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Tasocitinib plus Methotrexate
Tasocitinib plus Methotrexate is a Small molecule drug developed by Pfizer. It is currently in Phase 2 development.
Tasocitinib, a small molecule, is being studied in combination with methotrexate for the treatment of Psoriatic Arthritis, Rheumatoid Arthritis, Colitis, and Ulcerative Colitis. However, there is no verified information available on the specific combination of Tasocitinib and Methotrexate, as the provided facts refer to Tofacitinib, not Tasocitinib.
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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 | Tasocitinib plus Methotrexate |
|---|---|
| Sponsor | Pfizer |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
- Upper respiratory tract infection
- Nasopharyngitis
- Urinary tract infection
- COVID-19
- Alanine aminotransferase increased
- Lymphopenia
- Nausea
- Headache
- Hypertension
- Diarrhoea
- Dizziness
- SARS-CoV-2 test positive
Key clinical trials
- Efficacy of Tofacitinib on Skin Thickening in Diffuse Cutaneous Systemic Sclerosis: A Comparative Study With Methotrexate (PHASE4)
- Tofacitinib vs Methotrexate for Severe Alopecia Areata (TOFA-MTX-AA) (PHASE4)
- Determination of the Optimal Treatment Target in Ulcerative Colitis (PHASE4)
- Methotrexate Combined With Tofacitinib in Rheumatoid Arthritis (NA)
- Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty (PHASE2)
- Induction and Tapering Therapy With Tofacitinib and Glucocorticoid in Patients With Polymyalgia Rheumatica (PHASE3)
- Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response (PHASE3)
- Efficacy of Tofacitinib, Methotrexate Combination Therapy Versus Upadacitinib, Methotrexate Combination Therapy in Moderate to Severe Rheumatoid Arthritis (PHASE3)
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:
- Tasocitinib plus Methotrexate CI brief — competitive landscape report
- Tasocitinib plus Methotrexate updates RSS · CI watch RSS
- Pfizer portfolio CI
Frequently asked questions about Tasocitinib plus Methotrexate
What is Tasocitinib plus Methotrexate?
Who makes Tasocitinib plus Methotrexate?
What development phase is Tasocitinib plus Methotrexate in?
What are the side effects of Tasocitinib plus Methotrexate?
Related
- Manufacturer: Pfizer — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing