Food and Drug Administration approves first once-weekly basal insulin

Overview

For 104 years, every insulin on the market has required at least one injection per day. On March 26, the FDA approved Awiqli, a once-weekly basal insulin from Novo Nordisk for adults with type 2 diabetes. That cuts basal insulin injections from 365 to 52 per year.

More than 8 million Americans inject insulin, and many delay or avoid starting it altogether because of the daily burden. A weekly option lowers that barrier at a moment when the pharmaceutical industry's attention has largely shifted to weight-loss drugs. Eli Lilly is close behind with its own weekly insulin.

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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Key Indicators

104 years

Time since insulin's discovery

Every prior insulin formulation required at least daily injection since 1922.

52 vs. 365

Annual injections

Awiqli reduces basal insulin injections from daily to weekly.

93.7%

Patient preference

Share of clinical trial participants who preferred weekly over daily dosing.

~40 million

Americans with diabetes

Approximately 12% of the United States population has diagnosed or undiagnosed diabetes.

Voices

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People Involved

Mike Doustdar

Led company through Awiqli's approval

Organizations Involved

Novo Nordisk

Pharmaceutical company

Manufacturer of Awiqli; planning US launch in second half of 2026

Danish pharmaceutical company that is the world's largest insulin producer and maker of the blockbuster weight-loss drug Wegovy.

U.S. Food and Drug Administration

Federal Agency

Approved Awiqli after initially issuing rejection in 2024

The United States federal agency responsible for evaluating and approving drugs, biologics, and medical devices.

Eli Lilly and Company

Pharmaceutical company

Developing competing once-weekly insulin efsitora alfa

American pharmaceutical company developing insulin efsitora alfa, a rival once-weekly basal insulin that showed 40% lower severe hypoglycemia rates than daily insulin in clinical trials.

Timeline

July 1921 March 2026

9 events Latest: March 26th, 2026 · 4 months ago

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March 2026
FDA approves Awiqli, first once-weekly basal insulin
Latest Regulatory

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.
March 26th, 2026
September 2025
Novo Nordisk resubmits application for type 2 diabetes only
Regulatory

After resolving manufacturing issues and dropping the type 1 diabetes indication, Novo Nordisk resubmitted its biologics license application narrowed to type 2 diabetes.
September 1st, 2025
July 2024
FDA issues complete response letter rejecting application
Regulatory

The FDA rejected insulin icodec's initial application, citing manufacturing concerns and safety issues in the type 1 diabetes population.
July 1st, 2024
May 2024
FDA advisory committee votes against type 1 diabetes indication
Regulatory

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.
May 24th, 2024
April 2023
Novo Nordisk submits biologics license application to FDA
Regulatory

Novo Nordisk filed its initial biologics license application for insulin icodec covering both type 1 and type 2 diabetes.
April 1st, 2023
September 2021
Novo Nordisk begins phase 3 ONWARDS program
Clinical Trial

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.
September 27th, 2021
April 2000
Lantus approved as first long-acting basal insulin analog
Regulatory

The FDA approved insulin glargine (Lantus), the first long-acting basal insulin analog providing roughly 24-hour coverage with once-daily dosing.
April 20th, 2000
January 1922
First human insulin injection
Medical Milestone

Fourteen-year-old Leonard Thompson receives the first insulin injection given to a human patient at Toronto General Hospital.
January 11th, 1922
July 1921
Banting and Best isolate insulin
Discovery

Frederick Banting and Charles Best at the University of Toronto isolate insulin from a dog's pancreas, laying the groundwork for diabetes treatment.
July 27th, 1921

Historical Context

3 moments from history that rhyme with this story — and how they unfolded.

July 1921 – January 1922

Discovery of insulin and first human treatment (1921–1922)

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.

Then

Commercial insulin production began within a year. Patients who would have died within months gained decades of life.

Now

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.

Why this matters now

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.

April 2000

Introduction of long-acting insulin glargine, Lantus (2000)

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.

Then

Lantus became the world's best-selling insulin, generating over $7 billion annually at its peak. It simplified diabetes management for millions.

Now

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.

Why this matters now

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.

August 2022

Inflation Reduction Act insulin price cap (2022)

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.

Then

Approximately 50,000 additional insulin prescriptions per month among Medicare beneficiaries, suggesting cost had been a barrier to treatment.

Now

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.

Why this matters now

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.