Onswik (insulin efsitora alfa) / Eli Lilly - LARVOL DELTA

U.S. Food and Drug Administration (FDA) approves Lilly's Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin injection treatment for adults living with type 2 diabetes (PRNewswire) - "The FDA approval is based on data from the QWINT Phase 3 clinical trials, which evaluated the safety and efficacy of once-weekly Onswik in over 3,400 adults with type 2 diabetes....The Onswik KwikPen will be available in the U.S. in the coming months in two concentrations: 500 units/mL (contains 1,500 units total) and 1,000 units/mL (contains 3,000 units total)."

FDA approval • Launch US • Type 2 Diabetes Mellitus

Use of Continuous Glucose Monitoring Indicators to Guide Dose Titration of Weekly Basal Insulin Efsitora Alfa in Insulin-Naive and Basal Insulin-Experienced Adults with Type 2 Diabetes: A Retrospective Analyis. (PubMed, Diabetes Technol Ther) - "In insulin-naive and basal insulin-experienced populations treated with weekly efsitora, CGM indicators of hypoglycemia and fasting glucose yielded clinically equivalent dose titration decisions as CGM-derived hypoglycemic events and self-monitoring FPG, respectively. These findings support translation of established titration practices to a CGM-based workflow in insulin-naive and basal insulin-experienced adults with T2D, consistent with recommendations for CGM use in adults with diabetes on insulin therapy."

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

Insulin Efsitora Demonstrates Similar Efficacy and Safety Profiles to Insulin Icodec in Insulin-Experienced Individuals With Type 2 Diabetes Mellitus: Matching-Adjusted Indirect Comparisons of QWINT-3 Versus ONWARDS 2, and QWINT-4 Versus ONWARDS 4. (PubMed, Diabetes Obes Metab) - "These indirect comparisons suggest that efsitora had lower event rates of hypoglycaemia and less weight gain compared to icodec in basal insulin-experienced participants. Efsitora was comparable to icodec for all other endpoints."

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

Post-hoc analysis of continuous glucose monitoring outcomes of insulin efsitora alfa vs once-daily insulin by baseline GLP-1 RA use in adults with type 2 diabetes (EASD 2026) - P3 | "Regardless of baseline GLP-1 RA use, participants treated with efsitora demonstrated greater TIR compared to baseline and low rates of hypoglycemia."

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

Insulin efsitora alfa in type 2 diabetes: Pharmacological properties for once weekly dosing (EASD 2026) - "Sponsored by Eli Lilly and Company"

Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Insulin efsitora alfa in type 2 diabetes: Insights from the QWINT clinical trial program (EASD 2026) - "Sponsored by Eli Lilly and Company"

Clinical • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Insulin efsitora alfa in type 2 diabetes: The evolution of basal insulin from daily to once-weekly formulations (EASD 2026) - "Sponsored by Eli Lilly and Company"

Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Duration and characteristics of hypoglycemia with once-weekly insulin efsitora alfa versus once-daily basal insulins in adults with type 2 diabetes: Exploratory safety analysis of QWINT 2-4. (PubMed, Diabetes Res Clin Pract) - "No clinically relevant differences were observed between the duration or characteristics of hypoglycemic events in efsitora and once-daily treatment groups in the QWINT-2, -3, and -4 trials."

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

Pharmacokinetics, Pharmacodynamics, and Safety of Once-Weekly Insulin Efsitora Alfa in Chinese Patients with Type 2 Diabetes: A Phase 1 Open-Label, Randomized, Active-Controlled Trial. (PubMed, Adv Ther) - P1 | "Once-weekly efsitora demonstrated promising PK and PD profiles and glycemic control comparable to once-daily glargine, with a similar safety profile, in Chinese patients with T2DM. These findings support further investigation of efsitora as a once-weekly basal insulin option in this population."

Journal • P1 data • PK/PD data • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Experiences of People with Type 2 Diabetes and Healthcare Professionals with Once-Weekly Insulin Efsitora Alfa in QWINT Phase 3 Trials: Qualitative In-Trial Interviews. (PubMed, Patient) - "This qualitative study provides in-depth insights of the experiences of PwD and HCPs with efsitora treatment. Both groups emphasized its convenience, flexibility, and ease of use, while remaining confident in its glycemic control. These findings augment both clinical and patient-reported data and indicate that efsitora may mitigate challenges in diabetes management by reducing the burden and demands associated with conventional daily basal insulin regimens."

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

On 25 June 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Onswik, intended for the treatment of type 2 diabetes mellitus. (European Medicines Agency) - "Onswik will be available as a 500 unit/ml and 1000 unit/ml solution for injection in a pre-filled pen. The active substance of Onswik is insulin efsitora alfa, a long-acting basal insulin analogue used in diabetes (ATC code: not yet assigned)."

CHMP • Type 2 Diabetes Mellitus

Comparative Effectiveness of Once-Weekly Insulin Efsitora Alfa in Patients with Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis (ERA 2026) - No abstract available

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

Efficacy and safety of once-weekly basal insulin analogs versus daily basal insulin analogs in adults with type 2 diabetes: a systematic review and meta-analysis. (PubMed, Curr Diab Rep) - "Recently developed once-weekly basal insulin analogs, including insulin icodec and insulin efsitora alpha (efsitora), aim to improve treatment adherence and patient convenience compared with daily basal insulin. Once-weekly basal insulin provides glycemic control comparable to daily basal insulin, with modest improvements in glycemic outcomes and similar hypoglycemia risk. Its primary advantage lies in treatment simplification and reduced injection burden, supporting its role as a convenient alternative to daily basal insulin in adults with T2DM."

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

CGM Data Provides Weekly Insulin Efsitora Dose Guidance Equivalent to the Current Standard of FBG and Hypoglycemia Events for T2D Insulin Naïve Adults: A Retrospective Analysis (ADA 2026) - "This retrospective analysis evaluated CGM-derived indicators for use in dose titration of weekly basal insulin in insulin-naïve adults with T2D. CGM indicators of FBG were calculated from 3730 weekly insulin dose decisions, while hypoglycemic events were assessed using CGM data from 6075 weeks in a phase 3 trial of once weekly insulin efsitora alfa (efsitora) in insulin-naïve adults with T2D (N=466)... Using CGM indicators of FBG resulted in equivalent dose-to-dose decisions as self-monitored FBG. Results demonstrated strong agreement between TBR thresholds and CGM-derived hypoglycemic events. These findings support potential utility of CGM in efsitora titration."

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

Post Hoc Analysis of Efficacy and Safety Outcomes of Efsitora vs. Once-Daily Insulin in Type 2 Diabetes by GLP-1RA Use across QWINT-1–4 Trials (ADA 2026) - "Introduction and Objective: The Phase 3 QWINT-1-4 trials demonstrated non-inferior glycated hemoglobin A1c (HbA1c) reduction with comparable rates of hypoglycemia for insulin efsitora alfa (efsitora) versus once-daily basal insulin comparators in adults living with type 2 diabetes (T2D). Safety and efficacy outcomes were generally comparable among individuals with T2D treated with efsitora or once-daily comparator, regardless of GLP-1 RA use, across QWINT trials."

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

Incidence of Medication Errors of Interest in the QWINT 1–4 Phase 3 Trial Program of Once-Weekly Basal Insulin Efsitora Alfa (Efsitora) (ADA 2026) - "In the QWINT 1-4 T2D trials, efsitora, a once-weekly innovative basal insulin, demonstrated non-inferior glycemic control and a safety profile comparable to daily basal insulins glargine and degludec (daily comparators). In the phase 3 QWINT 1-4 T2D trials, MEIs were infrequent (<2%) for both those taking once-weekly insulin efsitora and daily comparators. Further, of those participants who experienced MEIs, the majority completed treatment with comparable glycemic outcomes between treatment groups."

P3 data • Hypoglycemia • Metabolic Disorders

Hospitalizations and Outcomes in Adults with Type 2 Diabetes (T2D) Treated with Weekly Insulin Efsitora Alfa (Efsitora): Results from the QWINT Program (ADA 2026) - "This post hoc analysis examined hospitalizations and outcomes of QWINT participants. Adults with T2D (QWINT-1-4; efsitora N=1883, comparator N=1556) were randomized to efsitora or comparators (degludec or glargine). Participants treated with efsitora had similar incidence of hospitalizations, with limited impact on hypoglycemia rates or trial discontinuation compared to daily basal comparators."

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

CGM Data Provides Weekly Insulin Efsitora Dose Guidance Equivalent to the Current Standard of FBG and Hypoglycemia Events for T2D Basal Experienced Adults: A Retrospective Analysis (ADA 2026) - "This retrospective analysis evaluated CGM-derived indicators for use in dose titration of weekly basal insulin in insulin-experienced adults with T2D. CGM indicators of FBG and hypoglycemic events were calculated from 8183 weekly dose decisions, while hypoglycemic events were assessed using CGM data from 12160 weeks in a Phase 3 trial of once-weekly insulin efsitora alfa (efsitora) in insulin-experienced adults with T2D (n=655)... Using CGM indicators of FBG resulted in equivalent dose-to-dose decisions as self-monitored FBG. Strong agreement was demonstrated between TBR thresholds and CGM-derived hypoglycemic events. These findings support potential utility of CGM in efsitora titration."

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

Design and Evaluation of a Novel Clinical Decision Support Algorithm for Weekly Insulin Efsitora Alfa. (PubMed, J Diabetes Sci Technol) - "The investigational CDS system may achieve comparable FBG and HbA1c reductions, and lower hypoglycemia rates, compared with conventional algorithms for daily basal insulin titration."

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

Efficacy and safety of once-weekly insulin efsitora alfa versus daily basal insulin analogs in type 2 diabetes: a systematic review and meta-analysis. (PubMed, Ann Med Surg (Lond)) - "Despite the efficacy of once-daily basal insulins such as glargine and degludec, daily injections remain a barrier to adherence. Once-weekly insulin efsitora alfa demonstrates comparable efficacy and safety to daily basal insulin. However, further large-scale, long-term trials are warranted to confirm its durability, safety, and real-world effectiveness."

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

Efficacy and Safety of Insulin Efsitora Versus Degludec in Adults with Type 2 Diabetes Who Are Insulin-Naïve: Japan Subgroup Analysis of QWINT-2. (PubMed, Diabetes Ther) - P3 | "Once-weekly efsitora was comparable to once-daily degludec in reducing HbA1c in Japanese participants who were insulin-naïve. The efficacy and safety of efsitora in Japanese participants were consistent with the overall QWINT-2 study population."

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

Once-weekly insulin efsitora alfa showed consistent time in range and rates of hypoglycaemia throughout the week relative to day of administration in insulin naïve adults with T2D (DDG 2026) - "Does once-weekly insulin efsitora alfa deliver stable glycaemic control and low hypoglycaemia rates throughout the week in insulin-naïve adults with type 2 diabetes? Once weekly efsitora provides steady glycaemic control throughout the week with a consistently low incidence of hypoglycaemia, as assessed by masked CGM in insulin naïve adults with T2D."

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

Steady-state pharmacokinetics and glucodynamics of once-weekly insulin efsitora alfa (efsitora) in individuals with type 2 diabetes (T2D) (DDG 2026) - "Efsitora demonstrated a flat and prolonged PK profile providing a consistent level of exposure at steady-state and resulting in a stable glucose-lowering response across the weekly dosing interval."

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

Characteristics and Glycemic Outcomes of Insulin-Naive Adults With Type 2 Diabetes Treated With an Innovative Fixed-Dose Regimen of Weekly Insulin Efsitora in QWINT‑1 (DDG 2026) - "In 795 insulin-naïve adults with type 2 diabetes, how does weekly insulin efsitora alfa compare with daily insulin glargine over 52-weeks in terms of HbA1c reduction and incidence of hypoglycaemic events in QWINT-1?... Participants requiring higher efsitora doses had greater baseline BMI and glycaemic measures. HbA1c reductions were similar across efsitora doses compared to glargine at week-52. Fixed-dose titration did not increase clinically significant hypoglycemia rates."

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

Insulin efsitora alfa (Efsitora) demonstrates better overall health state vs . daily degludec in basal switch adults with type 2 diabetes in QWINT-3 (DDG 2026) - "Treatment with weekly efsitora resulted in greater tx satisfaction, better overall health state, and reduced tx burden vs degludec in adults with T2D currently treated with basal insulin. Greater satisfaction and perceived improved overall health state may improve adherence and clinical outcomes."

Clinical • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus