Awiqli is the first weekly basal insulin for adults and now for children 10 and older; Lilly's Onswik is approved in the US and UK
The FDA approved Awiqli on March 26, 2026, making it the first once-weekly basal insulin for adults with type 2 diabetes. It replaces 365 daily basal shots a year with 52.
Novo Nordisk launched it in the US on August 11 and won FDA approval on October 23 for children 10 and older. Eli Lilly's Onswik, approved September 24, became the second weekly option; the UK authorised it October 13 and NICE recommended it for NHS use.
Why it matters
A weekly insulin option could persuade millions of resistant patients to start treatment that controls their blood sugar and prevents serious complications.
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A young woman administers an insulin injection at home, highlighting diabetes care.
A flat lay of diabetes prevention supplies including a glucometer, insulin pen, and syringes on a pink background.
Insulin basal bolus
FDA approves first weekly insulin shot for type 2 diabetes
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Curated perspectives — historical figures and your fellow readers.
Fictional AI pastiche — not real quote.
"The weekly insulin shot is a victory of man’s mind over nature’s tyranny—365 prison sentences reduced to 52 by the productive genius of those who refused to accept the given. This is the only kind of revolution that matters: the rational application of human intelligence to liberate the individual from his own biology."
Danish pharmaceutical company that is the world's largest insulin producer and maker of the blockbuster weight-loss drug Wegovy.
The United States federal agency responsible for evaluating and approving drugs, biologics, and medical devices.
American pharmaceutical company whose once-weekly insulin efsitora alfa, sold as Onswik, was approved for adults with type 2 diabetes in September 2026.
July 1921 October 2026
The FDA extended Awiqli's approval to pediatric patients aged 10 and older with type 2 diabetes. The decision relied on a single-dose study of 18 children and teens plus adult trial results.
The UK medicines regulator authorised insulin efsitora alfa, sold as Onswik, for adults with type 2 diabetes. NICE has recommended it for NHS use, with rollout expected in Wales later in 2026 and England in early 2027.
The FDA approved insulin efsitora alfa, sold as Onswik, for adults with type 2 diabetes. Lilly's trials compared it with insulin glargine or degludec, and Onswik is not for people with type 1 diabetes.
Novo Nordisk announced the US launch of Awiqli for adults with type 2 diabetes. The company said it will be sold at over 70,000 pharmacies, with affordability programs for eligible patients.
The FDA approved Awiqli (insulin icodec) for adults with type 2 diabetes, making it the first insulin in history that does not require daily injection.
After resolving manufacturing issues and dropping the type 1 diabetes indication, Novo Nordisk resubmitted its biologics license application narrowed to type 2 diabetes.
The FDA rejected insulin icodec's initial application, citing manufacturing concerns and safety issues in the type 1 diabetes population.
The FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 7–4 that insulin icodec's benefits did not outweigh risks for type 1 diabetes, citing higher hypoglycemia rates.
Novo Nordisk filed its initial biologics license application for insulin icodec covering both type 1 and type 2 diabetes.
Novo Nordisk launched the ONWARDS clinical trial program, comprising six phase 3 trials testing insulin icodec against daily basal insulins in approximately 4,300 adults.
The FDA approved insulin glargine (Lantus), the first long-acting basal insulin analog providing roughly 24-hour coverage with once-daily dosing.
Fourteen-year-old Leonard Thompson receives the first insulin injection given to a human patient at Toronto General Hospital.
Frederick Banting and Charles Best at the University of Toronto isolate insulin from a dog's pancreas, laying the groundwork for diabetes treatment.
Discussed by: Endocrinologists interviewed by Healio and STAT News; clinical researchers publishing in The Lancet
If Awiqli's pricing is competitive with existing long-acting daily insulins and insurance formularies grant broad coverage, the convenience advantage could make weekly insulin the default starting point for the millions of type 2 diabetes patients who initiate basal insulin each year. The 93.7% patient preference rate in clinical trials suggests rapid adoption once access barriers are resolved. Eli Lilly's efsitora alfa entering the market would accelerate this shift by creating price competition.
Discussed by: Canada's Drug Agency (CADTH) reimbursement review; health economists analyzing insulin market dynamics
If Novo Nordisk prices Awiqli at a significant premium to daily basal insulins, insurers and pharmacy benefit managers may restrict access through prior authorization requirements or unfavorable formulary placement. This happened with other branded insulin innovations. The result would be adoption concentrated among patients with generous insurance coverage, while the majority of insulin users stay on daily generics.
Discussed by: Novo Nordisk corporate communications; type 1 diabetes advocacy organizations
The FDA rejected icodec for type 1 diabetes due to higher hypoglycemia rates, but future trials with refined dosing protocols, continuous glucose monitoring integration, or modified formulations could address the safety gap. If Novo Nordisk or competitors generate sufficient safety data, regulators could eventually authorize weekly insulin for the 2 million Americans with type 1 diabetes. This path would likely take several years.
Discussed by: Biotech analysts at BioSpace; pharmaceutical industry coverage by STAT News
Eli Lilly's efsitora alfa showed a 40% lower rate of severe hypoglycemia compared to daily insulin in trials — a potential advantage over Awiqli's safety profile. If both weekly insulins reach market within a year of each other, the resulting competition could pressure prices downward and push insurers to cover at least one weekly option broadly, benefiting patients. This dynamic echoes the GLP-1 market, where Novo Nordisk and Lilly compete on both efficacy and access.
3 moments from history that rhyme with this story — and how they unfolded.
Frederick Banting and Charles Best isolated insulin from a dog's pancreas at the University of Toronto in the summer of 1921. On January 11, 1922, 14-year-old Leonard Thompson became the first human to receive an insulin injection, transforming type 1 diabetes from a death sentence into a manageable condition. Banting and laboratory director J.J.R. Macleod received the Nobel Prize in 1923.
Commercial insulin production began within a year. Patients who would have died within months gained decades of life.
Insulin became one of the most important drugs in medical history, but required daily injection for over a century — a burden Awiqli now begins to reduce.
Awiqli is the first fundamental change to insulin dosing frequency since insulin therapy began 104 years ago, making this approval one of the most significant milestones in the drug's history.
The FDA approved insulin glargine (Lantus), the first long-acting basal insulin analog, manufactured by Sanofi. Lantus provided approximately 24-hour glucose-lowering activity with a single daily injection, replacing older formulations like NPH insulin that required twice-daily dosing and caused more unpredictable blood sugar swings.
Lantus became the world's best-selling insulin, generating over $7 billion annually at its peak. It simplified diabetes management for millions.
Long-acting analogs became the standard of care for basal insulin therapy, but the once-daily injection requirement remained unchanged for the next 26 years.
Lantus halved the injection frequency from twice daily to once daily. Awiqli now takes the next leap, reducing it to once weekly — a proportionally larger reduction in patient burden.
The United States Congress passed the Inflation Reduction Act, which capped out-of-pocket insulin costs at $35 per month for Medicare Part D enrollees beginning January 2023. The cap addressed decades of insulin price increases that had forced some patients to ration doses, with documented cases of rationing-related deaths.
Approximately 50,000 additional insulin prescriptions per month among Medicare beneficiaries, suggesting cost had been a barrier to treatment.
Established the political precedent that insulin pricing is a federal policy issue, though the cap does not yet apply to all privately insured or uninsured patients.
Awiqli arrives in a market where insulin affordability is already a major policy issue. Its pricing and insurance coverage will determine whether the weekly convenience advantage reaches the patients who stand to benefit most, or becomes another premium-priced innovation accessible mainly to the well-insured.