Aumolertinib
As of the edition of 20 October 2026, Aumolertinib is a small molecule: marketed, first approved in 2026 (EU); acts on EGFR.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2026
- Kind
- Small molecule
- Brand name
- Aumseqa
- First approved
- 12 February 2026 (EU)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- SFL Pharmaceuticals Deutschland
- Registered trials
- 60, 2 stopped early
- Disease areas
- Cancer; Lungs and airways; Nervous system; Digestive system; Injuries
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Aumolertinib.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| EGFR | Epidermal growth factor receptor | P00533 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 5 | 1 | 2 | 0 |
| Phase 1 | 7 | 2 | 2 | 0 |
| Phase 2 | 32 | 0 | 12 | 1 |
| Phase 3 | 16 | 0 | 9 | 1 |
| All trials | 60 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| SFL Pharmaceuticals Deutschland | Originator | 2026 to now |