> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/firmonertinib-1107bf98-5b0b-42bc-a524-ed82fe088880
> Record changed: 2026-10-13

# Firmonertinib

Highest phase reached

Phase 3

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297258)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297258)

## Development status

**Listing at source**

Listed

**Highest phase reached**

Phase 3

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297258)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297258)

**Drug name**

Firmonertinib

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297258)

**Molecular weight**

568.6

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297258)

**Structure (SMILES)**

C=CC(=O)Nc1cc(Nc2nccc(-c3cn(C)c4ccccc34)n2)c(OCC(F)(F)F)nc1N(C)CCN(C)C

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297258)

### Other names (18)

- afu
- AFU
- alflutinib
- Alflutinib
- ast 2818
- AST-2818
- ast2818
- AST2818
- firmonertinib
- Firmonertinib
- firmonertinib \[INN\]
- FIRMONERTINIB \[USAN\]
- Firmonertinib \[WHO-DD\]
- firmonertinib inn
- firmonertinib usan
- firmonertinib who dd
- furmonertinib
- Furmonertinib

## Identifiers

**CAS registry numbers**

- 1869057-83-9

**ChEMBL ID**

CHEMBL4297258

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297258)

**InChIKey**

GHKOONMJXNWOIW-UHFFFAOYSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297258)

**PubChem compound IDs**

- 118861389

**FDA ingredient codes (UNII)**

- A49A7A5YN4

## Regulatory information

### Other regulatory facts

**Patents**

0

**Designations**

2

**First in class**

No

**Fast track**

No

**Breakthrough designation**

Yes

**Orphan designation**

No

**Priority review**

No

**Orphan exclusivity**

No

**Accelerated approval**

No

## Pharmacology

### Drug classification

**Pharmacology name**

firmonertinib

**Type**

Synthetic organic

**Drug name stem**

\-tinib

**Approval recorded by Guide to Pharmacology**

Yes

### Mechanisms of action (2)

- **Action**  
Inhibition

**Action type**  
Inhibitor

**Target**  
epidermal growth factor receptor

**Gene symbol**  
EGFR

**Protein identifier**  
P00533
- **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 (4)

- **Condition**  
Adenocarcinoma of Lung

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000571

**Subject identifier**  
D000077192
- **Condition**  
Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000616

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

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0003060

**Subject identifier**  
D002289
- **Condition**  
Lung Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0008903

**Subject identifier**  
D008175

### Open Targets indications (9)

- **Condition identifier**  
EFO\_0000571

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000616

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0003060

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0005288

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_1001012

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0005061

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0005070
- **Condition identifier**  
MONDO\_0005233

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0008903

**Highest recorded phase**  
2

### Trial references (28)

- NCT02973763  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02973763)
- NCT03452592  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03452592)
- NCT04853342  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04853342)
- NCT04858958  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04858958)
- NCT04895930  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04895930)
- NCT04958967  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04958967)
- NCT04970693  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04970693)
- NCT05165355  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05165355)
- NCT05209256  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05209256)
- NCT05255406  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05255406)
- NCT05334277  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05334277)
- NCT05379803  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05379803)
- NCT05430802  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05430802)
- NCT05445310  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05445310)
- NCT05465343  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05465343)
- NCT05466149  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05466149)
- NCT05548348  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05548348)
- NCT05813522  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05813522)
- NCT05987826  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05987826)
- NCT05994131  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05994131)
- NCT06319950  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06319950)
- NCT06339242  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06339242)
- NCT06394674  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06394674)
- NCT04965831  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04965831)
- NCT05079022  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05079022)

And 3 more, listed on the interactive page.

## Chemical properties

**Hydrogen bond acceptors**

9

**Hydrogen bond donors**

2

**Polar surface area**

100.44

**Calculated partition coefficient (ALogP)**

4.84

**Calculated partition coefficient (XLogP)**

4.4

**Prodrug**

No

**Chirality**

Achiral

**Inorganic**

No

**Rule-of-five violations**

1

**Rotatable bonds**

11

**Heavy atoms**

41

**Molecular formula**

C28H31F3N8O2

**Monoisotopic mass**

568.25220675

**Natural product**

No

## Pharmacologic actions

- Protein Kinase Inhibitors  
Agents that inhibit PROTEIN KINASES.

## Related records

### Trials (65)

- A Clinical Trial of Furmonertinib Combination Therapy As Neoadjuvant Treatment in Resectable EGFR-Mutated NSCLC
- A Clinical Trial of Furmonertinib Combined With Anlotinib as First-line Treatment for Advanced NSCLC With EGFR-sensitive Mutations and Brain Metastasis
- A Prospective Study of Firmonertinib as First-line Adaptive Therapy Guided by Dynamic ctDNA (MRD) Changes in Locally Advanced or Metastatic EGFR-mutated Non-small Cell Lung Cancer
- A Study of Furmonertinib Combined With Chemotherapy in the Treatment of NSCLC With Leptomeningeal Metastasis
- A Study of Furmonertinib Combined With Radiotherapy for Non-small Cell Lung Cancer With Oligoprogression
- A Study of MHB036C Combined With Anti-tumor Therapies in Patients With Advanced Lung Cancer
- A Study of SKB571 Combination Therapy in Participants With Non-Small Cell Lung Cancer (NSCLC)
- A Study to Assess the Efficacy and Safety of Firmonertinib Versus Placebo for Adjuvant Treatment in Participants With Stage IB - IIIB NSCLC With Uncommon Epidermal Growth Factor Receptor (EGFR) Mutations, Following Complete Surgical Resection With or Without Adjuvant Chemotherapy（FIRMOST）
- Adjuvant Furmonertinib in Stage IA With High Risk Factors and Stage IB Non-small Cell Lung Cancer
- Adjuvant Targeted-therapy for Patients With Resected High-risk EGFR-mutant Stage IB-IIA Non-small Cell Lung Carcinoma
- AI-guided Prognostication and Cranial Radiotherapy Optimization in EGFR-TKI-treated Non-small Cell Lung Cancer Patients With Baseline Brain Metastases
- Alflutinib Mesylate Versus Gefitinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer （FLAG）
- Alflutinib Versus Alflutinib Plus Chemotherapy for NSCLC
- An Observational Study of Furmonertinib for EGFR Mutation-positive NSCLC Patients With Brain Metastasis
- AST2818 in Advanced Non-Small Cell Lung Cancer With EGFR Mutations
- Combining Furmonertinib With Local Therapy for Inoperable Early-stage Lung Cancer: A Phase II Trial
- ctDNA-MRD Based Adjuvant Targeted Therapy for EGFR Positive Stage I Lung Adenocarcinomas
- Disitamab Vedotin Combined Therapy for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations
- Efficacy and Safety of Alflutinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer Patients With T790M
- Efficacy and Safety of Furmonertinib in EGFR-Mutant, PD-L1+ Patients With Locally Advanced or Metastatic NSCLC (FUTURE)

### In development for (4)

- [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
- Neoplasm Phase 2
- [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) Phase 3

### 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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