FDA Approves Onswik, a Once-Weekly Insulin Shot for Type 2 Diabetes

Published on September 25, 2026

Onswik (insulin efsitora alfa) is a long-acting (basal) insulin medicine for adults with type 2 diabetes. It is approved for use alongside diet and exercise to help lower high blood sugar levels. Onswik is given as an injection under the skin.

In type 2 diabetes, your body can’t properly use insulin or make enough of it to manage blood sugar. Insulin is a natural hormone that moves sugar from your blood into your cells, where it is used for energy. Onswik works just like natural insulin. It helps your muscles and fat tissue absorb sugar from the blood. It also stops your liver from making too much sugar.

Most basal insulins must be injected daily, but Onswik is injected only once a week. That’s because Onswik stays active in your body much longer.

The FDA approved Onswik based on four large clinical trials called the QWINT studies. These studies included more than 3,400 adults with type 2 diabetes. Researchers compared weekly Onswik injections to daily insulin injections, such as insulin glargine and insulin degludec. 

In all four studies, once-weekly Onswik lowered blood sugar levels to a similar extent as daily insulins. Blood sugar control was tested using an A1c blood test. People using Onswik had a similar drop in A1c levels as people using daily injections. Regardless of which injection they were using, all people in the study spent a similar amount of time in their healthy blood sugar range.

Onswik showed a safety profile similar to that of daily basal insulins. The most common side effect seen during the studies was low blood sugar (hypoglycemia). Very few patients experienced severe episodes of low blood sugar.

You inject Onswik under your skin once every week, on the same day each week. Shots can be given in your stomach area, upper arm, thigh, or buttocks. You should pick a different spot for each injection to help prevent issues such as skin thickening, pits, or lumps. 

Always check the product label before injecting the medicine to avoid mix-ups with other insulins. Never share your injection pen with another person. 

The most common side effect of Onswik is low blood sugar, also called hypoglycemia. Early signs include feeling dizzy, shaky, anxious, sweaty, hungry, or confused. Other common side effects include rash, itching, allergic reactions, swelling in the hands or feet, and weight gain. Be sure to check and manage your blood sugar levels regularly as directed by your healthcare provider.

Tell your healthcare provider about all health conditions and medicines you take. Taking certain heart medications or other diabetes pills can raise your risk for low blood sugar or heart failure. Onswik should not be used by people with type 1 diabetes because it increases the risk of severe low blood sugar.

Onswik is not recommended during pregnancy or while breastfeeding. It is not known if it can harm a fetus or pass into breast milk. If you are pregnant, planning to become pregnant, or nursing, talk to your healthcare provider before taking this medicine.

 

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