Last reviewed 2026-05-22 · How we verify

Tofacitinib 10mg (tofacitinib-10mg)

Pfizer Inc. · Phase 3 active ✓ Verified May 2026 Quality 0/100

Tofacitinib 10mg (generic name: tofacitinib-10mg) is a drug developed by Pfizer Inc.. It is currently in Phase 3 development.

Tofacitinib inhibits Janus kinases (JAKs), reducing cytokine signaling and inflammation.

Tofacitinib 10mg is a small molecule Janus Kinase (JAK) inhibitor. It has been studied in clinical trials for various conditions, including COVID-19 pneumonia, interstitial pneumonitis, and alopecia areata.

Likelihood of approval

61.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
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.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+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-10mg
Sponsor	Pfizer Inc.
Phase	Phase 3

Mechanism of action

Tofacitinib blocks the activity of Janus kinases (JAKs), which are enzymes involved in the signaling pathways of various cytokines. By inhibiting JAKs, tofacitinib reduces the inflammatory response in conditions like rheumatoid arthritis.

Approved indications

No approved indications tracked.

Common side effects

Abnormal liver function

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Tofacitinib 10mg CI brief — competitive landscape report
Tofacitinib 10mg updates RSS · CI watch RSS
Pfizer Inc. portfolio CI

Frequently asked questions about Tofacitinib 10mg

What is Tofacitinib 10mg?

Tofacitinib 10mg (tofacitinib-10mg) is a pharmaceutical drug developed by Pfizer Inc..

How does Tofacitinib 10mg work?

Tofacitinib inhibits Janus kinases (JAKs), reducing cytokine signaling and inflammation.

Who makes Tofacitinib 10mg?

Tofacitinib 10mg is developed by Pfizer Inc. (see full Pfizer Inc. pipeline at /company/pfizer).

What is the generic name of Tofacitinib 10mg?

tofacitinib-10mg is the generic (nonproprietary) name of Tofacitinib 10mg.

What development phase is Tofacitinib 10mg in?

Tofacitinib 10mg is in Phase 3.

What are the side effects of Tofacitinib 10mg?

Common side effects of Tofacitinib 10mg include Abnormal liver function.

Manufacturer: Pfizer Inc. — full pipeline

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