Once-Weekly Basal Insulins: Insulin Icodec and Insulin Efsitora

For a century, background (basal) insulin has meant at least one injection every day. Two newer insulins are built to last a full week: insulin icodec and insulin efsitora alfa. A 2026 review in an obstetrics journal put the arithmetic plainly: a weekly basal insulin cuts basal injections from a minimum of 365 a year to 52. This page gathers what the large trials found, number by number, for both insulins in type 2 and type 1 diabetes, how the trials set and changed the dose, what regulators have approved, and what is still unknown. The wider menu of insulins, from rapid-acting to daily long-acting, is covered on Insulin Types and Dosing Strategies.

Table of Contents

  1. How Insulin Icodec Lasts a Week
  2. How Insulin Efsitora Alfa Lasts a Week
  3. The ONWARDS Trials of Insulin Icodec in Type 2 Diabetes
  4. The QWINT Trials of Insulin Efsitora in Type 2 Diabetes
  5. Type 1 Diabetes and the Low Blood Sugar Signal
  6. Weight, Time in Range and Other Safety Measures
  7. How the Trials Set and Changed the Dose
  8. Regulatory Status, 2024 to 2026
  9. What Is Not Yet Known
  10. Key Research Papers
  11. Connections
  12. Featured Videos

How Insulin Icodec Lasts a Week

Insulin icodec is human insulin with a few deliberate changes. The paper that first described the molecule in 2021 (Nishimura and colleagues) lists them: a side chain carrying a 20-carbon fatty diacid is attached to the insulin, and three amino acids are swapped (at positions A14, B16 and B25). The fatty side chain makes the insulin stick, strongly but reversibly, to albumin, the most common protein in blood. The swapped amino acids make the molecule more stable and weaken its grip on the insulin receptor, which slows how fast the body clears it.

The result is a circulating reserve. Most of the insulin icodec in the blood is parked on albumin at any moment and is released slowly; only the free fraction acts on cells. In the first dose-escalation trial in people with type 2 diabetes, the mean half-life was 196 hours, a little over eight days, and the glucose-lowering effect was spread close to evenly across the whole week. The 2021 paper also reports that in cells, insulin icodec triggers the same receptor signals as human insulin, binds the related insulin-like growth factor 1 (IGF-1) receptor proportionately less, and has a low growth-promoting (mitogenic) effect compared with human insulin.

The U.S. prescribing information, approved in 2026, gives the same picture in regulatory language: plasma protein binding above 99%, a half-life of about one week regardless of dose, and steady blood levels reached after 2 to 3 weeks when the first dose is a one-time 50% larger dose, or after 3 to 4 weeks without it. A 2025 practical review in the journal Drugs adds that albumin outnumbers insulin icodec in the blood by about 2,000 to 1, so the insulin occupies less than 0.05% of available albumin, and that the long action comes from albumin binding rather than from a depot under the skin. The label states that kidney impairment, including dialysis, and liver impairment did not change how the body handles insulin icodec in dedicated studies.

How Insulin Efsitora Alfa Lasts a Week

Insulin efsitora alfa takes a different route. It is a fusion protein: a single-chain version of insulin joined by a short linker to the fragment crystallizable (Fc) region of a human antibody (immunoglobulin G2). The 2022 laboratory paper by Moyers and colleagues found that this insulin binds the human insulin receptor about two orders of magnitude (roughly a hundredfold) more weakly than human insulin in cell assays, yet still switches the receptor fully on, and that its binding to the insulin-like growth factor 1 receptor was so low it could not be measured precisely. In diabetic rats, its glucose-lowering effect persisted through 336 hours after one injection, with a terminal half-life of about 120 hours in those rats.

In people, the half-life is far longer. The first human studies (Heise and colleagues, 2023) measured a half-life of about 17 days, with a low peak-to-trough ratio of 1.14 at steady state, meaning blood levels barely rose and fell across the week. The 2026 U.S. label explains the long action by three features: the molecule is too large for the kidneys to filter quickly; the fragment crystallizable piece binds the neonatal fragment crystallizable receptor, which protects it from breakdown (the same recycling system that keeps antibodies in the blood for weeks); and weak insulin receptor binding means less of it is cleared by the receptor itself. The label reports a half-life of about 17 days at steady state and a week-to-week variation in exposure of 5%. Steady state takes 8 to 10 weeks without a one-time starting dose and 4 to 6 weeks with one.

Both insulins share one practical consequence that both U.S. labels state: their long action may delay recovery from a low blood sugar compared with shorter-acting insulins, and dose changes take weeks to show their full effect. For insulin efsitora, the label states that a change in dose first shows in fasting glucose within 1 to 2 weeks, with the full effect at about 4 weeks.

The ONWARDS Trials of Insulin Icodec in Type 2 Diabetes

The manufacturer-funded ONWARDS programme tested weekly insulin icodec against the standard daily long-acting insulins: insulin glargine U100 and insulin degludec. All were "treat-to-target" trials, in which both groups adjust their dose toward the same fasting glucose goal, so the comparison is about how well and how safely each insulin gets there. Five trials enrolled people with type 2 diabetes. The main measure was the change in glycated hemoglobin (HbA1c), the blood test that reflects average glucose over about three months. "Combined level 2 or 3 hypoglycemia" means readings below 54 mg/dL (3.0 mmol/L) plus severe episodes where another person had to help. In each pair of figures below, the weekly insulin comes first.

Several details sit behind the table. In ONWARDS 1, average glycated hemoglobin fell from 8.50% to 6.93% with insulin icodec and from 8.44% to 7.12% with insulin glargine U100, and time spent in the 70 to 180 mg/dL range during weeks 48 to 52 was 71.9% against 66.9%, a difference of 4.27 percentage points; the U.S. label translates that into about one more hour a day in range. In ONWARDS 3, the only double-blind trial, people injected a placebo on the other schedule so that nobody knew which insulin was active. In ONWARDS 4, people on insulin icodec needed a lower mealtime insulin dose. ONWARDS 5 also found higher scores on treatment-satisfaction and adherence questionnaires with weekly insulin, but its authors note they could not separate the effect of the insulin from the effect of the app.

Across the programme, low blood sugar events in type 2 diabetes stayed below one per person-year with both weekly and daily insulin in every trial except the basal-plus-mealtime trial (ONWARDS 4), where rates were higher with both, as the 2025 Drugs review describes. The direction was not always level, however: point estimates for lows were higher with insulin icodec in ONWARDS 1, 2 and 3, and statistically so in ONWARDS 3 over 26 weeks and in ONWARDS 1 over 83 weeks.

The QWINT Trials of Insulin Efsitora in Type 2 Diabetes

The QWINT programme, also funded by its manufacturer, used a wider margin for "non-inferiority" (0.4 percentage points of glycated hemoglobin, against 0.3 in the ONWARDS trials that state one), so its results are read as "at least as good" rather than "better" unless superiority was shown. Again, the weekly insulin figure comes first.

In QWINT-2, time in the 70 to 180 mg/dL range during weeks 48 to 52 was 64.3% with insulin efsitora and 61.2% with insulin degludec, a difference of 3.1 percentage points. QWINT-1 tested a simpler dosing scheme (described under dosing below): at week 52 the average total weekly insulin dose was 289.1 units with insulin efsitora against 332.8 units with insulin glargine, and the median number of dose changes was 2 against 8. In QWINT-3, serious adverse events were reported in 16% of people on insulin efsitora (1% judged treatment-related) and 11% on insulin degludec (under 1% treatment-related); the most frequent, at about 1%, were mainly heart- and circulation-related in both groups, and nine deaths (seven and two) were judged unrelated to treatment. A 2026 commentary in the Drug and Therapeutics Bulletin reviewed the QWINT-1 result for prescribers.

Type 1 Diabetes and the Low Blood Sugar Signal

People with type 1 diabetes make essentially no insulin of their own, so they depend on injected basal insulin plus mealtime insulin, and small mismatches turn into lows quickly. Each weekly insulin had one large type 1 trial, and both found the same pattern: glycated hemoglobin fell about as much as with daily insulin degludec, but low blood sugar was more frequent.

A follow-up analysis of continuous glucose monitoring data from ONWARDS 6 (Danne and colleagues, 2025) added detail. Measured by the sensor rather than finger-stick readings, the excess of clinically significant lows was smaller (rate ratios of 1.38 at 26 weeks and 1.28 at 57 weeks, against 1.88 and 1.79 from finger sticks), but still favoured daily insulin. Time in range peaked on days 2 to 4 after each weekly injection, when time below range also rose. Once a low began, its median length was similar on both insulins: about 35 minutes.

Regulators drew different conclusions from the same data. The European Medicines Agency authorised insulin icodec for adults with type 1 as well as type 2 diabetes, always combined with mealtime insulin, and its public summary notes that after 52 weeks the drop in glycated hemoglobin had narrowed to 0.37 points with insulin icodec against 0.54 with insulin degludec. The U.S. approval of insulin icodec covers type 2 diabetes only. The U.S. label for insulin efsitora states that it is not recommended in type 1 diabetes because of the increased risk of severe hypoglycemia, citing the 10% against 3% figure. A 2025 mini-review (Denimal) sums up the evidence: limited data in type 1 diabetes, comparable glycated hemoglobin reduction, higher rates of low blood sugar. That review's full text reports that a new trial, ONWARDS 11, will compare insulin icodec with insulin glargine in type 1 diabetes.

Weight, Time in Range and Other Safety Measures

Weight. Insulin of any kind tends to add weight. In ONWARDS 2, weight changed by +1.40 kg with insulin icodec and −0.30 kg with insulin degludec. In ONWARDS 3, people gained 2.8 kg and 2.3 kg, a difference that was not statistically significant. A 2024 meta-analysis of the phase 3 icodec trials (Lisco and colleagues; 4,347 people) found a small extra weight gain of 0.62 kg with weekly insulin. A 2025 meta-analysis of six insulin efsitora trials in type 2 diabetes (3,967 people) found no significant difference in weight change against daily insulin.

Overall control. The same icodec meta-analysis found glycated hemoglobin 0.14 points lower with weekly insulin, a greater chance of reaching under 7% without a clinically relevant or severe low (risk ratio 1.17), no difference in time in range overall, and a similar frequency of low blood sugar. Insulin icodec did better when used as the only insulin than alongside mealtime insulin, and lows were more likely when sulfonylurea or glinide tablets were also taken (risk ratio 1.42). The efsitora meta-analysis found no difference in glycated hemoglobin, a small gain in time in range (0.80 percentage points), and a higher rate of treatment-emergent adverse events (risk ratio 1.13), while serious adverse events, allergic reactions, injection-site reactions and lows were comparable.

Continuous glucose monitoring in type 2 diabetes. In an analysis of masked sensor data from ONWARDS 1, time in range met the international target of more than 70% with insulin icodec but not with insulin glargine U100 during the middle, end and extension periods of the trial; time below 54 mg/dL stayed below the 1% target in both groups, and median length of a low was 35 minutes or less in both.

Pooled safety. A 2026 pooled analysis of ONWARDS 1 to 6 (2,170 people on each side) found similar rates per 100 person-years of all adverse events (248.49 against 242.53), serious adverse events (14.51 against 14.03) and allergic (hypersensitivity) reactions (5.88 against 6.74). Injection-site reactions, mostly mild, were more common with insulin icodec (5.86 against 3.66). Time to a first major heart or stroke event did not differ (hazard ratio 0.93, with a wide 95% confidence interval of 0.56 to 1.56).

Antibodies. Both U.S. labels report antibodies against the insulin. For insulin icodec, 79.0% of insulin-naive and 70.7% of insulin-experienced trial participants tested positive at least once, with no identified clinically significant effect over 26 weeks. For insulin efsitora, 7% of insulin-naive and 3% of insulin-experienced participants developed new antibodies; in 23 people (about 1% of those treated) these antibodies sped up clearance of the drug about fivefold, and the label states such people may need higher doses.

The two weekly insulins compared. No randomised trial has put them side by side. A 2026 matching-adjusted indirect comparison, which statistically lines up results from separate trials, found similar glycated hemoglobin results; in people switching from daily basal insulin (QWINT-3 against ONWARDS 2) it estimated 1.52 kg less weight gain and a lower rate of level 2 or 3 lows (rate ratio 0.436) with insulin efsitora, and in people on mealtime insulin (QWINT-4 against ONWARDS 4) no meaningful differences.

How the Trials Set and Changed the Dose

Weekly insulin is measured in the same units as daily insulin, so a weekly dose looks large: roughly seven daily doses given at once. The pens are concentrated accordingly. The U.S. labels list insulin icodec at 700 units per mL and insulin efsitora at 500 and 1,000 units per mL.

Insulin icodec

In the ONWARDS trials, the dose was adjusted once a week, by 20 units up or down (or left alone), based on three pre-breakfast finger-stick readings taken on the two days before and the day of adjustment, aiming for 80 to 130 mg/dL. The U.S. label describes the same 20-unit steps and the same target across its four supporting trials. For people new to insulin, the U.S. label's starting dose is 70 units once a week; the Drugs review reports that the Chinese label starts at 70 units and the Japanese label at 30 to 70 units. For people switching from daily basal insulin, the U.S. label sets the first week's dose at the previous daily dose times 7, times 1.5 (a one-time 50% extra), and the second week's dose at the daily dose times 7; the European summary describes the 50% first-dose increase as optional in type 2 and always used in type 1. A missed dose, per the U.S. label, is taken within 4 days; after more than 4 days it is skipped.

Insulin efsitora alfa

QWINT-1 tested a deliberately simple scheme for people new to insulin: start at 100 units once a week and, every 4 weeks if fasting glucose was above target, step up to fixed doses of 150, then 250, then 400 units, aiming for 80 to 130 mg/dL. A follow-up report (Connery and colleagues, 2026) found that 76% of people stayed on one of the fixed doses, most reached their final dose by week 16, every fixed dose brought average glycated hemoglobin under 7.0%, and level 2 or 3 lows after a dose step stayed under 0.5 events per year. The U.S. label offers this fixed-dose option or a flexible one (a one-time 300-unit first dose, then 100 units, then changes of 20 to 40 units a week). For people switching from daily basal insulin, the label's one-time first dose is the daily dose times 7, times 3, then the daily dose times 7.

What the labels say about short-term changes

Because the insulin lasts so long, both U.S. labels state that changing the weekly dose is not advised (icodec) or not recommended (efsitora) for an acute illness or short-term changes in activity or diet; the labels point instead to other adjustments, such as glucose intake or changes to other diabetes medicines. The Drugs review notes there are no clinical data on insulin icodec during sick days and that its guidance there is expert opinion. Both labels warn that serious lows requiring hospital care have followed mix-ups between insulins and errors in dose or frequency, and both state the pen contents are not to be drawn into a syringe. In a crossover study (Pieber and colleagues, 2023) that deliberately gave double or triple doses at steady state, the share of people whose glucose fell below 3.0 mmol/L (54 mg/dL) was similar for insulin icodec and daily insulin glargine U100 (39.5% against 35.7% after a double dose; 52.6% against 70.0% after a triple dose), and recovery with intravenous glucose took under 30 minutes in every case.

Regulatory Status, 2024 to 2026

The reasons behind the 2024 U.S. decision are not stated in the 2026 approval letter, and this page does not speculate on them.

What Is Not Yet Known

For background on why low blood sugar matters and how it is recognised, see Hypoglycemia Awareness and Prevention. Severe low blood sugar with confusion, seizure or loss of consciousness is treated by hospitals as an emergency; the labels add that recovery may take longer with a long-acting insulin.

Key Research Papers

  1. Nishimura E, Pridal L, Glendorf T, Hansen BF, Hubálek F, Kjeldsen T, Kristensen NR, Lützen A, Lyby K, Madsen P, Pedersen TÅ, Ribel-Madsen R, Stidsen CE, Haahr H. Molecular and pharmacological characterization of insulin icodec: a new basal insulin analog designed for once-weekly dosing. BMJ Open Diabetes Res Care. 2021;9(1):e002301. PubMed PMID: 34413118
  2. Moyers JS, Hansen RJ, Day JW, Dickinson CD, Zhang C, Ruan X, Ding L, Brown RM, Baker HE, Beals JM. Preclinical Characterization of LY3209590, a Novel Weekly Basal Insulin Fc-Fusion Protein. J Pharmacol Exp Ther. 2022;382(3):346-355. PubMed PMID: 35840338
  3. Heise T, Chien J, Beals JM, Benson C, Klein O, Moyers JS, Haupt A, Pratt EJ. Pharmacokinetic and pharmacodynamic properties of the novel basal insulin Fc (insulin efsitora alfa), an insulin fusion protein in development for once-weekly dosing for the treatment of patients with diabetes. Diabetes Obes Metab. 2023;25(4):1080-1090. PubMed PMID: 36541037
  4. Rosenstock J, Bain SC, Gowda A, Jódar E, Liang B, Lingvay I, Nishida T, Trevisan R, Mosenzon O; ONWARDS 1 Trial Investigators. Weekly Icodec versus Daily Glargine U100 in Type 2 Diabetes without Previous Insulin. N Engl J Med. 2023;389(4):297-308. PubMed PMID: 37356066
  5. Philis-Tsimikas A, Asong M, Franek E, Jia T, Rosenstock J, Stachlewska K, Watada H, Kellerer M. Switching to once-weekly insulin icodec versus once-daily insulin degludec in individuals with basal insulin-treated type 2 diabetes (ONWARDS 2): a phase 3a, randomised, open label, multicentre, treat-to-target trial. Lancet Diabetes Endocrinol. 2023;11(6):414-425. PubMed PMID: 37148899
  6. Lingvay I, Asong M, Desouza C, Gourdy P, Kar S, Vianna A, Vilsbøll T, Vinther S, Mu Y. Once-Weekly Insulin Icodec vs Once-Daily Insulin Degludec in Adults With Insulin-Naive Type 2 Diabetes: The ONWARDS 3 Randomized Clinical Trial. JAMA. 2023;330(3):228-237. PubMed PMID: 37354562
  7. Mathieu C, Ásbjörnsdóttir B, Bajaj HS, Lane W, Matos ALSA, Murthy S, Stachlewska K, Rosenstock J. Switching to once-weekly insulin icodec versus once-daily insulin glargine U100 in individuals with basal-bolus insulin-treated type 2 diabetes (ONWARDS 4): a phase 3a, randomised, open-label, multicentre, treat-to-target, non-inferiority trial. Lancet. 2023;401(10392):1929-1940. PubMed PMID: 37156252
  8. Bajaj HS, Aberle J, Davies M, Donatsky AM, Frederiksen M, Yavuz DG, Gowda A, Lingvay I, Bode B. Once-Weekly Insulin Icodec With Dosing Guide App Versus Once-Daily Basal Insulin Analogues in Insulin-Naive Type 2 Diabetes (ONWARDS 5): A Randomized Trial. Ann Intern Med. 2023;176(11):1476-1485. PubMed PMID: 37748181
  9. Russell-Jones D, Babazono T, Cailleteau R, Engberg S, Irace C, Kjaersgaard MIS, Mathieu C, Rosenstock J, Woo V, Klonoff DC. Once-weekly insulin icodec versus once-daily insulin degludec as part of a basal-bolus regimen in individuals with type 1 diabetes (ONWARDS 6): a phase 3a, randomised, open-label, treat-to-target trial. Lancet. 2023;402(10413):1636-1647. PubMed PMID: 37863084
  10. Pieber TR, Arfelt KN, Cailleteau R, Hart M, Kar S, Mursic I, Svehlikova E, Urschitz M, Haahr H. Hypoglycaemia frequency and physiological response after double or triple doses of once-weekly insulin icodec vs once-daily insulin glargine U100 in type 2 diabetes: a randomised crossover trial. Diabetologia. 2023;66(8):1413-1430. PubMed PMID: 37308751
  11. Rosenstock J, Juneja R, Beals JM, Moyers JS, Ilag L, McCrimmon RJ. The Basis for Weekly Insulin Therapy: Evolving Evidence With Insulin Icodec and Insulin Efsitora Alfa. Endocr Rev. 2024;45(3):379-413. PubMed PMID: 38224978
  12. Lisco G, De Tullio A, De Geronimo V, Giagulli VA, Guastamacchia E, Piazzolla G, Disoteo OE, Triggiani V. Once-Weekly Insulin Icodec in Diabetes Mellitus: A Systematic Review and Meta-Analysis of Randomized Clinical Trials (ONWARDS Clinical Program). Biomedicines. 2024;12(8):1852. PubMed PMID: 39200316
  13. Bergenstal RM, Weinstock RS, Mathieu C, Onishi Y, Vijayanagaram V, Katz ML, Carr MC, Chang AM. Once-weekly insulin efsitora alfa versus once-daily insulin degludec in adults with type 1 diabetes (QWINT-5): a phase 3 randomised non-inferiority trial. Lancet. 2024;404(10458):1132-1142. PubMed PMID: 39270686
  14. Bergenstal RM, Ásbjörnsdóttir B, Watt SK, Lingvay I, Mader JK, Nishida T, Rosenstock J. Continuous glucose monitoring-based metrics and the duration of hypoglycaemia events with once-weekly insulin icodec versus once-daily insulin glargine U100 in insulin-naive type 2 diabetes: an exploratory analysis of ONWARDS 1. Lancet Diabetes Endocrinol. 2024;12(11):799-810. PubMed PMID: 39374601
  15. Wysham C, Bajaj HS, Del Prato S, Franco DR, Kiyosue A, Dahl D, Zhou C, Carr MC, Case M, Firmino Gonçalves L; QWINT-2 Investigators. Insulin Efsitora versus Degludec in Type 2 Diabetes without Previous Insulin Treatment. N Engl J Med. 2024;391(23):2201-2211. PubMed PMID: 39254740
  16. Rosenstock J, Bailey T, Connery L, Miller E, Desouza C, Wang Q, Leohr J, Knights A, Carr MC, Child CJ; QWINT-1 trial investigators. Weekly Fixed-Dose Insulin Efsitora in Type 2 Diabetes without Previous Insulin Therapy. N Engl J Med. 2025;393(4):325-335. PubMed PMID: 40548694
  17. Philis-Tsimikas A, Bergenstal RM, Bailey TS, Jinnouchi H, Thrasher JR, Ilag L, Mitra J, Syring K, Threlkeld RJ. Once-weekly insulin efsitora alfa versus once-daily insulin degludec in adults with type 2 diabetes currently treated with basal insulin (QWINT-3): a phase 3, randomised, non-inferiority trial. Lancet. 2025;405(10497):2279-2289. PubMed PMID: 40562047
  18. Blevins T, Dahl D, Pérez Manghi FC, Murthy S, Ortiz Carrasquillo R, Li X, Chang AM, Carr MC, Katz M. Once-weekly insulin efsitora alfa versus once-daily insulin glargine U100 in adults with type 2 diabetes treated with basal and prandial insulin (QWINT-4): a phase 3, randomised, non-inferiority trial. Lancet. 2025;405(10497):2290-2301. PubMed PMID: 40562048
  19. Philis-Tsimikas A, Aberle J, Bajaj H, Lingvay I, Mu Y, Shaikh S, Vianna A, Watada H, Del Prato S. Clinical Use of Once-Weekly Insulin Icodec: Translating Clinical Trial Data into Practical Guidance for Diabetes Management. Drugs. 2025;85(10):1253-1268. PubMed PMID: 40802020
  20. Danne T, Engberg S, Irace C, Kjaersgaard MIS, Klonoff DC, Mathieu C, Kehlet Watt S, Russell-Jones D. Continuous Glucose Monitoring Metrics and Continuous Glucose Monitoring-Based Hypoglycemia, Including Duration, in Individuals with Type 1 Diabetes Switching to Once-Weekly Insulin Icodec: A Post Hoc Evaluation of ONWARDS 6. Diabetes Technol Ther. 2025;27(12):963-972. PubMed PMID: 40742780
  21. Denimal D. Emerging perspectives on once-weekly insulins in type 1 and type 2 diabetes: a mini-review. Front Endocrinol (Lausanne). 2025;16:1656884. PubMed PMID: 40937414
  22. Mehmood H, Alowami M, Hlaing TS, Zaya KN, Uraiby Y, Alam AM, Adala A, Ikram O, Ali SF, Farhan M, Zulfiqar E, Ahmed M, Ahmed R, Naeem A. Once-Weekly Insulin Efsitora Alfa Versus Once Daily Insulin in Patients With Type 2 Diabetes: A Systematic Review and Meta-Analysis. Endocrinol Diabetes Metab. 2025;8(6):e70126. PubMed PMID: 41152194
  23. Drummond RF, Seif KE, Higgs AJ, Reece EA. Diabetes in pregnancy and major new advances in diabetes care using long-acting and ultralong-acting insulins. Am J Obstet Gynecol. 2026;234(2):297-309. PubMed PMID: 40886785
  24. Connery L, Rosenstock J, Rasouli N, Cheng AYY, Liebl A, Wang Q, Pires V, Knights A, Davidson MB, Child CJ. Glycaemic Control According to the Final Insulin Dose Using an Innovative Fixed-Dose Titration of Weekly Insulin Efsitora in Insulin-Naïve Type 2 Diabetes. Diabetes Obes Metab. 2026;28(7):6217-6224. PubMed PMID: 42070786
  25. Khong TK, Vanniasegaram D. Once-weekly insulin (insulin efsitora) for patients with type 2 diabetes. Drug Ther Bull. 2026;64(7):100-102. PubMed PMID: 42270287
  26. Bajaj HS, Andersen SB, Hristova B, Hulkund S, Kellerer M, Mu Y, Vinther S, Lingvay I. Once-Weekly Insulin Icodec: Safety Profile in Type 2 and Type 1 Diabetes Based on a Pooled Analysis of ONWARDS 1-6. Endocr Pract. 2026;32(10):1475-1482. PubMed PMID: 42119975
  27. Bajaj HS, Fischer M, Davidson MB, Tarafder AM, Michaels CJ, Tao RH, Pashley A, Amis J, Redig J. 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. Diabetes Obes Metab. 2026;28(11):10725-10735. PubMed PMID: 42680157

Regulatory Documents

  1. U.S. Food and Drug Administration. Insulin icodec-abae: approval letter, BLA 761326, 26 March 2026. accessdata.fda.gov
  2. U.S. Food and Drug Administration. Insulin icodec-abae: supplement approval letter (children 10 years and older) and prescribing information, revised October 2026. Letter · Label
  3. U.S. Food and Drug Administration. Insulin efsitora alfa-gobe: approval letter, BLA 761408, 23 September 2026, and prescribing information. Letter · Label
  4. European Medicines Agency. Insulin icodec: European public assessment report, medicine overview (authorised 17 May 2024). ema.europa.eu

PubMed Topic Searches

  1. PubMed: insulin icodec randomised trials
  2. PubMed: insulin efsitora alfa and the QWINT trials
  3. PubMed: once-weekly basal insulin, type 1 diabetes and hypoglycemia
  4. PubMed: once-weekly insulin and pregnancy

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