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Drug

Quetiapine Fumarate

Established medicine
ClassSerotonin 2a (5-HT2a) receptor antagonistResearchActive indication expansion

Also known as Seroquel, Quetiapine hemifumarate, quetiapine (as fumarate).

RxNorm221153ChEMBLCHEMBL3188993UNII2S3PL1B6UJ
3
Research papers
2
Active clinical trials
3
Protein targets
9
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Label change: QUETIAPINE FUMARATE (ANDA090681)

Regulatory2026-09-22FDA

A Randomized Clinical Trial of Quetiapine to Reduce Post Concussive Syndrome Polypharmacy

Clinical trial2025-07-11Results expected Q2 2028 · ClinicalTrials.gov

Label change: QUETIAPINE FUMARATE (ANDA090681)

Regulatory2023-09-19FDA

Label change: QUETIAPINE FUMARATE (ANDA090681)

Regulatory2023-04-19FDA

Label change: QUETIAPINE FUMARATE (ANDA090681)

Regulatory2023-04-19FDA

Label change: QUETIAPINE FUMARATE (ANDA090681)

Regulatory2023-04-19FDA

Risk and Protective Factors for SGA-induced Metabolic Syndrome in Bipolar Youth

Clinical trial2022-11-25Results posted · ClinicalTrials.gov

Chinese Longitudinal and Systematic Study of Bioplar Disorder

Clinical trial2022-10-17Results expected Q4 2026 · ClinicalTrials.gov

Quetiapine Augmentation of Prolonged Exposure (PE) Therapy for the Treatment of Co-occurring PTSD and Mild Traumatic Brain Injury

Clinical trial2022-10-17Completed · ClinicalTrials.gov

Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) 2018 guidelines for the management of patients with bipolar disorder.

Research2018-03-14Bipolar disorders

A double-blind, placebo-controlled trial to assess the efficacy of quetiapine fumarate XR in very heavy-drinking alcohol-dependent patients.

Research2011-09-26Alcoholism, clinical and experimental research

Effectiveness of antipsychotic drugs in patients with chronic schizophrenia.

Research2005-09-19The New England journal of medicine

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Quetiapine Fumarate
Aliases & brands
SeroquelQuetiapine hemifumaratequetiapine (as fumarate)
RxNorm CUI
221153
ChEMBL ID
CHEMBL3188993
UNII
2S3PL1B6UJ
Primary mechanism
Serotonin 2a (5-HT2a) receptor antagonist
Regulatory jurisdictions
fda

Pharmacology & targets

3 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

5-hydroxytryptamine receptor 2A
HTR2A · P28223
ANTAGONISTSerotonin 2a (5-HT2a) receptor antagonist
5-hydroxytryptamine receptor 2C
HTR2C · P28335
ANTAGONISTSerotonin 2c (5-HT2c) receptor antagonist
D(2) dopamine receptor
DRD2 · P14416
ANTAGONISTDopamine D2 receptor antagonist

Regulatory timeline

9 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval on record (generic/biosimilar)
2016-11-01
Latest approval
2017-05-09
Authorities
FDA
Total events
9
fdaU.S. Food and Drug Administration· 9 events
2026-09-22Label change
Label change: QUETIAPINE FUMARATE (ANDA090681)
Evidence ↗
2023-09-19Label change
Label change: QUETIAPINE FUMARATE (ANDA090681)
Evidence ↗
2023-04-19Label change
Label change: QUETIAPINE FUMARATE (ANDA090681)
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

55 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
55
registered trials across all phases
LATEST COMPLETION 2022
2
Active studies
2
Recruiting
46
Late-stage (III+)
44
Completed
9
Discontinued
PHASE DISTRIBUTIONn = 55
Early Phase 11Phase 14Phase 24Phase 327Phase 412Phase N / A7

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

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, Phase 4 Study

TerminatedPH IVAstraZenecan=1312012

Efficacy of Quetiapine XR Versus Divalproex on Clinical Outcome Quality of Sleep and Quality of Life in Bipolar Depression

WithdrawnPH IVBo-Hyun Yoon2011

A 4-week, Multi-Centre, Open-label, Non-comparative, Phase IV Study of the Broad Clinical Benefit for Seroquel XR (Quetiapine Fumarate Extended Release) With Flexible Dose as an add-on Therapy in the Treatment of Acute Bipolar Mania Patients With Partial Response to Current Therapy

TerminatedPH IVAstraZenecan=322011

An Open Label, Multicenter, Single Arm, 4-Week Study to Evaluate the Efficacy and Safety of Flexible Dose of Quetiapine Fumarate (Seroquel) Switching From Other Drugs in the Treatment of Acute Manic Patients With Bipolar Disorder

Unknown statusPH IVGuangzhou Mental Hospitaln=1202010

Pilot Study to Evaluate the Efficacy and Safety of Quetiapine Fumarate Instant-Release (Seroquel IR) in Controlling Agitation and Aggressive Symptoms in the Acute Treatment of Patients With Schizophrenia

Unknown statusPH IVSichuan Universityn=702010

Recent completions

Trials that read out recently, adding to the completed evidence base.

Quetiapine Augmentation of Prolonged Exposure (PE) Therapy for the Treatment of Co-occurring PTSD and Mild Traumatic Brain Injury

CompletedPH IThe University of Texas Health Science Center at San Antonion=282022

Risk and Protective Factors for SGA-induced Metabolic Syndrome in Bipolar Youth

CompletedPH IIIUniversity of Cincinnatin=192018

A Randomized, Open Label, Two-Treatment, Two-Period, Two-Sequence, Crossover, Single Dose, Bioequivalence Study of Quetiapine Fumarate Tablets 25 mg With Seroquel® 25 mg in Normal, Healthy, Adult, Human Subjects, Under Fasting Condition

CompletedPH IIPCA Laboratories Ltd.n=542011

A Randomized, Open Label, Two-Treatment, Two-Period, Two-Sequence, Crossover, Single Dose, Bioequivalence Study of Quetiapine Fumarate Tablets 25 mg With Seroquel® 25 mg in Normal, Healthy, Adult, Human Subjects, Under Fed Condition

CompletedPH IIPCA Laboratories Ltd.n=542011

A Double-Blind, Placebo-Controlled Trial of the Efficacy of Quetiapine for the Reduction of Cocaine Use

CompletedN/ASeattle Institute for Biomedical and Clinical Researchn=602010

Randomized, Open-Label, Balanced, Two-treatment, Two-period, Two-sequence, Crossover, Multicentric Experimental Bioequivalence Study of Quetiapine Fumarate Film-coated Tablets 300 mg (Test)and Seroquel Film-coated Tablets 300 mg (Reference) Under Fasting Condition

CompletedPH IDr. Reddy's Laboratories Limitedn=542010

Research activity

3 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
2005–2018
Journals, researchers & institutions
Top journals
  • Alcoholism, clinical and experimental research1
  • Bipolar disorders1
  • The New England journal of medicine1
Leading researchers
  • Afshar M1
  • Alda M1
  • Beaulieu S1
  • Berk M1
  • Bond DJ1
  • Brunette MF1
  • Calabrese JR1
  • Ciraulo D1
Leading institutions
free-text, unnormalised
  • College of Physicians and Surgeons1
  • Dalhousie University1
  • Department of Psychiatry & Behavioral Sciences Stanford University1
  • George Washington University1
  • IMPACT Strategic Research Centre1
  • Institute of Neuroscience1

Related drugs

7 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Olanzapine

Acts on the same molecular target as Quetiapine Fumarate, with 4 overlapping disease areas.

3 shared targets4 shared diseases2 shared papers
Risperidone

Acts on the same molecular target as Quetiapine Fumarate, with 3 overlapping disease areas.

3 shared targets3 shared diseases1 shared paper
Perphenazine

Acts on the same molecular target as Quetiapine Fumarate, with 3 overlapping disease areas.

Shared target3 shared diseases1 shared paper
Ziprasidone

Studied across 3 of the same disease areas as Quetiapine Fumarate in the shared literature.

3 shared diseases1 shared paper
Bupropion

Studied across the same disease area as Quetiapine Fumarate in the shared literature.

1 shared disease1 shared paper
Lamotrigine

Studied across the same disease area as Quetiapine Fumarate in the shared literature.

1 shared disease1 shared paper
Valproic Acid

Studied across the same disease area as Quetiapine Fumarate in the shared literature.

1 shared disease1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.