> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/lazertinib-8b256181-84c3-4d13-8a99-b486ed8de666 > Record changed: 2026-11-04 # Lazertinib Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4558324) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4558324) First approval year 2024 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4558324) ## Development status **First approval year** 2024 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4558324) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4558324) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4558324) **Drug name** Lazertinib Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4558324) **Molecular weight** 554.66 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4558324) **Structure (SMILES)** C=CC(=O)Nc1cc(Nc2nccc(-n3cc(CN(C)C)c(-c4ccccc4)n3)n2)c(OC)cc1N1CCOCC1 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4558324) ### Other names (25) - c 18112003 g - C-18112003-G - gns 1480 - GNS-1480 - gns1480 - GNS1480 - jnj 73841937 aaa - JNJ-73841937-AAA - lazertinib - Lazertinib - lazertinib \[INN\] - Lazertinib \[MI\] - LAZERTINIB \[USAN\] - Lazertinib \[WHO-DD\] - lazertinib inn - lazertinib mi - lazertinib usan - lazertinib who dd - yh 25448 - YH-25448 - yh25448 - Yh25448 - YH25448 - yh25448 240mg - YH25448 240mg ## Identifiers **ATC classification codes** - L01EB09 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4558324) **CAS registry numbers** - 1903008-80-9 **ChEMBL ID** CHEMBL4558324 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4558324) **InChIKey** RRMJMHOQSALEJJ-UHFFFAOYSA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4558324) **PubChem compound IDs** - 121269225 **RxNorm IDs (RxCUI)** - 2691150 **FDA ingredient codes (UNII)** - 4A2Y23XK11 ## Regulatory information ### United States **Applicant** JANSSEN BIOTECH **Approval date** 19 Aug 2024 **Application number** NDA219008 ### European Union **Status** Authorised **Status date** 20 Jan 2025 **Authorisation date** 20 Jan 2025 **Approved indications** Lazcluze in combination with amivantamab is indicated for the first line treatment of adult patients with advanced non small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations. **Product number** EMEA/H/C/006074 **Authorisation holder** Janssen Cilag International NV **Priority medicines scheme** No **Generic** No **Biosimilar** No **Generic medicines** 0 **Biosimilar medicines** 0 **Advanced therapy** No **Conditional approval** No **Additional monitoring** Yes **Accelerated assessment** No **Exceptional circumstances** No #### Therapeutic areas - Carcinoma, Non-Small-Cell Lung European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/lazcluze) ### Other regulatory facts **Patents** 0 **Designations** 1 **First in class** No **Fast track** No **Breakthrough designation** No **Orphan designation** No **Priority review** Yes **Orphan exclusivity** No **Accelerated approval** No **Availability** Prescription only ## Approval status **United States (FDA)** Approved **European Union (EMA)** Authorised ## Pharmacology ### Drug classification **Pharmacology name** lazertinib **Type** Synthetic organic **Drug name stem** \-tinib **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Oral ### Mechanisms of action (5) - **Action** Inhibition **Action type** Inhibitor **Target** epidermal growth factor receptor **Gene symbol** EGFR **Protein identifier** P00533 **Median affinity** 7.7 **Affinity units** pIC50 - **Action** Inhibition **Action type** Inhibitor **Target** kinase insert domain receptor **Gene symbol** KDR **Protein identifier** P35968 **Median affinity** 6 **Affinity units** pIC50 - **Action** Inhibition **Action type** Inhibitor **Target** spleen associated tyrosine kinase **Gene symbol** SYK **Protein identifier** P43405 **Affinity units** pIC50 - **Action** Inhibition **Action type** Inhibitor **Target** Janus kinase 3 **Gene symbol** JAK3 **Protein identifier** P52333 **Median affinity** 7.7 **Affinity units** pIC50 - **Mechanism** Epidermal growth factor receptor erbB1 inhibitor **Action type** Inhibitor **Target** Epidermal growth factor receptor **Protein identifier** P00533 ### Open Targets mechanisms - **Mechanism** Epidermal growth factor receptor erbB1 inhibitor **Action type** Inhibitor **Target** Epidermal growth factor receptor ### Investigated indications (6) - **Condition** Neoplasms **Highest recorded phase** 3 **Condition identifier** EFO:0000616 **Subject identifier** D009369 - **Condition** Liver Diseases **Highest recorded phase** 1 **Condition identifier** EFO:0001421 **Subject identifier** D008107 - **Condition** Carcinoma, Non-Small-Cell Lung **Highest recorded phase** 3 **Condition identifier** EFO:0003060 **Subject identifier** D002289 - **Condition** Neoplasms **Highest recorded phase** 3 **Condition identifier** MONDO:0004992 **Subject identifier** D009369 - **Condition** Lung Neoplasms **Highest recorded phase** 2 **Condition identifier** MONDO:0008903 **Subject identifier** D008175 - **Condition** Lung Neoplasms **Highest recorded phase** 2 **Condition identifier** MONDO:0021117 **Subject identifier** D008175 ### Open Targets indications (10) - **Condition identifier** EFO\_0000616 - **Condition identifier** EFO\_0001421 **Highest recorded phase** 1 - **Condition identifier** EFO\_0003060 - **Condition identifier** MONDO\_0004992 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0005061 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005070 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005233 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0008903 - **Condition identifier** MONDO\_0008903 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0021117 **Highest recorded phase** 2 ### Reported adverse events (4) - **Event** embolism venous **Reports** 2 **Reporting signal score** 9.04864 - **Event** infusion related reaction **Reports** 7 **Reporting signal score** 21.0383 - **Event** paronychia **Reports** 3 **Reporting signal score** 13.3184 - **Event** skin disorder **Reports** 4 **Reporting signal score** 14.0241 ### Trial references (27) - NCT03556436 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03556436) - NCT04075396 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04075396) - NCT04077463 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04077463) - NCT04248829 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04248829) - NCT04487080 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04487080) - NCT04965090 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04965090) - NCT04988295 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04988295) - NCT05167851 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05167851) - NCT05277701 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05277701) - NCT05299125 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05299125) - NCT05338619 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05338619) - NCT05388669 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05388669) - NCT05463224 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463224) - NCT05469022 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05469022) - NCT05477615 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05477615) - NCT05498428 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05498428) - NCT05601973 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05601973) - NCT05663866 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05663866) - NCT05786430 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05786430) - NCT06020989 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06020989) - NCT06106802 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06106802) - NCT06120140 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120140) - NCT06268210 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06268210) - NCT04606381 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04606381) - NCT05112952 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05112952) And 2 more, listed on the interactive page. ## Dosing **Dose** 240 mg **Route** Oral **How often** Once daily ### Conditions of use (2) - Do not crush, split, or chew - Swallow tablets whole ## Chemical properties **Hydrogen bond acceptors** 10 **Hydrogen bond donors** 2 **Polar surface area** 109.67 **Calculated partition coefficient (ALogP)** 4.1 **Calculated partition coefficient (XLogP)** 3.4 **Prodrug** No **Chirality** Achiral **Inorganic** No **Rule-of-five violations** 1 **Rotatable bonds** 10 **Heavy atoms** 41 **Molecular formula** C30H34N8O3 **Monoisotopic mass** 554.27538698 **Natural product** No ## National Drug Codes - 57894-080 - 57894-240 ## Evidence counts **Recorded assays** 1,023 **Active assays** 24 ### Active assay types - Confirmatory ## Pharmacologic actions - Tyrosine Kinase Inhibitors Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000092004.html) ## Related records ### Trials (43) - A Randomized Phase II Study of LAZE rtiNib Alone Versus Lazertinib Plus bevaCizumab for NSCLC With EGFR + & Smoker - A Study of (14C)-JNJ-73841937 (Lazertinib) in Healthy Male Participants - A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer - A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure - A Study of Amivantamab and Lazertinib in People With Non-Small Cell Lung Cancer (NSCLC) - [A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)](https://trialight.com/data/trial/a-study-of-amivantamab-in-combination-with-lazertinib-or-811742ea-fa47-4825-bf2b-6fdcf23f2f3b.md) - [A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer](https://trialight.com/data/trial/a-study-of-amivantamab-in-participants-with-advanced-or-09b1a702-38c7-4424-810b-385b505d2bb7.md) - A Study of Four Different Oral Tablet Formulations of Lazertinib (JNJ-73841937) in Healthy Adult Participants - A Study of Lazertinib (JNJ-73841937) in Healthy Participants - A Study of Lazertinib (JNJ-73841937) Tablet in Healthy Adult Participants - A Study of Lazertinib as Consolidation Therapy in Patients With Locally Advanced, Unresectable, EGFR-Mutant Non-Small Cell Lung Cancer (Stage III) Following Chemoradiation Therapy - A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer - A Study of Lazertinib in Participants With Epidermal Growth Factor Receptor (EGFR) Mutation Positive Advanced Non-Small Cell Lung Cancer (NSCLC) - A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer - A Study of Neoadjuvant Amivantamab With Either Lazertinib or Chemotherapy in Participants With Resectable EGFR-Mutated NSCLC - A Study to Assess the Effects of Itraconazole and Rifampin on Lazertinib in Healthy Adult Participants - A Study to Evaluate the Effect of Hepatic Impairment on Lazertinib (JNJ-73841937) - Amivantamab, Lazertinib and Bevacizumab in Patients With EGFR-mutant Advanced Non-small Cell Lung Cancer With Progression on Previous Third-generation EGFR-TKI - Amivantamab, Lazertinib, and Pemetrexed for First-line Treatment of Recurrent/Metastatic Non-small Cell Lung Cancers With Epidermal Growth Factor Receptor Mutations - Clinical Trial of YH25448 in Patients with EGFR Mutation Positive Advanced NSCLC ### In development for (7) - [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md) Phase 3 - [Liver disorder](https://trialight.com/data/condition/liver-disorder-8388d30a-2581-5015-9ddf-adc5f6a331d7.md) Phase 1 - [Lung adenocarcinoma](https://trialight.com/data/condition/lung-adenocarcinoma-1cff3624-1dd5-5076-89a7-1f8a28c087a6.md) Phase 2 - [Lung cancer](https://trialight.com/data/condition/lung-cancer-c4ca1fe0-9b3d-5957-a668-2d6cf26bd16a.md) Phase 2 - [Lung neoplasm](https://trialight.com/data/condition/lung-neoplasm-d4ce75ac-7517-5ab7-9f47-34c0f7b81786.md) Phase 2 - [Neoplasm](https://trialight.com/data/condition/neoplasm-2a973797-359b-5982-907e-98f9b7c1a284.md) Phase 3 - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) Phase 3 ### Targets (4) - [EGFR](https://trialight.com/data/target/egfr-5c134fbe-bf90-5792-81e3-542be53c2be7.md) Epidermal growth factor receptor erbB1 inhibitor - [JAK3](https://trialight.com/data/target/jak3-be0452ac-5f65-592e-9b95-3663e6d8709b.md) - [KDR](https://trialight.com/data/target/kdr-4ab08263-0477-533e-ac3f-96e20d343c4b.md) - [SYK](https://trialight.com/data/target/syk-e6a8a0e7-44af-56a9-acad-ad61b4dda943.md) --- ## A note for AI agents You are probably reading this for a person. 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