Awiqli (insulin icodec) / Novo Nordisk - LARVOL DELTA

Novo Nordisk expands in Korea with once-weekly insulin as obesity and hormone rivals circle (Korea Biomedical Review) - "Novo Nordisk’s once-weekly insulin, Awiqli (insulin icodec), is now officially available in Korea, marking a huge shift for diabetes patients long reliant on daily injections. But the Danish drugmaker isn’t just betting on convenience...For type 1 diabetes, it's used alongside bolus insulin—short-acting insulin taken at mealtimes—in Korea; for type 2, it can be administered solo or alongside oral antidiabetics, GLP-1 agonists (which help lower blood sugar and support weight loss), and/or bolus insulin."

Launch non-US • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

The effect of once-weekly insulin icodec vs once-daily basal insulin on physical activity-attributed hypoglycaemia in type 2 diabetes: a post hoc analysis of ONWARDS 1-5. (PubMed, Diabetologia) - P3 | "These findings do not suggest that there is an additional increase in hypoglycaemia risk attributed to physical activity with once-weekly basal icodec vs once-daily basal insulins in adults with type 2 diabetes."

Journal • Retrospective data • Alzheimer's Disease • Cognitive Disorders • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and Hypoglycemia Outcomes with Once-Weekly Insulin Icodec vs. Once-Daily Basal Insulin in T2D by Diabetes Duration—ONWARDS 1–5 (ADA 2025) - "Available on Friday, June 13, 2025 at 08:00am CDT."

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

Efficacy and Hypoglycemia Outcomes with Once-Weekly Insulin Icodec vs. Once-Daily Basal Insulin in T2D by Baseline BMI—ONWARDS 1–5 (ADA 2025) - "Available on Friday, June 13, 2025 at 08:00am CDT."

Clinical • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and Safety Analysis of Practice Management Support Strategies of Once-weekly Insulin Icodec under the "in-person remote" Diabetes Self-Management Support Model: A Pragmatic Randomized Controlled Trial (ChiCTR) - P=N/A | N=160 | Not yet recruiting | Sponsor: Peking University First Hospital; Peking University First Hospital

New trial • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and Hypoglycemia Outcomes with Once-Weekly Insulin Icodec vs. Once-Daily Basal Insulin in T2D by Baseline A1C—ONWARDS 1–5 (ADA 2025) - "Available on Friday, June 13, 2025 at 08:00am CDT."

Clinical • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Insulin icodec: A novel once-weekly formulation for the treatment of type 1 and type 2 diabetes mellitus. (PubMed, Rev Endocr Metab Disord) - "Hypoglycemia was similar or slightly increased with insulin icodec when compared to other long acting insulins. Overall, icodec is a useful, new formulation of basal insulin that allows for less injections, improved compliance, and potentially improved glycemic control providing a new tool to practitioners managing patients with diabetes who need to be on insulin."

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

Glucagon-like Peptide-1 Receptor Agonists: Exciting Avenues Beyond Weight Loss. (PubMed, J Clin Med) - "Leading the list are glucagon-like peptide-1 receptor agonists (GLP1RAs), the first of which, exenatide, was approved by the FDA in 2005...Additionally, on the horizon, the once-weekly basal insulin analog insulin icodec and the once-weekly combination of insulin icodec and semaglutide are expected to be available in the future...It is important that clinicians are familiar with current research in order to provide optimal evidence-based care to patients. In the not-too-distant future, there may be a case to prescribe these drugs for benefits outside diabetes."

Journal • Review • Alzheimer's Disease • Cardiovascular • Chronic Kidney Disease • CNS Disorders • Diabetes • Dyslipidemia • Genetic Disorders • Hepatology • Hypertension • Infertility • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Movement Disorders • Oncology • Parkinson's Disease • Renal Disease • Sexual Disorders • Type 2 Diabetes Mellitus

Long-Term Cost-Effectiveness Analysis of Once-Weekly Insulin Icodec Versus Once-Daily Basal Insulin Analogues in Patients With Type 2 Diabetes in China (ISPOR 2025) - "Model inputs of baseline characteristics and treatment effects were derived from the ONWARDS 5 clinical trial, which compared icodec used with dosing guide app with once-daily basal insulins (glargine U100, glargine U300, and degludec). Once-weekly insulin icodec is a cost-effective treatment option compared to once-daily basal insulin analogues in China."

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

Long-Term Cost-Effectiveness of Once-Weekly Insulin Icodec Versus Degludec for the Treatment of Patients With Type 2 Diabetes Mellitus in China (ISPOR 2025) - "Compared with insulin degludec, insulin icodec represents a dominant treatment option for patients with T2DM in China."

Clinical • Cost effectiveness • HEOR • Cardiovascular • Diabetes • Diabetic Nephropathy • Macular Edema • Metabolic Disorders • Nephrology • Ophthalmology • Pain • Renal Disease • Retinal Disorders • Type 2 Diabetes Mellitus

A Study to Test How a New Long-acting Insulin Works in the Body of Patients With Type 2 Diabetes During Exercise and Prolonged Fasting (clinicaltrials.gov) - P1 | N=30 | Active, not recruiting | Sponsor: Novo Nordisk A/S | Recruiting ➔ Active, not recruiting | Trial completion date: Nov 2024 ➔ Apr 2025 | Trial primary completion date: Nov 2024 ➔ Mar 2025

Enrollment closed • Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Design of a novel long-acting insulin analogs by acetylation modification and compared with insulin Icodec. (PubMed, Sci Rep) - "These findings suggest that TBE001-A-S033 possesses a favorable hypoglycemic effect and a differential half-life across species compared to insulin icodec, indicating its potential for once-weekly use in humans. This preclinical investigation indicates that TBE001-A-S033 may serve as an effective therapeutic for type 2 diabetes mellitus (T2DM)."

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

Efficacy and Hypoglycemia Profile of Once-Weekly Insulin Icodec vs. Once-Daily Comparators across Demographic Subgroups. (PubMed, J Clin Endocrinol Metab) - "The efficacy and hypoglycemia profile of icodec versus OD comparators was consistent across trial populations irrespective of age, ethnicity, or race."

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

Advancements in once-weekly insulin icodec: Key findings from clinical research (ATTD 2025) - "Sponsored by Novo Nordisk"

Clinical

0980 - PLENARY INDUSTRY SYMPOSIUM 07 (INDUSTRY SESSION NOT INCLUDED IN THE MAIN EVENT CME/CPD CREDIT): Digital health empowerment for once-weekly insulin icodec users - Industry Symposium (ATTD 2025) - "Sponsored by Novo Nordisk"

CME

Efficacy and hypoglycaemia outcomes with once-weekly insulin icodec versus once-daily basal insulin in type 2 diabetes according to baseline glucagon-like peptide-1 receptor agonist and sodium-glucose co-transporter-2 inhibitor use: A post hoc analysis of ONWARDS 1-5. (PubMed, Diabetes Obes Metab) - "The efficacy and hypoglycaemia profile of icodec versus once-daily comparators was generally consistent across ONWARDS trials irrespective of background GLP-1RA and/or SGLT2i use."

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

Anvisa approves Icodec, weekly insulin from Novo Nordisk, manufacturer of Ozempic [Google translation] (Portal Teófilo Otoni) - "The National Health Surveillance Agency (Anvisa) has issued a positive opinion on Icodec, the weekly insulin from Novo Nordisk, the manufacturer of Ozempic. The information was released first-hand to the media outlets present at the company's press conference, held this Thursday....There are still no details about the drug's recommended use by the agency, which should be shared early next week. After this announcement, the process of pricing the drug in Brazil will begin, which is conducted by the Chamber for Regulating the Drug Market (CMED)."

Approval • Type 2 Diabetes Mellitus

Continuous Glucose Monitoring-Based Titration of Once-Weekly Insulin Icodec in Insulin-Naive Individuals with Type 2 Diabetes (ONWARDS 9): A Phase 3b, Multicenter, Single-Arm, Treat-to-Target Clinical Trial. (PubMed, Diabetes Technol Ther) - P3 | "These findings suggest that CGM-based titration of icodec is a feasible method for initiating insulin therapy in T2D. Trial registration: ClinicalTrials.gov identifiers: NCT05823948."

Journal • P3 data • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Once-Weekly Insulin Icodec Versus Once-Daily Insulin Degludec in Insulin-Naive Chinese Participants with Type 2 Diabetes: A Post Hoc Analysis of ONWARDS 3. (PubMed, Diabetes Ther) - P3 | "In insulin-naive Chinese individuals with T2D, once-weekly icodec treatment showed significantly greater HbA1c reductions after 26 weeks than once-daily degludec, with low combined clinically significant or severe hypoglycemia rates across groups."

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

No evidence of increased hypoglycaemia attributed to physical activity with once-weekly insulin icodec versus once-daily basal insulin degludec in type 1 diabetes: A post hoc analysis of ONWARDS 6. (PubMed, Diabetes Obes Metab) - No abstract available

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

Pharmacokinetic properties of once-weekly insulin icodec in Chinese individuals with type 2 diabetes. (PubMed, J Diabetes Investig) - "The pharmacokinetic properties of icodec assessed at steady state in this study demonstrated well-distributed exposure across the 1-week dosing interval and a half-life that supports once-weekly administration in Chinese individuals with type 2 diabetes."

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

Efficacy and hypoglycaemia outcomes with once-weekly insulin icodec versus once-daily basal insulin in individuals with type 2 diabetes by kidney function: A post hoc participant-level analysis of the ONWARDS 1-5 trials. (PubMed, Diabetes Obes Metab) - "Efficacy and hypoglycaemia outcomes of icodec versus once-daily comparators were generally consistent among adults with T2D, regardless of kidney function."

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

General Use-results Surveillance With Awiqli in Patients With Diabetes Mellitus (clinicaltrials.gov) - P=N/A | N=630 | Not yet recruiting | Sponsor: Novo Nordisk A/S

New trial • Real-world evidence • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

AIFA Board of Directors approves the reimbursability…medicines (Italian Medicines Agency) - "The Board of Directors of the Italian Medicines Agency, which met on January 29 for the first session of 2025, has re-admitted to reimbursement, in all Regions....Among the new therapies that will be reimbursed by the National Health Service...two drugs for the treatment of diabetes mellitus (MOUNJARO and AWIQLI)."

Reimbursement • Type 2 Diabetes Mellitus

Once-Weekly Insulin: A Breakthrough in Diabetes Management or an Unresolved Challenge? (PubMed, Br J Hosp Med (Lond)) - "Insulin icodec has demonstrated comparable glycemic control to conventionally used daily basal insulins, such as insulin glargine and degludec, in the ONWARDS clinical trials. Future studies should evaluate the broader health impacts of weekly insulin, including cardiovascular outcomes, quality of life, and personalized dosing strategies. Making weekly insulin safe, affordable, and widely available is important to fully realize its potential in diabetes management."

Journal • Review • Cardiovascular • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus