Novo Nordisk Pharma Ltd.'s once-weekly type 2 diabetes treatment KeyIns® Prefilled Pen (ingredients: insulin icodec/semaglutide) received domestic marketing approval from the Ministry of Food and Drug Safety on May 21, 2026.
KeyIns® is a combination product that merges the once-weekly basal insulin formulation Awiqli® (insulin icodec) with the once-weekly GLP-1 receptor agonist Ozempic® (semaglutide). It is indicated for adult patients with type 2 diabetes whose blood glucose is inadequately controlled on basal insulin or GLP-1 RA, and can be used in combination with oral hypoglycemic agents.
The approval is based on the COMBINE 1, 2, and 3 Phase 3 clinical trials, which were multinational, multicenter, open-label, randomized studies. In COMBINE 1, the KeyIns® group showed a 1.55 percentage point reduction in HbA1c from baseline at 52 weeks, demonstrating superiority over the insulin icodec monotherapy group (-0.89%). In COMBINE 2, KeyIns® achieved a 1.35 percentage point reduction versus semaglutide 1.0 mg monotherapy (-0.90%), confirming superiority. In COMBINE 3, KeyIns® showed non-inferiority (-1.47%) compared to basal-bolus insulin combination therapy (-1.40%). Safety profiles across all three studies were reported as similar to the control groups.
In South Korea, only 32.4% of adult diabetes patients achieve the HbA1c target of below 6.5%, and the burden of injection frequency has been cited as a barrier to insulin and GLP-1 RA prescription. KeyIns® is expected to improve patient compliance by replacing daily insulin and GLP-1 RA monotherapy or combination therapy with a once-weekly regimen.
"Daily repeated injections have been one of the factors reducing treatment adherence and persistence," said Kim Sung-rae, President of the Korean Diabetes Association. "KeyIns® enhances convenience with once-weekly administration while potentially reducing total insulin usage through the complementary actions of insulin and GLP-1 RA."
Casper Rosée Poulsen, General Manager of Novo Nordisk Korea, stated, "KeyIns® is the first once-weekly insulin and GLP-1 RA combination product in Korea, built on Novo Nordisk's over 100 years of scientific expertise. We will continue to strive for expanding innovative treatment options and advancing the diabetes treatment environment in Korea."
Photo: KeyIns® logo / Provided by Enzyme Health
Source: Read the original report | Published: May 21, 2026