Once-weekly Awiqli insulin wins FDA approval for Novo Nordisk (NVO)
Rhea-AI Filing Summary
Novo Nordisk reports that the US FDA has approved Awiqli® (insulin icodec-abae) injection 700 units/mL, the first and only once-weekly long-acting basal insulin for adults with type 2 diabetes, used along with diet and exercise to improve blood sugar control.
The approval is based on the ONWARDS phase 3a programme in about 2,680 adults, where once-weekly Awiqli® was compared with daily basal insulin and met its primary goal of lowering HbA1c, with an overall safety profile consistent with the basal insulin class.
Novo Nordisk plans to launch Awiqli® in the FlexTouch® device in the US in the second half of 2026. Awiqli® is now approved in the US, EU and 13 additional countries, expanding the company’s diabetes treatment portfolio.
Positive
- FDA approval of Awiqli® in the US as the first and only once-weekly basal insulin for adults with type 2 diabetes, supported by phase 3a ONWARDS data, broadens Novo Nordisk’s diabetes treatment options and may enhance its competitive position in insulin therapies.
Negative
- None.
Insights
FDA approval of once-weekly Awiqli® strengthens Novo Nordisk’s diabetes franchise.
Novo Nordisk has secured US FDA approval for Awiqli®, a once-weekly basal insulin for adults with type 2 diabetes. This adds a differentiated product to its insulin portfolio, supported by the ONWARDS phase 3a programme in roughly 2,680 adults versus daily basal insulin.
The filing notes that Awiqli® achieved its primary endpoint of HbA1c reduction with a safety profile broadly consistent with existing basal insulins. That combination of efficacy and familiar safety may support adoption among clinicians looking to simplify insulin regimens for suitable patients.
The company expects a US launch of Awiqli® via the FlexTouch® device in the second half of 2026. With approvals already in the US, EU and 13 other countries, subsequent disclosures in company filings can provide more clarity on uptake, reimbursement dynamics and any contribution to overall diabetes portfolio growth.
AI-generated analysis. How Rhea-AI works. Not financial advice.
FAQ
What did Novo Nordisk (NVO) announce regarding Awiqli in the US?
Why is Awiqli important for type 2 diabetes patients and Novo Nordisk (NVO)?
What clinical data supported Awiqli’s FDA approval for Novo Nordisk (NVO)?
When will Novo Nordisk (NVO) launch Awiqli in the US and in what device?
In which regions is Awiqli currently approved for Novo Nordisk (NVO)?
How is Awiqli administered and who is it indicated for according to Novo Nordisk (NVO)?
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
________________
FORM 6-K
________________
REPORT OF FOREIGN PRIVATE ISSUER
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
March 27, 2026
________________
NOVO NORDISK A/S
(Exact name of Registrant as specified in its charter)
Novo Allé 1
DK- 2880, Bagsvaerd
Denmark
(Address of principal executive offices)
________________
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F
| Form 20-F ☒ | Form 40-F ☐ |
Novo Nordisk A/S: Awiqli® approved in the US, the first and only once-weekly basal insulin treatment for adults with type 2 diabetes
| • | Awiqli® (insulin icodec-abae) injection is the first-ever once-weekly basal insulin approved by the FDA |
| • | Awiqli® offers adults with type 2 diabetes an alternative to daily basal insulin injections, reducing these injections from seven to one per week |
| • | Novo Nordisk expects to launch Awiqli® nationwide in the US in the second half of 2026. |
Bagsværd, Denmark, 27 March 2026 – Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved Awiqli® (insulin icodec-abae) injection 700 units/mL, the first and only once-weekly, long-acting basal insulin, indicated as an adjunct to diet and exercise to improve glycaemic control (blood sugar) in adults living with type 2 diabetes. The approval offers the only once-weekly basal insulin option, providing a new treatment solution that fits different patient routines and preferences for adults living with type 2 diabetes.
The approval is based on results from the ONWARDS phase 3a programme in type-2-diabetes for once-weekly Awiqli® injection, which comprises four randomised, active-controlled, treat-to-target trials in approximately 2,680 adults with uncontrolled type 2 diabetes, used in combination with a mealtime insulin or in combination with common oral anti-diabetic agents and/or GLP-1 receptor agonists. The clinical programme evaluated once-weekly Awiqli® vs daily basal insulin and demonstrated efficacy in the primary endpoint of HbA1c reduction across the ONWARDS pivotal clinical trial programme in adults with type 2 diabetes. Across ONWARDS trials, the safety profile of Awiqli® was overall consistent with the daily basal insulin class.
“The Awiqli® approval reflects Novo Nordisk’s ongoing efforts to advance healthcare innovation and strengthen support for people living with diabetes. As the first FDA-approved, once-weekly basal insulin for adults with type 2 diabetes, it offers an important new treatment option. At a time when parts of the industry are stepping back from insulin, we are reaffirming our commitment - continuing to invest in innovation, access, and supply for the millions of patients who rely on insulin every day,” said Mike Doustdar, president and CEO of Novo Nordisk.
Novo Nordisk expects to launch Awiqli® in the FlexTouch® device in the US in the second half of 2026. Awiqli® is now approved in the US, EU, and 13 additional countries, with market-specific indications for diabetes.
Novo Nordisk A/S Investor Relations | Novo Allé 1 2880 Bagsværd Denmark | Telephone: +45 4444 8888 | www.novonordisk.com |
| Company announcement No 22/ 2026 |
About Awiqli®
Awiqli® (insulin icodec-abae) injection 700 units/mL is a prescription medicine and is the first and only FDA-approved once-weekly basal insulin indicated as an adjunct to diet and exercise for adults with type 2 diabetes. Awiqli® is designed as an alternative to daily basal insulin, and its approval is supported by the ONWARDS clinical programme, which evaluated its efficacy and safety across diverse adult populations living with type 2 diabetes. Awiqli® is administered once weekly on the same day each week using the Awiqli® FlexTouch® device.
About Novo Nordisk
Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 68,800 people in 80 countries and markets its products in around 170 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube.
Publication of inside information pursuant to Market Abuse Regulation, Article 17.
Contacts for further information
| Novo Nordisk Media: | |
| Ambre James-Brown +45 3079 9289 globalmedia@novonordisk.com |
Liz Skrbkova (US) +1 609 917 0632 lzsk@novonordisk.com |
| Novo Nordisk Investors: | |
| Michael Novod +45 3075 6050 nvno@novonordisk.com |
Jacob Martin Wiborg Rode +45 3075 5956 jrde@novonordisk.com |
| Sina Meyer +45 3079 6656 azey@novonordisk.com |
Max Ung +45 3077 6414 mxun@novonordisk.com |
| Christoffer Sho Togo Tullin +45 3079 1471 cftu@novonordisk.com |
Alex Bruce +45 3444 2613 axeu@novonordisk.com |
| Frederik Taylor Pitter +1 609 613 0568 fptr@novonordisk.com |
Novo Nordisk A/S Investor Relations | Novo Allé 1 2880 Bagsværd Denmark | Telephone: +45 4444 8888 | www.novonordisk.com |
| Company announcement No 22/ 2026 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf of the undersigned, thereunto duly authorized.
| Date: March 27, 2026 |
NOVO NORDISK A/S
Maziar Mike Doustdar Chief Executive Officer |