FDA Approves Foundayo, a New GLP-1 Weight Loss Pill, but Asks for More Safety Data

Federal regulators have approved a new once-daily GLP-1 pill called Foundayo for weight management, making it the second medication of its kind available in tablet form.

The U.S. Food and Drug Administration (FDA) granted fast-track approval to orforglipron, the active ingredient in Foundayo, which is made by Eli Lilly. The pill is meant to be used alongside a reduced-calorie diet and increased physical activity to help adults with obesity or overweight who also have at least one weight-related health condition lose weight and keep it off long term.

Foundayo joins a tablet version of Wegovy, which received approval in January, as the only GLP-1 drugs available as pills.

The starting dose of Foundayo is 0.8 milligrams taken once daily. After at least 30 days, the dose increases to 2.5 mg, then to 5.5 mg after another 30 days. Depending on how well a person responds and tolerates the drug, the dose may go up to 9 mg, 14.5 mg, or 17.2 mg, with at least 30 days between each increase.

Eli Lilly says Foundayo will be available through LillyDirect starting April 6, with prescriptions accepted immediately. It is expected to reach retail pharmacies and telehealth providers soon after.

For people with commercial insurance, the monthly cost could be as low as $25. Those who pay out of pocket can get the lowest dose for $149 per month. Eligible Medicare Part D members may pay $50 per month starting as early as July 1.

Experts say the approval is a welcome step in the fight against obesity.

“It’s a significant milestone to have another GLP-1 tablet,” said Dr. Pouya Shafipour, a family and obesity medicine physician at Providence Saint John’s Health Center in Santa Monica, CA.

Dr. Zhaoping Li, chief of the Division of Clinical Nutrition at UCLA Health, agreed. “It is great to have new tools added to our toolbox to deal with obesity,” she said.

Fast approval for Foundayo

The FDA approved Foundayo under its National Priority Voucher pilot program, which speeds up the review of drugs that address major public health needs. The application was approved just 50 days after it was submitted.

The approval was based on two randomized, double-blind, placebo-controlled trials that lasted 72 days. The studies included adults with obesity or overweight who also had at least one weight-related health condition.

In the ATTAIN-1 trial, people who took the highest dose of Foundayo and stayed on the treatment lost an average of 27 pounds. Those who took a placebo lost about 2 pounds.

Like other GLP-1 drugs, Foundayo can cause side effects such as nausea, constipation, diarrhea, vomiting, abdominal pain, and headache. The FDA also requires a boxed warning about possible thyroid C-cell tumors.

FDA requests more safety data

In its approval letter, the FDA asked Eli Lilly to study potential risks tied to Foundayo, especially those involving the heart and liver. The agency wants the company to look into serious conditions like stroke, heart attack, and liver injury that could be linked to the drug.

The FDA says the current data is not enough to fully understand those risks. It also wants long-term information on any possible link to thyroid cancer and more details on delayed stomach emptying, a condition where food stays in the stomach longer than normal.

The FDA did not ask for these extra studies when it approved the Wegovy pill. However, Wegovy uses semaglutide, a drug that has been studied for many years. Foundayo uses orforglipron, a newer ingredient that does not have the same long-term safety record.

It is important to note that this does not mean a safety problem has been found. It simply means the FDA wants more complete long-term data.

Foundayo can be taken without food

Unlike the Wegovy pill, which must be taken on an empty stomach with a 30-minute wait before eating or drinking, Foundayo can be taken with or without food.

“We believe Foundayo can help level the playing field for those living with obesity or who are overweight and living with weight-related complications,” said David Ricks, chair and CEO of Eli Lilly, in a statement. “As a convenient, once-daily oral pill that delivers meaningful weight loss, this is obesity care designed for the real world.”

Shafipour noted that more research is needed to know whether Foundayo produces long-term results. “We don’t know in reality how much weight people will lose,” he said. “We need to wait and see on that long-term data.”

He added that pill forms of GLP-1 drugs could help people stick to their weight loss plans. “People are used to taking pills,” he said. “Getting a shot throughout your life is not fun.”

Dr. Mir Ali, a bariatric surgeon and medical director of MemorialCare Surgical Weight Loss Center in Fountain Valley, CA, said the choice between a pill and an injection depends on the person. “Preferences vary by patient,” he said. “Some prefer weekly injections while others prefer a [daily] pill. A primary advantage of the pill is that it does not require refrigeration, making it more convenient for travel.”

He added, “While most studies indicate that oral forms may be slightly less effective than injections, they remain very effective. Ultimately, the choice depends on the patient’s lifestyle and personal preference.”

Tips for weight loss, with or without medications

Whether or not you take GLP-1 drugs, certain lifestyle habits can help with weight loss and weight management. These include:

– Eating fewer carbohydrates

– Getting enough protein and fiber

– Keeping a food diary

– Exercising regularly

– Managing stress

– Limiting or avoiding alcohol

– Getting enough sleep

Shafipour stressed the importance of a diet rich in protein and fiber, along with daily aerobic and strength-building exercise. He also said quality sleep helps balance hormones and control hunger, and stress management can help with blood sugar levels.

The Centers for Disease Control and Prevention (CDC) recommends that adults get 150 minutes of moderate-intensity activity each week, plus at least two days of strength training.

Ali said a proper diet is essential. “The foundation of an effective diet — which we recommend to all patients regardless of whether they utilize surgery, medication, or counseling — is the reduction of carbohydrate and sugar intake,” he explained. “By emphasizing protein and non-starchy vegetables, the body is encouraged to utilize fat stores for energy, resulting in weight loss.”

Li said the best approach to weight management is focusing on lifestyle. “Changing your lifestyle is challenging, but it is fundamental not only for weight loss but also for improving overall health,” she noted. “Modern weight management no longer focuses solely on energy balance. It also places strong emphasis on the quality of the diet.”