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FDA and UK authorization of Eli Lilly's Onswik insulin

Updated 1 time since CLSTR started tracking revisions of this situation.

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2026-09-27 14:56 UTC → 2026-10-14 06:15 UTC · added removed

FDA approval and UK authorization of Eli Lilly's Onswik insulin

The U.S. Food and Drug Administration (FDA) has approved Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin injection developed by Eli Lilly for adults with type 2 diabetes. Clinical data from the QWINT program, involving over 3,400 adults across four Phase 3 trials, demonstrated that the medication is noninferior to once-daily glargine U-100 or degludec U-100 in reducing HbA1c levels. While the weekly regimen offers increased convenience, studies indicated it was not more effective than daily insulin. In insulin-naive adults, a fixed-dose regimen was associated with a 43% reduction in the rate of clinically significant or severe hypoglycemia compared to glargine, which researchers attributed to a flatter pharmacokinetic profile. Onswik is the second weekly basal insulin to receive FDA approval in the United States, following Novo Nordisk’s Awiqli. The medication has already received regulatory approvals in Japan, Mexico, and the European Union. It In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) has authorized Onswik for treating type 2 diabetes in adults. The medication utilizes a slow-release mechanism where insulin molecules attach to albumin in the blood and bind to a fat molecule to ensure a steady stream of insulin over approximately seven to eight days. The National Institute for Health and Care Excellence (NICE) has also issued guidance recommending Onswik as an option for certain adults. Medical professionals have noted that because the medication remains active for a full week, recovering from accidental hypoglycemia may take longer than with daily options. Onswik is not recommended for individuals with type 1 diabetes due to an increased risk of severe hypoglycemia, and its safety and efficacy in children have not been established.

Versions

  1. 2026-10-14 06:15 UTC FDA and UK authorization of Eli Lilly's Onswik insulin
  2. 2026-09-27 14:56 UTC FDA approval of Eli Lilly's Onswik insulin

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