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Tasocitinib plus Methotrexate

Pfizer · Phase 2 active Small molecule ✓ Verified May 2026 Quality 10/100

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.

Likelihood of approval
18.3% vs 15.3% industry baseline
If approved by FDA: likely 2031–2034
Steps remaining: Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • 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.
Predicted approval windows by jurisdiction (conditional on FDA approval)
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 nameTasocitinib plus Methotrexate
SponsorPfizer
ModalitySmall molecule
PhasePhase 2

Approved indications

No approved indications tracked.

Common side effects

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Tasocitinib plus Methotrexate

What is Tasocitinib plus Methotrexate?

Tasocitinib plus Methotrexate is a Small molecule drug developed by Pfizer.

Who makes Tasocitinib plus Methotrexate?

Tasocitinib plus Methotrexate is developed by Pfizer (see full Pfizer pipeline at /company/pfizer).

What development phase is Tasocitinib plus Methotrexate in?

Tasocitinib plus Methotrexate is in Phase 2.

What are the side effects of Tasocitinib plus Methotrexate?

Common side effects of Tasocitinib plus Methotrexate include Upper respiratory tract infection, Nasopharyngitis, Urinary tract infection, COVID-19, Alanine aminotransferase increased, Lymphopenia.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing