Onswik (insulin efsitora alfa-gobe) was approved by the FDA on September 23, 2026 to improve glycemic control in adults with type 2 diabetes mellitus, as an adjunct to diet and exercise, the 41st novel drug approval of 2026 on the FDA's Novel Drug Approvals list.
The FDA approved Onswik (insulin efsitora alfa-gobe), Lilly's once-weekly basal insulin for adults with type 2 diabetes, on September 23, 2026 (BLA 761408). Lilly announced the approval on September 24, 2026. It is on the FDA's 2026 Novel Drug Approvals list.
The FDA's approval letter for BLA 761408 is dated September 23, 2026 and states that Onswik is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (FDA approval letter); the letter gives the application as received September 23, 2025. Lilly announced the approval on September 24, 2026 (Lilly release). Per Lilly, the approval rests on the Phase 3 QWINT program, four trials in more than 3,400 adults with type 2 diabetes, in each of which once-weekly Onswik met its primary endpoint of non-inferior A1C reduction versus daily insulin glargine U-100 or insulin degludec U-100. Lilly says Onswik should not be used in type 1 diabetes and that the KwikPen will be available in the U.S. in the coming months in 500 and 1,000 units/mL strengths. pdufa.bio did not hold a goal date for this application, so no early or late margin is computed.
Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.
Primary source: FDA approval letter, BLA 761408, September 23, 2026
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| OrbiMed Advisors | 257,900 | $309.3 million | filed August 14, 2026 |
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Yes. The approval of the application for Onswik (insulin efsitora alfa-gobe) was announced on September 23, 2026; pdufa.bio holds no FDA record stating the exact day the FDA acted. The primary source is linked on this page.
Onswik (insulin efsitora alfa-gobe) is an Eli Lilly and Company (LLY) program. The company announced the FDA decision on September 23, 2026; the company's own announcement is linked on this page.
Measured over the 120 trading days before the decision (T-120 to T-1), LLY moved +22.6%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.