> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/aumolertinib-1339ec2f-ba43-4359-aaa7-6a9516518faa
> Record changed: 2026-10-13

# Aumolertinib

Highest phase reached

Phase 3

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4761468)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4761468)

## Development status

**Listing at source**

Listed

**Highest phase reached**

Phase 3

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4761468)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4761468)

**Drug name**

Aumolertinib

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4761468)

**Molecular weight**

525.66

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4761468)

**Structure (SMILES)**

C=CC(=O)Nc1cc(Nc2nccc(-c3cn(C4CC4)c4ccccc34)n2)c(OC)cc1N(C)CCN(C)C

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4761468)

### Brand names (4)

- ameile
- Ameile
- amerol
- Amerol

### Other names (26)

- almonertinib
- Almonertinib
- ameile
- Ameile
- amerol
- Amerol
- aumolertinib
- Aumolertinib
- aumolertinib \[INN\]
- AUMOLERTINIB \[USAN\]
- Aumolertinib \[WHO-DD\]
- aumolertinib inn
- aumolertinib usan
- aumolertinib who dd
- egfr t790m inhibitor hs 10296
- Egfr t790m inhibitor hs-10296
- eq 143
- EQ-143
- eq143
- EQ143
- hs 10206
- hs 10296
- Hs 10296
- HS-10206
- Hs-10296

And 1 more, listed on the interactive page.

## Identifiers

**CAS registry numbers**

- 1899921-05-1

**ChEMBL ID**

CHEMBL4761468

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4761468)

**InChIKey**

DOEOECWDNSEFDN-UHFFFAOYSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4761468)

**PubChem compound IDs**

- 121280087

**FDA ingredient codes (UNII)**

- T4RS462G19

### ATC classification codes (2)

- L01EB
- L01EB11

Sources for recorded values

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4761468)

## Regulatory information

### European Union

**Status**

Authorised

**Status date**

12 Feb 2026

**Authorisation date**

12 Feb 2026

**Approved indications**

Aumseqa as monotherapy is indicated for:- the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC)whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations (forbiomarker-based patient selection, see section 4.2).- the treatment of adult patients with advanced EGFR T790M mutation-positive NSCLC (forbiomarker-based patient selection, see section 4.2)

**Product number**

EMEA/H/C/006069

**Authorisation holder**

SFL Pharmaceuticals Deutschland GmbH

**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/aumseqa)

### Other regulatory facts

**First in class**

No

**Orphan designation**

No

## Pharmacology

### Drug classification

**Pharmacology name**

aumolertinib

**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

**Median affinity**

8.72

**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 (7)

- **Condition**  
Carcinoma

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000313

**Subject identifier**  
D002277
- **Condition**  
Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000616

**Subject identifier**  
D009369
- **Condition**  
Carcinoma, Squamous Cell

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000707

**Subject identifier**  
D002294
- **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**  
3

**Condition identifier**  
MONDO:0008903

**Subject identifier**  
D008175

### Open Targets indications (12)

- **Condition identifier**  
EFO\_0000616
- **Condition identifier**  
EFO\_0000707

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0001421

**Highest recorded phase**  
1
- **Condition identifier**  
EFO\_0003060
- **Condition identifier**  
EFO\_1001012

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0004992

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0004992

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

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0005096

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

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0008903

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0008903

**Highest recorded phase**  
3

### Trial references (46)

- NCT02759640  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02759640)
- NCT02977364  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02977364)
- NCT04423185  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04423185)
- NCT02981108  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02981108)
- NCT03849768  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03849768)
- NCT03904823  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03904823)
- NCT04500704  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04500704)
- NCT04500717  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04500717)
- NCT04553887  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04553887)
- NCT04592666  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04592666)
- NCT04636593  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04636593)
- NCT04646824  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04646824)
- NCT04685070  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04685070)
- NCT04687241  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04687241)
- NCT04762459  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04762459)
- NCT04870190  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04870190)
- NCT04905550  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04905550)
- NCT04923906  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04923906)
- NCT04951635  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04951635)
- NCT04951648  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04951648)
- NCT04952168  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04952168)
- NCT04969965  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04969965)
- NCT05430386  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05430386)
- NCT05493501  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05493501)
- NCT05503888  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05503888)

And 21 more, listed on the interactive page.

## Chemical properties

**Hydrogen bond acceptors**

8

**Hydrogen bond donors**

2

**Polar surface area**

87.55

**Calculated partition coefficient (ALogP)**

5.31

**Calculated partition coefficient (XLogP)**

4.2

**Prodrug**

No

**Chirality**

Achiral

**Inorganic**

No

**Rule-of-five violations**

2

**Rotatable bonds**

11

**Heavy atoms**

39

**Molecular formula**

C30H35N7O2

**Monoisotopic mass**

525.28522338

**Natural product**

No

## Evidence counts

**Recorded assays**

27

**Active assays**

10

### Active assay types

- Confirmatory

## Biological measurements

### Observed measurements

#### Oral bioavailability

**Median**

52

**Mean**

52

**Minimum**

52

**Maximum**

52

**Unit**

%

**Assays**

1

**Standard deviation**

0

**Summary method**

median

**Censored results excluded**

0

**Other units excluded**

0

**Unknown units excluded**

0

#### Measurement types

- F

## Related records

### Trials (66)

- A Clinical Study of the Combination of Anlotinib and Aumolertinib in the First-line Treatment of Advanced NSCLC With EGFR 21L858R Mutation
- A Dose Exploration Study of Almonertinib for EGFRm NSCLC Patients With Brain/Leptomeningeal Metastasis (ARTISTRY)
- A Phase 2 Trial of Almonertinib With Concurrent Radiotherapy in The Treatment of Local Advanced EGFR-mutant NSCLC
- A Phase I Study of HRS2300 or Combined With SHR-1316 or SHR-1701 or Trametinib or Almonertinib in Patients With Advanced Malignancies
- A Phase IB/II Clinical Study of SHR-9839 for Injection Combined With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors
- A Phase II Trial of Upfront Radiotherapy Plus Almonertinib for Epidermal Growth Factor Receptor(EGFR)-Mutant Non-small-cell Lung Cancer(NSCLC) Patients With Brain Metastases
- A Phase III Study to Assess the Effects of Almonertinib Following Chemoradiation in Patients With Stage III Unresectable Non-small Cell Lung Cancer
- A Phase III Study to Assess the Efficacy and Safety of Almonertinib Versus Platinum-based Chemotherapy as First-line Therapy in Patients With Locally Advanced or Metastatic NSCLC Harbouring Uncommon EGFR Mutation
- A Study Evaluating the Effect of Aumolertinib on the Pharmacokinetics of Midazolam in Patients With NSCLC
- A Study of Almonertinib Combined With Palbociclib in Patients With Advanced Solid Tumors Harboring KRAS Mutations
- A Study of Aumolertinib in European Participants With Non-Small Cell Lung Cancer
- A Study of BL-B01D1 and Almonertinib in Patients With Resectable EGFR+ Stage II-IIIB NSCLC
- A Study of Famitinib in Combination With HS-10296 in Patients With EGFR-mutant NSCLC
- A Study of HS-10241 Combined With Almonertinib Versus Platinum-based Chemotherapy in Treatment of Advanced NSCLC With MET Amplification After Failure of EGFR-TKI Therapy
- [A Study of HS-20117 Combined With Aumolertinib in Participants With Advanced Non-Squamous Non-Small Cell Lung Cancer](https://trialight.com/data/trial/a-study-of-hs-20117-combined-with-aumolertinib-in-99409578-e6c5-4fa4-aaf4-8ab6dbfd3676.md)
- A Study of SHR-A2009 Combined With Aumolertinib Versus Aumolertinib for First-line Treatment in EGFR-mutated, Advanced or Metastatic NSCLC
- A Study to Evaluate Safety and Efficacy of HS-10296 as First-Line Treatment in Patients
- A Study to Evaluate Safety, PK and Efficacy of HS-10296 in Patients With NSCLC
- Almonertinib as First-line Treatment in Patients With EGFR Mutations Positive in Advanced NSCLC With Brain Metastases
- Almonertinib as First-line Treatment in Patients With EGFR+ Positive Pulmonary Adenosquamous Carcinoma or Combined Adenocarcinoma and Squamous Cell Carcinoma

### In development for (7)

- [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md) Phase 3
- [Carcinoma](https://trialight.com/data/condition/carcinoma-575e4c82-5fa5-5455-b1b7-30972eca1a2f.md) Phase 1
- [Liver disorder](https://trialight.com/data/condition/liver-disorder-8388d30a-2581-5015-9ddf-adc5f6a331d7.md) Phase 1
- [Lung cancer](https://trialight.com/data/condition/lung-cancer-c4ca1fe0-9b3d-5957-a668-2d6cf26bd16a.md) Phase 3
- Neoplasm 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
- [Squamous cell carcinoma](https://trialight.com/data/condition/squamous-cell-carcinoma-44944de3-3c1f-5714-9da2-a28db7d896c2.md) Phase 2

### 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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