Wednesday, July 8, 2026

Drug profile · INN

tofacitinib

tofacitinib (XELJANZ) is a janus kinase (jak) 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 (L04) L04AF01
US status approved
Patents linked 0
Pipeline programs 0
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Drug details — tofacitinib
US status
approved
Class
Antineoplastic and immunomodulating agents (L04)
Route
ORAL
Patents
0
Programs
0
Data quality
0.84

Quick answer

tofacitinib (XELJANZ) is a janus kinase (jak) inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN tofacitinib
Brand XELJANZ
Mechanism Janus Kinase (JAK) inhibitor
Therapeutic class Antineoplastic and immunomodulating agents (L04)
Route ORAL
Formulation TABLET
ATC code L04AF01

Mechanism of action

Janus Kinase (JAK) inhibitor

Approval history

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

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 tofacitinib?

tofacitinib (XELJANZ) is a janus kinase (jak) inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for tofacitinib?

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

What is the US approval status of tofacitinib?

tofacitinib 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.