Lorlatinib
As of the edition of 20 October 2026, Lorlatinib is a small molecule: marketed, first approved in 2018 (JP); acts on ALK; US protection ends in 2038.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Small molecule
- Brand name
- Lorbrena
- First approved
- 21 September 2018 (JP)
- Approvals on record
- 9 in 5 regions
- Holder of the most recent approval
- Pfizer; 2 holders in all
- Registered trials
- 67, 8 stopped early
- Disease areas
- Cancer; Lungs and airways; Nervous system; Urinary and reproductive; Hormones; Blood and lymph
US protection
US protection ends in 2038.
The last listed US drug-substance patent ends in 2038. The application that gives this date is held by Pfizer.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
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Target
| Gene | Protein | UniProt |
|---|---|---|
| ALK | ALK tyrosine kinase receptor | Q9UM73 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 19 | 7 | 8 | 1 |
| Phase 1 | 16 | 10 | 3 | 3 |
| Phase 2 | 24 | 4 | 12 | 4 |
| Phase 3 | 3 | 0 | 3 | 0 |
| Phase 4 | 5 | 2 | 3 | 0 |
| All trials | 67 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Applicant and Lead sponsor of trials | 2017 to now |