Imlunestrant
As of the edition of 20 October 2026, Imlunestrant is a small molecule: marketed, first approved in 2025 (US); acts on ESR1; no US protection is listed.
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
- Inluriyo
- First approved
- 25 September 2025 (US)
- Approvals on record
- 4 in 3 regions
- Holder of the most recent approval
- Eli Lilly; 2 holders in all
- Registered trials
- 16, 0 stopped early
- Disease areas
- Cancer; Skin and connective tissue; Pregnancy and women's health; Urinary and reproductive; Hormones; Digestive system
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Target
| Gene | Protein | UniProt |
|---|---|---|
| ESR1 | Estrogen receptor | P03372 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 9 | 6 | 3 | 0 |
| Phase 2 | 5 | 0 | 5 | 0 |
| Phase 3 | 2 | 0 | 2 | 0 |
| All trials | 16 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Eli Lilly | Originator, Applicant and Lead sponsor of trials | 2019 to now |