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Tofacitinib XR (tofacitinib-xr)
Tofacitinib XR (generic name: tofacitinib-xr) is a JAK inhibitor drug developed by Pfizer Inc.. It is currently in preclinical development for Rheumatoid Arthritis.
Tofacitinib XR is a small molecule used to treat various inflammatory conditions, including Chronic Granulomatous Disease, Inflammatory Gastrointestinal Disease, Inflammatory Skin Disease, Inflammatory Lung Disease, and Cutaneous Lupus. It is administered as an extended-release formulation of tofacitinib, a medication that has been studied in clinical trials for its safety and efficacy in treating these conditions.
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Baseline preclinical → approval rate
+5.0pp
Industry-wide preclinical drugs reach approval ~5% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable. -
Big-pharma sponsor
+3.0pp
Pfizer Inc. is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2036–2040 | — |
| EMA | EU | 2037–2041 | +0.7 yr |
| MHRA | GB | 2037–2041 | +0.7 yr |
| Health Canada | CA | 2037–2042 | +0.9 yr |
| TGA | AU | 2037–2042 | +1.2 yr |
| PMDA | JP | 2037–2042 | +1.5 yr |
| NMPA | CN | 2038–2043 | +2.3 yr |
| MFDS | KR | 2037–2042 | +1.4 yr |
| CDSCO | IN | 2037–2043 | +1.8 yr |
| ANVISA | BR | 2038–2043 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | tofacitinib-xr |
|---|---|
| Sponsor | Pfizer Inc. |
| Drug class | JAK inhibitor |
| Target | JAK1, JAK2, JAK3, TYK2 |
| Therapeutic area | Immunology |
| Phase | preclinical |
Approved indications
- Rheumatoid Arthritis — 1L|2L|3L+
Pipeline indications
- Cutaneous Lupus — Phase 1
- Dermatomyositis — Phase 1
Common side effects
Key clinical trials
- Safety and Efficacy of Tofacitinib for Chronic Granulomatous Disease With Inflammatory Complications (PHASE1, PHASE2)
- Korean Post-marketing Surveillance for Xeljanz XR
- Evaluation of Tofacitinib in Prevention of Photosensitivity in Lupus (PHASE1)
- Comparative Analysis of Outcomes Among Patients Treated With Xeljanz vs Biologics
- Study of Tofacitinib in Refractory Dermatomyositis (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Tofacitinib XR CI brief — competitive landscape report
- Tofacitinib XR updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI
Frequently asked questions about Tofacitinib XR
What is Tofacitinib XR?
What is Tofacitinib XR used for?
Who makes Tofacitinib XR?
What is the generic name of Tofacitinib XR?
What drug class is Tofacitinib XR in?
What development phase is Tofacitinib XR in?
What does Tofacitinib XR target?
Related
- Drug class: All JAK inhibitor drugs
- Target: All drugs targeting JAK1, JAK2, JAK3, TYK2
- Manufacturer: Pfizer Inc. — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Rheumatoid Arthritis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing