QUETIAPINE FUMARATE · Hikma
Quetiapine tablet is an atypical antipsychotic indicated for the treatment of: Schizophrenia Bipolar I disorder manic episodes Bipolar disorder, depressive episodes Quetiapine tablets are indicated for the treatment of schizophrenia. The efficacy of quetiapine tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years).
Details
- Status
- Prescription
- First Approved
- 1997-09-26
- Routes
- ORAL
- Dosage Forms
- TABLET, TABLET, EXTENDED RELEASE
Companies
QUETIAPINE FUMARATE Approval History
What QUETIAPINE FUMARATE Treats
3 indicationsQUETIAPINE FUMARATE is approved for 3 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Schizophrenia
- Bipolar I Disorder
- Bipolar II Disorder
QUETIAPINE FUMARATE Boxed 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. Quetiapine is not approved for elderly patients with dementia-related psychosis ( 5.1 ) Suicidal Thoughts and Behaviors Increased risk of sui...
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. Quetiapine 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 ( 5.2 ) 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 )]. Quetiapine 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 )]. Quetiapine is not approved for use in pediatric patients under ten years of age [see USE IN SPECIFIC POPULATIONS ( 8
QUETIAPINE FUMARATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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 QUETIAPINE FUMARATE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
10 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 |
| 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 |
| 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.
QUETIAPINE FUMARATE FDA Label Details
Indications & Usage
FDA Label (PDF)Quetiapine tablet is an atypical antipsychotic indicated for the treatment of: Schizophrenia Bipolar I disorder manic episodes Bipolar disorder, depressive episodes 1.1 Schizophrenia Quetiapine tablets are indicated for the treatment of schizophrenia. The efficacy of quetiapine tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). The effectiveness of quetiapine tablets for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see CLINICAL STUDIES ]. 1.2 Bipolar D...
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 ...
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SEROQUEL
Full clinical data, patents, trials, and competitive landscape for quetiapine fumarate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.