The FDA-Approved GLP-1 Weight-Loss Pill

Orforglipron, sold as Foundayo, is a once-a-day GLP-1 pill for weight loss. It is a tablet, not a shot. The FDA approved it on April 1, 2026. It needs a prescription [S1][S2].

Quick facts

• What it is: a daily GLP-1 tablet made by Eli Lilly and Company [S1][S2].

• FDA status: approved April 1, 2026, for long-term weight management in certain adults [S1][S3].

• Main trial result: people on the highest dose tested lost 11.2% of their body weight on average over 72 weeks. People on placebo lost 2.1% [S4].

• Biggest safety note: it carries a boxed warning (the FDA's strongest) for thyroid C-cell tumors [S1].

Who it is approved for

The FDA approved Foundayo for adults with obesity, or adults with overweight who also have at least one weight-related health problem. It is meant to be used with a lower-calorie diet and more physical activity, to lose excess weight and keep it off [S1][S2].

The approval covers this product, taken by mouth, for this use only. It is not approved for other conditions.

How it differs from GLP-1 shots

• It is a pill you take once a day, not a weekly injection [S1][S2].

• It is a small molecule, not a peptide like the injectable GLP-1 drugs [S2][S4].

• Lilly says it can be taken any time of day, with no food or water rules. The FDA says it does not need to be taken on an empty stomach [S1][S2].

• It was discovered by Chugai Pharmaceutical and licensed by Lilly in 2018 [S2].

How the approval happened

• The FDA says Foundayo was the first new molecular entity (a new active ingredient) approved under its Commissioner's National Priority Voucher pilot program. The decision came 50 days after filing [S1].

• Two 72-week, placebo-controlled trials supported the approval [S1].

What the main trial found (ATTAIN-1)

• 3,127 adults with obesity and no diabetes took part for 72 weeks [S4][S5].

• Average weight change was -7.5%, -8.4% and -11.2% across the three doses tested, vs -2.1% on placebo [S4].

• On the highest dose tested, 54.6% lost at least 10% of their body weight, vs 12.9% on placebo [S4].

• Waist size, blood pressure, triglycerides and non-HDL cholesterol improved more than on placebo [S4].

Side effects and risks

• The most common side effects in the trial were stomach and gut problems, mostly mild to moderate [S4]. The FDA lists nausea, constipation, diarrhea, vomiting, indigestion, stomach pain, headache, tiredness, burping, heartburn, gas and hair loss [S1].

• Side effects led 5.3% to 10.3% of people on orforglipron to stop, vs 2.7% on placebo [S4].

• Boxed warning: thyroid C-cell tumors. It should not be used by people with a personal or family history of medullary thyroid cancer, or with MEN 2 [S1].

• Other FDA warnings include pancreatitis, severe stomach problems, kidney injury from dehydration, low blood sugar, allergic reactions, gallbladder problems, eye changes in people with type 2 diabetes, and risk during anesthesia [S1].

• It should not be combined with another GLP-1 drug [S1].

• Read the FDA prescribing information and Medication Guide for the full list [S3].

What's next for orforglipron

Lilly is studying it, but it is not approved, for type 2 diabetes, sleep apnea, knee osteoarthritis pain, high blood pressure, peripheral artery disease and stress urinary incontinence [S2].

Related: Retatrutide (investigational), Survodutide, Mazdutide.

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The PeptideX team