD PROLACTIN ABNORMAL
Nms0.9%
top term: NEUROLEPTIC MALIGNANT SYNDROME
Orthostatic0.5%
top term: HYPOTENSION
Spontaneous reports — a signal of reporting share, not incidence.
Trials
65
Proposal To Develop A Rapid And Cost-Effective Diagnostic Test For Schizophrenia
NCT03781115Phase 1Recruiting
Atypical Antipsychotics Influence on the Safety of the Heart and Monitoring Indicators Model Building
NCT04446234Phase 4Unknown
A Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication
NCT03557931Phase 2Completed
The Treatment Efficacy of Combination Atypical Antipsychotics With Sertraline in Patients With Schizophrenia
NCT04076371—Completed
Family Intervention in Recent Onset Schizophrenia Treatment (FIRST)
NCT02600741—Completed
The Efficacy And Safety Of Intramuscular Ziprasidone For Three Days In Patients With Psychotic Agitation
NCT02935998Phase 4Unknown
Pharmacovigilance in Gerontopsychiatric Patients
NCT02374567Phase 3Terminated
Antipsychotics and Gene Expression in Soft Tissues
NCT01185743Phase 4Completed
The Role of miR-30 Family Dysregulation in Response to Antipsychotic Treatment
NCT02650102Phase 1, Phase 2Unknown
Evaluation of the Necessity of Long-term Pharmacological Treatment With Antipsychotics in Schizophrenic Patients
NCT02307396Phase 4Completed
A Randomized Double-blind Trial With 6 Antipsychotic Drugs for Schizophrenia
NCT02192723—Completed
Comparative Study of Aripiprazole, Quetiapine and Ziprasidone in Treatment of First Episode Psychosis: 3-year Follow-up
NCT02526030Phase 4Completed
Effectiveness of Ziprasidone for Patients With Schizophrenia
NCT01198353Phase 4Completed
Ziprasidone in the Psychosis Prodrome
NCT00635700Phase 2Completed
One-Year Trial Of Oral Ziprasidone In Patients With Metabolic Syndrome
NCT00748566Phase 4Terminated
Safety and Efficacy of Aripiprazole and Ziprasidone Among Schizophrenic Patients With Metabolic Syndrome
NCT01714011Phase 4Completed
Ziprasidone vs Standard Therapy for Agitated Patients in the ED
NCT00786318Phase 4Withdrawn
High-Dose Oral Ziprasidone Versus Conventional Dosing in Participants With Residual Schizophrenia Symptoms
NCT00403546Phase 3Completed
Improving Diabetes Risk Factors in Persons With Schizophrenia or Bipolar Disorder by Switching to Ziprasidone
NCT00538642—Completed
Comparative Study of Aripiprazole, Quetiapine and Ziprasidone in the Treatment of First Episode Nonaffective Psychosis
NCT02305823Phase 4Completed
Neurocognitive Effectiveness in Treatment of First-episode Non-affective Psychosis: 1-year Follow-up
NCT02534363Phase 4Completed
Preventing Relapse in Schizophrenia: Oral Antipsychotics Compared To Injectables: Evaluating Efficacy
NCT00330863Phase 4Completed
A Non-Interventional Post-Marketing Surveillance Study to Evaluate the Safety and Efficacy of Zeldox Capsule
NCT01053429—Completed
Effect of Ziprasidone on Glucose & Plasma Lipids in Diabetes (II) and Schizophrenia or Schizoaffective Disorder
NCT00395031Phase 2, Phase 3Completed
KOLs & investigators
12
Stefan Leucht, ProfessorKOL score 87
Benedicto Crespo-Facorro, ProfessorKOL score 12
Jeffrey A. Lieberman, MDKOL score 9
Scott W. Woods, MDKOL score 8
Joseph Zohar, MDKOL score 8
Mathias Zink, MDKOL score 6
David C. Henderson, MDKOL score 6
John W. Newcomer, MDKOL score 5
Donald C. Goff, M.D.KOL score 5
Helge Frieling, Prof., MDKOL score 5
Jean-Pierre Lindenmayer, M.D.KOL score 5
Facts & assertions
26 sourced
Anda Generic Count
39
Boxed Warning
present
Dosing Frequency
twice daily
Faers Share Anticholinergic
0.013
Faers Share Eps Akathisia
0.1
Faers Share Gi
0.037
Faers Share Mortality
0.04
Faers Share Nms
0.01
Faers Share Orthostatic
0.005
Faers Share Prolactin
0.01
Faers Share Qt Cardiac
0.017
Faers Share Sedation
0.053
Faers Share Weight Metabolic
0.15
Fda Pharm Class Epc
Atypical Antipsychotic [EPC]
Has Generic Competition
yes
Mechanism Of Action
12.1 Mechanism of Action The mechanism of action of ziprasidone in the treatment of the listed indications could be mediated through a combination of dopamine type 2 (D 2 ) and serotonin type 2 (5HT 2 ) antagonism.
Originator Company
Viatris
Safety Eps Akathisia
present in label
Safety Nms
present in label
Safety Orthostatic
present in label
Safety Prolactin
present in label
Safety Qt Prolongation
present in label
Safety Sedation Somnolence
present in label
Safety Weight Metabolic
present in label
Us Approved
yes
Us Original Approval Date
2001-02-05
relationships
The graph out of here
developer
trial
indication
indication
indication
indication
indication
KOL
Stefan Leucht, Professor
personKOL score 87
Benedicto Crespo-Facorro, Professor
personKOL score 12
Jeffrey A. Lieberman, MD
personKOL score 9
Scott W. Woods, MD
personKOL score 8