Friday, July 10, 2026

Drug profile · INN

osimertinib mesylate

osimertinib mesylate (TAGRISSO) is a epidermal growth factor receptor erbb1 inhibitor. Route of administration: oral. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 0
Pipeline programs 4
News articles 0
Drug details — osimertinib mesylate
US status
approved
Class
Route
ORAL
Patents
0
Programs
4
Data quality
0.84

Quick answer

osimertinib mesylate (TAGRISSO) is a epidermal growth factor receptor erbb1 inhibitor. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN osimertinib mesylate
Brand TAGRISSO
Mechanism Epidermal growth factor receptor erbB1 inhibitor
Target Epidermal growth factor receptor
Route ORAL
Formulation TABLET

Mechanism of action

Epidermal growth factor receptor erbB1 inhibitor

Primary target: Epidermal growth factor receptor

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. Osimertinib Phase 3 · First People's Hospital · Non-small Cell Carcinoma
  2. CA244-0001 Phase 2 · Bristol-Myers Squibb Australia · Advance solid tumors
  3. osimertinib mesylate tablets and anlotinib hydrochloride capsules Phase 2 · First People's Hospital · Non Small Cell Lung Cancer
  4. Osimertinib Phase 1 · PUMA BIOTECHNOLOGY · Lung Cancer Metastatic

Related & competitor drugs

  1. erlotinib hydrochloride Epidermal growth factor receptor erbB1 inhibitor
  2. lapatinib ditosylate Receptor protein-tyrosine kinase erbB-2 inhibitor
  3. mobocertinib Antineoplastic and immunomodulating agents (L01)
  4. mobocertinib succinate Epidermal growth factor receptor erbB1 inhibitor
  5. neratinib maleate Receptor protein-tyrosine kinase erbB-2 inhibitor
  6. afatinib dimaleate Epidermal growth factor receptor erbB1 inhibitor

Frequently asked questions

What is osimertinib mesylate?

osimertinib mesylate (TAGRISSO) is a epidermal growth factor receptor erbb1 inhibitor. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for osimertinib mesylate?

TAGRISSO is a marketed brand name for osimertinib mesylate. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of osimertinib mesylate?

osimertinib mesylate 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.