Lilly to offer all approved doses of Zepbound (tirzepatide) single-dose vials through LillyDirect Self Pay Pharmacy Solutions

With the addition of 12.5 mg and 15 mg vials, all approved doses of Zepbound will be available in single-dose vials for $499/month or less, regardless of insurance status, under Zepbound Self Pay Journey Program

In a clinical trial, adults with obesity or overweight and a weight-related medical condition taking Zepbound 15 mg lost 48 lbs (~21% weight loss) and approximately 1 in 3 on Zepbound 15 mg lost over 58 lbs (25% weight loss)

INDIANAPOLIS, June 16, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) today announced that the highest approved doses of Zepbound (tirzepatide)—12.5 mg and 15 mg—will soon be available in single-dose vials for $499 per month through LillyDirect's Self Pay Pharmacy Solutions and the Zepbound Self Pay Journey Program.¹ Health care providers can begin prescribing the 12.5 mg and 15 mg vials on July 7, and shipments to patients will begin in early August. With the addition of these doses, every strength of Zepbound vial will be available for $499/month or less ($349 for the 2.5 mg starter dose) to any eligible adult with obesity and a valid prescription, regardless of insurance.

"Obesity is a serious, chronic disease, and access to obesity medications should be treated with the same urgency as other chronic conditions," said Rhonda Pacheco, group vice president of U.S. Cardiometabolic Health at Lilly. "Lilly was the first company to offer a self-pay solution for an FDA-approved obesity medication, and we continue to work to expand coverage for Zepbound. In the meantime, the availability of the two highest-dose Zepbound vials gives providers and patients another important treatment option."

Zepbound is an injectable prescription medicine that may 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. It may also help adults with 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 whether Zepbound is safe and effective for use in children.

Patients with obesity who choose to self pay will soon be able to access the complete range of Zepbound single-dose vials, including 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg. Patients on the 2.5 mg starter dose will pay $349 for their first month, then $499 per month for the 5 mg dose, which is the next step in treatment. Through the Zepbound Self Pay Journey Program, designed to support patients throughout their obesity treatment journey, the 7.5 mg ($599), 10 mg ($699), 12.5 mg ($849), and 15 mg ($1,049) doses will be available at a reduced monthly cost of $499 for the first fill and refills made within 45 days of the prior delivery. The recommended starting dosage is 2.5 mg taken once weekly for four weeks. After 4 weeks the dosage is increased to 5 mg. The health care provider may increase the dosage in 2.5 mg increments after at least four weeks on the current dose until recommended maintenance dosage is achieved. The 2.5 mg starting dose is not an approved maintenance dose. The maximum dose is 15 mg.

Zepbound is also available in 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg per 0.5 mL doses in a single-dose pen (autoinjector). The 2.5 mg is a starting dose and not an approved maintenance dose. The recommended maintenance doses are 5 mg, 10 mg, or 15 mg injected subcutaneously once per week for weight reduction and long-term maintenance. The recommended maintenance doses are 10 mg or 15 mg for OSA.

New resources on Zepbound.lilly.com offer step-by-step guidance for appealing coverage denials and submitting letters of medical necessity. To learn more about LillyDirect, please visit LillyDirect.lilly.com.

In a 72-week study of adults without diabetes, average weight loss was 15.0% (34 lbs) for 5 mg, 19.5% (44 lbs) for 10 mg, 20.9% (48 lbs) for 15 mg, and 3.1% (7 lbs) for placebo. Average starting weights were 226.8 lbs for 5 mg, 233.3 lbs for 10 mg, 232.8 lbs for 15 mg, and 231.0 lbs for placebo.

In another 72-week study of adults with diabetes, average weight loss was 12.8% (28 lbs) for 10 mg, 14.7% (33 lbs) for 15 mg, and 3.2% (7 lbs) for placebo. Average starting weights were 222.4 lbs for 10 mg, 219.6 lbs for 15 mg, and 224.2 lbs for placebo. Participants had a reduced calorie diet and had increased physical activity in both studies.

Further assessment of data for the 72-week study of adults without diabetes, showed the percent who saw ≥25% body weight loss (57-58 lbs) were 15.3% for 5 mg, 32.3% for 10 mg, 36.2% for 15 mg and 1.5% for placebo. Results were based on less-rigorous assessment and may be due to chance. Factors beyond Zepbound may have contributed to weight loss.

Individual results varies. Zepbound is not for cosmetic weight loss. 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 health care 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.

About Zepbound (tirzepatide) injection 

Zepbound 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. 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.

About LillyDirect

LillyDirect* is a digital health platform offering disease management resources that make it easier for people living with chronic conditions to access quality care and personalized information. LillyDirect also offers direct home delivery of select Lilly medicines through third-party pharmacy dispensing services, ensuring patients receive their safe, effective, and FDA-approved Lilly medicines from a secure and trusted source. Prescription fulfillment through LillyDirect is open to all U.S. healthcare providers licensed to prescribe Lilly medicines and is listed as a pharmacy option in all major electronic health records (EHR) systems. To learn more about LillyDirect, please visit: LillyDirect.lilly.com.



INDICATIONS AND SAFETY SUMMARY WITH WARNINGS

Zepbound^® (ZEHP-bownd) is an injectable prescription medicine that may 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.

It should be used with a reduced-calorie diet and increased physical activity.

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.

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.

Kidney problems (kidney failure). 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.

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 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.

Depression or thoughts of suicide. You should pay attention to changes in your mood, behaviors, feelings or thoughts. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.

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. 

• Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea which could increase your risk of low blood sugar. Talk to your healthcare provider about low blood sugar levels and how to manage them. 

• 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 kidneys, 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. It is not known if Zepbound passes 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. 
• Zepbound is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm. 
• 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, seek medical advice promptly, or contact a Poison Center expert right away at 1-800-222-1222. 

Zepbound injection is approved as a 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg per 0.5 mL in single-dose pen or single-dose vial.

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 20DEC2024

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

* The in-person and telehealth providers listed on the LillyDirect site are independent. Treatment decisions and prescribing practices are made based on the independent medical judgment of the provider's care team. They may prescribe medication or another course of treatment.

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), including statements about the supply and access of Zepbound (tirzepatide) as a treatment for adults with obesity or overweight and reflects Lilly's current belief 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 future study results will be consistent with the results to date, that Zepbound will receive additional regulatory approvals, or that Lilly will execute its strategy as planned. 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.

¹ Zepbound Self Pay Journey Program lowers the price of the 7.5 mg, 10 mg, 12.5 mg and 15 mg vials only on first fill and when prescriptions are refilled within 45 days of their previous delivery. The 12.5 mg and 15 mg vials are priced at $849 and $1,049, respectively, if refilled outside of the 45-day window.

PP-ZP-US-2133 06/2025 ©Lilly USA, LLC 2025. All rights reserved.

Refer to:      Courtney Kasinger; [email protected]; 317-501-7056 (Media)

                     Michael Czapar; [email protected]; 317-617-0983 (Investors)

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