Novo Nordisk's Awiqli Makes History as First Once-Weekly Insulin
By FieldPulse Editorial · March 26, 2026
Tags: FDA, Diabetes, GLP-1
The FDA has approved Novo Nordisk's Awiqli, the first and only once-weekly basal insulin for type 2 diabetes. US launch expected in H2 2026 via the FlexTouch pen device.
The FDA on March 26 approved Novo Nordisk's Awiqli (insulin icodec) , making it the first and only once-weekly basal insulin available for adults with type 2 diabetes.
The approval represents a paradigm shift in insulin therapy — reducing injection burden from seven times per week to just once — and has major implications for how diabetes is managed in primary care, endocrinology, and the field force that supports those specialties.
Awiqli will be delivered via Novo Nordisk's established FlexTouch pen device , a familiar format for patients and prescribers already using the company's insulin portfolio.
The US commercial launch is expected in the second half of 2026, giving Novo's field teams several months to prepare market access strategies, medical education campaigns, and formulary positioning ahead of availability.
The Clinical Case for Once-Weekly Dosing The approval is built on a robust registrational program that demonstrated non-inferiority to daily basal insulins on HbA1c reduction, with the obvious convenience advantage of a single weekly injection.
For the roughly 8.4 million Americans currently on basal insulin, the compliance and quality-of-life implications are substantial.
Missed doses, injection fatigue, and the day-to-day burden of daily insulin regimens are well-documented contributors to suboptimal glycemic control — and Awiqli directly addresses all three.
The clinical data showed comparable hypoglycemia rates to daily insulin glargine, which will be critical for payer and formulary discussions.
Hypoglycemia risk has historically been the key objection that physicians raise when considering any change to a patient's insulin regimen, and Awiqli's safety profile should help neutralize that concern in selling conversations.
Competitive Landscape: Lilly, Sanofi, and the Insulin Market Novo Nordisk has a meaningful first-mover advantage.
Eli Lilly has been developing its own once-weekly insulin (efsitora alfa), but that program is behind Awiqli in the.