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Tyrosine kinase inhibitor (TKI) (tyrosine-kinase-inhibitor-tki)
Tyrosine kinase inhibitor (TKI) (generic name: tyrosine-kinase-inhibitor-tki) is a TKIs Small molecule drug developed by Pfizer Inc.. It is currently in preclinical development.
TKIs
Tyrosine kinase inhibitors (TKIs) are a class of medications used to treat various types of cancer, including non-small cell lung cancer, HER2-positive breast cancer, brain metastases, myelofibrosis, and hepatocellular carcinoma. Examples of TKIs include Crizotinib, which is specifically used to treat ALK-rearranged advanced squamous cell carcinoma.
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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). -
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 | tyrosine-kinase-inhibitor-tki |
|---|---|
| Sponsor | Pfizer Inc. |
| Drug class | TKIs |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | preclinical |
Approved indications
Pipeline indications
- Renal Cell Carcinoma (RCC) — preclinical
Common side effects
Key clinical trials
- Phase 2 Study of Dacomitinib in NSCLC (Phase 2)
- Lorlatinib in ALK Inhibitor Treated Unresectable Advanced/Recurrent ALK-Positive Non Small Cell Lung (Phase 4)
- Study to Evaluate Chronic Myeloid Leukemia Treatment Landscape and Real-life Treatment Outcomes in H (N/A)
- A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Di (Phase 3)
- A Study to Learn About Lorlatinib in Patients With Non-Small Cell Lung Cancer Which Could Not Be Con (N/A)
- Study to Evaluate Clinical Real World Outcomes of Lorlatinib After Alectinib in ALK-Positive NSCLC J (N/A)
- Study of Lorlatinib In People With ALK-positive Non-small Cell Lung Cancer (Phase 4)
- Interleukin 11, Thrombocytopenia, Imatinib in Chronic Myelogenous Leukemia (CML) Patients (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:
- Tyrosine kinase inhibitor (TKI) CI brief — competitive landscape report
- Tyrosine kinase inhibitor (TKI) updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI
Frequently asked questions about Tyrosine kinase inhibitor (TKI)
What is Tyrosine kinase inhibitor (TKI)?
How does Tyrosine kinase inhibitor (TKI) work?
Who makes Tyrosine kinase inhibitor (TKI)?
What is the generic name of Tyrosine kinase inhibitor (TKI)?
What drug class is Tyrosine kinase inhibitor (TKI) in?
What development phase is Tyrosine kinase inhibitor (TKI) in?
Related
- Drug class: All TKIs drugs
- Manufacturer: Pfizer Inc. — full pipeline
- Therapeutic area: All drugs in Oncology
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing