drug
as of 2026-07-01Quetiapine
Seroquel IR 300mgSeroquel IR 25mgQuetiapine Formulation A 300mgQuetiapine Formulation B 300mgQuetiapine Formulation 25mgSeroquel Sustained Release (SR)Seroquel Immediate Release (IR)quetiapine fumarate tablets
UNII 2S3PL1B6UJRxCUI 153638, 153639, 153640, 284509, 312743, 312744FDA_ApplNo NDA020639SPL_set_id 473a3ac4-67f4-4782-baa9-7f9bdd8761f4FDA_sponsor CHEPLAPHARMOrangeBook_Appl A077380, A077745, A078679, A090120, A090323, A090482, A090681, A090749
at a glance
Synthesized from structured facts only — each point cited above.
Mechanism & identity
Modality
small molecule
Mechanism of action
12.1 Mechanism of Action The mechanism of action of quetiapine in the listed indications is unclear. However, the efficacy of quetiapine in these indications could be mediated through a combination of dopamine type 2 (D 2 ) and serotonin type 2A (5HT 2A ) antagonism. The active metabolite, N-desalkyl quetiapine (norquetiapine), has similar activity at D 2 , but greater activity at 5HT 2A receptors, than the parent drug (quetiapine).
Indications
Labeled
SchizophreniaBipolar depressionBipolar maniaMajor depressive disorder
Investigational (via trials)
Adverse-event signal
FAERS spontaneous · within-drug share
Weight Metabolic6.5%
top term: DIABETES MELLITUS
Sedation5.2%
top term: FATIGUE
Gi4.7%
top term: NAUSEA
Mortality4.4%
top term: COMPLETED SUICIDE
Eps Akathisia1.7%
top term: TREMOR
Anticholinergic1.3%
top term: CONSTIPATION
Qt Cardiac1.3%
top term: TACHYCARDIA
Orthostatic1.0%
top term: HYPOTENSION
Nms0.6%
top term: NEUROLEPTIC MALIGNANT SYNDROME
Spontaneous reports — a signal of reporting share, not incidence.
Trials
105
Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure
NCT05603104Phase 3Recruiting
Comparing Antipsychotic Medications in LBD Over Time
NCT05590637Phase 4Recruiting
Atypical Antipsychotics Influence on the Safety of the Heart and Monitoring Indicators Model Building
NCT04446234Phase 4Unknown
A Study of the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia.
NCT04115319Phase 3Completed
A 6-week Study to Evaluate the Efficacy and Safety of Lurasidone HCL in Acutely Psychotic Patients With Schizophrenia
NCT03465787Phase 3Completed
A Study to Compare Disease Progression and Modification Following Treatment With Paliperidone Palmitate Long-Acting Injection or Oral Antipsychotics in Participant's With Recent-onset Schizophrenia or Schizophreniform
NCT02431702Phase 3Completed
Trial to Assess the Bioavailability of Quetiapine Versus Seroquel® in Subjects With Schizophrenia or Bipolar Disorder
NCT03872596Phase 1Completed
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
A Trial to Explore Acceptance and Performance of Using a Digital Medicine System With Healthcare Professionals and Adults With Schizophrenia, Schizoaffective Disorder, or First Episode Psychosis on an Oral Atypical Antipsychotic
NCT03568500Phase 4Completed
Family Intervention in Recent Onset Schizophrenia Treatment (FIRST)
NCT02600741—Completed
Study Investigating the Effect of Lu AF35700 on Cardiac Repolarization in Men and Women With Schizophrenia and Schizoaffective Disorder
NCT02901587Phase 1Completed
Cannabidiol as a Different Type of an Antipsychotic: Drug Delivery and Interaction Study
NCT02051387Phase 1Completed
Pharmacovigilance in Gerontopsychiatric Patients
NCT02374567Phase 3Terminated
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 Study to Assess the Clinical Utility of Antipsychotic Medication Levels in Plasma as Determined by Liquid Chromatography-Tandem Mass Spectrometry
NCT02462473Phase 2Terminated
Tolerance and Effect of Antipsychotics in Children and Adolescents With Psychosis
NCT01119014Phase 4Completed
Brexpiprazole in Patients With Acute Schizophrenia
NCT01810380Phase 3Completed
Antipsychotic to Treat Psychosis Syndrome
NCT02137616—Unknown
Parallel Group, Multiple Dose Pharmacokinetics Study of Five Antipsychotic Medications in Psychiatric Participants
NCT02087579Phase 1Completed
High Dose of Quetiapine in Treating Subjects With Treatment Refractory Schizophrenia or Schizoaffective Disorder
NCT00297947Phase 2, Phase 3Completed
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
15 Month Study for Adults Who Have Been Diagnosed With Schizophrenia and Incarcerated
NCT01157351Phase 4Completed
KOLs & investigators
12
Stefan Leucht, ProfessorKOL score 87
Leslie L Citrome, MD, MPHKOL score 32
Benedicto Crespo-Facorro, ProfessorKOL score 12
Jeffrey A. Lieberman, MDKOL score 9
Scott W. Woods, MDKOL score 8
Niels Bilenberg, Professor, MD.KOL score 8
Peter G. Falkai, Prof. Dr.KOL score 8
Gang Wang, MDKOL score 7
Dilip V. Jeste, MDKOL score 7
Trisha Suppes, MD, PhDKOL score 7
Professor Jayashri KulkarniKOL score 6
Jose M Canive, MDKOL score 5
Facts & assertions
24 sourced
Anda Generic Count
187
Boxed Warning
present
Dosing Frequency
once daily
Faers Share Anticholinergic
0.013
Faers Share Eps Akathisia
0.017
Faers Share Gi
0.047
Faers Share Mortality
0.044
Faers Share Nms
0.006
Faers Share Orthostatic
0.01
Faers Share Qt Cardiac
0.013
Faers Share Sedation
0.052
Faers Share Weight Metabolic
0.065
Has Generic Competition
yes
Mechanism Of Action
12.1 Mechanism of Action The mechanism of action of quetiapine in the listed indications is unclear. However, the efficacy of quetiapine in these indications could be mediated through a combination of dopamine type 2 (D 2 ) and serotonin type 2A (5HT 2A ) antagonism. The active metabolite, N-desalky
Originator Company
Cheplapharm
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
1997-09-26
relationships
The graph out of here
developer
company
trial
indication
indication
indication
indication
indication
KOL
Stefan Leucht, Professor
personKOL score 87
Leslie L Citrome, MD, MPH
personKOL score 32
Benedicto Crespo-Facorro, Professor
personKOL score 12
Jeffrey A. Lieberman, MD
personKOL score 9