Wednesday, July 8, 2026

Drug profile · INN

olanzapine

olanzapine (APO-OLANZAPINE ODT) is a d2-like dopamine receptor antagonist. Associated with Alphapharm Pty Ltd. Route of administration: intramuscular. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved PMDA: approved NMPA: clinical trials Nervous system (N05) N05AH03
US status approved
Patents linked 3
Pipeline programs 10
News articles 1
Drug details — olanzapine

Quick answer

olanzapine (APO-OLANZAPINE ODT) is a d2-like dopamine receptor antagonist. Associated with Alphapharm Pty Ltd. Route of administration: intramuscular. Current US regulatory status: approved.

Key facts

INN olanzapine
Brand APO-OLANZAPINE ODT
Mechanism D2-like dopamine receptor antagonist
Target D2-like dopamine receptor
Therapeutic class Nervous system (N05)
Route INTRAMUSCULAR
Formulation TABLET, ORALLY DISINTEGRATING
ATC code N05AH03

Mechanism of action

D2-like dopamine receptor antagonist

Primary target: D2-like dopamine receptor

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
PMDA approved
NMPA clinical trials

Recent coverage

Pipeline programs

  1. Olanzapine Phase 3 · Janssen Cilag International · Bipolar Disorder
  2. Phase 1: Olanzapine Phase 3 · Shanghai Mental Health · Schizophrenia
  3. XPORT-MM-028 Phase 2 · Karyopharm Therapeutics · Penta-refractory multiple myeloma and triple-class refractor
  4. Olanzapine Phase 1 · CORCEPT THERAPEUTICS · Antipsychotic-induced Weight Gain
  5. Olanzapine Extended Release Phase 1 · Teva Pharma · Schizophrenia, Schizoaffective Disorder
  6. TV44749-BA-10196 Phase 1 · Anaxis Pharma · Schizophrenia
  7. INTENSIFY SZ Approved · Disc Medicine · schizophrenia, schizoaffective disorder, schizophrenifom dis
  8. NL6220204217 Approved · Disc Medicine · HAMLETT compares regular treatment guidelines for patients i

Related & competitor drugs

  1. aripiprazole Nervous system (N05)
  2. brexpiprazole Nervous system (N05)
  3. brivaracetam Nervous system (N03)
  4. bupivacaine Nervous system (N01)
  5. buprenorphine Nervous system (N07)
  6. caffeine citrate Nervous system (N06)
  1. US 11813359

    Sustained release olanzapine formulations

    Expires Mon Nov 09 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 10646443

    Sustained release olanzapine formulations

    Expires Mon May 07 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 7323459

    Crystal forms, methods for their preparation and method for preparation of olanzapine

    Expires Mon Jan 24 2028 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is olanzapine?

olanzapine (APO-OLANZAPINE ODT) is a d2-like dopamine receptor antagonist. Associated with Alphapharm Pty Ltd. Route of administration: intramuscular. Current US regulatory status: approved.

What is the brand name for olanzapine?

APO-OLANZAPINE ODT is a marketed brand name for olanzapine. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of olanzapine?

olanzapine has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.