Insulin icodec/semaglutide

Insulin icodec/semaglutide
Combination of
Insulin icodec	Insulin analog
Semaglutide	GLP-1 receptor agonist
Clinical data
Trade names	Kyinsu
ATC code	A10AE57 (WHO) ;
Legal status
Legal status	EU: Rx-only;
Identifiers
KEGG	D13245;

Insulin icodec/semaglutide is an experimental fixed-dose combination of insulin icodec and semaglutide in development for type 2 diabetes by Novo Nordisk. The combination contains insulin icodec, a basal insulin analog; and semaglutide, a glucagon-like peptide 1 (GLP-1) receptor agonist. Insulin icodec regulates glucose metabolism by binding to insulin receptors. Semaglutide regulates insulin and glucagon secretion in a glucose-dependent manner by selectively binding to and activating the GLP-1 receptor, the target for native GLP-1.

Society and culture

Legal status

In September 2025, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Kyinsu, intended for treatment of type 2 diabetes mellitus. The applicant for this medicinal product is Novo Nordisk A/S. Insulin icodec/semaglutide was authorized for medical use in the European Union in November 2025.

References

1 2 3 4 5 6 7 "Kyinsu EPAR". European Medicines Agency (EMA). 19 September 2025. Retrieved 27 September 2025. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
1 2 "Kyinsu PI". Union Register of medicinal products. 27 November 2025. Retrieved 1 December 2025.
↑ Kalra, Sanjay; Bhattacharya, Saptarshi; Kapoor, Nitin (August 2021). "Contemporary Classification of Glucagon-Like Peptide 1 Receptor Agonists (GLP1RAs)". Diabetes Therapy. 12 (8): 2133–2147. doi:10.1007/s13300-021-01113-y. ISSN 1869-6953. PMC 8342688. PMID 34268675.
↑ "CTG Labs - NCBI". clinicaltrials.gov. Retrieved 5 November 2023.
↑ Doctorx (12 February 2020). "Novo Nordisk's Insulin Products, Pipeline May Energize The Stock". Seeking Alpha. Archived from the original on 5 November 2023. Retrieved 5 November 2023.

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[Kyinsu_EPAR-1] 1 2 3 4 5 6 7 "Kyinsu EPAR". European Medicines Agency (EMA). 19 September 2025. Retrieved 27 September 2025. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

[Kyinsu_PI-2] 1 2 "Kyinsu PI". Union Register of medicinal products. 27 November 2025. Retrieved 1 December 2025.

[3] Kalra, Sanjay; Bhattacharya, Saptarshi; Kapoor, Nitin (August 2021). "Contemporary Classification of Glucagon-Like Peptide 1 Receptor Agonists (GLP1RAs)". Diabetes Therapy. 12 (8): 2133–2147. doi:10.1007/s13300-021-01113-y. ISSN 1869-6953. PMC 8342688. PMID 34268675.

[4] "CTG Labs - NCBI". clinicaltrials.gov. Retrieved 5 November 2023.

[5] Doctorx (12 February 2020). "Novo Nordisk's Insulin Products, Pipeline May Energize The Stock". Seeking Alpha. Archived from the original on 5 November 2023. Retrieved 5 November 2023.