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LLY's Onswik Wins FDA Nod as a Once-Weekly Basal Insulin for T2D
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Key Takeaways
Lilly secured FDA approval for once-weekly Onswik to help adults with T2D control blood sugar.
Onswik delivered non-inferior A1C reductions versus daily basal insulins across the phase III QWINT studies.
Lilly plans a U.S. launch in the coming months, with Onswik KwikPen offered in two concentrations.
Eli Lilly and Company (LLY - Free Report) secured FDA approval for Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin to treat adults with type II diabetes (T2D). It is approved for use along with diet and exercise to help control blood sugar levels.
Onswik is designed to provide steady basal insulin levels for seven days, allowing patients to replace daily injections with a once-weekly option. Per the company, the drug could provide greater flexibility and convenience for adults with T2D who require insulin treatment.
Onswik is not approved for people with type I diabetes, as its use in this population may increase the risk of severe hypoglycemia (low blood sugar). The U.S. approval marks the fourth global regulatory approval for Onswik, following regulatory approvals in the European Union, Mexico and Japan.
Lilly plans to make the Onswik KwikPen available in the United States in the coming months. It will be offered in two concentrations, U-500 (500 units/mL) and U-1,000 (1,000 units/mL).
Year to date, shares of LLY have risen 10.5% compared with the industry’s 13.7% growth.
Image Source: Zacks Investment Research
Approval of LLY’s Onswik Based on QWINT Data
The FDA approval of Onswik was supported by data from the phase III QWINT clinical program, which evaluated the safety and efficacy of the once-weekly basal insulin in adults with T2D. Across the QWINT studies, Onswik met the primary endpoint by demonstrating non-inferior reductions in A1C compared with daily insulin glargine U-100 or insulin degludec U-100.
Onswik had an overall safety profile similar to the daily basal insulins evaluated in the studies.
Onswik Expands Lilly’s Broad T2D Portfolio
Onswik is not Lilly’s first basal insulin, but it is the company’s first once-weekly basal insulin. Lilly already markets daily basal insulins such as Basaglar and Rezvoglar. Onswik adds a once-weekly option to Lilly’s insulin portfolio, potentially reducing basal insulin injections from about 365 to 52 per year.
Lilly has a broad T2D portfolio that includes Mounjaro, a once-weekly GIP/GLP-1 medicine, as well as Basaglar and Rezvoglar as basal insulins. Its mealtime insulin products include Humalog and Lyumjev, while Glyxambi is an oral treatment for T2D. Together, these medicines give Lilly treatment options across weekly injectable, daily insulin, mealtime insulin and oral therapies.
However, Lilly’s Onswik may face direct competition from Novo Nordisk’s (NVO - Free Report) Awiqli in the U.S. market. Awiqli, approved by the FDA in March 2026 as the first once-weekly basal insulin for adults with T2D, offers a similar dosing advantage to Onswik by reducing basal insulin injections from seven per week to one.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have improved from a loss of 2 cents to earnings per share of 25 cents. Over the same period, earnings estimates for 2027 have risen from 25 cents to 86 cents. PGEN shares have gained 84.2% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 108.96%.
Over the past 60 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents per share. ACIU shares have lost 15.3% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.
View the Zacks #1 Rank List
Image: Bigstock
LLY's Onswik Wins FDA Nod as a Once-Weekly Basal Insulin for T2D
Key Takeaways
Eli Lilly and Company (LLY - Free Report) secured FDA approval for Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin to treat adults with type II diabetes (T2D). It is approved for use along with diet and exercise to help control blood sugar levels.
Onswik is designed to provide steady basal insulin levels for seven days, allowing patients to replace daily injections with a once-weekly option. Per the company, the drug could provide greater flexibility and convenience for adults with T2D who require insulin treatment.
Onswik is not approved for people with type I diabetes, as its use in this population may increase the risk of severe hypoglycemia (low blood sugar). The U.S. approval marks the fourth global regulatory approval for Onswik, following regulatory approvals in the European Union, Mexico and Japan.
Lilly plans to make the Onswik KwikPen available in the United States in the coming months. It will be offered in two concentrations, U-500 (500 units/mL) and U-1,000 (1,000 units/mL).
Year to date, shares of LLY have risen 10.5% compared with the industry’s 13.7% growth.
Image Source: Zacks Investment Research
Approval of LLY’s Onswik Based on QWINT Data
The FDA approval of Onswik was supported by data from the phase III QWINT clinical program, which evaluated the safety and efficacy of the once-weekly basal insulin in adults with T2D. Across the QWINT studies, Onswik met the primary endpoint by demonstrating non-inferior reductions in A1C compared with daily insulin glargine U-100 or insulin degludec U-100.
Onswik had an overall safety profile similar to the daily basal insulins evaluated in the studies.
Onswik Expands Lilly’s Broad T2D Portfolio
Onswik is not Lilly’s first basal insulin, but it is the company’s first once-weekly basal insulin. Lilly already markets daily basal insulins such as Basaglar and Rezvoglar. Onswik adds a once-weekly option to Lilly’s insulin portfolio, potentially reducing basal insulin injections from about 365 to 52 per year.
Lilly has a broad T2D portfolio that includes Mounjaro, a once-weekly GIP/GLP-1 medicine, as well as Basaglar and Rezvoglar as basal insulins. Its mealtime insulin products include Humalog and Lyumjev, while Glyxambi is an oral treatment for T2D. Together, these medicines give Lilly treatment options across weekly injectable, daily insulin, mealtime insulin and oral therapies.
However, Lilly’s Onswik may face direct competition from Novo Nordisk’s (NVO - Free Report) Awiqli in the U.S. market. Awiqli, approved by the FDA in March 2026 as the first once-weekly basal insulin for adults with T2D, offers a similar dosing advantage to Onswik by reducing basal insulin injections from seven per week to one.
LLY’s Zacks Rank & Stock to Consider
Lilly currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Precigen (PGEN - Free Report) , currently sporting a Zacks Rank #1 (Strong Buy), and AC Immune (ACIU - Free Report) carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have improved from a loss of 2 cents to earnings per share of 25 cents. Over the same period, earnings estimates for 2027 have risen from 25 cents to 86 cents. PGEN shares have gained 84.2% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 108.96%.
Over the past 60 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents per share. ACIU shares have lost 15.3% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.