Kyinsu
Metabolic· 1105 cited findings· 1 source document
Company: Novo Nordisk A S →
What the regulatory reviews say
Kyinsu is a drug for which a marketing authorisation application was submitted on 7 October 2024, with a CHMP positive opinion issued on 18 September 2025. The application status is 'approvable'. Clinical trials, including a Phase 3a trial with 1291 participants over 52 weeks, investigated its efficacy and safety. In these trials, Kyinsu demonstrated changes from baseline in HbA1c ranging from -0.89% to -1.55%. Estimated treatment differences for HbA1c ranged from -0.06% to -0.66%. The mean weekly total insulin dose estimated treatment difference was -270 U. The mean weekly basal insulin dose for Kyinsu (IcoSema) was 196 U and 182 U, compared to 285 U for IGlar+IAsp and 355 U for insulin icodec.
Safety findings for Kyinsu include a permanent discontinuation rate of 6.1-10.1% and a withdrawal rate of 4.1-5.4%. Intercurrent events for Kyinsu were observed at rates of 9.4%, 13.2%, and 16.7%, compared to 13.3% for insulin icodec, 18.9% for IGlar+IAsp, and 23.5% for semaglutide. One participant discontinued due to lack of efficacy. The drug has a shelf-life of 3 years, with an in-use stability period of 6 to 8 weeks when stored at 30°C.
Key figures — cited to the source page
| HbA1c change from baseline (Kyinsu) | -1.55 | Novo Nordisk A S — Kyinsu EMA EPAR public assessment report, p.83 |
| HbA1c estimated treatment difference | -0.66 | Novo Nordisk A S — Kyinsu EMA EPAR public assessment report, p.83 |
| Mean weekly total insulin dose ETD | -270 | Novo Nordisk A S — Kyinsu EMA EPAR public assessment report, p.85 |
| Permanent discontinuation rate (Kyinsu) | 6.1-10.1 | Novo Nordisk A S — Kyinsu EMA EPAR public assessment report, p.68 |
| Intercurrent events (Kyinsu) | 16.7 | Novo Nordisk A S — Kyinsu EMA EPAR public assessment report, p.71 |
| Intercurrent events (insulin icodec) | 13.3 | Novo Nordisk A S — Kyinsu EMA EPAR public assessment report, p.71 |
| CHMP positive opinion date | 18 September 2025 | Novo Nordisk A S — Kyinsu EMA EPAR public assessment report, p.7 |
| Marketing authorisation application status | approvable | Novo Nordisk A S — Kyinsu EMA EPAR public assessment report, p.31 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.