SEROQUEL (quetiapine fumarate)
SEROQUEL is indicated for the treatment of Schizophrenia; Bipolar Disorder.
How SEROQUEL Works
The precise mechanism of action of quetiapine is not fully established for its approved indications. Its efficacy is thought to be mediated through a combination of antagonism at dopamine type 2 (D2) and serotonin type 2 (5HT2) receptors. The drug’s active metabolite, norquetiapine, also contributes to the therapeutic effect by acting on D2 receptors and providing greater activity at 5HT2A receptors than the parent drug.
Details
- Status
- Prescription
- First Approved
- 1997-09-26
- Routes
- ORAL
- Dosage Forms
- TABLET
SEROQUEL Approval History
What SEROQUEL Treats
2 indicationsSEROQUEL is approved for 2 conditions since its original approval in 1997. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Schizophrenia
- Bipolar Disorder
SEROQUEL Boxed Warning
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death [see Warnings and Precautions (5.1) ] . SEROQUEL is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1) ] . Suicidal Thoughts and Behaviors Anti...
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death [see Warnings and Precautions (5.1) ] . SEROQUEL is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1) ] . Suicidal Thoughts and Behaviors Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions (5.2) ]. In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [ see Warnings and Precautions (5.2) ] . SEROQUEL is not approved for use in pediatric patients under ten years of age [see Use in Specific Populations (8.4) ] . WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Increased Mortality in Elderly Patients with Dementia-Related Psychosis • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. SEROQUEL is not approved for elderly patients with dementia-related psychosis ( 5.1 ) Suicidal Thoughts and Behaviors • Increased risk of suicidal thoughts and behavior in children, adolescents and young adults taking antidepressants ( 5.2 ) • Monitor for worsening and emergence of suicidal thoughts and behaviors (
SEROQUEL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to SEROQUEL
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06333990 | 20220796HU | Ph 3 | recruiting | Quetiapine to Reduce Post Concussive Syndrome After Mild Traumatic Brain Injury (mTBI) |
| NCT01858948 results posted | DK097599-01A1 5R01DK097599 | Ph 3 | completed | SGA-induced Metabolic Syndrome in Bipolar Youth |
| NCT00674765 results posted | 807057 - Kampan_AA016553 NIH Grant 1R01AA016553-01A1 | Ph 2 | completed | Seroquel for Frequent, Heavy Drinkers |
| NCT01254721 STAR results posted | D1443L00086 | Ph 4 | terminated | A Comparison of the Effectiveness of Seroquel XR and Seroquel XR Plus Lithium in Patients With Acute Bipolar Mania: An Open-label, Randomized, Parallel Groups, Rater-blinded, 4 Week, Multicenter, Comparative,Study |
| NCT00773162 | AzSeroSP | Ph 3 | completed | Flushing in Social Anxiety Disorder on Seroquel |
| NCT00672490 MANIA results posted | D1443L00023 | Ph 4 | completed | Quetiapine Fumarate (Seroquel) as Mono-Therapy or Adjunct to Lithium in the Treatment of Patients With Acute Mania in Bipolar Disorder |
| NCT01603186 | Ipca/ARL/257 | Ph 1 | completed | Bioequivalence Study of Quetiapine Fumarate Tablets 25 mg Under Fed Condition |
| NCT01603173 | Ipca/ARL/233 | Ph 1 | completed | Bioequivalence Study of Quetiapine Fumarate Tablets 25 mg Under Fasting Condition |
| NCT01587066 | D1443L00059 | Ph 4 | withdrawn | Efficacy of Quetiapine XR Versus Divalproex on Clinical Outcome Quality of Sleep and Quality of Life in Bipolar Depression |
| NCT01566487 | 353-09 | Ph 1 | completed | Bioequivalence Study of Quetiapine Fumarate Tablets 300 mg Under Fasting Condition |
| NCT00622245 | 12022A 2007-002551-17 | Ph 2 | terminated | Efficacy and Safety of Lu AA34893 in Patients With Bipolar Depression |
| NCT00702676 | D1443C00033 | Ph 1 | completed | Quetiapine Fumarate Immediate Release (IR) Versus Extended Release (XR) Dose Escalation Comparison |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SEROQUEL FDA Label Details
Indications & Usage
FDA Label (PDF)SEROQUEL is indicated for the treatment of Schizophrenia; Bipolar Disorder.
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.