FDA approves new insulin technologies for type 2 diabetes management

The US FDA approves two major diabetes management technologies: Eli Lilly's once-weekly basal insulin, Onswik, and DreaMed Diabetes's MODI app, which automates insulin dosing for injection users. Onswik reduces annual injections by over 300, while MODI brings continuous algorithmic adjustments to the 85% of US insulin users who rely on injections. Developed in collaboration with the Next October initiative, MODI is named in memory of Modi Amir, who was killed in the October 7 attacks.

Approval and availability of Onswik

• ▪The US Food and Drug Administration approved Eli Lilly's once-weekly basal insulin, Onswik, for adults with type 2 diabetes on September 24, 2026.
• ▪Eli Lilly plans to make Onswik available in the United States in the coming months as a pre-filled KwikPen in concentrations of 500 units and 1,000 units per milliliter, following prior approvals in Europe, Japan, and Mexico.

Clinical profile and safety of Onswik

• ▪Eli Lilly's once-weekly basal insulin, Onswik (insulin efsitora alfa-gobe), is intended to be used alongside diet and exercise to control high blood sugar in adults with type 2 diabetes.
• ▪In a late-stage trial of over 3,400 adults with type 2 diabetes, Eli Lilly's Onswik met its main goal of showing blood sugar reductions that were non-inferior to daily basal insulin glargine.
• ▪Eli Lilly warned that its once-weekly basal insulin, Onswik, should not be used in patients with type 1 diabetes due to an increased risk of severe hypoglycemia.
• ▪Eli Lilly stated that its once-weekly basal insulin, Onswik, could reduce the number of insulin injections by more than 300 per year compared with once-daily basal insulin.

FDA clearance of the MODI application

• ▪DreaMed Diabetes's MODI app is the first FDA-cleared technology designed to bring continuous, algorithmic dose adjustment to insulin injection users, spanning both basal-only and multiple daily injection regimens.
• ▪The Petah Tikva-based startup DreaMed Diabetes received FDA 510(k) clearance for MODI, a prescription app that delivers personalized insulin dosing recommendations to a patient's smartphone without requiring physician configuration or approval for every adjustment.
• ▪The US Food and Drug Administration cleared DreaMed Diabetes's prescription medical application, MODI, to automatically optimize insulin dosing for adults with type 2 diabetes using injections, as reported on September 28, 2026.

Memorialization of Modi Amir

• ▪The Next October initiative pairs Israeli startups with fallen heroes of the October 7 attacks to memorialize them through technological innovation.
• ▪The collaboration between DreaMed Diabetes and the family of Modi Amir was fostered by Next October, an initiative founded by Izhar, Hila, and Ofir Shay in memory of Yaron Shay, who fell defending Kibbutz Kerem Shalom on October 7.
• ▪With the blessing of the Amir family, DreaMed Diabetes officially registered the MODI application under Modi Amir's name with the US Food and Drug Administration to memorialize his legacy.
• ▪DreaMed Diabetes named its MODI application in memory of Modi (Mordechai) Amir, a 67-year-old technology enthusiast and resident of Kibbutz Kfar Aza who was killed during the October 7 terrorist attacks.

Insulin injection users

• ▪Over eight million people in the United States inject insulin daily, representing approximately 85% of US insulin users who rely on injections rather than insulin pumps.
• ▪Most patients using insulin injections experience gaps between clinical appointments during which their insulin dosages remain static, leaving a vast majority struggling to consistently hit target glucose levels.

Debatable claims

• ▪Pairing commercial startups with fallen conflict victims is an appropriate way to memorialize them
• ▪Reducing injection frequency justifies the potential safety risks of once-weekly insulin
• ▪Prescription apps should be allowed to adjust insulin doses without real-time physician approval