TheraRadar
Data updated: Jul 17, 2026

TOFACITINIB CITRATE · BRECKENRIDGE

Generic · see XELJANZ XR Trial Activity: Expansion 21 active trials
Immunology Approved 2012-11-06

TOFACITINIB CITRATE is FDA-approved to treat 5 conditions (same as XELJANZ XR).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Pfizer conducting 22 trials (34%)
50 indications explored (Broad Platform)
→ rheumatoid arthritis (11 trials)
→ psoriatic arthritis (7 trials)
→ ulcerative colitis (6 trials)
15
Indications
--
Phase 3 Trials
13
Years on Market

Details

Status
Prescription
First Approved
2012-11-06
Routes
ORAL
Dosage Forms
TABLET, SOLUTION, TABLET, EXTENDED RELEASE

Companies

BRECKENRIDGE Apotex AUSON SPECGX LLC BIOCON PHARMA AJANTA PHARMA LTD ZYDUS PHARMS MSN Aurobindo Pharma SOMERSET THERAPS LLC SCIEGEN PHARMS MACLEODS PHARMS LTD DEXCEL SINOTHERAPEUTICS INC Sun Pharma CONCORD BIOTECH LTD SAPTALIS PHARMS ORIENT PHARMA CO LTD MICRO LABS YAOPHARMA CO LTD Hikma
Active Ingredient: TOFACITINIB CITRATE

TOFACITINIB CITRATE Approval History

2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
55 FDA actions from 2021 to 2026
Jun 2026 ORIGINAL
Update
Jun 2026 ORIGINAL
Update
Jun 2026 ORIGINAL
Update

What TOFACITINIB CITRATE Treats

5 indications

TOFACITINIB CITRATE is approved for 5 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as XELJANZ XR (same active ingredient).

Source: FDA Label
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Clinical Trial Registry

2 trials
Trial Sponsor ID Phase Status Title
NCT05487963 CGB-500-001 Ph 1, Ph 2 completed Tolerability and Effectiveness of CGB-500 Topical Ointment, 1% Tofacitinib, for the Treatment of Atopic Dermatitis
NCT04468425 AC-1101-PK-001 Ph 1 completed Tofacitinib Citrate Topical Gel 3.2% FDA BA Bridging Study
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

TOFACITINIB CITRATE FDA Label Details

Indications & Usage

TOFACITINIB CITRATE is FDA-approved to treat 5 conditions — same approved indications as XELJANZ XR.

Looking for the branded version?

XELJANZ XR

Full clinical data, patents, trials, and competitive landscape for tofacitinib citrate.

See XELJANZ XR

Data Sources

FDA Approval: ANDA209633 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment