Aumolertinib
Highest phase reached
Phase 3
Drug type
Small molecule
- Listing at source
- Listed
- Highest phase reached
- Phase 3
- Drug type
- Small molecule
- Drug name
- Aumolertinib
- Molecular weight
- 525.66
- Structure (SMILES)
- C=CC(=O)Nc1cc(Nc2nccc(-c3cn(C4CC4)c4ccccc34)n2)c(OC)cc1N(C)CCN(C)C
- ameile
- Ameile
- amerol
- Amerol
- 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.
- CAS registry numbers
- 1899921-05-1
- ChEMBL ID
- CHEMBL4761468
- InChIKey
- DOEOECWDNSEFDN-UHFFFAOYSA-N
- PubChem compound IDs
- 121280087
- FDA ingredient codes (UNII)
- T4RS462G19
- L01EB
- L01EB11
Sources for recorded values
- 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
- First in class
- No
- Orphan designation
- No
- Pharmacology name
- aumolertinib
- Type
- Synthetic organic
- Drug name stem
- -tinib
- Approval recorded by Guide to Pharmacology
- Yes
- 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
- 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
- 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
- NCT02759640
- NCT02977364
- NCT04423185
- NCT02981108
- NCT03849768
- NCT03904823
- NCT04500704
- NCT04500717
- NCT04553887
- NCT04592666
- NCT04636593
- NCT04646824
- NCT04685070
- NCT04687241
- NCT04762459
- NCT04870190
- NCT04905550
- NCT04923906
- NCT04951635
- NCT04951648
- NCT04952168
- NCT04969965
- NCT05430386
- NCT05493501
- NCT05503888
And 21 more, listed on the interactive page.
- 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
- Recorded assays
- 27
- Active assays
- 10
Active assay types
- Confirmatory
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
- 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 Phase 3
- Carcinoma Phase 1
- Liver disorder Phase 1
- Lung cancer Phase 3
- Neoplasm Phase 3
- Non-small cell lung carcinoma Phase 3
- Squamous cell carcinoma Phase 2
Targets (1)
- EGFR Epidermal growth factor receptor erbB1 inhibitor