Eli Lilly gains FDA approval for once-weekly insulin Onswik and partners with InnoCare on drug discovery

Eli Lilly secured FDA approval for Onswik, a once-weekly basal insulin injection for type 2 diabetes designed to maintain steady insulin levels over seven days. The approval marks the fourth regulatory clearance globally, following earlier authorizations in Japan, Mexico, and Europe. Based on Phase 3 QWINT trial data in over 3,400 patients, Onswik demonstrated non-inferior A1C reduction comparable to daily insulin treatments. In a separate announcement, the company finalized a strategic licensing agreement with InnoCare Pharma to identify and develop new medicines against up to five targets. InnoCare will receive up to $100 million in upfront and near-term payments, plus up to $3.25 billion in milestone payments tied to commercial and development achievements, along with tiered royalties on net product sales.

1. FDA approved Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin injection, for type 2 diabetes on September 24, 2026.
2. Onswik approval represents the fourth worldwide regulatory clearance after Japan, Mexico, and Europe.
3. QWINT Phase 3 trials enrolled more than 3,400 type 2 diabetes patients and met all primary endpoints.
4. Onswik demonstrated non-inferior A1C reduction versus insulin degludec U-100 and insulin glargine U-100.
5. Onswik will be available in 500 units/mL and 1,000 units/mL concentrations in KwikPen devices.
6. InnoCare Pharma will utilize its proprietary drug discovery platform against up to five specific targets.
7. InnoCare positioned to receive up to $100 million in upfront and near-term payments.
8. InnoCare could secure approximately $3.25 billion in future commercial and development milestone payments plus tiered royalties.