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Zipalertinib
Zipalertinib is a Small molecule drug developed by Jonsson Comprehensive Cancer Center. It is currently in Phase 2 development. Also known as: CLN 081, CLN-081, CLN081, EGFR Mutant-specific Inhibitor CLN-081.
Zipalertinib is a small molecule inhibitor of the epidermal growth factor receptor (EGFR) being studied for the treatment of non-small cell lung cancer (NSCLC) with EGFR mutations, particularly exon 20 insertion mutations. It is being compared to a placebo in a clinical trial for adjuvant treatment in participants with Stage IB-IIIA NSCLC.
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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).
| 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 | Zipalertinib |
|---|---|
| Also known as | CLN 081, CLN-081, CLN081, EGFR Mutant-specific Inhibitor CLN-081, Mutation-specific EGFR TKI TAS6417 |
| Sponsor | Jonsson Comprehensive Cancer Center |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- REZILIENT3 (REsearching ZIpaLertinib In Egfr Non-small Cell Lung Cancer Tumors) (PHASE3)
- A Study of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions or Other Uncommon Mutation. (PHASE2)
- Zipalertinib With Carboplatin and Pemetrexed for the Treatment of Resectable, Stage II-IIIB, Non-Small Cell Lung Cancer (PHASE2)
- A Study to Assess the Efficacy and Safety of Zipalertinib Versus Placebo for Adjuvant Treatment in Participants With Stage IB-IIIA NSCLC With Uncommon EGFR Mutations, Following Complete Tumor Resection (PHASE3)
- A Phase 1/2 Trial of CLN-081 in Patients With Non-Small Cell Lung Cancer (PHASE1, PHASE2)
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:
- Zipalertinib CI brief — competitive landscape report
- Zipalertinib updates RSS · CI watch RSS
- Jonsson Comprehensive Cancer Center portfolio CI
Frequently asked questions about Zipalertinib
What is Zipalertinib?
Who makes Zipalertinib?
Is Zipalertinib also known as anything else?
What development phase is Zipalertinib in?
Related
- Manufacturer: Jonsson Comprehensive Cancer Center — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: CLN 081, CLN-081, CLN081, EGFR Mutant-specific Inhibitor CLN-081, Mutation-specific EGFR TKI TAS6417
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing