Drugs / Lazertinib
Lazertinib
also known as
YH25448 · C-18112003-G · GNS-1480 · JNJ-73841937-AAA · JNJ-73841937-ZCY · Lazcluze · Lazertinib mesilate hydrate · LAZERTINIB MESYLATE · +4 more
Small molecule targets EGFR via inhibition
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | LAZCLUZE | — | 2025-08-14 | fda.gov ↗ |
| Approved | EU (EMA) | Lazcluze | — | 2025-01-20 | europa.eu ↗ |
| Approved | US (FDA) | LAZCLUZE | — | 2024-08-19 | fda.gov ↗ |
Trials 34 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 19 trials | ||||||
| Phase 1 | NCT05896683 | May → Sep 2023 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT05742594 | Jan → Mar 2023 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT05112952 | Nov 2021 → Jul 2022 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT05076877 | Sep 2021 → Feb 2022 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT04410094 | Sep → Dec 2020 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT04410081 | Jul 2020 → Mar 2021 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT04077463 | Sep 2019 → Feb 2027 expected | non-small cell lung carcinoma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03556436 | Jul → Dec 2018 | non-small cell lung carcinoma | Yuhan Corporation | Completed | No outcome recorded |
| Phase 1 | NCT02609776 | May 2016 → Dec 2026 expected | non-small cell lung carcinoma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT04075396 | Oct 2019 → Jan 2021 | non-small cell lung carcinoma | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1/2 | NCT03046992 | Feb 2017 → Jan 2021 | — | Yuhan Corporation | Completed | No outcome recorded |
| Phase 219 trials | ||||||
| Phase 2 | NCT07586202 | Jul 2026 → Mar 2028 expected | non-small cell lung carcinoma | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 2 | NCT07507188 | Apr 2026 → Jan 2031 expected | non-small cell lung carcinoma | Yonsei University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06667076 | Dec 2024 → May 2029 expected | non-small cell lung carcinoma | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 2 | NCT06106802 | Jun 2024 → Sep 2029 expected | non-small cell lung carcinoma | Samsung Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06156527 | Sep 2023 → Sep 2026 expected | — | National Cancer Center, Korea | Recruiting | No outcome recorded |
| Phase 2 | NCT05299125 | May 2023 → Jan 2026 overdue | non-small cell lung carcinoma | Latin American Cooperative Oncology Group | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05786430 | Apr 2023 → Aug 2026 overdue | non-small cell lung carcinoma | Yonsei University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05601973 | Mar 2023 → Aug 2024 overdue | non-small cell lung carcinoma | ETOP IBCSG Partners Foundation | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05701384 | Feb 2023 → Jan 2024 | lung carcinoma | Samsung Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT05541822 | Jan 2023 → Feb 2029 expected | cancer | Abion Inc | Recruiting | No outcome recorded |
| Phase 2 | NCT05463224 | Jan 2023 → Dec 2026 expected | non-small cell lung carcinoma | Se-Hoon Lee | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05498428 | Nov 2022 → Aug 2027 expected | non-small cell lung carcinoma | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 2 | NCT05477615 | Aug 2022 → Jun 2023 | non-small cell lung carcinoma | Jin Hyoung Kang | Unknown | No outcome recorded |
| Phase 2 | NCT05338619 | Jun 2022 → Mar 2026 | non-small cell lung carcinoma | Sung Yong Lee | Unknown | No outcome recorded |
| Phase 2 | NCT05469022 | May 2022 → May 2024 overdue | non-small cell lung carcinoma | Konkuk University Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05277701 | Apr 2022 → Dec 2024 | non-small cell lung carcinoma | Yonsei University | Unknown | No outcome recorded |
| Phase 2 | NCT05167851 | Dec 2021 → Dec 2025 | non-small cell lung carcinoma | Yonsei University | Unknown | No outcome recorded |
| Phase 2 | NCT04965090 | Sep 2021 → Dec 2025 | non-small cell lung carcinoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT05326425 | Jun 2021 → Jun 2024 | lung neoplasm | Jin Hyoung Kang | Unknown | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT04988295 | Nov 2021 → Jul 2023 overdue | non-small cell lung carcinoma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04487080 | Sep 2020 → Aug 2023 overdue | non-small cell lung carcinoma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04248829 | Feb 2020 → Jul 2022 | non-small cell lung carcinoma | Yuhan Corporation | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04829422 | — | lung cancer | Yuhan Corporation | Approved for marketing | No outcome recorded |
Also used as a comparator or background therapy in 6 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 24 trials | ||||||
| Phase 2 | NCT06120140 Background | Feb 2024 → May 2027 expected | non-small cell lung carcinoma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06020989 Comparator | Sep 2023 → Sep 2024 | non-small cell lung carcinoma | Yonsei University | Unknown | No outcome recorded |
| Phase 2 | NCT05663866 Background | May 2023 → Mar 2024 overdue | non-small cell lung carcinoma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06268210 Comparator | Feb 2022 → May 2028 expected | non-small cell lung carcinoma | Yonsei University | Active not recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT05388669 Background | Aug 2022 → Jan 2024 overdue | non-small cell lung carcinoma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT07469488 Background | Apr 2026 → Aug 2029 expected | non-small cell lung carcinoma, toxic dermatosis, venous thromboembolism | Shanghai Pulmonary Hospital, Shanghai, China | Not yet recruiting | No outcome recorded |
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 43 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lazertinib | “Only for amivantamab + lazertinib therapy, per CSCO guidelines and physician judgment.” NCT07469488 ↗37 |
| Known as | C-18112003-G | ChEMBL registry synonym — accepted as the source's own label CHEMBL4558324 ↗ |
| Known as | GNS-1480 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4558324 ↗ |
| Known as | JNJ-73841937-AAA | ChEMBL registry synonym — accepted as the source's own label CHEMBL4558324 ↗ |
| Known as | JNJ-73841937-ZCY | ChEMBL registry synonym — accepted as the source's own label CHEMBL4558324 ↗ |
| Known as | Lazcluze | ChEMBL registry synonym — accepted as the source's own label CHEMBL4558324 ↗ |
| Known as | Lazertinib mesilate hydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL4558324 ↗ |
| Known as | LAZERTINIB MESYLATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4558324 ↗ |
| Known as | Lazertinib mesylate monohydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL4558324 ↗ |
| Known as | Leclaza | ChEMBL registry synonym — accepted as the source's own label CHEMBL4558324 ↗ |
| Known as | R-605024 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4558324 ↗ |
| Known as | YH25448 | “lazertinib(YH25448)” NCT05326425 ↗ |
| Known as | YH25448AM | ChEMBL registry synonym — accepted as the source's own label CHEMBL4558324 ↗ |
| Action | Inhibit | “lazertinib, a third-generation EGFR TKI” PMID 37710001 ↗ Sep 2023 |
| Modality | Small molecule | “lazertinib, a third-generation EGFR TKI” PMID 37710001 ↗ Sep 2023 |
| Route | Oral | “YH25448, an oral, mutant-selective, irreversible third-generation EGFR-TKI” PMID 30670498 ↗ Jan 2019 |
| Target | EGFR | “lazertinib, a third-generation EGFR TKI” PMID 37710001 ↗ Sep 2023 |