Insulin icodec and semaglutide
Brand Kyinsu
Fixed weekly combination of insulin icodec and semaglutide, authorised in the EU on 24 November 2025 for adults not controlled on basal insulin or a GLP-1 drug. A CHMP opinion of 15 October 2026 recommends removing that prior treatment condition.
Insulin icodec and semaglutide comes from Novo Nordisk and sits in the Incretins class on the board. Route: weekly injection. Use tracked here: Adults with insufficiently controlled type 2 diabetes, with diet, exercise and oral antidiabetic drugs. It stands at Approved on the board, with 2 news moves logged; the latest is dated 30 Oct 2026.
- 05ApprovedHere now
- 04FiledApplication submitted to a regulator and under review.
- 03Phase 3Large confirmatory trials meant to support a filing.
- 02Phase 2Does it work at all, and at which dose? Hundreds of patients.
- 01Phase 1First doses in people. Safety, dose range, how the body handles it.
- Company
- Novo Nordisk
- Mechanism
- Once weekly basal insulin analogue combined with a GLP-1 receptor agonist in one product
- Given as
- weekly injection
- Lead use on the board
- Adults with insufficiently controlled type 2 diabetes, with diet, exercise and oral antidiabetic drugs
- Moves logged
- 2latest 4 days ago
Insulin icodec and semaglutide news moves
-
IcoSema weekly injection aims for a first European launch in Italy
Italian specialists want Novo Nordisk's insulin icodec and semaglutide combination offered first in Italy after the CHMP widened its EU indication and COMBINE 4 was published. No Italian reimbursement decision or trial figures were reported.
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Kyinsu CHMP opinion widens the EU label beyond people already on insulin or GLP 1
The EMA committee recommends dropping the rule that adults must first be insufficiently controlled on basal insulin or a GLP-1 drug. The studies behind the change are not yet public, and the Commission has the final word.
Other incretins molecules on the board, with their current stage.