A filing plan is not an approval date.

Prepared September 14, 2026 · Publisher review required · No clinician review claimed

The most useful date currently available is a planned submission window—not an FDA approval deadline.

What Lilly has said

In its August 5, 2026 results announcement, Lilly described plans to submit a retatrutide Biologics License Application in the first quarter of 2027. A company statement archived by the SEC remains a company statement; the SEC is not confirming the medical or regulatory outcome. S02: Second-quarter 2026 results, Exhibit 99.1

What the FDA framework adds

For original BLAs, FDA’s PDUFA VII action goals are measured from the 60-day filing date: 10 months for standard review and 6 months for priority review. These goals address agency action, not a guarantee that a product will be approved. S04: PDUFA VII performance goals, section I.A.1, printed page 4

Using a January–March 2027 submission range produces an illustrative January–March 2028 action window under the standard assumption. A hypothetical priority scenario produces September–November 2027. Neither is an assigned date, and priority review is not established by the sources reviewed here.

What remains unknown

The actual submission and filing acceptance, review designation, any retatrutide-specific target date, the decision, final indications, labeling and retail availability all require separate confirmation. Delays or requests for additional information can change the calendar.