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Tofacitinib 5 MG (tofacitinib-5-mg)
Tofacitinib 5 MG (generic name: tofacitinib-5-mg) is a Patients receive Tofacitinib and Naproxene drug developed by Pfizer Inc.. It is currently in preclinical development.
Patients receive Tofacitinib and Naproxene
Tofacitinib 5 MG is a small molecule Janus Kinase (JAK) inhibitor used to treat conditions such as Psoriatic Arthritis and Psoriasis. It works by inhibiting the Janus Kinase (JAK) enzyme, which plays a role in the body's inflammatory response.
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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-5-mg |
|---|---|
| Sponsor | Pfizer Inc. |
| Drug class | Patients receive Tofacitinib and Naproxene |
| Therapeutic area | Immunology |
| Phase | preclinical |
Mechanism of action
Tofacitinib works by targeting and blocking proteins called JAK (Janus kinase) enzymes. These enzymes sit inside immune cells and act like molecular "switches" that turn on inflammatory signals. By blocking these switches, tofacitinib prevents immune cells from producing the chemical messengers that cause inflammation, pain, and joint damage. In rheumatoid arthritis, the immune system mistakenly attacks joint tissue, causing swelling and destruction. Tofacitinib interrupts this process at a fundamental level by preventing the activation of T cells and B cells—the immune cells driving this attack. This dual action of blocking both cell activation and inflammatory messenger production makes it particularly effective at reducing symptoms and slowing disease progression. Unlike older biologic drugs that must be injected, tofacitinib is taken as an oral tablet, making it more convenient for patients. It typically works faster than traditional therapies, often providing symptom relief within weeks rather than months. However, because it broadly suppresses immune signaling, patients taking it need monitoring to ensure their immune system can still fight genuine infections.
Approved indications
Pipeline indications
- Axial Spondyloarthritis — preclinical
Common side effects
Key clinical trials
- Extension Study Of Stage 1 Subjects Of Study A3921009 For The Prevention Of Acute Rejection In Kidne (Phase 2)
- A One-Year Study To Evaluate The Effects And Safety Of CP-690,550 In Patients With Moderate To Sever (Phase 3)
- A Study To Compare The Effectiveness Of Tofacitinib 11 Mg Once A Day To Tofacitinib 5 Mg Twice A Day (N/A)
- A Study Evaluating The Efficacy And Safety Of CP-690,550 In Asian Subjects With Moderate To Severe P (Phase 3)
- Safety and Efficacy of Tofacitinib in Hospitalized Participants With COVID-19 Pneumonia Who Are Rece (Phase 2)
- Dose-Ranging Study Of Tofacitinib In Adults With Active Ankylosing Spondylitis (Phase 2)
- Long-Term Safety Study Of Tofacitinib In Patients With Juvenile Idiopathic Arthritis (Phase 2/3)
- A Study To Evaluate The Mechanism Of Action Of CP-690,550 In Patients With Rheumatoid Arthritis (Phase 2)
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 5 MG CI brief — competitive landscape report
- Tofacitinib 5 MG updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI
Frequently asked questions about Tofacitinib 5 MG
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Related
- Drug class: All Patients receive Tofacitinib and Naproxene drugs
- Manufacturer: Pfizer Inc. — full pipeline
- Therapeutic area: All drugs in Immunology
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing