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FDA Approves Foundayo, a Wegovy Alternative GLP-1 Pill for Weight Loss

The FDA has approved a new once-daily GLP-1 pill for weight loss. Image Credit: Healthline/Photo by Eli Lilly

Federal regulators have given the green light to a new GLP-1 weight loss tablet that people can take with or without food.

Officials at the Food and Drug Administration (FDA) have issued fast-track approvalTrusted Source to orforglipron, a “molecular entity” pill manufactured by Eli Lilly and sold under the brand name Foundayo.

Foundayo was approved for use in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain long-term weight reduction in adults with obesity or overweight with at least one weight-related comorbid condition.

Foundayo is now the second GLP-1 medication to be approved in pill form. A tablet form of the semaglutide-based drug Wegovy was given the go-ahead in January.

Foundayo is an oral GLP-1 receptor agonist taken once daily. The starting dosage is 0.8 milligrams (mg), increased to 2.5 mg after at least 30 days, and then to 5.5 mg after another 30 days. The dosage may be increased to 9 mg, 14.5 mg, or 17.2 mg after at least 30 days at each level based on treatment response and tolerability, according to the FDA.

Eli Lilly officials said Foundayo will be available via LillyDirect with prescriptions accepted immediately and shipping beginning April 6. Broad availability through U.S. retail pharmacies and telehealth providers is expected soon.

Company officials added that eligible people with commercial insurance may pay as little as $25 per month for the drug. Individuals opting for self-pay can purchase Foundayo for $149 per month for the lowest dose. Additionally, eligible Medicare Part D individuals may be able to get Foundayo for $50 per month, beginning as early as July 1.

A 59-year-old man lost 25 pounds on Foundayo, the new GLP-1 weight-loss pill

It’s here. The first no-fuss once-daily GLP-1 pill for weight loss, Eli Lilly’s Foundayo, was approved by the US Food and Drug Administration on Wednesday.

It’s a watershed moment for the type 2 diabetes and weight loss industry. Until now, patients taking the new class of GLP-1 drugs have had to choose from either a weekly injection that’s stored in the refrigerator, like Ozempic, Wegovy, or Zepbound, or swallow a once-daily pill that requires patients to take it first thing in the morning on an empty stomach with a small glass of water (Rybelsus or Wegovy pill, from Novo Nordisk).

This new medicine, generically called orforgipron, is a big win for Eli Lilly, potentially unlocking a worldwide market of millions more patients who want the convenience of a daily pill they can slot into their existing medicine regimen, at any hour of the day.

What it’s like to take Foundayo: less hunger, slower digestion

Adam Salberg was one of the first patients to try the pill out in real life. The 59-year-old from New Jersey got a sneak peek at what it’s like to be on this new medication when he participated in an 18-month clinical trial Eli Lilly conducted in 2024 and 2025 to gauge safety and efficacy.

Salberg heard about the clinical trial in an email. He had tried losing weight many times before, but nothing seemed to stick.

“I thought I was doing things right with exercise and a balanced diet, but I was never, ever really satisfied with the weight management I was able to maintain on my own,” Salberg told Business Insider.

So, he enrolled in the trial, hoping for something different. He liked the idea of a daily pill that he could take alongside his other prescription medications. It made it easy to slot this new routine into his existing regimen.

“I travel a lot for work,” he said. “I already had oral medication I was taking, so it was just very simple to add it.”

For the first five days he was on the medication, Salberg didn’t notice anything remarkable happening. The first time he noticed something different was at dinner, on that fifth night.

“We were just having a good meal, I think it was roast chicken,” he said. “I had about a portion, and then realized I was perfectly satisfied. I didn’t need any more food, and I was able to just comfortably set it aside. Then I realized: wait a minute, I’ve never done that before!”

His biggest side effect: slow digestion

FDA approves Eli Lilly’s GLP-1 pill, opening the next phase of the weight loss drug market

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The U.S. Food and Drug Administration has approved Eli Lilly’s GLP-1 pill, the company said, a major milestone for the Indianapolis-based drugmaker and one that will test the market for new weight loss medications.

Lilly said the once-daily pill, Foundayo, will start shipping from direct-to-consumer platform LillyDirect on Monday and will be available at pharmacies and on telehealth platforms “shortly after.” People with insurance coverage could pay $25 a month with a coupon from Lilly, while people paying out of pocket could pay between $149 and $349, depending on the dose.

The approval comes just a few months after Lilly submitted the drug to the FDA as part of a program that grants speedy reviews for drugs that are considered national priority interests. That means Lilly will introduce Foundayo only about three months behind Novo Nordisk’s Wegovy pill, setting the stage for the next battle between the rival drugmakers in the next frontier for GLP-1 drugs.

“It’s a big moment,” Eli Lilly CEO Dave Ricks said in an interview with CNBC. “We’ve obviously been working in this category of medicines for a while with the first GLP-1 medication 20 years ago and improving ever since. Here is an option that’s not more effective … but it’s more accessible, it’s easier to fit into your daily routine.”

Lilly licensed the molecule, orforglipron, from Japanese drugmaker Chugai in 2018, paying just $50 million up front for global rights to the drug. But there are still questions about how big the drug will become. It doesn’t produce as much weight loss as Lilly’s best-selling shot Zepbound. Millions of people are already used to the routine of injecting themselves once a week.

FDA approves Eli Lilly’s GLP-1 pill, opening the next phase of the weight loss drug market

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Analysts estimate Foundayo sales will reach $14.79 billion by 2030, according to FactSet. That compares to expectations of $24.68 billion for the weight loss drug Zepbound and $44.87 billion for Mounjaro, which is marketed for diabetes in the U.S. and obesity and diabetes in the rest of the world.

Ricks said shots haven’t been as big of a barrier to uptake as Lilly once thought they would be. He still sees Foundayo as an attractive option for people who would rather take a pill or who are searching for a lower price than the injectables.

He sees it playing a role in maintenance, for people who achieve their goal weight with a shot and want to keep the weight off. And he sees Foundayo as a way to “reach the planet” without the manufacturing constraints or cold-chain requirements that come with Zepbound.

Foundayo is a small molecule whereas Zepbound and Wegovy are peptides, which require more intensive manufacturing processes, a barrier Ricks thinks will hinder generic versions of Wegovy that have recently launched in some other countries, including India.

″[Foundayo] does allow for scalability, and that will allow us to launch this globally on the first instance,” Ricks said. “So today, you can get the oral [Wegovy] in the U.S., but you really can’t get it elsewhere. This will be marketed around the world. As soon as we have regulatory approvals, we essentially have as much scale as we need to supply the world with an oral GLP-1 inhibitor.”

Foundayo (Orforglipron) – Uses, Side Effects, and More

Overview: Foundayo is a GLP-1 agonist. It is used to help people lose weight. Some common side effects include nausea, diarrhea or constipation, vomiting, stomach pain, and upset stomach. Contact your health care provider if you have severe stomach pain or if you have nausea, vomiting, or diarrhea that does not go away. Foundayo is an oral tablet that can be taken with or without food.

Uses

What is Foundayo used for?

Foundayo (orforglipron) is commonly used for weight loss and long-term weight management in people who have obesity or who are overweight with other weight-related health conditions.

Foundayo may also be used for other conditions as determined by your health care provider.

How does Foundayo work (mechanism of action)?

Foundayo works by acting like a natural hormone in your body called glucagon-like peptide-1 (GLP-1). This hormone helps control your appetite. Foundayo attaches to GLP-1 receptors, which are found in parts of the brain that help control hunger. By turning on these receptors, it helps reduce appetite and may help you eat less.

How is Foundayo supplied (dosage forms)?

How should I store Foundayo?

Store Foundayo at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Keep Foundayo in the original bottle and carton with the lid on to protect the medicine from light.

Side Effects

What are the most common side effects of Foundayo?

The most common side effects of Foundayo are listed below. Tell your health care provider if you have any of these side effects that bother you.

There may be other side effects of Foundayo that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Foundayo?

While less common, the most serious side effects of Foundayo are described below, along with what to do if they happen.

Severe Allergic Reactions. Foundayo may cause allergic reactions, which can be serious. Stop taking Foundayo and get help right away if you have any of the following symptoms of a serious allergic reaction.

Thyroid Tumors. Foundayo may cause thyroid tumors. Some of these tumors could be cancerous. Tell your health care provider right away if you notice any of the following symptoms of a thyroid tumor.

Pancreatitis. Foundayo may cause inflammation of the pancreas (pancreatitis). Stop taking Foundayo and call your health care provider right away if you have symptoms of pancreatitis, including vomiting or severe pain in the upper part of your belly that travels to your back.

Severe Stomach Problems. Severe stomach problems may happen with Foundayo. Call your health care provider if you have nausea, vomiting, or diarrhea that is severe or does not go away.

Gallbladder Problems. Foundayo may cause gallbladder problems, including cholecystitis and cholelithiasis (also known as gallstones). Call your health care provider right away if you have any of the following symptoms.

Low Blood Sugar (Hypoglycemia). Foundayo may cause low blood sugar, especially when used with insulin or other medicines that increase insulin levels. Hypoglycemia can be serious and may lead to death if left untreated. Call your health care provider right away if you have any of the following symptoms of hypoglycemia.

Dehydration. Foundayo may cause diarrhea, nausea, and vomiting, which may lead to dehydration. Dehydration may cause kidney damage. If you have nausea, vomiting, or diarrhea, drink plenty of water so that you do not get dehydrated. Call your health care provider right away if you have severe vomiting or diarrhea that will not go away or any of the following symptoms of kidney damage.

Warnings & Precautions

Who should not take Foundayo?

Allergies to Ingredients. People who are allergic to any of the following should not take Foundayo.

Thyroid Cancer or Endocrine Condition. Foundayo should not be used if you or someone in your family has had medullary thyroid carcinoma (MTC) or if you have a condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Tell your health care provider about your current and past health conditions and your family medical history.

What should I know about Foundayo before taking it?

Do not take Foundayo unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Foundayo with other people, even if they have the same condition as you. It may harm them.

What should I tell my health care provider before taking Foundayo?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Foundayo is right for you.

Upcoming Surgery or Procedure. Tell your health care provider that you take Foundayo before any planned surgeries or procedures that require anesthesia or deep sedation. Foundayo may cause your stomach to empty more slowly, which can increase the risk of food getting into your lungs (aspiration) during surgery or procedures.

Other Current and Past Health Conditions. Tell your health care provider if you have any of the following.

Other Medicines and Supplements. Foundayo may interact with other medicines and supplements. Before taking Foundayo, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. Foundayo may cause harm to a fetus. If you can become pregnant, you should use effective birth control while taking Foundayo. Talk to your health care provider about your birth control options. Tell your health care provider if you are pregnant or plan to become pregnant. If you become pregnant, stop taking Foundayo and contact your health care provider right away. You can also register for the Foundayo Pregnancy Registry by calling 800-545-5979. This registry collects information about the use of Foundayo during pregnancy.

Breastfeeding. It is not known if Foundayo passes into breast milk. Breastfeeding is not recommended while taking Foundayo. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should take Foundayo while breastfeeding.

How can I get more information about Foundayo?

For more information about Foundayo, you can visit the drugmaker’s website at www.foundayo.lilly.com or call them at 800-545-5979.

Interactions

Does Foundayo interact with foods or drinks?

Does Foundayo interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Foundayo.

Some other medicines may alter the blood levels of Foundayo, and vice versa. Foundayo may also affect the absorption of some other medicines. Tell your health care provider about all medicines that you take or have recently taken. In particular, make sure you tell your health care provider if you take a birth control pill.

This may not be a complete list of medicines that can interact with Foundayo. Always check with your health care provider.

Overdose/Missed Dose

What should I do if I accidentally use too much Foundayo?

If you or someone else has used too much Foundayo, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Foundayo?

If you miss a dose, take it as soon as you remember. Do not take double or extra doses. If you miss taking Foundayo for 7 or more days in a row, contact your health care provider. They will let you know if you need to restart Foundayo at a lower dose to help reduce the risk of side effects.

Lilly expects approval for Foundayo in more than 40 countries over the next year. The company since 2020 has invested more than $55 billion in manufacturing, which includes opening new sites and expanding existing plants to produce the pill.

In the U.S., Lilly will compete with Novo’s newly launched Wegovy pill. Early demand for that pill has been stronger than expected, with Novo reporting more than 600,000 prescriptions in March.

Novo CEO Mike Doustdar told CNBC in February that one of the earliest takeaways from the launch is that the pill appears to be expanding the obesity treatment market, drawing in new patients rather than converting existing ones from injections. Ricks agreed with that assessment and said Lilly doesn’t care whether people take Foundayo or Zepbound.

“We want people to be on the medicine that meets their health goals,” Ricks said. “If it has Lilly on the box, that’s the goal we have.”

Novo plans to argue that the Wegovy pill is more effective than Foundayo. The Wegovy pill showed around 16.6% weight loss on average in a late-stage trial, while Lilly’s oral drug caused roughly 12.4% on average in a separate study, when analyzing patients who stayed on treatment. Lilly’s Zepbound has consistently shown it can help people lose more than 20% of their body weight.

Meanwhile, Lilly plans to tout the fact that Foundayo can be taken at any time without any restrictions, while the Wegovy pill needs to be taken first thing in the morning on an empty stomach with only a few ounces of water.

Where the two drugs are the same is the starting price. The lowest doses of both drugs will cost $149 for cash-paying customers thanks to an agreement the companies struck with the Trump administration last fall. And price is the most important factor for patients, said Dr. Nidhi Kansal, an obesity medicine doctor at Northwestern Medicine.

“Unfortunately, price is what is driving the decision-making between clinicians and patients for these drugs because they’re all excellent drugs and we have lots of options now, but it’s still a financial decision at the end of the day,” Kansal said.

The lower price point and the approachability of a pill versus a shot opens up the market to casually interested patients, said BMO Capital Markets analyst Evan David Seigerman. Seniors on Medicare will be able to access Foundayo and other GLP-1 obesity medicines for $50 a month starting this summer as part of Lilly and Novo’s deals with the Trump administration. Ricks expects a “pretty robust” response to the program, which Lilly built into its financial guidance for the year.

Analysts say a successful launch of Foundayo is key to Lilly’s stock recovering from recent weakness. The company’s shares have fallen about 14% this year after a meteoric rise that briefly made Lilly the first trillion-dollar market cap health-care company. Sales are a lagging indicator, so analysts will be tracking prescriptions to monitor uptake of the pill, said Cantor Fitzgerald analyst Carter Gould.

“If scripts are going in the right direction, and you’re seeing the continued gains, my guess is people will look through any sort of choppiness around [the first or second quarter],” Gould said.

Another factor for Lilly’s performance this year is a forthcoming readout for its more potent obesity shot, retatrutide. The company has already shared some late-stage data on that drug, but the most important trial is one studying the treatment specifically for weight loss. If retatrutide lives up to its expectations, Lilly would be on its way to creating a portfolio of obesity medicines.

“The future will be more choices, and that’s a great thing,” Ricks said. “And we hope Lilly is the one presenting those choices.”

In the U.S., Lilly will compete with Novo’s newly launched Wegovy pill. Early demand for that pill has been stronger than expected, with Novo reporting more than 600,000 prescriptions in March.

“We want people to be on the medicine that meets their health goals,” Ricks said. “If it has Lilly on the box, that’s the goal we have.”

“The future will be more choices, and that’s a great thing,” Ricks said. “And we hope Lilly is the one presenting those choices.”

Salberg said he could feel his digestive system slowing down, making him feel fuller faster than before. What used to be a normal portion was simply too much food now. It was surprising, he said, having 50-plus years of eating habits shift like that overnight.

GLP-1 drugs work by mimicking a hunger-regulating hormone we produce naturally (called glucagon-like peptide 1) that makes us feel full. The drugs are more powerful than our own hunger hormone, though, lasting longer, slowing down our digestion, and improving blood sugar control.

Over the course of the trial, Salberg committed to other healthy lifestyle changes. He made it a habit to go to the gym roughly three days a week for a mix of cardio and strength training, which doctors generally recommend to patients on GLP-1 drugs to help prevent muscle wasting. And he improved his diet, swapping out more red meat and saturated fats for lean proteins like roasted chicken or grilled fish, plus lots of vegetables on the side, a healthy, Mediterranean-style diet plan many dietitians recommend.

He lost 25 pounds and has kept most of it off

After two months, Salberg had lost seven pounds. The next month, he shed five more. By the end of the trial, he’d stabilized at a new weight, 25 pounds lighter than he’d been before. He tightened his belt loop up by two notches.

Once the trial was over, Salberg did notice his old appetite kick back in, after about six weeks without any medication in his system. But he said he’s been able to maintain most of the weight loss he accomplished on the trial.

“A little bit did come back, but nowhere close to where I was,” he said. He credits the weight maintenance to continued portion control and healthy movement.

Now that Foundayo is on the market, he’s planning to chat to his doctor about possibly getting back on the medication. If it’s covered by insurance, the pill could cost him as little as $25 a month. Eli Lilly is also selling the pill directly on its website, with cash pay prices of $149 to $349 a month, depending on the dose.

Foundayo Orforglipron

FDA Approves Foundayo, a Wegovy Alternative GLP-1 Pill for Weight Loss

A 59-year-old man lost 25 pounds on Foundayo, the new GLP-1 weight-loss pill

What it’s like to take Foundayo: less hunger, slower digestion

His biggest side effect: slow digestion

FDA approves Eli Lilly’s GLP-1 pill, opening the next phase of the weight loss drug market

FDA approves Eli Lilly’s GLP-1 pill, opening the next phase of the weight loss drug market

Foundayo (Orforglipron) – Uses, Side Effects, and More

Uses

What is Foundayo used for?

How does Foundayo work (mechanism of action)?

How is Foundayo supplied (dosage forms)?

How should I store Foundayo?

Side Effects

What are the most common side effects of Foundayo?

What are the serious side effects of Foundayo?

Warnings & Precautions

Who should not take Foundayo?

What should I know about Foundayo before taking it?

What should I tell my health care provider before taking Foundayo?

How can I get more information about Foundayo?

Interactions

Does Foundayo interact with foods or drinks?

Does Foundayo interact with other medicines (drug interactions)?

Overdose/Missed Dose

What should I do if I accidentally use too much Foundayo?

What should I do if I miss a dose of Foundayo?

He lost 25 pounds and has kept most of it off

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