Awiqli, a Once-a-Week Insulin Shot for Type 2 Diabetes, Gets FDA Approval
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Once-a-Week Insulin Shot Could Be a Game Changer for Type 2 Diabetes

The FDA approval of Awiqli is a ‘huge deal’ for people looking for an alternative to daily shots, experts say.
Once-a-Week Insulin Shot Could Be a Game Changer for Type 2 Diabetes
If you take insulin every day for type 2 diabetes, you may find it a challenge to squeeze daily shots into your life. Now there is a new alternative: the first once-a-week insulin injection, which just received approval by the U.S. Food and Drug Administration (FDA).

Awiqli is designed to replace daily basal insulin shots. People with type 2 diabetes take the medication once a week through a disposable prefilled pen.

“This is a huge deal and meets a big unmet need in the diabetes community,” says John Aurora, PharmD, CDCES, a clinical pharmacist and diabetes educator at Tufts Medical Center in Boston.

More than 37 million Americans have diabetes, and over 8 million of those rely on insulin, according to the American Diabetes Association (ADA).

Here’s what you need to know about Awiqli, which drugmaker Novo Nordisk says will be available nationally in the coming months.

Clinical Trial Results Found Awiqli Has Similar Results to Daily Insulin Injections

The FDA approval was based on findings from the ONWARDS type 2 diabetes trial, which consisted of four randomized, controlled trials involving almost 3,000 adults with uncontrolled type 2 diabetes.

Researchers had study participants take Awiqli or daily basal insulin. People in both groups were also taking mealtime insulin and oral diabetes drugs or GLP-1 medication.

The researchers found that people on Awiqli achieved the same blood sugar management as those on daily basal insulin. (This was measured by A1C blood tests measuring average blood sugar levels over the past two to three months.)

The trial found no differences in safety between Awiqli and daily insulin injections. Potential side effects also were similar, including:

  • Hypoglycemia (low blood sugar)
  • Rare, serious allergic reactions
  • Reactions at the injection site
  • Skin thickening or pits at the injection site
  • Itching
  • Rash
  • Swelling of the hands and feet
  • Weight gain

Awiqli Is Not Approved for Kids or People With Type 1 Diabetes

The FDA did not approve Awiqli for use in children and teens.

While other countries, including Canada, have approved Awiqli for use in people with type 1 diabetes, the FDA determined in 2024 that the medication had a higher risk of causing low blood sugar in people with type 1 diabetes, and so declined to approve it for this group.

Why This FDA Approval Matters, According to Experts

Many people with type 2 diabetes may have a hard time with the scheduling demands and inconvenience of giving themselves basal (long-lasting) insulin, frequently in addition to mealtime (short-acting) insulin.

For these people, Awiqli “may make a difference in terms of quality of life and help with adherence to an insulin regimen,” says Jessica Cording, RD, the author of The Little Book of Game-Changers.

But Cording says it’s “really important” that doctors provide adequate education to patients on how to safely use the weekly injection, as well as alerting patients to potential interactions with other medications and supplements.

Aurora notes that many people with type 2 diabetes are reluctant to make the switch from oral diabetes medications to daily insulin shots when the need arises. But many of these patients are already on a weekly GLP-1 injection, he points out.

“Patients would likely be more willing to add in another weekly injection, allowing us to intensify therapy more quickly versus going months back and forth on whether to start daily insulin injections,” he says.

There Is Another Once-Weekly Insulin Medication in Development

Awiqli may soon have competition; drugmaker Eli Lilly has a once-weekly insulin called efsitora in development.

Multiple phase 3 clinical trials have shown that the medication reduces A1C as well as daily insulin injections and is safe. The company announced in June that it planned to submit the drug to U.S. regulatory agents by the end of 2025.

EDITORIAL SOURCES
Everyday Health follows strict sourcing guidelines to ensure the accuracy of its content, outlined in our editorial policy. We use only trustworthy sources, including peer-reviewed studies, board-certified medical experts, patients with lived experience, and information from top institutions.
Resources
  1. FDA Approves Novo Nordisk’s Awiqli, the First and Only Once-Weekly Basal Insulin Treatment for Adults with Type 2 Diabetes. Novo Nordisk. March 26, 2026.
  2. American Diabetes Association Announces Support for INSULIN Act at Senate Press Conference. American Diabetes Association. June 22, 2022.
  3. Patient Medication Information. Novo Nordisk Canada.
  4. Lilly’s Once-Weekly Insulin Efsitora Alfa Demonstrated A1C Reduction and a Safety Profile Consistent With Daily Insulin in Multiple Phase 3 Trials. Lilly. June 22, 2025.

Emily Kay Votruba

Fact-Checker
Emily Kay Votruba has copy edited and fact-checked for national magazines, websites, and books since 1997, including Self, GQ, Gourmet, Golf Magazine, Outside, Cornell University Press, Penguin Random House, and Harper's Magazine. Her projects have included cookbooks (Padma Lakshmi's Tangy Tart Hot & Sweet), self-help and advice titles (Mika Brzezinski's Know Your Value: Women, Money, and Getting What You're Worth), memoirs (Larry King's My Remarkable Journey), and science (Now You See It: How the Brain Science of Attention Will Transform How We Live, Work, and Learn, by Cathy Davidson). She started freelancing for Everyday Health in 2016.
Korin Miller

Korin Miller

Author

Korin Miller is a health journalist with more than a decade of experience in the field. She covers a range of health topics, including nutrition, recent research, wellness, fitness, mental health, and infectious diseases.

Miller received a double bachelor's in international relations and marketing from The College of William & Mary and master's in interactive media from American University. She has been published in The Washington Post, Prevention, Cosmopolitan, Women's Health, The Bump, and Yahoo News, among others.

When she's not working, Miller is focused on raising her four young kids.