On March 26, 2026, the FDA approved Awiqli (insulin icodec), the first once-weekly basal insulin for adults with type 2 diabetes. Developed by Novo Nordisk, Awiqli eliminates the need for daily insulin injections, replacing them with a single subcutaneous injection once per week. For the estimated 8.4 million Americans who use basal insulin, this approval has the potential to dramatically simplify daily diabetes management.
What Is Awiqli?
Awiqli is the brand name for insulin icodec, an ultra-long-acting basal insulin analog. It is a modified human insulin molecule engineered to bind reversibly to albumin in the bloodstream, creating a slow-release depot that maintains steady glucose-lowering activity for a full seven days after each injection.
This is not a new drug class — it is insulin, fundamentally. But the pharmacokinetic engineering is what makes it remarkable. By extending the half-life from roughly 24 hours (daily insulins) to approximately 196 hours (about 8 days), Novo Nordisk has turned a daily obligation into a weekly one.
How Awiqli Works
Traditional basal insulins like Lantus (glargine) and Tresiba (degludec) work by forming slow-dissolving depots under the skin or binding to albumin to extend duration. Awiqli takes the albumin-binding strategy further:
- After injection, insulin icodec binds strongly to circulating albumin
- Only a small fraction of the total circulating insulin icodec is unbound (active) at any given time
- The gradual release from albumin provides flat, steady basal insulin coverage over 7 days
- The molecule also has reduced clearance by the insulin receptor, further extending its duration
The result is a remarkably stable pharmacokinetic profile that avoids the peaks and troughs common with shorter-acting insulins, while requiring only 52 injections per year instead of 365.
Clinical Trial Data: The ONWARDS Program
Awiqli's approval was based on the ONWARDS clinical trial program, a series of six Phase 3 trials enrolling over 4,000 adults with type 2 diabetes across multiple treatment settings.
ONWARDS 1: Insulin-Naive Patients
| Endpoint | Awiqli (weekly) | Lantus (daily) |
|---|---|---|
| HbA1c reduction at 52 weeks | -1.55% | -1.35% |
| Achieved HbA1c < 7% | 68% | 59% |
| Rate of clinically significant hypoglycemia | 0.30 events/patient-year | 0.16 events/patient-year |
Awiqli demonstrated non-inferiority and statistical superiority to Lantus in HbA1c reduction in insulin-naive patients, with a greater proportion of patients reaching target HbA1c.
ONWARDS 3: Switching from Daily Basal Insulin
In patients already on daily basal insulin, switching to Awiqli resulted in comparable HbA1c control with high patient satisfaction scores. Over 80% of patients in the trial preferred the weekly dosing regimen over their previous daily schedule.
ONWARDS 5: Basal-Bolus Comparison
Awiqli also showed non-inferiority when used as the basal component in a basal-bolus regimen, confirming its versatility across different insulin treatment strategies.
Awiqli vs. Daily Insulins
| Feature | Awiqli (icodec) | Tresiba (degludec) | Lantus (glargine) | Levemir (detemir) |
|---|---|---|---|---|
| Dosing frequency | Once weekly | Once daily | Once daily | Once or twice daily |
| Injections per year | 52 | 365 | 365 | 365–730 |
| Half-life | ~196 hours | ~25 hours | ~12 hours | ~5–7 hours |
| HbA1c reduction | -1.55% | -1.3 to -1.5% | -1.3 to -1.5% | -1.0 to -1.3% |
| Hypoglycemia risk | Slightly higher vs glargine | Low | Moderate | Moderate |
| Flexibility | Same day each week | Any time, flexible | Same time daily | Same time daily |
| Manufacturer | Novo Nordisk | Novo Nordisk | Sanofi | Novo Nordisk |
Dosing and Administration
Awiqli is administered as a once-weekly subcutaneous injection using a prefilled pen. Key dosing details:
- Starting dose (insulin-naive): 70 units once weekly (equivalent to approximately 10 units/day of daily basal insulin)
- Switching from daily basal insulin: Multiply the current total daily basal dose by 7 for the weekly Awiqli dose
- Titration: Adjust dose weekly based on fasting blood glucose targets, typically in increments of 20 units
- Injection day: Choose the same day each week. If a dose is missed, administer as soon as possible if the next dose is at least 3 days away
Side Effects and Safety
The most commonly reported side effects in clinical trials included:
- Hypoglycemia — the most important risk. Rates of clinically significant hypoglycemia (blood glucose <54 mg/dL) were slightly higher with Awiqli compared to Lantus in some trials. Because of its long half-life, hypoglycemia episodes may take longer to resolve.
- Injection site reactions (mild, infrequent)
- Weight gain — comparable to daily basal insulins (~1.5–2.0 kg over 52 weeks)
Important safety consideration: Because insulin icodec has an extremely long half-life, dose adjustments take longer to take effect. Patients who experience hypoglycemia should work closely with their healthcare provider, and overcorrection with rapid dose increases should be avoided.
Who Is Awiqli For?
Awiqli is currently approved for adults with type 2 diabetes only. It is not approved for type 1 diabetes at this time, though trials in type 1 patients are ongoing.
Ideal candidates include:
- Patients who struggle with daily insulin adherence — missing doses, inconsistent timing
- Patients with injection fatigue who want fewer needle sticks
- Caregivers managing insulin for elderly patients where a weekly schedule simplifies logistics
- Patients newly starting basal insulin who may find a weekly injection less intimidating
Awiqli may be less ideal for patients who:
- Have frequent hypoglycemia episodes or are hypoglycemia-unaware
- Require rapid dose adjustments (the long half-life makes fine-tuning slower)
- Have type 1 diabetes (not yet approved for this indication)
Cost and Insurance Coverage
Novo Nordisk has announced that Awiqli will be priced competitively with existing basal insulins. The estimated list price is approximately $400–$550 per month, though the net price after rebates and manufacturer coupons is expected to be lower.
Key coverage considerations:
- Most commercial insurance plans are expected to cover Awiqli, potentially with prior authorization requirements
- Medicare Part D plans will likely include Awiqli, though formulary tier placement will vary
- Novo Nordisk offers a savings card program for eligible commercially insured patients, with potential copays as low as $25/month
- The Inflation Reduction Act's $35/month insulin cap for Medicare beneficiaries may apply, though this depends on specific plan formulary decisions
The Bottom Line
Awiqli is the first once-weekly insulin, and it delivers on its core promise: equivalent or superior blood sugar control with dramatically fewer injections. For the millions of people with type 2 diabetes who take daily basal insulin, switching to 52 injections per year instead of 365 is not a trivial convenience — it is a meaningful quality-of-life improvement that can improve adherence and outcomes.
The tradeoffs are real: a slightly higher hypoglycemia signal in some trials and slower dose-adjustment dynamics. But for the right patient, Awiqli represents one of the most practical advances in insulin therapy in decades.
Use the MedSwitcher comparison tool to compare Awiqli to your current insulin side-by-side.
Sources
- FDA Press Release: Approval of Awiqli (insulin icodec), March 26, 2026.
- Novo Nordisk ONWARDS clinical trial program publications.
- Rosenstock J, et al. Once-Weekly Insulin for Type 2 Diabetes without Previous Insulin Treatment. N Engl J Med. 2023.
- Lantus, Tresiba, and Levemir prescribing information.
- MedSwitcher editorial analysis, April 2026.