A once-weekly insulin injection called Awiqli, manufactured by Novo Nordisk, has been approved in more than a dozen countries and could soon reach the United States, potentially eliminating the need for daily basal insulin shots for millions of people with type 2 diabetes. For families managing a loved one’s care — particularly those navigating dementia alongside diabetes — this shift from 365 injections per year down to 52 represents far more than a medical convenience. It could meaningfully reduce caregiver burden, medication errors, and the daily friction that makes diabetes management in cognitively impaired adults so difficult. The drug, known generically as insulin icodec, received approval from the European Commission in May 2024 and has been available in Canada since June 2024.
It is also approved in Japan, China, Australia, and other markets. In the United States, however, Awiqli is not yet FDA-approved as of March 2026. Novo Nordisk resubmitted its application in September 2025, this time seeking approval only for adults with type 2 diabetes, and a decision is expected sometime this year. For caregivers and patients watching this space, the distinction matters: this is a real, clinically tested medication already in use abroad, but it is not yet available through American pharmacies or prescribers. This article covers how Awiqli works, what the clinical trial data actually shows, why the FDA initially rejected it, what the approval timeline looks like for the U.S., how it could change diabetes management for people with cognitive decline, and what caregivers should know before talking to a doctor about it.
Table of Contents
- What Is Awiqli and How Does a Once-Weekly Insulin Injection Replace Daily Shots?
- What Does the Clinical Evidence Say About Effectiveness and Safety?
- Why Did the FDA Reject Awiqli Initially and What Changed?
- How Could Once-Weekly Insulin Change Diabetes Care for People With Dementia?
- What Are the Risks and Limitations Caregivers Should Understand?
- What Will Awiqli Cost and Is It Available Outside the United States?
- What Comes Next for Weekly Insulin and Dementia-Related Diabetes Care?
- Conclusion
- Frequently Asked Questions
What Is Awiqli and How Does a Once-Weekly Insulin Injection Replace Daily Shots?
Awiqli is the brand name for insulin icodec, the first once-weekly basal insulin analogue designed to cover a patient’s basal insulin needs for a full seven days with a single subcutaneous injection. The drug works by binding to albumin in the bloodstream, which acts as a slow-release carrier. Insulin is gradually freed from this albumin bond over the course of a week, maintaining steady glucose levels without the peaks and valleys that can accompany daily dosing. The half-life of icodec is approximately one week, which is what makes the extended dosing schedule possible. To put this in practical terms, consider a 78-year-old woman with moderate Alzheimer’s disease and type 2 diabetes.
Her daughter visits every morning to administer a daily insulin glargine injection, arrange meals, and check blood sugar. If Awiqli were available to her, that daily injection could become a weekly one — administered during a single caregiving visit, a home health aide appointment, or even a weekly doctor’s check-in. The remaining six days of the week would no longer require someone to be physically present at a specific time solely for an insulin injection. This does not eliminate all diabetes management tasks. Blood sugar monitoring, dietary considerations, and oral medications may still require daily attention. But removing the daily injection removes one of the most logistically demanding elements of the routine, especially for patients who resist needles due to confusion or agitation — behaviors common in mid-to-late stage dementia.
What Does the Clinical Evidence Say About Effectiveness and Safety?
The evidence base for Awiqli comes from the ONWARDS clinical trial program, which studied approximately 4,000 adults with type 2 diabetes across five randomized, active-controlled trials labeled ONWARDS 1 through 5. These were not placebo-controlled studies. Participants receiving icodec were compared against people taking established daily insulin treatments, which gives the results more real-world relevance. In ONWARDS 3, patients taking icodec saw their HbA1c — the standard measure of long-term blood sugar control — decrease from 8.6% to 7.0% over 26 weeks, compared with a drop from 8.5% to 7.2% in the group receiving daily insulin degludec. that difference was enough to demonstrate not just non-inferiority but statistical superiority. ONWARDS 1 showed similar results against insulin glargine, with no significant difference in rates of severe hypoglycemia.
ONWARDS 9 reported an HbA1c decrease from 8.18% to 7.00% at 26 weeks, a reduction of 1.17 percentage points. However, the picture is not uniformly positive. In ONWARDS 6, which studied icodec in people with type 1 diabetes, the rate of clinically significant hypoglycemia was substantially higher — 19.9 events per patient-year with icodec versus 10.4 with daily degludec. This nearly doubled hypoglycemia risk is the primary reason Novo Nordisk dropped the type 1 diabetes indication from its U.S. resubmission entirely. For caregivers of people with dementia, this finding deserves attention: hypoglycemia in a cognitively impaired person can mimic or worsen confusion, increase fall risk, and trigger emergency hospitalizations. Even in the type 2 diabetes trials where hypoglycemia rates were more comparable, any patient with impaired ability to recognize or communicate low blood sugar symptoms requires closer monitoring during the transition period.
Why Did the FDA Reject Awiqli Initially and What Changed?
The FDA’s path for Awiqli has been more complicated than the approvals it received in Europe and Canada. In May 2024, an FDA advisory committee voted against recommending approval for the type 1 diabetes indication, citing the elevated hypoglycemia risk seen in the ONWARDS 6 trial. Then in July 2024, the FDA issued a Complete Response Letter — a formal rejection of the initial application — citing manufacturing process concerns and unresolved questions about the type 1 diabetes indication. A Complete Response Letter does not mean the drug is unsafe or ineffective. It means the agency needs more information or changes before it can approve. In this case, Novo Nordisk spent more than a year addressing the manufacturing issues and made a strategic decision to narrow the scope of its application.
When the company resubmitted the Biologics License Application on September 29, 2025, it sought approval only for adults with type 2 diabetes, removing the more controversial type 1 diabetes indication altogether. This narrowing is a pragmatic move. The type 2 diabetes data is substantially cleaner from a safety standpoint, and type 2 diabetes represents the far larger patient population. For families waiting in the U.S., the resubmission means Awiqli is back in the FDA’s review queue with a decision expected sometime in 2026. No specific approval date has been announced as of March 2026. Patients and caregivers should be cautious about news headlines that describe Awiqli as “approved” without specifying the country — the drug is approved and available in multiple nations, but it cannot be legally prescribed in the United States until the FDA acts.
How Could Once-Weekly Insulin Change Diabetes Care for People With Dementia?
Managing diabetes in someone with dementia is one of the most underappreciated challenges in elder care. Cognitive decline affects a person’s ability to follow medication schedules, recognize symptoms of high or low blood sugar, communicate discomfort, and cooperate with injections. Daily insulin therapy requires a reliable caregiver to be present at roughly the same time each day, which creates scheduling pressure on family members, home health aides, and assisted living staff. A once-weekly injection shifts the logistics considerably. Instead of coordinating daily visits around an injection window, a caregiver could administer Awiqli during a weekly check-in, a scheduled home health visit, or a recurring medical appointment. For patients in memory care facilities, staff could batch weekly insulin administration into a single medication pass rather than managing it as a daily task for each resident.
The reduction from 365 to 52 injections per year also means 313 fewer instances where a patient might become agitated, combative, or distressed by the needle — a meaningful quality-of-life improvement for people who experience behavioral and psychological symptoms of dementia. The tradeoff is flexibility. With daily insulin, if a patient’s blood sugar runs unexpectedly high or low, the next day’s dose can be adjusted immediately. With weekly insulin, the drug is already in the body and will continue releasing for days. This does not mean doses cannot be adjusted — they can, at the next weekly injection — but there is less room for rapid fine-tuning. For patients with highly variable blood sugar, unpredictable eating patterns, or acute illnesses that affect glucose levels, this slower adjustment cycle requires more proactive monitoring rather than less.
What Are the Risks and Limitations Caregivers Should Understand?
The most important limitation is one that applies to all long-acting medications in vulnerable populations: if something goes wrong, you cannot simply stop the drug and have it clear the system quickly. Insulin icodec’s week-long half-life means that if a patient experiences a serious hypoglycemic episode, the insulin will continue to be active for days afterward. In a cognitively intact adult, this is manageable — they can eat, check their blood sugar, and communicate with their doctor. In a person with moderate or severe dementia who cannot reliably report symptoms, prolonged insulin activity after a hypoglycemic event creates a window of sustained risk that requires vigilant monitoring. Caregivers should also understand that Awiqli has not been specifically studied in populations with dementia or significant cognitive impairment.
The ONWARDS trials enrolled adults with type 2 diabetes, but trial participants are typically screened for the ability to comply with study protocols, report symptoms, and manage aspects of their own care. Elderly patients with dementia represent a different clinical reality, and the safety profile may not translate perfectly. This is not unique to Awiqli — most diabetes medications lack robust data in dementia populations — but it is worth raising with a prescriber. Finally, the transition from daily to weekly insulin is itself a period of increased risk. Dosing conversions must be handled carefully, and during the first several weeks the body is adjusting to a different pharmacokinetic profile. For any patient, but especially one who cannot articulate how they are feeling, the transition period warrants more frequent blood sugar checks and closer caregiver attention, not less.
What Will Awiqli Cost and Is It Available Outside the United States?
For families with connections to countries where Awiqli is already approved, the drug is currently accessible. In Canada, where it has been available since June 30, 2024, the annual cost is approximately 1,356 Canadian dollars at a maintenance dose equivalent to 50 units per day, according to a CADTH assessment. The European Medicines Agency approved Awiqli in May 2024, and it is also available in Japan, China, Australia, and additional markets — more than a dozen countries in total.
U.S. pricing has not been established because the drug has not yet received FDA approval. Given the current landscape of insulin pricing in the United States, where list prices have historically been significantly higher than in other countries, it is impossible to predict what Awiqli will cost American patients until Novo Nordisk sets a price and insurance coverage decisions are made. Caregivers planning ahead should watch for the FDA decision and subsequent announcements about formulary coverage from Medicare Part D plans and major insurers.
What Comes Next for Weekly Insulin and Dementia-Related Diabetes Care?
If the FDA approves Awiqli in 2026 as expected, it will become the first once-weekly insulin available to American patients with type 2 diabetes. This approval would likely trigger a broader conversation about how long-acting insulin formulations could be integrated into dementia care protocols, memory care facility medication policies, and home health aide training programs. It may also accelerate research into other long-acting diabetes therapies — both insulin and non-insulin — that reduce the frequency of patient interaction required for effective glucose management. The intersection of diabetes and dementia is a growing clinical reality.
An estimated 25 to 30 percent of people with dementia also have diabetes, and that overlap is projected to increase as the population ages. Innovations that simplify chronic disease management in cognitively impaired patients are not just convenient — they are necessary. Awiqli is not a cure for the complexity of managing these dual diagnoses, but it removes one significant daily obstacle. For caregivers who have spent years showing up every morning to give a shot, that weekly reprieve may matter more than any clinical trial number.
Conclusion
Awiqli represents a genuine shift in how basal insulin therapy could work — one injection per week instead of one per day, backed by clinical trial data showing comparable or superior blood sugar control in type 2 diabetes. For caregivers managing a loved one with both diabetes and dementia, the practical implications are substantial: fewer injections, fewer daily coordination demands, and fewer moments of needle-related distress. The drug is already approved and in use across more than a dozen countries, and a U.S. FDA decision is expected in 2026.
That said, this is not a decision to make without careful medical guidance. The week-long duration of action means less flexibility for rapid dose adjustments, the drug has not been specifically studied in dementia populations, and the transition period from daily to weekly insulin requires close monitoring. Caregivers should bring this information to their loved one’s endocrinologist or primary care physician, ask about the current FDA status, and discuss whether once-weekly insulin would be appropriate given their specific clinical situation. The goal is not simply fewer injections — it is better, safer, more sustainable diabetes management for people whose cognitive decline already makes every daily task harder than it should be.
Frequently Asked Questions
Is Awiqli (once-weekly insulin) FDA-approved in the United States?
No. As of March 2026, Awiqli has not received FDA approval in the U.S. Novo Nordisk resubmitted its application in September 2025 seeking approval for type 2 diabetes in adults, and a decision is expected sometime in 2026. The drug is approved and available in Canada, Europe, Japan, Australia, and other countries.
Can Awiqli be used for type 1 diabetes?
The current U.S. application is for type 2 diabetes only. Clinical trials in type 1 diabetes showed a nearly doubled rate of clinically significant hypoglycemia compared to daily insulin, which led Novo Nordisk to drop the type 1 indication from its resubmission to the FDA.
Is once-weekly insulin safe for someone with dementia?
Awiqli has not been specifically studied in people with dementia or significant cognitive impairment. While the clinical trial data in type 2 diabetes is promising, the week-long duration of action and the inability of many dementia patients to communicate symptoms like low blood sugar mean that careful medical evaluation and enhanced monitoring are essential. Discuss this option with a doctor who understands both conditions.
How much does Awiqli cost?
In Canada, the annual cost is approximately 1,356 Canadian dollars at a standard maintenance dose. U.S. pricing has not been established and will depend on the FDA approval, the list price set by Novo Nordisk, and insurance coverage decisions.
Does once-weekly insulin eliminate the need for daily diabetes management?
No. Awiqli replaces the daily basal insulin injection, but patients may still need blood sugar monitoring, oral diabetes medications, dietary management, and potentially mealtime insulin. It reduces one significant daily task but does not eliminate diabetes care.
What should I do if I want my family member to try Awiqli?
Speak with their endocrinologist or primary care physician about whether once-weekly insulin would be appropriate for their specific situation. If you are in the U.S., ask about the current FDA status and whether a transition plan makes sense to prepare for potential approval. If you are in a country where the drug is already approved, your doctor can evaluate whether the switch from daily insulin is clinically appropriate.
