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Insulin efsitora alfa

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Insulin efsitora alfa
Clinical data
Trade namesOnswik, Onswik Kwikpen
Other namesLY3209590; LY-3209590, insulin efsitora alfa-gobe
License data
Routes of
administration		Subcutaneous
Drug classAntidiabetic agent
ATC code
  • None
Legal status
Legal status
Identifiers
CAS Number
UNII
KEGG
Chemical and physical data
FormulaC2810H4296N776O882S32
Molar mass64087.75 g·mol−1

Insulin efsitora alfa, sold under the brand name Onswik, is an antidiabetic medication used for the treatment of type 2 diabetes.[2] It is a long-acting insulin analog developed by Eli Lilly.[1]

Insulin efsitora alfa was authorized for medical use in the European Union in August 2026,[2] and approved for medical use in the United States in September 2026.[5]

Medical uses

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In the European Union, insulin efsitora alfa is indicated for the treatment of type 2 diabetes in adults.[2]

In the United States, insulin efsitora alfa indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.[1]

History

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The glycemic control and safety of insulin efsitora alfa were found similar to insulin degludec in a phase II trial.[6][7][8]

Society and culture

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In June 2026, 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 Onswik, intended for the treatment of type 2 diabetes.[2] The applicant for this medicinal product is Eli Lilly Nederland.[2] Insulin efsitora alfa was authorized for medical use in the European Union in August 2026.[2][3]

Insulin efsitora alfa was approved for medical use in the United States in September 2026.[4]

Names

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Insulin efsitora alfa is the international nonproprietary name.[9]

Insulin efsitora alfa is sold under the brand names Onswik[2][3] and Onswik KwikPen.[4]

References

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  1. 1 2 3 https://pi.lilly.com/us/onswik-uspi.pdf
  2. 1 2 3 4 5 6 7 8 "Onswik EPAR". European Medicines Agency (EMA). 26 June 2026. Retrieved 5 September 2026.
  3. 1 2 3 "Onswik PI". Union Register of medicinal products. 21 August 2026. Retrieved 5 September 2026.
  4. 1 2 3 4 "U.S. Food and Drug Administration (FDA) approves Lilly's Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin injection treatment for adults living with type 2 diabetes" (Press release). Eli Lilly. 24 September 2026. Retrieved 25 September 2026 – via PR Newswire.
  5. ↑ "Onswik (insulin efsitora alfa-gobe) FDA Approval History". Drugs.com. Retrieved 25 September 2026.
  6. ↑ Heise T, Chien J, Beals JM, Benson C, Klein O, Moyers JS, et al. (2023). "Pharmacokinetic and pharmacodynamic properties of the novel basal insulin Fc (insulin efsitora alfa), an insulin fusion protein in development for once-weekly dosing for the treatment of patients with diabetes". Diabetes, Obesity and Metabolism. 25 (4): 1080–1090. doi:10.1111/dom.14956. PMID 36541037. S2CID 255034380.
  7. ↑ Moyers JS, Hansen RJ, Day JW, Dickinson CD, Zhang C, Ruan X, et al. (2022). "Preclinical Characterization of LY3209590, a Novel Weekly Basal Insulin Fc-Fusion Protein". Journal of Pharmacology and Experimental Therapeutics. 382 (3): 346–355. doi:10.1124/jpet.122.001105. PMID 35840338.
  8. ↑ Kazda CM, Bue-Valleskey JM, Chien J, Zhang Q, Chigutsa E, Landschulz W, et al. (2023). "Novel Once-Weekly Basal Insulin Fc Achieved Similar Glycemic Control With a Safety Profile Comparable to Insulin Degludec in Patients With Type 1 Diabetes". Diabetes Care. 46 (5): 1052–1059. doi:10.2337/dc22-2395. PMC 10154655. PMID 36920867.
  9. ↑ World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 84". WHO Drug Information. 34 (3). hdl:10665/340680.
[edit]
  • "Insulin Efsitora Alfa ( Code - C174820 )". EVS Explore.
  • Clinical trial number NCT05662332 for "A Study of Insulin Efsitora Alfa (LY3209590) Compared to Glargine in Adult Participants With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-1) (QWINT-1)" at ClinicalTrials.gov
  • Clinical trial number NCT05362058 for "A Study of Insulin Efsitora Alfa (LY3209590) Compared to Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-2)" at ClinicalTrials.gov
  • Clinical trial number NCT05275400 for "A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin" at ClinicalTrials.gov
  • Clinical trial number NCT05462756 for "A Study of Insulin Efsitora Alfa (LY3209590) as a Weekly Basal Insulin Compared to Insulin Glargine in Adult Participants With Type 2 Diabetes on Multiple Daily Injections (QWINT-4)" at ClinicalTrials.gov
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