FDA approves supplemental application for Eli Lilly's Inluriyo
The efficacy supplement for imlunestrant tosylate tablets received FDA approval, with a status date of September 18, 2026.
The FDA has approved a supplemental new drug application (SUPPL 1) for Inluriyo, made by Eli Lilly and Co. The submission was classified as an efficacy supplement, and its status was recorded as approved with a submission status date of September 18, 2026.1
Inluriyo is an oral tablet formulation. The product's active ingredient is imlunestrant tosylate, listed at a strength equivalent to 200mg base.1
The FDA classified the review under standard priority. The application was designated as review priority "STANDARD."1
Regulatory documentation associated with this approval includes both a labeling update and an approval letter. The application docs list a Label document dated September 22, 2026, and a Letter document also dated September 22, 2026.1
The application is tracked under NDA218881 with this being the first efficacy supplement (SUPPL 1) filed for the product. No additional details on the specific clinical indication, trial data, or dosing regimen changes are included in the available regulatory record.
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