FDA Approves a Second Once-Weekly Insulin: Lilly's Onswik Joins Novo's Awiqli
Published: September 30, 2026 · 3 min read · By Grey Peptides News Desk · ✓ Sourced
FDA approved Onswik (insulin efsitora alfa-gobe), Eli Lilly's once-weekly basal insulin, on September 23, 2026, to improve blood sugar control in adults with type 2 diabetes. It is the second weekly insulin in the US after Novo Nordisk's Awiqli (insulin icodec-abae), approved on March 26. Neither is approved for type 1 diabetes, and Onswik's pens deliver up to 800 units in a single injection.
Two weekly insulins in one year
FDA's list of novel approvals for 2026 records Onswik on September 23, for adults with type 2 diabetes as an adjunct to diet and exercise; Lilly announced it the next day. It is the second once-weekly basal insulin FDA has approved. The first, Novo Nordisk's Awiqli, was approved on March 26 for the same group. Until this year, basal insulin meant a daily injection; a weekly one means 52 injections a year instead of about 365.
What the trials showed
Onswik fuses a single-chain insulin variant to an antibody Fc fragment, which gives it a half-life of about 17 to 19 days and a nearly flat level across the week. Lilly says four QWINT trials in more than 3,400 adults with type 2 diabetes supported the approval, and in each one its HbA1c lowering was non-inferior to daily insulin glargine or degludec. QWINT-1 tested a fixed-dose regimen for people starting insulin: 100 units a week, then steps of 150, 250 and 400 units every four weeks as needed. It needed a median of 2 dose changes over a year, against 8 with daily glargine.
Why not type 1 diabetes
A fifth trial, QWINT-5, tested Onswik in type 1 diabetes. HbA1c results matched degludec, but level 2 or severe hypoglycaemia was more frequent (14.03 against 11.59 events per patient-year). Lilly's safety summary says people with type 1 diabetes should not use Onswik because of that risk, and Awiqli's label is likewise limited to type 2 diabetes in adults.
Pens that need care
Onswik comes in two KwikPens, 500 and 1,000 units per mL, able to deliver up to 400 or 800 units in one injection; Lilly says they will reach US pharmacies in the coming months. Both weekly insulins carry warnings against drawing the insulin out of the pen with a syringe, because of overdose and severe hypoglycaemia. Our insulin efsitora entry sets out all five QWINT trials, and the same-syringe section of our mixing guide covers why insulins are not mixed with other injectables.
Related on Grey Peptides
All five QWINT trials and the pharmacology, study by study. Insulin icodec encyclopedia entry
Awiqli, the first weekly insulin approved in the US. Mixing two injectables in one syringe
What the labels say about combining insulin with other drugs.
U.S. Food and Drug Administration - Novel Drug Approvals for 2026
Page content current as of September 28, 2026, read September 30, 2026; application numbers from Drugs@FDA; pen and safety details from Lilly's announcement of September 24, 2026.