Awiqli (insulin icodec) / Novo Nordisk - LARVOL DELTA

Novo Nordisk…announced that the US Food and Drug Administration (FDA) has approved Awiqli (insulin icodec-abae) injection 700 units/mL, the first and only once-weekly, long-acting basal insulin, indicated as an adjunct to diet and exercise to improve glycemic control (blood sugar) in adults living with type 2 diabetes (PRNewswire) - "This approval is based on results from the ONWARDS type 2 diabetes phase 3a program for once-weekly Awiqli injection which comprises four randomized, active-controlled, treat-to-target trials in approximately 2,680 adults with uncontrolled type 2 diabetes, used in combination with a mealtime insulin or in combination with common oral anti-diabetic agents and/or GLP-1 receptor agonists."

FDA approval • Type 2 Diabetes Mellitus

Therapeutic Transition to Weekly Basal Insulin Icodec plus Tirzepatide in Type 2 Diabetes: An Early Real-World Experience (ADA 2026) - "Available on Friday, May 29, 2026 at 12:00am CDT."

Clinical • Real-world • Real-world evidence • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Glucodynamics and Hypoglycemia Risk during Exercise or Fasting in Individuals with T2D Receiving Once‑Weekly Basal Insulin Icodec (ADA 2026) - "Available on Friday, May 29, 2026 at 12:00am CDT."

Clinical • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy, Glycemic Variability, and Safety of Insulin Icodec Combined with Semaglutide in Simplifying Complex Polypharmacy for Uncontrolled Type 2 Diabetes: A Retrospective Study (ADA 2026) - "Available on Friday, May 29, 2026 at 12:00am CDT."

Retrospective data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

An integrated bioprocess for the production of insulin icodec in Pichia pastoris. (PubMed, Prep Biochem Biotechnol) - "The structural and functional equivalence to commercial insulin icodec was verified by RP-HPLC, HR-LC-MS, peptide mapping, and cell-based proliferation assays. Collectively, this study establishes a comprehensive and high-yield platform for insulin icodec biosimilar production and provides a generalizable framework for the manufacturing of other long-acting or structurally complex insulin analogs."

Journal • Diabetes • Metabolic Disorders

Early Real-World Implementation of Once-Weekly Insulin Icodec in Type 2 Diabetes. (PubMed, Diabetes Obes Metab) - No abstract available

Journal • Real-world evidence • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Where Are We With Weekly Insulin? The Pros and Cons (AACE 2026) - "Insulin icodec is approved for use in the European Union, Canada, Australia, Japan, and Switzerland, but not the US...One faculty member could have experience in the clinical trials with the weekly insulins, and another could give a view from the regulatory perspective. Learning Objectives: • After participating in this session, attendees should be able to explain the pharmacokinetic and pharmacological properties of weekly insulins.• After participating in this session, attendees should be able to identify three type of patients who might benefit from once weekly basal insulins.• After participating in this session, attendees should be able to assess the safety and efficacy of weekly insulins in type 1 diabetes."

Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

EFFECTIVENESS AND SAFETY OF ONCE-WEEKLY INSULIN ICODEC: A SINGLE-CENTER REAL-WORLD STUDY (ATTD 2026) - "In this real-world study, icodec proved an effective and safe option."

Clinical • Real-world • Real-world evidence • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

NN1436-7727: A Research Study to See How Well Weekly Insulin Icodec Maintains Blood Sugar Levels Compared to Daily Basal Insulins in Adults with Type 2 Diabetes (clinicaltrialsregister.eu) - P4 | N=204 | Not yet recruiting | Sponsor: Novo Nordisk A/S

New P4 trial • Real-world evidence • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Cost-utility of once-weekly insulin icodec versus once-daily basal insulins for type 2 diabetes in China. (PubMed, Diabetes Obes Metab) - "Once-weekly icodec represents a cost-effective and clinically beneficial alternative to once-daily basal insulin analogues for Chinese adults with type 2 diabetes within the current reimbursement framework."

HEOR • Journal • Cardiovascular • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Once-weekly insulin icodec versus once-daily insulin degludec for type 2 diabetes in China: A cost-utility and budget impact analysis. (PubMed, Diabetes Obes Metab) - "Within the current reimbursement context in China, once-weekly icodec is a dominant strategy compared with degludec, offering greater health benefits at a lower cost for patients with type 2 diabetes and generating potential annual savings."

HEOR • Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and hypoglycaemia outcomes of once-weekly insulin icodec versus once-daily basal insulin comparators across baseline HbA1c, BMI and duration of type 2 diabetes subgroups: A post hoc analysis of ONWARDS 1-5. (PubMed, Diabetes Obes Metab) - "The efficacy and hypoglycaemia profile of icodec versus OD basal insulin comparators was overall consistent across trial populations irrespective of baseline HbA1c, BMI or T2D duration."

Journal • Retrospective data • Diabetes • Hypoglycemia • Metabolic Disorders • Severe Hypoglycemia • Type 2 Diabetes Mellitus

Once-weekly administration of insulin in the real-world management of type 2 diabetes. A Delphi-like consensus. (PubMed, Acta Diabetol) - "The advent of once-weekly insulin icodec therapy is an unprecedent breakthrough in diabetes care. Compared with once-daily insulin analogues, it offers a simplified, secure, enhanced, and sustained glycemic control, counteracting therapeutic inertia, expectedly improving adherence to insulin therapy. Insulin icodec can not only enable personalized treatment and positively impact the clinical outcome, but also improve patient satisfaction and overall quality of life."

Journal • Real-world evidence • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Research Study to See How Insulin Icodec Helps People With Type 1 Diabetes Control Their Blood Sugar (clinicaltrials.gov) - P=N/A | N=245 | Recruiting | Sponsor: Novo Nordisk A/S | Not yet recruiting ➔ Recruiting

Enrollment open • Real-world evidence • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

A Phase IIIb Clinical Study to Assess the Efficacy and Safety of GZR4 in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin (clinicaltrials.gov) - P3 | N=300 | Recruiting | Sponsor: Gan & Lee Pharmaceuticals. | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

The safety of novel once-weekly insulins in the management of diabetes. (PubMed, Expert Opin Drug Saf) - "This narrative review summarizes the characteristics, advantages, and drawbacks of the two OWI products on the market and in development, namely insulin icodec and insulin efsitora...However, increased risks of hypoglycemia and weight gain were seen in some studies. The clinical concerns regarding hypoglycemia led the US regulatory agency to vote against recommending approval of icodec for use in patients with type 1 diabetes."

Journal • Review • Diabetes • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

The Long-Term Cost-Effectiveness of Insulin Icodec vs. Once-Daily Basal Insulin Analogs in Italy (ISPOR-EU 2025) - "OBJECTIVES: Daily basal insulin injections remain a cornerstone of type 2 diabetes (T2D) management, yet their frequency can impose a considerable burden on patients' quality of life. Based on a willingness-to-pay range of EUR 25,000-40,000 per QALY gained, icodec was projected to be highly cost-effective for treating insulin-naïve people with T2D in Italy, resulting from a reduced injection burden and a lowered incidence of diabetes-related complications."

Cost effectiveness • HEOR • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Systematic Review of the Cost-Effectiveness of Insulin Therapies in the Treatment of Type 2 Diabetes (ISPOR-EU 2025) - "Insulin icodec showed both cost savings (USD 479.96-974.01) and improved outcomes (0.04-0.08 QALYs) versus insulin degludec. Insulin glargine 100 was cost-effective compared to NPH insulin (ICERs USD 423.85-21,589.82) and dominant over insulin detemir... SR highlights the cost-effectiveness of various insulin therapies and offers valuable data for future pharmacoeconomic research. However, studies from Southeast Asia, including Vietnam, remain limited, indicating a need for further regional research."

Cost effectiveness • HEOR • Review • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

An Adjusted Indirect Comparison of Once-Weekly Insulin Efsitora Alfa vs. Insulin Icodec for Adults With Type 2 Diabetes Mellitus Previously Treated With Basal Insulin (ISPOR-EU 2025) - "Efsitora showed comparable results to icodec for all efficacy, composite and key safety endpoints in individuals with T2DM previously treated with basal insulin."

Clinical • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

An Adjusted Indirect Comparison of Once-Weekly Insulin Efsitora Alfa vs. Insulin Icodec for Adults With Type 2 Diabetes Mellitus Previously Treated With Basal-Bolus Insulin (ISPOR-EU 2025) - "Efsitora showed comparable results to icodec for key efficacy and safety endpoints in adults with T2DM previously treated with basal-bolus insulin."

Clinical • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Cost-Effectiveness of Once-Weekly Insulin Icodec versus Daily Basal Insulins in Chinese Adults with T2DM: A Treatment-Background Stratified Analysis. (PubMed, Clinicoecon Outcomes Res) - "Insulin icodec offers cost-saving potential versus degludec in insulin-naïve T2DM patients. For basal and basal-bolus-treated patients, the clinical use of icodec needs to be critically evaluated for cost burden, and it is recommended that it be used preferentially in patients who are sensitive to the frequency of injections."

HEOR • Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Case of Insulin Edema Syndrome Improved by Weekly Insulin. (PubMed, JCEM Case Rep) - "Weekly insulin icodec was introduced, which was well-tolerated by the patient and improved her adherence to therapy and her insulin edema without significant weight gain. Insulin edema is a diagnosis of exclusion, and clinicians should be aware of this clinical entity. The use of third-generation long-acting insulin analog may be helpful in some patients with this syndrome."

Journal • Diabetes • Immunology • Metabolic Disorders • Type 2 Diabetes Mellitus

Is once-weekly insulin a viable alternative for type 2 diabetes? A meta-analysis of randomized controlled trials. (PubMed, Diabetol Int) - "Once-weekly novel insulin preparations such as Icodec and basal insulin Fc (BIF)/insulin Efsitora Alfa have raised hope among clinicians and patients when they were developed and evaluated in a series of clinical trials...No significant differences were observed between once-weekly and once-daily insulin for other safety outcomes. Once-weekly insulin regimen was superior in reducing HbA1c level while maintaining a similar safety profile to the once-daily insulin regimen, thus suggesting that such regimen may potentially be an alternative to the currently established once-daily basal insulin regimen."

Journal • Retrospective data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and safety of once-weekly basal insulin therapy in people with type 1 diabetes: A systematic review and meta-analysis. (PubMed, Diabetes Obes Metab) - "This meta-analysis is the first to evaluate the efficacy and safety of once-weekly basal insulin therapy exclusively in adults with type 1 diabetes and including all published RCTs. The analysis demonstrated a similar glucose-lowering effect compared to once-daily basal insulin but revealed an increased occurrence of severe hypoglycaemia."

Journal • Retrospective data • Diabetes • Hypoglycemia • Metabolic Disorders • Severe Hypoglycemia • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

Pharmacokinetic Characteristics of a Once-Weekly Combination Therapy of Insulin Icodec and Semaglutide Versus Its Separate Components in Chinese Individuals with Type 2 Diabetes. (PubMed, Diabetes Ther) - P1 | "In Chinese individuals with T2D, icodec pharmacokinetics and semaglutide total exposure are unaffected when combining icodec and semaglutide in IcoSema. However, maximum semaglutide concentration is higher and occurs earlier with IcoSema. This information may help to ensure suitable dose recommendations for IcoSema."

Clinical • Journal • PK/PD data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus