Eli Lilly and Company

Lilly's capital commitments to expand manufacturing in its home state now total $21 billion since 2020

Lilly Lebanon Advanced Therapies opens as company's first dedicated genetic medicine manufacturing facility

LEBANON, Ind., May 6, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced an additional $4.5 billion investment across two of its three Lebanon sites—bringing the company's total Indiana capital expansion commitments since 2020 to more than $21 billion. Lilly's evolving pipeline, as well as anticipated demand for its medicines, prompted this additional commitment. The investment will incorporate new process designs and technologies at Lilly Lebanon API, one of the company's future active pharmaceutical ingredient sites, as well as Lilly Lebanon Advanced Therapies, its first dedicated genetic medicine manufacturing facility opening today.

Lilly Lebanon Advanced Therapies is designed to support both clinical and commercial production of advanced therapies that target disease at the genetic level and will include a full spectrum of genetic medicine modalities from research-stage development through large-scale commercial supply. Designing and building for these modalities required developing new manufacturing processes without established commercial precedent. This facility is the first of three planned sites on the Lebanon campus, which will also include Lilly Lebanon API and the Lilly Medicine Foundry.

Lebanon, Indiana, is the cornerstone of Lilly's domestic manufacturing buildout. In 2024, Lilly announced plans to make both Zepbound® (tirzepatide) and Mounjaro® (tirzepatide), the most prescribed injectable medications for weight management¹ and type 2 diabetes² respectively, at its Lebanon API site. Today's investment expands that commitment further, including planned production of Foundayo™ (orforglipron), Lilly's first FDA-approved, once-daily pill for weight loss that can be taken without food or water restrictions,³ and retatrutide, an investigational triple hormone receptor agonist in late-stage development for obesity and cardiometabolic disease.

"Lilly's legacy of firsts in Indiana continues today—and the best measure of that legacy is what we do next," said David A. Ricks, Lilly chair and CEO. "From genetic medicines that could one day prevent disease at its source, to Foundayo, a pill making weight loss treatment accessible to millions, we are not just discovering the medicines of the future—we are building the world's most advanced plants to make them. When our Lebanon API site opens in 2027, it will be the largest API production site in U.S. history, a commitment we chose to build here, at home."

"This expansion reflects the strength of a long-standing partnership between Lilly and the state of Indiana – one that continues to deliver real results for Hoosiers," said Governor Mike Braun. "With this investment in Lebanon and across the state, Indiana is reinforcing its position as a prime destination for life sciences and advanced manufacturing, spanning innovation, production and global distribution. Together, we are helping lead the future of medicine while creating high-quality jobs and new opportunities for our communities."

Lilly's manufacturing investment extends well beyond its campus walls. According to a report that will be released next week by Indiana University's Kelley School of Business, Indiana Business Research Center, "Measuring Lilly's Economic and Civic Contributions in Indiana," Lilly accounts for 70% of Indiana's pharmaceutical GDP and every Lilly job supports more than two additional jobs across the state. Further, the company estimates that for every dollar it spends in the area, up to four dollars in additional local economic activity is generated.

"Findings from the Kelley School's Indiana Business Research Center report demonstrate Lilly's investments in Indiana are transforming communities across the state in meaningful and far-reaching ways," IU President Pamela Whitten said. "Lilly's sustained investments since 2020 underscore the growing strength of Indiana's life sciences sector. Progress at this scale is possible only through robust partnerships, and Indiana University is moving with purpose alongside Lilly to advance innovation that improves health, prepares a world-class workforce and drives economic vitality."

Lilly's U.S. capital expansion commitments since 2020 total more than $50 billion, investments made possible thanks to policies that promote domestic manufacturing. The company plans to break ground on several of its recently announced U.S. manufacturing sites this year.  

Optional Quote for Media:

"Today's announcement is a milestone for the City of Lebanon, a testament to the strength of our local workforce, and the vitality of our city," said Matt Gentry, Mayor of Lebanon. "Lilly has been an incredible partner, and their decision to further invest in our community ensures that Lebanon will remain at the forefront of the pharmaceutical industry for decades to come. We look forward to the continued growth and the positive impact this will have on our city and the entire state of Indiana."

About Zepbound^® (tirzepatide) injection 

Zepbound^® (tirzepatide) is the first and only dual GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist obesity medication. Zepbound tackles an underlying cause of excess weight. It reduces appetite and how much you eat. Zepbound is indicated for adults with obesity, or some adults who are overweight and also have at least one weight-related medical problem, to lose weight and keep it off. Additionally, Zepbound is FDA-approved to treat adults with moderate-to-severe obstructive sleep apnea and obesity. Zepbound should be used with a reduced-calorie diet and increased physical activity. 

About Mounjaro^®  (tirzepatide) injection

Mounjaro^® (tirzepatide) is an injectable medicine for adults and children 10 years of age and older with type 2 diabetes used along with diet and exercise to improve blood sugar (glucose). As the first and only FDA-approved GIP and GLP-1 receptor agonist, Mounjaro is a single molecule that activates the body's receptors for GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1). It is not known if Mounjaro is safe and effective for use in children under 10 years of age. 

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 without restrictions on food and water intake.² Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018. In addition to chronic weight management, Foundayo 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 retatrutide 

Retatrutide is an investigational once-weekly triple hormone receptor agonist. Retatrutide is a single molecule that activates the body's receptors for glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-1 (GLP-1), and glucagon. Lilly is studying retatrutide in several Phase 3 clinical trials to evaluate its potential efficacy and safety in obesity and overweight with at least one weight-related medical problem, type 2 diabetes, knee osteoarthritis, moderate-to-severe obstructive sleep apnea, chronic low back pain, cardiovascular and renal outcomes, and metabolic dysfunction-associated steatotic liver disease. Retatrutide is an investigational molecule that is legally available only to participants in Lilly's clinical trials. 

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 www.fda.gov/medwatch.  

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 will be 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 contact Lilly at 1-800-LillyRx (1-800-545-5979). 

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 www.zepbound.lilly.com. 

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 25FEB2026  

Zepbound®, its delivery device base and KwikPen® are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates. 

INDICATION AND SAFETY SUMMARY WITH WARNINGS

Mounjaro® (mown-JAHR-OH) is an injectable medicine for adults and children 10 years of age and older with type 2 diabetes used along with diet and exercise to improve blood sugar (glucose).  

• • It is not known if Mounjaro is safe and effective for use in children under 10 years of age.  

Warnings - Mounjaro 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 Mounjaro if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC). 
• Do not use Mounjaro if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). 
• Do not use Mounjaro if you are allergic to it or any of the ingredients in Mounjaro. 

Mounjaro may cause serious side effects, including: 

Inflammation of the pancreas (pancreatitis). Stop using Mounjaro 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.  

Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Mounjaro with another medicine 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, or mood changes, hunger, weakness and feeling jittery. 

Serious allergic reactions. Stop using Mounjaro 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, and very rapid heartbeat.  

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. 

Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Mounjaro. Tell your healthcare provider if you have stomach problems that are severe or will not go away.  

Changes in vision. Tell your healthcare provider if you have changes in vision during treatment with Mounjaro. 

Gallbladder problems. Gallbladder problems have happened in some people who use Mounjaro. 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), and clay-colored stools. 

Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Mounjaro may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Mounjaro before you are scheduled to have surgery or other procedures. 

Common side effects 

The most common side effects of Mounjaro include nausea, diarrhea, decreased appetite, vomiting, constipation, indigestion, and stomach (abdominal) pain. These are not all the possible side effects of Mounjaro. Talk to your healthcare provider about any side effect that bothers you or doesn't go away.  

Tell your healthcare provider if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch. 

Before using Mounjaro 

• Your healthcare provider should show you how to use Mounjaro before you use it for the first time. 
• Talk to your healthcare provider about low blood sugar and how to manage it. 
• If you take birth control pills by mouth, talk to your healthcare provider before you use Mounjaro. Birth control pills may not work as well while using Mounjaro. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Mounjaro and for 4 weeks after each increase in your dose of Mounjaro. 

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 other 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)?

❑ Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? It is not known if Mounjaro will harm your unborn baby. Mounjaro may pass into your breast milk. 

❑ Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements? 

How to take 

• Read the Instructions for Use that come with Mounjaro.  
• Use Mounjaro exactly as your healthcare provider says.  
• A caregiver may give you Mounjaro injections, or you may self-inject if a healthcare provider determines that it is appropriate. 
• Inject Mounjaro under the skin (subcutaneously) of your stomach (abdomen), thigh, or another person should inject in the back of the upper arm. Do not inject Mounjaro into a muscle (intramuscularly) or vein (intravenously). 
• Use Mounjaro 1 time each week, at any time of the day.  
• Do not mix insulin and Mounjaro together in the same injection. 
• You may give an injection of Mounjaro and insulin in the same body area (such as your stomach area), but not right next to each other. 
• Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection. 
• If you take too much Mounjaro, 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  

Mounjaro is a prescription medicine available as a pre-filled single-dose pen in 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg per 0.5 mL injection. For more information, call 1-800-LillyRX (800-545-5979) or go to www.mounjaro.lilly.com. 

This summary provides basic information about Mounjaro 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 Mounjaro and how to take it. Your healthcare provider is the best person to help you decide if Mounjaro is right for you. 

TR CON BS  19DEC2025

Mounjaro® and its delivery device base are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates. 

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 www.fda.gov/medwatch. 

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. 

Endnotes and References  

1.   Based on IQVIA® National Prescription Audit Data as of April 16, 2026. 

2.   Data based on IQVIA® APLD Claims Data as of January 23, 2026.

3.   Ma X, Liu R, Pratt EJ, Benson CT, Bhattachar SN, Sloop KW. Effect of Food Consumption on the Pharmacokinetics, Safety, and Tolerability of Once-Daily Orally Administered Orforglipron (LY3502970), a Non-peptide GLP-1 Receptor Agonist. Diabetes Ther. 2024 Apr;15(4):819-832. https://doi.org/10.1007/s13300-024-01554-1. Epub 2024 Feb 24. PMID: 38402332; PMCID: PMC10951152. 

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 nearly 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. C-LLY

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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), including about planned capital investments in new manufacturing capacity, production and delivery of medicines, including Foundayo and retatrutide, hiring and related initiatives and the economic impact thereof and reflects Lilly's current beliefs and expectations. However, as with any such undertaking, there are substantial risks and uncertainties in the manufacturing process, development and commercialization of pharmaceutical products any of which could impact the overall commercial success of our products, and as related to cost, completion timing, expected capacity, personnel, and other factors which could impact expected benefits of the capacity expansion and related initiatives. For further discussion of risks and uncertainties relevant to Lilly's business 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.   

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SOURCE Eli Lilly and Company

In LUCENT-3, more than 60% of patients who achieved disease clearance at one year maintained it after four years of continuous Omvoh treatment

Disease clearance is a high clinical bar in UC requiring simultaneous symptomatic, endoscopic and histologic remission

INDIANAPOLIS, May 5, 2026 /PRNewswire/ -- New long-term data from Eli Lilly and Company (NYSE: LLY) show patients with moderately to severely active ulcerative colitis (UC) treated with Omvoh (mirikizumab-mrkz) achieved durable disease clearance through four years of continuous treatment. In the LUCENT-3 open-label extension study, 63.5% of Omvoh-treated patients who achieved disease clearance at one year sustained it at four years. These results will be presented at Digestive Disease Week^® (DDW) and represent the first time an interleukin-23p19 (IL-23p19) inhibitor has demonstrated durable disease clearance through four years in people with UC.¹

Disease clearance is the simultaneous achievement of symptomatic, endoscopic and histologic remission. In real-world studies, achieving disease clearance has been associated with reduced rates of hospitalizations and surgery.^2-3 While previously reported four-year Omvoh data showed durable individual outcomes, this new analysis goes further by evaluating those outcomes together as a composite endpoint, reflecting a higher clinical bar.

"Ulcerative colitis is a lifelong disease, and every person living with the condition deserves a treatment that can deliver strong and durable disease control, not just symptom relief," said Adrienne Brown, executive vice president and president of Lilly Immunology. "Disease clearance sets that bar higher, and these data show Omvoh-treated patients achieved and sustained it over four years with consistent monthly dosing."

Durable Disease Clearance in Ulcerative Colitis

Disease clearance was evaluated among patients who achieved clinical remission with Omvoh at one year in the LUCENT-2 maintenance study and continued treatment in LUCENT-3, an open-label extension study. This analysis, which was not pre-specified, showed 63.5% of Omvoh-treated patients who achieved disease clearance at one year sustained it at four years.^* Even at the most stringent measure — requiring endoscopic normalization in addition to symptomatic and histologic remission — 61.3% of patients who achieved it at one year maintained it through four years.^†

"What makes these data so compelling is that they go beyond individual measures of improvement to show that patients treated with Omvoh achieved disease clearance, with simultaneous symptomatic, endoscopic and histologic remission, maintained over four years," said Jean-Frédéric Colombel, M.D., director of the Susan and Leonard Feinstein Inflammatory Bowel Disease Clinical Center at the Icahn School of Medicine at Mount Sinai. "Until now, disease clearance has not been demonstrated for this length of time for any IL-23p19 therapy in ulcerative colitis. For a progressive disease like ulcerative colitis, that level of durable remission has the potential to change the long-term course of the disease for patients." 

These findings expand the growing body of long-term data on Omvoh in inflammatory bowel disease (IBD), building on previously disclosed four-year results in UC and three-year results in Crohn's disease, including reduction of serious disease-related complications. In LUCENT-3, one UC-related hospitalization and zero UC-related surgeries were reported by patients treated with Omvoh during the three-year long-term extension.⁴

The long-term safety profile in patients with moderately to severely active UC was consistent with the known safety profile of Omvoh with no new safety signals observed. Of patients who completed one year of blinded Omvoh maintenance therapy in LUCENT-2 and continued on to LUCENT-3, 12% reported a serious adverse event, while 7% discontinued treatment due to an adverse event.⁵ The most common adverse reactions (reported in at least 2% of subjects at a higher frequency than placebo) associated with Omvoh treatment in LUCENT-1 and -2 were upper respiratory tract infections, injection site reactions, arthralgia, rash, headache and herpes viral infection.⁶

Lilly continues to advance the standard of care in gastroenterology through the next wave of immunology innovation, including combination approaches, novel mechanisms and the potential of incretins. In UC, Lilly is pursuing combination studies of mirikizumab aimed at delivering breakthrough induction efficacy while maintaining long-term remission and safety. These include studies with eltrekibart (NCT06598943), a monoclonal antibody that targets neutrophil-driven inflammation, and with zotemtegrast (NCT07186101), an oral α4β7 integrin inhibitor. The COMMIT-UC (NCT06937086) and COMMIT-CD (NCT06937099) trials are investigating the concomitant use of mirikizumab and an incretin-based therapy in adults with UC or Crohn's disease and obesity or overweight with at least one additional weight-related comorbid condition. In addition, trials of mirikizumab in pediatric patients are ongoing in UC (NCT05784246) and Crohn's disease (NCT05509777).

Omvoh has received regulatory approvals for the treatment of moderately to severely active UC and moderately to severely active Crohn's disease in adults and has been approved in 47 countries around the world. In the U.S., Omvoh is also approved for a single-injection maintenance regimen in UC.

About the LUCENT Clinical Trial Program

Omvoh was studied in two Phase 3 clinical trials which evaluated the efficacy and safety of Omvoh in adults with moderately to severely active UC, in both biologic-naïve patients and those who had previously failed a biologic or Janus kinase inhibitor (JAKi).

The randomized, double‑blind, placebo‑controlled LUCENT‑1 (induction) study included patients with an inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators, biologic therapy, or JAKi, and LUCENT‑2 (maintenance) evaluated continued treatment versus placebo in patients who achieved a clinical response to Omvoh in LUCENT‑1.⁵

LUCENT-3, the single-arm long-term Phase 3 open-label extension of LUCENT-1 and LUCENT-2, evaluated the efficacy and safety of Omvoh in patients with UC for an additional three years of treatment (up to four years total).

Using a modified non-responder imputation analysis to handle discontinuation and missing data, 49.7% and 42.8% of patients who achieved disease clearance and stringent disease clearance at one year, respectively, sustained it at four years.¹

About Omvoh

Omvoh (mirikizumab-mrkz) is an interleukin-23p19 (IL-23p19) antagonist indicated for the treatment of moderately to severely active ulcerative colitis and Crohn's disease in adults. Omvoh selectively targets the p19 subunit of IL-23 and inhibits the IL-23 pathway. Inflammation due to over-activation of the IL-23 pathway plays a critical role in the pathogenesis of inflammatory bowel disease.⁶

Omvoh and its delivery device base are trademarks owned by Eli Lilly and Company.

Endnotes and References

*Observed cases, post hoc. Symptomatic remission [Mayo stool frequency (SF)=0, or SF=1 with a ≥1-point decrease from baseline, and rectal bleeding=0], and histologic-endoscopic mucosal remission [Histologic remission (Geboes score ≤2B.0) and endoscopic remission (endoscopic subscore [ES] of 0 or 1, excluding friability)].

†Observed cases, post hoc. Symptomatic + histologic remission + endoscopic normalization (ES=0).

¹Magro F, et al. Mirikizumab demonstrates consistent and sustained disease clearance at four years of treatment in patients with moderately to severely active ulcerative colitis. Digestive Disease Week 2026. May 2-5, 2026.

²Andronic AM, et al. J Crohn's Colitis. 2023;17(Supplement_1):i529. https://doi.org/10.1093/ecco-jcc/jjac190.0528

³Pai RK, et al. Expert Rev Gastroenterol Hepatol. 2024;18(1-3):73–87. https://doi.org/10.1080/17474124.2024.2326838

⁴Magro F, et al. J Crohn's Colitis. 2026;20(Suppl 1):jjaf231.1300. https://doi.org/10.1093/ecco-jcc/jjaf231.1300

⁵Sands, B, et al. Mirikizumab provides sustained long-term efficacy up to 4 years of treatment for ulcerative colitis: final results from the LUCENT-3 open-label extension study. 2025 United European Gastroenterology Week. October 4-7, 2025.

⁶Omvoh. Prescribing Information. Lilly USA, LLC.

Indications and Usage for Omvoh^® (mirikizumab-mrkz) (in the United States)

Omvoh is an interleukin-23 antagonist indicated for adults with:

• Moderately to severely active ulcerative colitis
• Moderately to severely active Crohn's disease

Important Safety Information for Omvoh (mirikizumab-mrkz)

CONTRAINDICATIONS

Omvoh is contraindicated in patients with a history of serious hypersensitivity reaction to mirikizumab-mrkz or any of the excipients.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions

Serious hypersensitivity reactions, including anaphylaxis during intravenous infusion, have been reported with Omvoh administration. Infusion-related hypersensitivity reactions, including mucocutaneous erythema and pruritus, were reported during induction. If a severe hypersensitivity reaction occurs, discontinue Omvoh immediately and initiate appropriate treatment.

Infections

Omvoh may increase the risk of infection. Do not initiate treatment with Omvoh in patients with a clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing Omvoh. Instruct patients to seek medical advice if signs or symptoms of clinically important acute or chronic infection occur. If a serious infection develops or an infection is not responding to standard therapy, monitor the patient closely and do not administer Omvoh until the infection resolves.

Tuberculosis

Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Omvoh. Do not administer Omvoh to patients with active TB infection. Initiate treatment of latent TB prior to administering Omvoh. Consider anti-TB therapy prior to initiation of Omvoh in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after Omvoh treatment. In clinical trials, subjects were excluded if they had evidence of active TB, a history of active TB, or were diagnosed with latent TB at screening.

Hepatotoxicity

Drug-induced liver injury in conjunction with pruritus was reported in a clinical trial subject following a longer than recommended induction regimen. Omvoh was discontinued. Liver test abnormalities eventually returned to baseline. Evaluate liver enzymes and bilirubin at baseline and for at least 24 weeks of treatment. Monitor thereafter according to routine patient management. Consider other treatment options in patients with evidence of liver cirrhosis. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Instruct patients to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction.

Immunizations

Avoid use of live vaccines in patients treated with Omvoh. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating therapy, complete all age-appropriate vaccinations according to current immunization guidelines. No data are available on the response to live or non-live vaccines in patients treated with Omvoh.

ADVERSE REACTIONS

Most common adverse reactions associated with Omvoh (≥2% of subjects and at a higher frequency than placebo) in ulcerative colitis treatment are upper respiratory tract infections and arthralgia during the induction study (UC-1), and upper respiratory tract infections, injection site reactions, arthralgia, rash, headache, and herpes viral infection during the maintenance study (UC-2). Most common adverse reactions associated with Omvoh in the Crohn's disease study (CD-1) (≥5% of subjects and at a higher frequency than placebo) are upper respiratory tract infections, injection site reactions, headache, arthralgia, and elevated liver tests.

Omvoh injection is available as a 300 mg/15 mL solution in a single-dose vial for intravenous infusion, and as a 100 mg/mL solution or a 200 mg/2 mL solution in a single dose prefilled pen or prefilled syringe for subcutaneous injection. Refer to the Prescribing Information for dosing information.

MR HCP ISI CD APP

Click to access provided Prescribing Information and Medication Guide. See Instructions for Use provided with the device.

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 nearly 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 references 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 Omvoh (mirikizumab-mrkz) as a treatment for people with moderate to severe ulcerative colitis and moderate to severe Crohn's disease 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 study results to date, that Omvoh will receive additional regulatory approvals, or that Omvoh 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.

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SOURCE Eli Lilly and Company