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Drug

Olanzapine

Approved · EMA
ClassD2-like dopamine receptor antagonistEmerging researchLate-stage developmentCooling momentum
Also known as Lybalvi, Symbyax, ZyPREXA, Olanzapin+2 more

Lybalvi, Symbyax, ZyPREXA, Olanzapin, Olanzapina, Olanzapinum.

5
Research papers
16
Active clinical trials
5
Protein targets
11
Regulatory events
Latest activity
beta

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

GI-05: The Impact of Olanzapine Among Patients Receiving Neoadjuvant Chemotherapy for Gastric Cancer

Clinical trial2026-06-18Results expected Q3 2028 · ClinicalTrials.gov

Olanzapine for prevention of chemotherapy-induced nausea and vomiting in children and adolescents: a multi-center, feasibility study.

Research2017-08-30Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer

Approval: Olazax (EMA)

Regulatory2009-12-11EMA

Approval: Olazax Disperzi (EMA)

Regulatory2009-12-10EMA

Profile

Identifiers & mechanism

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

Canonical name
Olanzapine
Aliases & brands
LybalviSymbyaxZyPREXAOlanzapinOlanzapinaOlanzapinum
RxNorm CUI
61381
ChEMBL ID
CHEMBL715
ATC codes
N05AH03
UNII
N7U69T4SZR
Primary mechanism
D2-like dopamine receptor antagonist
Regulatory jurisdictions
ema

Pharmacology & targets

5 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

ANTAGONISTD2-like dopamine receptor antagonist
ANTAGONISTSerotonin 2a (5-HT2a) receptor antagonist
ANTAGONISTSerotonin 2c (5-HT2c) receptor antagonist
ANTAGONISTD2-like dopamine receptor antagonist
ANTAGONISTD2-like dopamine receptor antagonist

Regulatory timeline

11 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
1996-09-27
Latest approval
2009-12-11
Authorities
EMA
Total events
11
emaEuropean Medicines Agency· 11 events
2025-08-12Market withdrawalMarket
Market withdrawal: Olanzapine Apotex (EMA)
Indication: Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shownShow full indication

Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.

Evidence ↗
2009-12-11Approval
Approval: Olazax (EMA)
Indication: Adults Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who haveShow full indication

Adults Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.

Evidence ↗
2009-12-10Approval
Approval: Olazax Disperzi (EMA)
Indication: Adults Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who haveShow full indication

Adults Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

196 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
196
registered trials across all phases
LATEST COMPLETION 2025
16
Active studies
15
Recruiting
144
Late-stage (III+)
145
Completed
35
Discontinued
PHASE DISTRIBUTIONn = 196
Early Phase 13Phase 118Phase 1 / 24Phase 227Phase 2 / 34Phase 350Phase 462Phase N / A28

Late-stage studies

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

Recent completions

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

Research activity

5 papers

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

Publications over time
20052020
Most influential
Recent papers
Major research themes2
Ambulatory Surgical Procedures1Weight Gain1
Journals, researchers & institutions
Top journals
  • Anesthesiology1
  • Bipolar disorders1
  • Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer1
  • The American journal of psychiatry1
  • The New England journal of medicine1
Leading researchers
  • Alda M1
  • Ascher-Walsh C1
  • Barr Grzesh RL1
  • Beaulieu S1
  • Berk M1
  • Blank SV1
  • Bond DJ1
  • Calabrese JR1
Leading institutions
free-text, unnormalised
  • McMaster University2
  • Blavatnik Family Women's Health Research Institute (S.V.B.) Division of Plastic and Reconstructive Surgery1
  • Children's Hospital1
  • Children's Hospital of Eastern Ontario1
  • College of Physicians and Surgeons1
  • Connecticut Children's Medical Center1

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).

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

3 shared targets4 shared diseases2 shared papers

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

3 shared targets3 shared diseases1 shared paper

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

Shared target3 shared diseases1 shared paper

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

3 shared diseases1 shared paper

Studied across the same disease area as Olanzapine in the shared literature.

1 shared disease1 shared paper

Studied across the same disease area as Olanzapine in the shared literature.

1 shared disease1 shared paper

Studied across the same disease area as Olanzapine 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.