On 24 September 2026, Eli Lilly announced that the FDA has approved Onswik™ (insulin efsitora alfa-gobe), a once-weekly basal insulin injection for treatment of type 2 diabetes in adults. It is indicated for use as an adjunct to diet and exercise to control high blood sugar and will be available in a KwikPen® (500 units/mL and 1000 units/mL) “in the coming months”.
The FDA approval was based on positive results from the QWINT Phase 3 trials. The trials evaluated the safety and efficacy of once-weekly Onswik™ in over 3400 patients across four studies (QWINT-1, QWINT-2, QWINT-3 and QWINT-4). In each QWINT trial, Onswik™ met the primary endpoint of non-inferior A1C reduction from baseline that was comparable to Sanofi’s Lantus® (insulin glargine) or Novo Nordisk’s Tresiba® (insulin degludec).
According to Eli Lilly, the US approval for Onswik™ follows positive regulatory action in Europe (CHMP recommendation in June 2026), Japan (PMDA approved in September 2026) and Mexico.
Onswik™ is the second once-weekly basal insulin approved by the FDA. Novo Nordisk’s Awiqli® (insulin icodec-abae) injection was the first once-weekly basal insulin for adults with type 2 diabetes to receive FDA approval (March 2026). It was launched in August 2026 as a pre-filled pen (700 units/mL).