Mobocertinib
As of the edition of 20 October 2026, Mobocertinib is a small molecule: marketed, first approved in 2021 (US); acts on EGFR; US protection ends in 2035.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Small molecule
- Brand name
- Exkivity
- First approved
- 15 September 2021 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Takeda
- Registered trials
- 12, 1 stopped early
- Disease areas
- Cancer; Lungs and airways; Pregnancy and women's health; Urinary and reproductive
US protection
US protection ends in 2035.
The last listed US drug-substance patent ends in 2035. The application that gives this date is held by Takeda.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product4 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 4 listings behind itRequest 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 | 1 | 0 | 0 | 0 |
| Phase 1 | 8 | 7 | 1 | 0 |
| Phase 2 | 2 | 0 | 1 | 1 |
| Phase 3 | 1 | 0 | 1 | 0 |
| All trials | 12 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Takeda | Originator and Lead sponsor of trials | 2016 to now |