FDA approves Eli Lilly's Onswik, a new insulin efsitora alfa-gobe injection

The FDA's drug approvals database shows a new molecular entity application for Onswik, submitted by Eli Lilly and Co, with an original approval action recorded on September 23, 2026. The record identifies the application as BLA761408, ORIG 1, with submission class Type 1 - New Molecular Entity, submission status AP, and submission status date 2026-09-23.¹

Onswik contains insulin efsitora alfa-gobe as its active ingredient. The listing describes two subcutaneous injectable products under the Onswik brand name, one at a strength of 1000 units per milliliter and another at 500 units per milliliter.¹

The submission was reviewed under standard review priority rather than priority review.¹ Eli Lilly and Co is listed as the sponsor of the application.¹

The FDA database also references an approval letter tied to the application. That document is dated September 25, 2026, and is hosted on the agency's drug approval documents site under the identifier 761408Orig1s000ltr.pdf.¹

The source record does not include additional detail on clinical trial data, labeled indications, or dosing schedules for Onswik beyond the strengths listed for the two injectable formulations. Readers seeking further specifics on the drug's approved use or supporting trial results will need to consult the full approval letter or Lilly's own disclosures, which are not included in this database entry.