Inluriyo (imlunestrant tosylate)
New molecular entity
- Region
- 🇺🇸 US
- Active substance
- imlunestrant tosylate
- Company
- Eli Lilly And Co
- Status
- Approved
- FDA approval
- Thu 25 Sep 2025
- Designations
- New molecular entity
- Application
- NDA218881
- Official record
- www.accessdata.fda.gov
Regulatory milestones
Fri 09 Jan 2026🇪🇺 EU approval (EC decision)
Inluriyo (imlunestrant) approved in the EU
Marketing authorisation to Eli Lilly Nederland B.V.; Additional monitoring · source
Thu 13 Nov 2025🇪🇺 CHMP positive opinion
Inluriyo (imlunestrant): CHMP positive opinion
Eli Lilly Nederland B.V.; Additional monitoring · source
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.