Wednesday, July 8, 2026

Drug profile · INN

axitinib

axitinib (INLYTA) is a vascular endothelial growth factor receptor inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved NMPA: clinical trials Antineoplastic and immunomodulating agents (L01) L01EK01
US status approved
Patents linked 0
Pipeline programs 10
News articles 0
Drug details — axitinib
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
ORAL
Patents
0
Programs
10
Data quality
0.89

Quick answer

axitinib (INLYTA) is a vascular endothelial growth factor receptor inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN axitinib
Brand INLYTA
Mechanism Vascular endothelial growth factor receptor inhibitor
Target Vascular endothelial growth factor receptor
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route ORAL
Formulation TABLET
ATC code L01EK01

Mechanism of action

Vascular endothelial growth factor receptor inhibitor

Primary target: Vascular endothelial growth factor receptor

Approval history

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

Pipeline programs

  1. 2023/3764 Phase 3 · George Institute for · Metastatic renal cell carcinoma (mRCC)
  2. B9991046 Phase 3 · First Biotech (Australia) · Cancer
  3. MK-3475-426 Phase 3 · MSD Merck Sharp · Metastatic renal cell carcinoma
  4. Axitinib Phase 2 · ADIAL PHARMACEUTICALS · Melanoma
  5. Axitinib Phase 2 · United Therapeutics Europe · Clear-cell Metastatic Renal Cell Carcinoma
  6. BO43936 Phase 2 · HOFFMANN-LA ROCHE · Untreated Locally Advanced Unresectable or Metastatic Renal
  7. C6461008 Phase 2 · First Biotech (Australia) · ADVANCED OR METASTATIC RENAL CELL CARCINOMA
  8. MEPENDAX Phase 2 · Ishita Pharma - · Ependymoma, Medulloblastoma

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. azacitidine Antineoplastic and immunomodulating agents (L01)
  6. azathioprine Antineoplastic and immunomodulating agents (L04)

Frequently asked questions

What is axitinib?

axitinib (INLYTA) is a vascular endothelial growth factor receptor inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for axitinib?

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

What is the US approval status of axitinib?

axitinib 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.