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Tofacitinib 2 mg
Tofacitinib 2 mg is a Small molecule drug developed by Pfizer. It is currently in Phase 2 development.
Tofacitinib 2 mg is used to treat conditions such as Rheumatoid Arthritis, Polyarticular Course Juvenile Idiopathic Arthritis (JIA), and Psoriasis. It is studied in combination with methotrexate and without methotrexate, and is compared to Adalimumab with methotrexate in clinical trials.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Pfizer 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 | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 2 mg |
|---|---|
| Sponsor | Pfizer |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
- Upper respiratory tract infection
- Bronchitis
- Urinary tract infection
- Nasopharyngitis
- Herpes zoster
- Hypertension
- Rheumatoid arthritis
- Fall
- Back pain
- Arthralgia
- Sinusitis
- Diarrhoea
Key clinical trials
- Safety and Efficacy of Tofacitinib for Chronic Granulomatous Disease With Inflammatory Complications (PHASE1, PHASE2)
- The Efficacy and Safety of Anti-inflammation Treatment (Hirudoid Introduction Followed by Yellow Light Therapy) Combined With Tofacitinib and Doxycycline in Chinese Adult Patients With Mild to Moderate Erythematous Telangiectatic Rosacea (NA)
- Long-Term Safety Study Of Tofacitinib In Patients With Juvenile Idiopathic Arthritis (PHASE2, PHASE3)
- Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis (PHASE3)
- A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC) (PHASE4)
- Therapies for Down Syndrome Regression Disorder (PHASE2)
- Evaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative Colitis (PHASE3)
- A Study on the Efficacy and Safety of JAK Inhibitors Versus Calcineurin Inhibitors as Initial Therapy for Interstitial Lung Disease Associated With Antisynthetase Syndrome (NA)
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 2 mg CI brief — competitive landscape report
- Tofacitinib 2 mg updates RSS · CI watch RSS
- Pfizer portfolio CI
Frequently asked questions about Tofacitinib 2 mg
What is Tofacitinib 2 mg?
Who makes Tofacitinib 2 mg?
What development phase is Tofacitinib 2 mg in?
What are the side effects of Tofacitinib 2 mg?
Related
- Manufacturer: Pfizer — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing