Wednesday, July 8, 2026

Drug profile · INN

tofacitinib citrate

tofacitinib citrate (XELJANZ INITIAL APPROVAL) is a janus kinase (jak) inhibitor. Route of administration: oral. Current US regulatory status: approved.

FDA: approved PMDA: approved
US status approved
Patents linked 2
Pipeline programs 16
News articles 0
Drug details — tofacitinib citrate
US status
approved
Class
Route
ORAL
Patents
2
Programs
16
Data quality
0.84

Quick answer

tofacitinib citrate (XELJANZ INITIAL APPROVAL) is a janus kinase (jak) inhibitor. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN tofacitinib citrate
Brand XELJANZ INITIAL APPROVAL
Mechanism Janus Kinase (JAK) inhibitor
Target Janus Kinase (JAK)
Route ORAL
Formulation TABLET, EXTENDED RELEASE

Mechanism of action

Janus Kinase (JAK) inhibitor

Primary target: Janus Kinase (JAK)

Approval history

Authority Status Date
FDA approved
PMDA approved

Pipeline programs

  1. A3921145 Phase 3 · First Biotech (Australia) · Juvenile Idiopathic Arthritis (JIA)
  2. A3921210 Phase 3 · First Biotech (Australia) · Ulcerative Colitis (UC)
  3. APHP200026 Phase 3 · PARItec · Patients with GPA and inadequate response to standard of car
  4. SMART-JIA Phase 3 · George Institute for · Juvenile Idiopathic Arthritis
  5. Tofacitinib 5 mg BID Phase 3 · Pfizer · Psoriatic Arthritis
  6. Tofacitinib Phase 2 · Peking University Biologics · Primary Sjögren's Syndrome
  7. BLCL-TOF-EU-01 Phase 1 · Anaxis Pharma · No medical condition.
  8. BLCL-TOF-FDA-03 Phase 1 · Anaxis Pharma · No medical condition

Related & competitor drugs

  1. delgocitinib Dermatologicals (D11)

Related patents

  1. US 10472366

    Glucuronide prodrugs of tofacitinib

    Expires Mon Nov 07 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 10233174

    Thiocarbamate prodrugs of tofacitinib

    Expires Mon Mar 14 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is tofacitinib citrate?

tofacitinib citrate (XELJANZ INITIAL APPROVAL) is a janus kinase (jak) inhibitor. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for tofacitinib citrate?

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

What is the US approval status of tofacitinib citrate?

tofacitinib citrate 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.