Foundayo™ (orforglipron), Lilly's new oral GLP-1 pill for weight loss, now available in the U.S.

Foundayo™ (orforglipron), Lilly's new oral GLP-1 pill for weight loss, now available in the U.S.

Foundayo is now available via LillyDirect^® and telehealth providers and is shipping to retail pharmacies nationwide

Foundayo, the only GLP-1 pill for weight loss that can be taken any time of day without food or water restrictions, starts at $25 per month with commercial coverage and $149 per month with self-pay

INDIANAPOLIS, April 9, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that Foundayo™ (orforglipron) is now available to adults with obesity or overweight with weight-related medical problems following the U.S. Food and Drug Administration (FDA) approval on April 1, 2026. When used alongside a reduced-calorie diet and increased physical activity, Foundayo helps individuals lose excess body weight and keep the weight off. Foundayo is a once-daily pill for weight loss that can be taken without food or water restrictions. People can now access Foundayo via LillyDirect^® and telehealth providers, with availability expanding to U.S. retail pharmacies beginning today.

"Foundayo delivers meaningful weight loss – an average of 27 pounds at the highest dose – and we made the path from prescription to doorstep as simple as possible," said Ilya Yuffa, executive vice president and president of Lilly USA and Global Customer Capabilities. "Millions of Americans can now connect with a health care professional to determine if Foundayo is right for them and receive the medicine at their door through LillyDirect's free home delivery, or access it through telehealth providers or local retail pharmacies."

Foundayo is available starting at $149 per month at the lowest dose for self-pay patients.¹ Eligible and commercially insured people with coverage for Foundayo may pay as little as $25 per month with the Foundayo savings card.² Additionally, eligible Medicare Part D individuals may be able to get Foundayo for $50 per month, beginning July 1, 2026. To understand your options, visit www.foundayo.lilly.com.

Supported by the rigorous ATTAIN clinical trial program, Foundayo was proven to help people lose weight and keep it off. In the ATTAIN-1 trial, individuals taking the highest dose of Foundayo and who stayed on treatment lost an average of 27.3 pounds (12.4%) compared to 2.2 pounds (0.9%) with placebo.³ Participants taking Foundayo, regardless of trial completion, lost an average of 25 pounds (11.1%), compared to 5.3 pounds (2.1%) with placebo.⁴ In the ATTAIN program, Foundayo also led to reductions in many markers of cardiovascular risk, including waist circumference, non-HDL cholesterol, triglycerides and systolic blood pressure across all doses.

Use of Foundayo with other GLP-1 receptor agonist medicines is not recommended. It is not known whether Foundayo is safe and effective for use in children. 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 health care provider. 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. Please see Indication and Safety Summary with Warning below and full Prescribing Information and Medication Guide.

To learn more about Foundayo, please visit www.foundayo.lilly.com. To learn more about LillyDirect, please visit www.lilly.com/lillydirect.

Obesity Medicine Access
Obesity remains one of the few major chronic diseases without consistent insurance coverage across U.S. health plans. Even as new medicines transform treatment, approximately half of Americans with employer-sponsored insurance lack coverage for obesity management medications.⁵ As part of Lilly's commitment to expanding obesity medicine access and improving affordability, Lilly has expanded self-pay access for individual patients.

About Foundayo (orforglipron)⁶
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.⁷ Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018. Orforglipron is being studied in clinical trials for other conditions such as type 2 diabetes, obstructive sleep apnea, osteoarthritis knee pain, hypertension, peripheral artery disease and stress urinary incontinence.

About ATTAIN-1 and ATTAIN-2 clinical trial program
The ATTAIN Phase 3 global clinical development program for orforglipron has enrolled more than 4,500 people with obesity or overweight across two global registration trials.

ATTAIN-1 (NCT05869903) was a Phase 3, 72-week, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of orforglipron at various doses to placebo in adults with obesity, or overweight with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease, who did not have diabetes. The trial randomized 3,127 participants across the U.S., Brazil, China, India, Japan, South Korea, Puerto Rico, Slovakia, Spain and Taiwan to receive various doses of orforglipron or placebo along with healthy diet and physical activity. The primary objective of the study was to demonstrate that orforglipron is superior to placebo in body weight reduction from baseline after 72 weeks.

ATTAIN-2 (NCT05872620) was a Phase 3, 72-week, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of various doses of orforglipron with placebo in adults with obesity or overweight and type 2 diabetes. The trial randomized over 1,600 participants across the U.S., Argentina, Australia, Brazil, China, Czechia, Germany, Greece, India, South Korea and Puerto Rico to receive various doses of orforglipron or placebo along with healthy diet and physical activity. The primary objective of the study was to demonstrate that orforglipron is superior to placebo in mean body weight change from baseline at 72 weeks.

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. For self-pay only. Prescription required. Terms apply. Additional taxes and fees may apply. One month is defined as 30 days. For full terms and conditions, learn more at foundayo.lilly.com.
2. Governmental beneficiaries excluded, terms and conditions apply. Learn more at foundayo.lilly.com.
3. The efficacy estimand represents efficacy had all randomized participants remained on study intervention (with possible dose interruptions and modifications) for 72 weeks without initiating prohibited weight management treatments.⁶
4. The treatment-regimen estimand represents the estimated average treatment effect regardless of adherence to study intervention or initiation of prohibited weight management treatments.⁶
5. International Foundation of Employee Benefit Plans. Pulse Survey: GLP-1 Drugs Corporate Only. Published 2024. Accessed November 5, 2025. https://www.ifebp.org/docs/default-source/pdf/resources---news/pulse-surveys/survey-glp-drugs-2024.pdf.
6. Foundayo. Prescribing Information. Lilly USA, LLC.
7. 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. 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 Foundayo (orforglipron) as a treatment for adults with obesity or some adults with overweight who also have weight-related medical problems 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 can be no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with the results to date, that orforglipron will receive additional regulatory approvals, or that orforglipron will be commercially successful or that we will meet anticipated timelines for its commercialization. For further discussion of these and other risks and uncertainties, see Lilly's most recent 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-20652 04/2026 ©Lilly USA, LLC 2026. All rights reserved.

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