Documentary record · October 19, 2026 edition
Onswik (insulin efsitora alfa) — once-weekly basal insulin for adults with type 2 diabetes
APPROVED; supply expected "in the coming months".
SOURCE-VERIFIED · HUMAN REVIEW PENDING
Event date
September 23, 2026
Lifecycle state
APPROVED; supply expected "in the coming months".
Source published
September 24, 2026
Source checked
October 19, 2026
Published on KPSGILL
- Approval: FDA action September 23, 2026 (Eli Lilly).
- Indication: glycemic control in adults with type 2 diabetes.
- Evidence: the QWINT-1 to -4 trials (more than 3,400 adults) showed A1C reduction non-inferior to daily glargine or degludec.
- Status: APPROVED; supply expected "in the coming months".
- Not established: use in type 1 diabetes (not for use, because of increased risk of severe hypoglycemia) or in children.
- Correction to circulating briefs: Onswik is Lilly's efsitora, not Novo Nordisk's insulin icodec. Lilly does not describe it as the first U.S. weekly insulin.
Sources
- FDA Novel Drug Approvals 2026 (Onswik 9/23) Primary · 2026-09-23 · checked 2026-10-19
- Lilly release Onswik Company · 2026-09-24 · checked 2026-10-19
Related on this site
Register: the record store · record id fda-onswik-efsitora-weekly-insulin-2026-09-23 · SOURCE-VERIFIED · HUMAN REVIEW PENDING.