Cover: AI-generated illustration of the Lilly and Novo Nordisk rivalry. The packaging shown is not real product packaging, and the image does not show Onswik or Awiqli.
The U.S. Food and Drug Administration approved Onswik (insulin efsitora alfa-gobe), Eli Lilly's once-weekly basal insulin for adults with type 2 diabetes, on 24 September 2026. It is the second weekly insulin cleared in the United States, six months after Novo Nordisk's Awiqli, and it cuts basal insulin injections from about 365 a year to 52.
- What: FDA approval of Onswik as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
- Evidence: the QWINT Phase 3 programme, four registration studies in more than 3,400 adults, each meeting its primary endpoint of non-inferior A1C reduction against a daily basal insulin.
- Safety: Lilly states that Onswik should not be used by people with type 1 diabetes because of an increased risk of severe hypoglycemia.
- Competition: Novo Nordisk's Awiqli (insulin icodec-abae) was approved by the FDA on 26 March 2026 for the same population.
- Ireland and the EU: Awiqli already appears on the HPRA medicines list under an EU licence. Onswik received a positive CHMP opinion on 25 June 2026.
- US launch: Lilly says the Onswik KwikPen will be available in the U.S. "in the coming months". Price: not disclosed.
What the FDA Approved
According to Lilly's announcement, Onswik is a long-acting basal insulin given by injection once a week, used with diet and exercise to control high blood sugar in adults with type 2 diabetes mellitus. It will come in a 3 mL pre-filled, single-patient-use KwikPen in two concentrations: 500 units/mL (1,500 units per pen) and 1,000 units/mL (3,000 units per pen).
The injection figure in the headline comes from Lilly's own footnote: about 52 injections a year with Onswik against 365 with a once-daily basal insulin. Lilly says this is the fourth global approval for the product in type 2 diabetes, after regulatory actions by the European Medicines Agency, Mexico's COFEPRIS and Japan's PMDA.
"For over a century, Lilly has been developing insulins that transformed diabetes care for millions of people worldwide, but delays in initiating treatment and the burden of daily injections can have a real impact on patients' day-to-day experience managing type 2 diabetes," said Kenneth Custer, Ph.D., executive vice president and president, Lilly Cardiometabolic Health. "Onswik offers a new once-weekly basal insulin option for patients and reflects our continued commitment to deliver innovative treatment options that expand choice and provide greater flexibility in how people manage type 2 diabetes."
The QWINT Trials Behind the Approval
The QWINT Phase 3 programme began in 2022. Lilly reports that in each of the four registration trials, once-weekly Onswik met the primary endpoint of non-inferior A1C reduction from baseline, comparable to insulin glargine U-100 or insulin degludec U-100. The four trials covered people starting insulin for the first time, people already on basal insulin, and people also taking mealtime insulin.
| QWINT-1 (NCT05662332) | |
|---|---|
| Population | Adults with type 2 diabetes new to insulin |
| Comparator | Daily insulin glargine, with a fixed-dose escalation for Onswik |
| Size and length | 795 randomised, 52 weeks |
| QWINT-2 (NCT05362058) | |
| Population | Adults with type 2 diabetes new to insulin |
| Comparator | Daily insulin degludec |
| Size and length | 928 randomised, 52 weeks |
| QWINT-3 (NCT05275400) | |
| Population | Adults already treated with basal insulin |
| Comparator | Daily insulin degludec |
| Size and length | 986 randomised, primary endpoint at 26 weeks, 78 weeks of treatment |
| QWINT-4 (NCT05462756) | |
| Population | Adults on basal insulin plus at least two mealtime injections a day |
| Comparator | Daily insulin glargine, both arms with insulin lispro |
| Size and length | 730 randomised, 26 weeks |
Together the four trials randomised 3,439 participants, in line with Lilly's "over 3,400" figure. QWINT-3 and QWINT-4 have been published as phase 3 randomised non-inferiority trials (Philis-Tsimikas et al. and Blevins et al.), as cited in Lilly's release.
Who Should Not Use Onswik
The prescribing summary in Lilly's release is direct: "Onswik should not be used by people who have type 1 diabetes due to increased risk of severe hypoglycemia (low blood sugar)." The approval is for adults with type 2 diabetes only.
Lilly lists the most common side effects as low blood sugar (hypoglycemia), allergic reactions, injection-site reactions, skin thickening or pits at the injection site (lipodystrophy), itching, rash, swelling of the hands and feet, and weight gain. As with any insulin, the release warns that low blood sugar can be serious. Anyone considering a switch should discuss it with their diabetes team; this article is not medical advice.
Onswik Versus Awiqli
Novo Nordisk reached the U.S. market first. The FDA approved Awiqli (insulin icodec-abae) 700 units/mL on 26 March 2026 as an adjunct to diet and exercise for adults with type 2 diabetes, and Novo said it expected a nationwide U.S. launch in the second half of 2026. The two products now compete for the same prescriptions.
| Onswik (Eli Lilly) | |
|---|---|
| Active substance | Insulin efsitora alfa-gobe |
| FDA approval | 24 September 2026 |
| Strengths | 500 units/mL and 1,000 units/mL |
| Phase 3 programme | QWINT |
| U.S. availability | "In the coming months" |
| Awiqli (Novo Nordisk) | |
| Active substance | Insulin icodec-abae |
| FDA approval | 26 March 2026 |
| Strength | 700 units/mL |
| Phase 3 programme | ONWARDS |
| U.S. availability | Nationwide launch expected in the second half of 2026 |
Both are indicated in the U.S. for adults with type 2 diabetes. Head-to-head data comparing the two weekly insulins has not been published, so any claim that one is better than the other is not supported by the evidence released so far.
Another Front in the Lilly and Novo Nordisk Rivalry
The two companies already lead the incretin market with tirzepatide (Lilly) and semaglutide (Novo Nordisk). That contest is visible in trial activity too: our registers currently track 53 current clinical trials naming semaglutide and 36 naming tirzepatide, across Ireland, the UK, the USA, India and China. Weekly basal insulin extends the same competition into a category where both companies have long histories.
Novo Nordisk has also combined the two approaches. Its fixed-ratio combination of insulin icodec and semaglutide, Kyinsu, was authorised in the EU in November 2025, according to the EMA. For trials of Novo's weekly insulin, see our insulin icodec trial page.
What It Means for Ireland and the EU
Irish patients are covered by EU-wide authorisations for both products, and the European position is further along for Novo Nordisk. Awiqli holds an EU licence (EU/1/24/1815) and appears on the HPRA's list of medicines, which we track in our Irish medicines database.
For Onswik, the EMA's Committee for Medicinal Products for Human Use adopted a positive opinion on 25 June 2026 for the treatment of type 2 diabetes in adults; the applicant is Eli Lilly Nederland B.V. Lilly describes Onswik as approved by the EMA. As of 25 September 2026, Onswik does not yet appear on the HPRA list in our data. Whether it reaches Irish patients, and when, also depends on HSE reimbursement, for which no decision has been announced. New EU decisions appear in our EMA approvals tracker.
Frequently Asked Questions
What is Onswik?
Onswik (insulin efsitora alfa-gobe) is Eli Lilly's once-weekly basal insulin injection. The FDA approved it on 24 September 2026 for adults with type 2 diabetes, alongside diet and exercise.
How is a weekly insulin different from a daily one?
A basal insulin provides a steady background level of insulin. A weekly product is given once every seven days instead of every day, which Lilly puts at about 52 injections a year instead of 365.
Can people with type 1 diabetes use Onswik?
No. Lilly states that Onswik should not be used by people with type 1 diabetes because of an increased risk of severe hypoglycemia.
What did the QWINT trials show?
In each of the four registration trials, involving more than 3,400 adults with type 2 diabetes, once-weekly Onswik met its primary endpoint of non-inferior A1C reduction compared with daily insulin glargine or insulin degludec.
Is Onswik available in Ireland?
Not yet in our HPRA data. It received a positive CHMP opinion in June 2026, and Lilly describes it as approved by the EMA. Irish availability also depends on HSE reimbursement, which has not been announced. Novo Nordisk's Awiqli is already on the HPRA list.
Which weekly insulin is better, Onswik or Awiqli?
There is no published head-to-head trial, so this cannot be answered from the evidence. Each was compared with daily basal insulins in its own programme.
Outlook
The next milestones are practical ones: Lilly's U.S. launch of the Onswik KwikPen in the coming months, Novo Nordisk's nationwide Awiqli rollout in the second half of 2026, and, for Irish readers, whether Onswik appears on the HPRA list and receives a reimbursement decision. We will update this article when those happen.
Sources
- Eli Lilly: U.S. FDA approves Lilly's Onswik (insulin efsitora alfa-gobe), 24 September 2026 (also published on BioSpace)
- Novo Nordisk: Awiqli approved in the US, March 2026
- European Medicines Agency: Onswik, CHMP positive opinion of 25 June 2026
- European Medicines Agency: Kyinsu
- Health Products Regulatory Authority (HPRA) medicines list, via the Priya Life Science Irish medicines database, checked 25 September 2026
- ClinicalTrials.gov records NCT05662332, NCT05362058, NCT05275400 and NCT05462756
