> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/lazertinib-mesylate-6e43140e-9e73-4520-9ea0-544e8808c3bb
> Record changed: 2026-10-13

# Lazertinib mesylate

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL6068478)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL6068478)

First approval year

2024

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL6068478)

## Development status

**First approval year**

2024

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL6068478)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL6068478)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL6068478)

**Drug name**

Lazertinib mesylate

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL6068478)

**Molecular weight**

668.78

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL6068478)

**Structure (SMILES)**

C=CC(=O)Nc1cc(Nc2nccc(-n3cc(CN(C)C)c(-c4ccccc4)n3)n2)c(OC)cc1N1CCOCC1.CS(=O)(=O)O.O

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL6068478)

### Brand names (4)

- lazcluze
- Lazcluze
- leclaza
- Leclaza

### Other names (24)

- jnj 73841937 zcy
- JNJ-73841937-ZCY
- lazcluze
- Lazcluze
- lazertinib mesilate hydrate
- Lazertinib mesilate hydrate
- LAZERTINIB MESILATE HYDRATE \[JAN\]
- lazertinib mesilate hydrate jan
- lazertinib mesylate
- Lazertinib mesylate
- LAZERTINIB MESYLATE \[USAN\]
- lazertinib mesylate monohydrate
- Lazertinib mesylate monohydrate
- Lazertinib mesylate monohydrate \[MI\]
- Lazertinib mesylate monohydrate \[WHO-DD\]
- lazertinib mesylate monohydrate mi
- lazertinib mesylate monohydrate who dd
- lazertinib mesylate usan
- r 605024
- R-605024
- r605024
- R605024
- yh25448am
- YH25448AM

## Identifiers

**ATC classification codes**

- L01EB09

Sources for recorded values

Source: [mor.nlm.nih.gov](https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=2691150)

**CAS registry numbers**

- 2411549-88-5

**ChEMBL ID**

CHEMBL6068478

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL6068478)

**InChIKey**

ZJPNGZUERUYZEG-UHFFFAOYSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL6068478)

**PubChem compound IDs**

- 163203547

**RxNorm IDs (RxCUI)**

- 2691150

**FDA ingredient codes (UNII)**

- WUT449BEG5

## Regulatory information

### United States

**Applicant**

JANSSEN BIOTECH

**Approval date**

19 Aug 2024

**Application number**

NDA219008

### Other regulatory facts

**Patents**

7

**Designations**

0

**Earliest recorded loss of exclusivity**

1 Aug 2041

**First in class**

No

**Fast track**

No

**Breakthrough designation**

No

**Orphan designation**

No

**Priority review**

No

**Orphan exclusivity**

No

**Accelerated approval**

No

**Availability**

Prescription only

## Pharmacology

### Drug classification

**Drug name stem**

\-tinib

#### Administration routes

- Oral

### Mechanisms of action

- **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 (2)

- **Condition**  
Neoplasms

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000616

**Subject identifier**  
D009369
- **Condition**  
Carcinoma, Non-Small-Cell Lung

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0003060

**Subject identifier**  
D002289

### Open Targets indications (4)

- **Condition identifier**  
EFO\_0000616
- **Condition identifier**  
EFO\_0003060
- **Condition identifier**  
MONDO\_0005070
- **Condition identifier**  
MONDO\_0005233

**Highest recorded phase**  
4

### Reported adverse events (4)

- **Event**  
embolism venous

**Reports**  
2

**Reporting signal score**

8.68753
- **Event**  
infusion related reaction

**Reports**  
7

**Reporting signal score**

21.1031
- **Event**  
paronychia

**Reports**  
3

**Reporting signal score**

13.3184
- **Event**  
skin disorder

**Reports**  
4

**Reporting signal score**

13.9953

## Chemical properties

**Hydrogen bond acceptors**

10

**Hydrogen bond donors**

2

**Polar surface area**

109.67

**Calculated partition coefficient (ALogP)**

4.1

**Prodrug**

No

**Chirality**

Achiral

**Inorganic**

No

**Rule-of-five violations**

1

**Rotatable bonds**

10

**Heavy atoms**

47

**Molecular formula**

C31H40N8O7S

**Monoisotopic mass**

668.27406682

**Natural product**

No

## Related records

### Trials (40)

- 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(Lazertinib) as the First-line Treatment in Patients With EGFR Mutation Positive Locally Advanced or Metastatic NSCLC (LASER301)

### Approved for (1)

- [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md)

### In development for (1)

- Neoplasm Phase 1

### Targets (1)

- [EGFR](https://trialight.com/data/target/egfr-5c134fbe-bf90-5792-81e3-542be53c2be7.md) Epidermal growth factor receptor erbB1 inhibitor

---

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