Insulin Glargine(Boehringer Ingelheim)

In ACHIEVE-4, participants taking Foundayo experienced a 16% lower risk of MACE-4 and a 23% lower risk of MACE-3, meeting the primary objective for non-inferiority compared to insulin glargine In pre-planned analyses, Foundayo showed a 53% lower risk of cardiovascular death and a 57% lower risk of all-cause death vs. insulin glargine, suggesting the potential for more comprehensive health benefits INDIANAPOLIS, Sept. 30, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY), the maker of Zepbound (tirzepatide), today announced detailed results from the Phase 3 ACHIEVE-4 trial evaluating the efficacy and safety of Foundayo (orforglipron) compared to titrated insulin glargine in adults with type 2 diabetes and obesity or overweight at increased cardiovascular risk. In the trial, which is the largest and longest study of this medicine in type 2 diabetes to date, Foundayo demonstrated a non-inferior risk of major adverse cardiovascular events (MACE) and improved A1C, weight and other key measures of cardiometabolic health compared with insulin glargine. Results from the trial were presented at the 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Milan, Italy, and simultaneously published in The Lancet. "For people living with type 2 diabetes, protecting the heart is as important as controlling blood sugar," said Klara Klein, M.D., Ph.D., Assistant Professor of Medicine, University of North Carolina School of Medicine. "ACHIEVE-4 reaffirmed the safety of orforglipron and demonstrated an association with a lower risk of major cardiovascular events and death. These results, paired with the simple administration of a once-daily pill, taken without fasting or water restrictions, could make orforglipron a compelling potential option across the globe." In the trial, the risk of cardiovascular death, heart attack, stroke, or hospitalization for unstable sudden chest pain (MACE-4) was 16% lower for Foundayo vs. insulin glargine (hazard ratio: 0.84; 95.0% CI: 0.59 to 1.20), meeting the prespecified criteria for demonstrating non-inferiority (upper limit of 95.0% CI of the hazard ratio < 1.8).1 The risk of cardiovascular death, heart attack, or stroke (MACE-3) was 23% lower for Foundayo vs. insulin glargine (hazard ratio: 0.77; 95.0% CI: 0.52 to 1.13). In pre-planned analyses, the risk of cardiovascular death was 53% lower (hazard ratio: 0.47; 95.0% CI: 0.25 to 0.90) and the risk of all-cause death was 57% lower (hazard ratio: 0.43; 95.0% CI: 0.25 to 0.75) for Foundayo vs. insulin glargine.2 In addition to demonstrating cardiovascular safety, Foundayo was associated with meaningful improvements across multiple cardiovascular risk factors. At week 52, participants treated with Foundayo experienced reductions in waist circumference by 7.0 cm, systolic blood pressure by 4.4 mmHg, triglycerides by 18.9%, non-HDL cholesterol by 6.6% and hsCRP, a marker of inflammation, by 38.9%.2 Foundayo was also associated with a slower decline in kidney function, a key contributor to cardiovascular risk, including a 2.8 mL/min/1.73 m² smaller reduction in eGFR and a 27.1% greater reduction in albuminuria compared to insulin glargine.2 ACHIEVE-4 Detailed Results "Foundayo has consistently delivered strong efficacy in type 2 diabetes across our Phase 3 ACHIEVE program," said Thomas Seck, M.D., senior vice president of product development, Lilly Cardiometabolic Health. "In ACHIEVE-4, our largest and longest study of this medicine, Foundayo helped more than half of participants reach an A1C of 6.5% or lower, with durable reductions in A1C and body weight and a favorable overall safety profile. This kind of efficacy reinforces our confidence that Foundayo could change how physicians and patients approach the treatment of type 2 diabetes." The overall safety and tolerability profile of Foundayo in ACHIEVE-4 was generally consistent with previous trials and with other incretins. The most common adverse events for participants taking Foundayo were nausea, vomiting, diarrhea, decreased appetite, and constipation. During the 52-week minimum treatment period, 10.6% of participants taking Foundayo discontinued treatment due to adverse events. To further evaluate the impact Foundayo has on cardiovascular outcomes in adults with obesity or overweight with or without type 2 diabetes, Lilly is conducting ATTAIN-OUTCOMES, an ongoing Phase 3 study in adults with established cardiovascular or kidney disease. About Foundayo (orforglipron) Foundayo™ (orforglipron) is FDA-approved for adults with obesity, or some adults with overweight who also have weight-related medical problems, to reduce excess body weight and maintain weight reduction long term, alongside a reduced-calorie diet and increased physical activity. Foundayo is a once-daily small molecule (non-peptide) oral glucagon-like peptide-1 receptor agonist that can be taken any time of the day with no planning around food or drink. Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018. In addition to chronic weight management, orforglipron is being studied as a potential treatment for type 2 diabetes, obstructive sleep apnea, osteoarthritis knee pain, hypertension, peripheral artery disease and stress urinary incontinence. About ACHIEVE-4 and ACHIEVE clinical trial program ACHIEVE-4 (NCT05803421) is a Phase 3, event-driven, randomized, open-label trial evaluating the efficacy and safety of Foundayo compared with insulin glargine U-100 in adults with type 2 diabetes and obesity or overweight (BMI ≥25 kg/m2) with increased risk of cardiovascular events. The trial randomized 2,749 participants across the U.S., Argentina, Austria, Brazil, Czechia, Germany, Greece, India, Italy, Mexico, Puerto Rico, Romania, Slovakia, South Korea, Spain and Turkey to receive either escalating doses of Foundayo or insulin glargine. The primary objective of the study was to demonstrate that Foundayo was non-inferior in the risk of major adverse cardiovascular events (MACE-4) compared to insulin glargine in adults with type 2 diabetes and obesity or overweight with increased risk for cardiovascular events who have taken at least one and no more than three oral anti-diabetic medications for at least 90 days prior to study start. Study participants had an A1C between ≥7.0% and ≤10.5% (≥7.5% and ≤10.5% if background diabetes medication included a sulfonylurea) and a BMI of ≥25 kg/m2 with stable weight (±5%) for at least 90 days prior to study start. Participants randomized to Foundayo initiated treatment with 0.8 mg once daily and increased the dose every four weeks until reaching a maximum tolerated dose (up to 17.2 mg). The trial was conducted using an investigational formulation of Foundayo at dosages equivalent to Foundayo tablets. The ACHIEVE Phase 3 global clinical development program for Foundayo began in 2023 and enrolled more than 6,000 people with type 2 diabetes across five global registration trials. Endnotes Time to first event analysis using Cox proportional hazard model using all randomized participants exposed to ≥1 dose of study intervention. All-cause death, waist circumference, serum lipids, blood pressure, hsCRP, cardiovascular death and kidney function endpoints were not controlled for family-wise type 1 error. Waist circumference, eGFR, albuminuria, serum lipids, blood pressure and hsCRP were based on efficacy estimand. The efficacy estimand represents efficacy had all randomized participants remained on study intervention (with possible dose interruptions and/or dose modifications) without initiating additional antihyperglycemic medications (>14 days of use). U.S. FOUNDAYO INDICATION AND SAFETY SUMMARY WITH WARNINGS Foundayo (fown-DAY-oh) is a prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off. Foundayo should not be used with other GLP-1 receptor agonist medicines. It is not known if Foundayo is safe and effective for use in children. Warnings – Foundayo may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider. Do not use Foundayo if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC). Do not use Foundayo if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use Foundayo if you have had a serious allergic reaction to orforglipron or any of the ingredients in Foundayo. Foundayo may cause serious side effects, including: Inflammation of the pancreas (pancreatitis). Stop taking Foundayo and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back. Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Foundayo. Tell your healthcare provider if you have stomach problems that are severe or will not go away. Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away. Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Foundayo with medicines that can cause low blood sugar, such as an insulin or sulfonylurea. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness, or feeling jittery. Serious allergic reactions. Stop using Foundayo and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat. Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Foundayo. Gallbladder problems. Gallbladder problems have happened in some people who use Foundayo. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools. Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Foundayo may increase the chance of food getting into your lungs during surgery or other procedures. Tell your healthcare providers that you are taking Foundayo before you are scheduled to have surgery or other procedures. Common side effects The most common side effects of Foundayo include nausea, constipation, diarrhea, vomiting, indigestion, stomach (abdominal) pain, headache, swollen belly, feeling tired, belching, heartburn, gas, and hair loss. These are not all the possible side effects of Foundayo. Talk to your healthcare provider about any side effect that bothers you or doesn't go away. Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or . Before taking Foundayo Tell your healthcare provider about all the medicines you take. Foundayo may affect the way some medicines work, and some medicines may affect the way Foundayo works. Pregnancy Exposure Registry: There will be a pregnancy exposure registry for women who have taken Foundayo during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979). If you take birth control pills by mouth, talk to your healthcare provider before you take Foundayo. Birth control pills may not work as well while taking Foundayo. Your healthcare provider may recommend another type of birth control for 30 days after starting Foundayo and for 30 days after each dose increase of Foundayo. Talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea. Review these questions with your healthcare provider: ❑ Do you have other medical conditions, including problems with your pancreas or kidneys, or severe problems with your liver, severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food? ❑ Do you have a history of diabetic retinopathy? ❑ Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)? ❑ Are you pregnant or plan to become pregnant? Foundayo may harm your unborn baby. ❑ Are you breastfeeding or plan to breastfeed? Breastfeeding is not recommended during treatment with Foundayo. ❑ Do you take any other prescriptions or over-the-counter medicines, vitamins, or herbal supplements? How to take Take Foundayo exactly as your healthcare provider tells you to. Use Foundayo with a reduced-calorie diet and increased physical activity. Take Foundayo by mouth 1 time each day, with or without food. Swallow tablets whole. Do not break, crush, or chew the tablet. If you miss a dose, take it as soon as possible. Do not take 2 doses of Foundayo in the same day. Do not take more than 1 tablet per day. If you miss taking Foundayo for 7 or more days in a row, call your healthcare provider to talk about how to restart your treatment. If you take too much Foundayo, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away. Learn more Foundayo is a prescription medicine available in 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg oral tablets. For more information, call 1-800-545-5979 or go to foundayo.lilly.com. This summary provides basic information about Foundayo but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Foundayo and how to take it. Your doctor is the best person to help you decide if Foundayo is right for you. OG CON BS APR2026 Foundayo™ is a trademark of Eli Lilly and Company. U.S. ZEPBOUND INDICATIONS AND SAFETY SUMMARY WITH WARNINGS Zepbound® (ZEHP-bownd) is an injectable prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with: obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off. moderate-to-severe obstructive sleep apnea (OSA) and obesity to improve their OSA. Zepbound contains tirzepatide and should not be used with other tirzepatide-containing products or any GLP-1 receptor agonist medicines. It is not known if Zepbound is safe and effective for use in children. Warnings - Zepbound may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider. Do not use Zepbound if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC). Do not use Zepbound if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use Zepbound if you have had a serious allergic reaction to tirzepatide or any of the ingredients in Zepbound. KwikPen®: Do not share your KwikPen with other people, even if the pen needle has been changed. You may give other people a serious infection or get a serious infection from them. Zepbound may cause serious side effects, including: Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Zepbound. Tell your healthcare provider if you have stomach problems that are severe or will not go away. Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away. Gallbladder problems. Gallbladder problems have happened in some people who use Zepbound. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools. Inflammation of the pancreas (pancreatitis). Stop using Zepbound and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. You may feel the pain from your abdomen to your back. Serious allergic reactions. Stop using Zepbound and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat. Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Zepbound with medicines that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness or feeling jittery. Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Zepbound. Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Zepbound may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Zepbound before you are scheduled to have surgery or other procedures. Common side effects The most common side effects of Zepbound include nausea, diarrhea, vomiting, constipation, stomach (abdominal) pain, indigestion, injection site reactions, feeling tired, allergic reactions, belching, hair loss, and heartburn. These are not all the possible side effects of Zepbound. Talk to your healthcare provider about any side effect that bothers you or doesn't go away. Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or . Before using Zepbound Your healthcare provider should show you how to use Zepbound before you use it for the first time. Talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea. If you take birth control pills by mouth, talk to your healthcare provider before you use Zepbound. Birth control pills may not work as well while using Zepbound. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Zepbound and for 4 weeks after each increase in your dose of Zepbound. Review these questions with your healthcare provider: ❑ Do you have other medical conditions, including problems with your pancreas, or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food? ❑ Do you take diabetes medicines, such as insulin or sulfonylureas? ❑ Do you have a history of diabetic retinopathy? ❑ Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)? ❑ Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements? ❑ Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? Zepbound may harm your unborn baby. Tell your healthcare provider if you become pregnant while using Zepbound. Zepbound may pass into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using Zepbound. Pregnancy Exposure Registry: There is a pregnancy exposure registry for women who have taken Zepbound during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may call 1-844-524-0039 or email at [email protected] or visit . How to take Read the Instructions for Use that come with Zepbound. Use Zepbound exactly as your healthcare provider says. Use Zepbound with a reduced-calorie diet and increased physical activity. Inject Zepbound under the skin (subcutaneously) of your stomach (abdomen), thigh, or have another person inject in the back of the upper arm. Do not inject ZEPBOUND into a muscle (intramuscularly) or vein (intravenously). Use Zepbound 1 time each week, at any time of the day. Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection. If you take too much Zepbound, call your healthcare provider, call the Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away. Zepbound is approved as a 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg injection. Learn more Zepbound is a prescription medicine. For more information, call 1-800-LillyRx (1-800-545-5979) or go to . This summary provides basic information about Zepbound but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Zepbound and how to take it. Your healthcare provider is the best person to help you decide if Zepbound is right for you. ZP CON BS 01SEP2026 Zepbound®, its delivery device base and KwikPen® are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates. About Lilly Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLY Trademarks and Trade Names All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies. Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Foundayo (orforglipron) as a potential treatment for adults with type 2 diabetes, potential efficacy and tolerability of Foundayo, and the timeline for future readouts, presentations, and other milestones relating to Foundayo and its clinical trials and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with expectations or study results to date, that Foundayo will prove to be a safe and effective treatment for type 2 diabetes, that Foundayo will receive additional regulatory approvals, or that Lilly will execute its strategy as expected. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. SOURCE Eli Lilly and Company 21% more press release views with Request a Demo

Onswik is designed to reduce injections by over 300 per year versus once-daily basal insulin 1,2 With Onswik, Lilly's type 2 diabetes portfolio expands to include a once-weekly basal insulin, alongside existing treatment options across insulins, incretins, oral and injectable medications INDIANAPOLIS , Sept. 24, 2026 /PRNewswire/ -- Eli Lilly and Company today announced the U.S. Food and Drug Administration (FDA) approval of Onswik™ (insulin efsitora alfa-gobe), a once-weekly basal insulin, indicated along with diet and exercise to control high blood sugar in adults with type 2 diabetes. Onswik is designed to deliver steady basal insulin levels over a full seven days. 2 "For over a century, Lilly has been developing insulins that transformed diabetes care for millions of people worldwide, but delays in initiating treatment and the burden of daily injections can have a real impact on patients' day-to-day experience managing type 2 diabetes," said Kenneth Custer, Ph.D., executive vice president and president, Lilly Cardiometabolic Health. "Onswik offers a new once-weekly basal insulin option for patients and reflects our continued commitment to deliver innovative treatment options that expand choice and provide greater flexibility in how people manage type 2 diabetes." This is the fourth global approval for Onswik for adults with type 2 diabetes, following regulatory actions from the European Medicines Agency (EMA), Mexico's Federal Commission for the Protection against Sanitary Risks (COFEPRIS) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA). 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. In each QWINT trial, once-weekly Onswik met the primary endpoint of non-inferior A1C reduction from baseline that was comparable to insulin glargine U-100 (glargine) or insulin degludec U-100 (degludec). 2-6 In these clinical trials, Onswik demonstrated an overall safety pro to the daily basal insulins studied. 3-6 Onswik should not be used by people who have type 1 diabetes due to increased risk of severe hypoglycemia (low blood sugar). Common side effects of Onswik include low blood sugar, allergic reactions, reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy), itching, rash, swelling of hands and feet, and weight gain. Please see Indication and Safety Summary below and full Prescribing Information and Patient Information . Around one in eight Americans live with diabetes, and most of them have type 2 diabetes. 7 Globally by 2030, over 510 million people are expected to live with the disease and 38 million of these are expected to use insulin. 8 Insulin remains an important treatment option for many people with type 2 diabetes who do not achieve glycemic goals with other therapies. 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). For more information about Onswik, please visit . About Onswik (insulin efsitora alfa-gobe) Onswik (insulin efsitora alfa-gobe) is a once-weekly basal insulin injection, FDA approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Its approval is supported by the QWINT clinical trial program, which evaluated its safety and efficacy in over 3,400 adults with type 2 diabetes. Onswik is also approved by the European Medicines Agency (EMA), the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) in Mexico and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for the treatment of adults with type 2 diabetes mellitus. About the QWINT clinical trial program The QWINT Phase 3 global clinical development program for insulin efsitora alfa-gobe (efsitora) in diabetes began in 2022 and enrolled over 3,400 people living with type 2 diabetes across four global registration studies. QWINT-1 (NCT05662332) was a parallel-design, open-label, treat-to-target, randomized controlled clinical trial comparing the efficacy and safety of efsitora as a once-weekly basal insulin using a fixed-dosage escalation to daily insulin glargine for 52 weeks in insulin-naïve adults with type 2 diabetes. The trial randomized 795 participants across the U.S., Argentina and Mexico to receive efsitora once weekly or insulin glargine once daily, administered subcutaneously. Participants treated with efsitora received a starting dose of 100 units of insulin, followed by escalation to fixed dosages of 150 units, 250 units and 400 units every four weeks, as needed, until achieving a target fasting blood glucose of 80-130 mg/dL. Participants with fasting blood glucose greater than 130 mg/dL on or after 16 weeks underwent additional weekly dosage adjustments as needed. The primary objective of the trial was to demonstrate non-inferiority in reducing A1C at week 52 with efsitora compared to daily use of insulin glargine. QWINT-2 (NCT05362058) was a parallel-design, open-label, treat-to-target, randomized controlled clinical trial comparing the efficacy and safety of efsitora as a once-weekly basal insulin to insulin degludec for 52 weeks in insulin-naïve adults with type 2 diabetes. The trial randomized 928 participants across the U.S., Brazil, Canada, China, Czechia (Czech Republic), Germany, Greece, Japan, Korea, Mexico and Puerto Rico to receive efsitora once weekly or insulin degludec once daily administered subcutaneously. The primary objective of the trial was to demonstrate non-inferiority in reducing A1C at week 52 with efsitora compared to insulin degludec. The trial was also designed to assess efficacy and safety for patients using and not using GLP-1 receptor agonists. QWINT-3 (NCT05275400) was a multicenter, randomized, parallel-design, open-label trial comparing the efficacy and safety of efsitora as a once-weekly basal insulin to insulin degludec for 78 weeks after a three-week lead-in followed by a five-week safety follow up period, in adults with type 2 diabetes who are currently treated with basal insulin. The trial randomized 986 participants across the U.S., Argentina, Hungary, Japan, Korea, Poland, Puerto Rico, Slovakia, Spain and Taiwan to receive efsitora once weekly or insulin degludec once daily, administered subcutaneously. The primary objective of the study was to demonstrate non-inferiority in reducing A1C at week 26 with efsitora compared to insulin degludec. QWINT-4 (NCT05462756) was a parallel-design, open-label, treat-to-target, randomized controlled clinical trial comparing the efficacy and safety of efsitora as a weekly basal insulin to insulin glargine for 26 weeks in adults with type 2 diabetes who have previously been treated with basal insulin and at least two injections per day of mealtime insulin. The trial randomized 730 participants across the U.S., Argentina, Germany, India, Italy, Mexico, Puerto Rico and Spain to receive efsitora once weekly or insulin glargine once daily, both of which were administered subcutaneously along with insulin lispro. The primary objective of the trial was to demonstrate non-inferiority in reducing A1C at week 26 with efsitora compared to insulin glargine. INDICATION AND SAFETY SUMMARY Onswik™ (ON-swihk) is a long-acting insulin that is used with diet and exercise to control high blood sugar in adults with type 2 diabetes mellitus. • Onswik should not be used by people who have type 1 diabetes mellitus. • It is not known if Onswik is safe and effective in children. Onswik™ KwikPen ® is available in 2 concentrations: U-500 and U-1,000 • U-500 (500 units/mL) prefilled pen can be injected in 5-unit increments and can deliver up to 400 units in a single injection. • U-1,000 (1,000 units/mL) prefilled pen can be injected in 10-unit increments and can deliver up to 800 units in a single injection. Warnings – Do not take Onswik if you: • are having an episode of low blood sugar (hypoglycemia) • have an allergy to insulin efsitora alfa-gobe or any of the ingredients in Onswik Do not share your Onswik KwikPen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them. Make sure you use the right type and dose of insulin. Always check the label on your insulin pen before each injection to avoid mix-ups with Onswik and other insulin products or injectable medicines used to treat diabetes. Pay close attention to how you select your Onswik dosage, which is different from other injectable diabetes medicines. Always make sure that you select the correct dosage of your Onswik KwikPen as prescribed by your healthcare provider, to avoid dosing errors and accidental overdose. People who are blind or have vision problems should not use this pen without help from a person trained to use the pen. Do not dial the maximum single dosage (400 units or 800 units) of your Onswik KwikPen, unless prescribed by your healthcare provider. Do not use a syringe to withdraw Onswik from your pen. Talk to your healthcare provider if you have any questions about how to correctly dose Onswik KwikPen. Onswik may cause serious side effects that can lead to death, including: • Low blood sugar (hypoglycemia). Signs and symptoms may include: dizziness or light-headedness, anxiety, irritability, mood change, confusion, shakiness, blurred vision, slurred speech, fast heartbeat, sweating, hunger, or headache. • Severe allergic reactions (whole body reaction). Stop using Onswik and get medical help right away if you have any of these signs or symptoms: rash over your whole body, fast heartbeat, trouble breathing, or sweating. • Low potassium in your blood (hypokalemia). • Heart failure. Taking diabetes pills called thiazolidinediones or TZDs with Onswik may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you have heart failure, it may get worse if you take TZDs with Onswik. Your healthcare provider should monitor you closely while you are taking TZDs with Onswik. Tell your healthcare provider if you have any new or worse symptoms of heart failure including: shortness of breath, sudden weight gain, swelling of your ankles or feet, or tiredness. Your healthcare provider may need to change or stop treatment with TZDs and Onswik. Your insulin dose may need to be changed because of: a change in level of physical activity or exercise, weight gain or loss, increased stress, change in diet, illness, or other medicines you take. Get emergency medical help if you have: trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, or confusion. Common side effects The most common side effects of Onswik include: low blood sugar (hypoglycemia), allergic reactions, reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy), itching, rash, swelling of your hands and feet, and weight gain. These are not all the possible side effects of Onswik. Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or . Before using Before taking Onswik, tell your healthcare provider about all your medical conditions and medicines you take, including if you: have liver or kidney problems. take diabetes medicines called TZDs. have heart problems. If you have heart failure, it may get worse while you take TZDs with Onswik. are pregnant, planning to become pregnant, or are breastfeeding. It is not known if Onswik may harm your unborn or breastfeeding baby. take prescription or over-the-counter medicines, vitamins, or herbal supplements. Before you start Onswik, talk to your healthcare provider about low blood sugar and how to manage it. How to take Read the Instructions for Use that come with your Onswik KwikPen. Your healthcare provider should show you how to use Onswik KwikPen before you use it for the first time. Take Onswik exactly as your healthcare provider tells you. Know the type, strength and amount of insulin you take. Do not change the type of insulin unless your healthcare provider tells you to. Inject Onswik 1 time each week, on the same day of the week. If you need to change the day of the week, you may do so at least 4 days since your last dose. Then continue to inject Onswik 1 time each week on the new day you have chosen. If you miss a dose of Onswik, take the missed dose as soon as possible within 4 days (96 hours) after the missed dose, then continue your regular weekly dose schedule. If more than 4 days have passed, skip the missed dose and take your next dose on the regularly scheduled day or take the missed dose then change your regular weekly dose schedule to start 1 week after your missed dose was injected. If you accidentally take your 1-time starting dose more than 1 time (2 times in a row) or take your weekly dose more than 1 time in the same week, skip your next week's dose. Inject Onswik under the skin (subcutaneously) of your stomach area, buttocks, thigh or back of the upper arms. Do not use Onswik in an insulin pump or inject Onswik into your vein or muscle. Change (rotate) your injection sites within the area you choose with each dose. Do not use the exact same spot for each injection. Do not inject into skin that is thickened or has pits or lumps. Do not inject into skin that is tender, bruised, scaly, or hard or into scars or damaged skin. Always use a new needle for each injection. If your needle is blocked, get a new needle. Do not reuse or share your needles with other people. Do not use a syringe to remove the solution from the pen. Do not dilute or mix Onswik with another insulin or liquid medicine. Check your blood sugar levels. Ask your healthcare provider what your blood sugar levels should be and when you should check your blood sugar levels. While taking Onswik, do not: drive or operate heavy machinery, until you know how Onswik affects you. drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Learn more Onswik is a prescription medicine available as a 500 units/mL or 1,000 units/mL injection in a 3 mL pre-filled, single-patient-use pen. For more information, call 1-800-545-5979 or go to onswik.lilly.com . This summary provides basic information about Onswik but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Onswik and how to take it. Your doctor is the best person to help you decide if Onswik is right for you. EF CON BS SEP2026 Onswik™ is a trademark and KwikPen ® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates. Endnotes and References Based on approximate number of injections per year for Onswik (52 injections) vs a once-daily basal insulin (365 injections). This information is not intended to make a comparison of safety or efficacy. Onswik. Prescribing Information. Lilly USA, LLC. Rosenstock J, Bailey T, Connery L, et al. Weekly fixed-dose insulin efsitora in type 2 diabetes without previous insulin therapy. N Engl J Med . 2025;393(4)(Incl suppl append):325-335. doi:10.1056/NEJMoa2502796 Wysham C, Bajaj HS, Del Prato S, et al. Insulin efsitora versus degludec in type 2 diabetes without previous insulin treatment. N Engl J Med . 2024;391(23)(Incl suppl mat):2201-2211. doi:10.1056/NEJMoa2403953 Philis-Tsimikas A, Bergenstal RM, Bailey TS, et al. 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)(Incl suppl mat):2279-2289. doi:10.1016/S0140-6736(25)01044-X Blevins T, Dahl D, Pérez Manghi FC, et al. 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. doi:10.1016/S0140-6736(25)01069-4 Centers for Disease Control and Prevention. About type 2 diabetes. CDC. Accessed August 10, 2026. Basu S, Yudkin JS, Kehlenbrink S, et al. Estimation of global insulin use for type 2 diabetes, 2018–30: a microsimulation analysis. Lancet Diabetes Endocrinol. 2019;7(1):25-33. doi:10.1016/S2213-8587(18)30303-6. Available from: About Lilly Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news , or follow us on Facebook , Instagram , and LinkedIn . P-LLY Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Onswik as a treatment for adults with type 2 diabetes and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that future study results will be consistent with study results to date, that Onswik will receive additional regulatory approvals, or that Onswik will be commercially successful. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. Trademarks and Trade Names All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies. CMAT-49583 09/2026 ©Lilly USA, LLC 2026. All rights reserved. Refer to: Rachel Sorvig; sorvig_rachel@lilly.com (Media) Michael Czapar; czapar_michael_c@lilly.com (Investors) View original content to download multimedia: SOURCE Eli Lilly and Company