Friday, July 10, 2026

Drug profile · INN

tucatinib

tucatinib (TUKYSA) is a receptor protein-tyrosine kinase erbb-2 inhibitor. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved Antineoplastic and immunomodulating agents (L01) L01EH03
US status approved
Patents linked 0
Pipeline programs 4
News articles 0
Drug details — tucatinib
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
ORAL
Patents
0
Programs
4
Data quality
0.84

Quick answer

tucatinib (TUKYSA) is a receptor protein-tyrosine kinase erbb-2 inhibitor. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN tucatinib
Brand TUKYSA
Mechanism Receptor protein-tyrosine kinase erbB-2 inhibitor
Target Receptor tyrosine-protein kinase erbB-2
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route ORAL
Formulation TABLET
ATC code L01EH03

Mechanism of action

Receptor protein-tyrosine kinase erbB-2 inhibitor

Primary target: Receptor tyrosine-protein kinase erbB-2

Approval history

Authority Status Date
FDA approved
EMA approved

Pipeline programs

  1. WO46069 Phase 3 · HOFFMANN-LA ROCHE · Pretreated Unresectable Locally Advanced or Metastatic human
  2. GEICAM/2020-08 Phase 2 · Ningbo Cancer Hospital · Non-resectable locally advanced or metastatic HER2-positive
  3. IC 2024-01 Phase 2 · George Institute for · HER3-mutant and HER2-not amplified metastatic breast cancer
  4. UC-BCG-2011 Phase 2 · Ningbo Cancer Hospital · HER2+ metastatic breast cancer with isolated brain progressi

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)

Frequently asked questions

What is tucatinib?

tucatinib (TUKYSA) is a receptor protein-tyrosine kinase erbb-2 inhibitor. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for tucatinib?

TUKYSA is a marketed brand name for tucatinib. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of tucatinib?

tucatinib 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.