lazertinib
Trade name: Lazcluze
Small moleculeapproved
Approved
Aug 19, 2024
Clinical trial activity
36 trials · 12 clinical orgs · 1 marketing orgs
Phase 1
11
Phase 2
26
Phase 3
4
Phase 4
0
Earliest trial started Feb 1, 2017 (NCT03046992)
Timeline
2010s
- Jan 1, 2017
Earliest Phase 1 Sponsor(trial)
2020s
- Jan 1, 2020
Earliest Phase 3 Sponsor(trial)
- Jan 1, 2021
Earliest Phase 2 Sponsor(trial)
- Aug 19, 2024
Johnson and Johnson — Earliest FDA Approval
- Aug 19, 2024
Johnson and Johnson — NDA Organization
Indications
Approved for
Mechanism of action
- Epidermal growth factor receptorINHIBITOR
Epidermal growth factor receptor inhibitor
Epidermal growth factor receptor erbB1 inhibitor
Approval history
- approvedPriority reviewAug 19, 2024
Chemistry & pharmacology
Loading structure…
SMILES
C=CC(=O)Nc1cc(Nc2nccc(-n3cc(CN(C)C)c(-c4ccccc4)n3)n2)c(OC)cc1N1CCOCC1- Mol. weight
- 554.66 g/mol
- Lipinski Ro5
- 1 violation(s)
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL6068478 ↗
- ChEMBLCHEMBL4558324 ↗
Also known as
- yh25448
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06667076 | Phase 2 | Nov 25, 2024 | — |
| NCT06268210 | Phase 2 | Mar 31, 2024 | Yonsei University |
| NCT06120140 | Phase 2 | Mar 8, 2024 | — |
| NCT06106802 | Phase 2 | Feb 2, 2024 | Sungkyunkwan University |
| NCT06020989 | Phase 2 | Sep 30, 2023 | Yonsei University |
| NCT06156527 | Phase 2 | Sep 5, 2023 | National Cancer Center, Korea |
| NCT05896683 | Phase 1 | May 30, 2023 | — |
| NCT05663866 | Phase 2 | Apr 9, 2023 | — |
| NCT05786430 | Phase 2 | Mar 31, 2023 | Yonsei University |
| NCT05601973 | Phase 2 | Feb 1, 2023 | ETOP IBCSG Partners Foundation, Janssen Pharmaceutica NV |
| NCT05701384 | Phase 2 | Feb 1, 2023 | Sungkyunkwan University |
| NCT05299125 | Phase 2 | Jan 31, 2023 | Janssen Pharmaceutica NV, Latin American Cooperative Oncology Group |
| NCT05742594 | Phase 1 | Jan 3, 2023 | — |
| NCT05463224 | Phase 2 | Dec 1, 2022 | Sungkyunkwan University |
| NCT05498428 | Phase 2 | Nov 11, 2022 | — |
| NCT05477615 | Phase 2 | Aug 31, 2022 | Catholic University of Korea, Korea University |
| NCT05388669 | Phase 3 | Aug 5, 2022 | — |
| NCT05338619 | Phase 2 | Jun 30, 2022 | Korea University, Yuhan Pharmaceutical Company |
| NCT05469022 | Phase 2 | May 19, 2022 | Konkuk University, Yuhan Pharmaceutical Company |
| NCT05277701 | Phase 2 | Apr 30, 2022 | Yonsei University |
Showing 20 of 36 trials
Page 1 / 2
Organizations
Research & Development (12)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Janssen Pharmaceutica NV | For profit | 11 | 8 | 3 | 2019 |
| Yuhan Pharmaceutical Company | For profit | 8 | 5 | 4 | 2017 |
| Yonsei University | Academic/Hospital | 5 | 5 | 1 | 2021 |
| Sungkyunkwan University | Academic/Hospital | 3 | 3 | 1 | 2022 |
| Catholic University of Korea | Academic/Hospital | 2 | 2 | 1 | 2021 |
| Korea University | Academic/Hospital | 2 | 1 | 1 | 2022 |
| ETOP IBCSG Partners Foundation | Academic/Hospital | 1 | 1 | 1 | 2023 |
| Konkuk University | Academic/Hospital | 1 | 1 | 1 | 2022 |
| Latin American Cooperative Oncology Group | Academic/Hospital | 1 | 1 | 1 | 2023 |
| Memorial Sloan-Kettering Cancer Center | Academic/Hospital | 1 | 1 | 1 | 2021 |
| National Cancer Center, Korea | Government | 1 | 1 | 1 | 2023 |
| Seoul National University | Academic/Hospital | 1 | 0 | 1 | 2018 |
12 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Johnson and Johnson | For profit | NDA | Aug 19, 2024 |