# Weekly insulin regulatory approvals

> Live situation record from CLSTR: https://clstr.news/situations/weekly-insulin-regulatory-approvals
> Updated: 2026-09-28T17:40:03.000Z. Sources: 5. Developments: 2.

Regulatory agencies in Brazil and the United States have approved new once-weekly injectable treatments for adults and children with type 2 diabetes.

In Brazil, Anvisa approved Kyinsu, a Novo Nordisk product that combines insulin icodeca and semaglutide. It is the first product to offer a fixed-dose combination of a basal insulin and a GLP-1 receptor agonist in a single weekly application. The treatment is intended for patients who have not achieved adequate glycemic control through other existing therapies.

In the United States, the FDA approved Eli Lilly’s Onswik (insulin efsitora alfa-gobe). Clinical trials, including the QWINT Phase III program, indicated that the once-weekly basal insulin achieved non-inferior reductions in glycated haemoglobin (A1C) compared to daily insulin glargine or insulin degludec. Onswik is intended for type 2 diabetes and is not recommended for type 1 diabetes due to risks of severe hypoglycemia. Common side effects noted include hypoglycemia, allergic reactions, and weight gain.

Expanding on previous approvals, the FDA also approved Novo Nordisk’s Awiqli (insulin icodec-abae) for children and adolescents aged 10 and older with type 2 diabetes. This follows an earlier adult indication granted in 2026. The once-weekly basal insulin is intended to improve glycemic control as an adjunct to diet and exercise, aiming to reduce injection frequency from seven times per week to once weekly.

## Timeline

### 2026-09-28: Eli Lilly receives FDA approval for once-weekly insulin Onswik

The FDA has approved Eli Lilly’s Onswik, a once-weekly basal insulin for adults with type 2 diabetes, aimed at reducing injection frequency and improving glycemic control.

2 sources. https://clstr.news/cluster/eli-lilly-receives-fda-approval-for-once-weekly-insulin-onswik

### 2026-09-28: Anvisa approves weekly insulin and semaglutide injection for type 2 diabetes

Anvisa has approved Novo Nordisk’s Kyinsu, a new weekly injectable combining insulin icodeca and semaglutide for adults with type 2 diabetes.

3 sources. https://clstr.news/cluster/anvisa-approves-weekly-insulin-and-semaglutide-injection-for-type-2-diabetes

---
Cite as: Weekly insulin regulatory approvals. CLSTR, https://clstr.news/situations/weekly-insulin-regulatory-approvals