Orforglipron (Foundayo): the daily GLP-1 pill, its doses, results and cost

Orforglipron is the active ingredient in Foundayo, a once-a-day tablet from Eli Lilly that the FDA approved on April 1, 2026 for weight management in adults. It belongs to the GLP-1 drug family and works on the same receptor as semaglutide, but it is not a peptide. It is a small molecule designed to be swallowed like an ordinary pill, and that difference is why there is no empty-stomach rule. On average it takes off less weight than the injectable drugs, at a lower self-pay price than some of them, and a prescriber sets the dose. Lilly also makes tirzepatide.

FDA approval, in brief

The approved use is narrow and specific: “in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.” The label says it should not be combined with another GLP-1 drug. It is not labeled for type 2 diabetes, and its safety and effectiveness in children are not known.

The FDA called this its fastest approval of a new molecular entity since 2002, issued 294 days before the application’s original target date of January 20, 2027.

Who is Foundayo for?

The label covers adults with obesity, or overweight with at least one weight-related condition. In practice, the National Institute of Diabetes and Digestive and Kidney Diseases describes weight management drugs as generally aimed at adults with a BMI of 30 or more, or 27 or more with a problem such as high blood pressure or type 2 diabetes. A pill suits people who would rather not inject, or who cannot manage an empty-stomach routine. Someone who wants the largest average weight loss will see bigger trial numbers on the injectables. Those are trade-offs for a prescriber to weigh with you.

Not a peptide: what that means

Semaglutide, tirzepatide and retatrutide are peptides, chains of amino acids modeled on gut hormones. Most peptide drugs in this class are given by injection. The NEJM authors of the main obesity trial describe orforglipron as “a small-molecule, nonpeptide oral glucagon-like peptide-1 (GLP-1) receptor agonist.” It is a conventional chemical drug that fits into the GLP-1 receptor and switches it on.

Three practical consequences follow from the label:

• No empty-stomach rule. The label says to take it once daily “with or without food.” In a food-effect study, exposure fell by 19% with food, which the label describes as not clinically relevant. The FDA’s announcement singled out that it “does not need to be taken on an empty stomach.”
• A daily pill, not a weekly shot. Its half-life is about 29 to 49 hours, so it is taken every day. Steady levels are reached after about a week.
• It is processed by the liver. Orforglipron is broken down mainly by the liver enzyme CYP3A4. That creates drug interactions that injectable peptides do not have (see below).

The FDA’s own description adds one more detail: it is a GLP-1 receptor “partial agonist,” meaning it activates the receptor without producing the maximal response a full agonist can.

What is the dose of Foundayo?

The label starts at 0.8 mg a day and steps up after at least 30 days on each dose, as far as a maximum of 17.2 mg.

The label says to follow this ladder “to reduce the risk of gastrointestinal (GI) adverse reactions.” One tablet a day, never more. Tablets are swallowed whole. The prescriber sets the dose; this table only reports the label.

Other label rules:

• Missed dose. The label says to take it as soon as possible, and not to double up. If 7 or more doses in a row are missed, the label says to restart the escalation at a lower dose.
• Strong CYP3A4 inhibitors. With a strong CYP3A4 inhibitor, the maximum dose is 9 mg. Strong inhibitors that also block OATP1B, such as ritonavir, should be avoided entirely. Strong CYP3A4 inducers should also be avoided.
• Simvastatin. The label says not to exceed 20 mg of simvastatin a day; orforglipron doubled exposure to its active form.
• Birth control pills. Because orforglipron slows stomach emptying, the label advises switching to a non-oral method or adding a barrier method for 30 days after starting and for 30 days after each dose increase. Non-oral hormonal contraceptives are not affected.
• Insulin or sulfonylureas. The label says to consider lowering their dose when starting Foundayo, to reduce the risk of low blood sugar.

How much weight do people lose on Foundayo?

On the top dose in ATTAIN-1, people lost an average of 11.1% of their body weight at 72 weeks, against 2.1% on placebo. The approval rested on ATTAIN-1 and ATTAIN-2, both 72 weeks long and placebo-controlled. The trials used an investigational capsule formulation at 6, 12 and 36 mg; the label reports those results as the equivalent Foundayo tablet doses of 5.5, 9 and 17.2 mg.

Source: Foundayo label, Table 6, intention-to-treat population, which counts everyone randomized. The NEJM paper reports ATTAIN-1 to one more decimal place (-7.5%, -8.4%, -11.2% versus -2.1%). Higher headline numbers in some coverage, around 12%, come from the efficacy estimand, which estimates the effect had everyone stayed on the drug.

These averages are lower than for the injectable peptides. In SURMOUNT-1, tirzepatide 15 mg produced 20.9% at 72 weeks. Different trials enrolled different people, so the comparison is rough, but the gap is large.

Other trials worth knowing:

• ACHIEVE-1 (NEJM 2025). In 559 adults with early type 2 diabetes, 40 weeks of orforglipron lowered A1c by 1.24 to 1.48 percentage points versus 0.41 on placebo, from a baseline of 8.0%, with weight loss of 4.5% to 7.6%.
• ACHIEVE-3 (Lancet 2026). Against oral semaglutide in 1,698 adults with type 2 diabetes on metformin, both orforglipron doses lowered A1c more than both semaglutide doses over 52 weeks. Side effects also ran higher: gastrointestinal events affected 58% to 59% on orforglipron versus 37% to 45% on oral semaglutide, and 9% to 10% stopped for side effects versus 4% to 5%.
• ACHIEVE-4 (Lancet 2026). In 2,749 adults with type 2 diabetes and heart or kidney disease, orforglipron was non-inferior to insulin glargine for major cardiovascular events over a median of two years (4.2% versus 5.0%; hazard ratio 0.84). This was a safety trial; it was not designed to show a heart benefit.
• ATTAIN-MAINTAIN (Nature Medicine 2026). People who had lost weight on tirzepatide or semaglutide injections were switched to orforglipron or placebo. At 52 weeks, those switched from tirzepatide kept an estimated 74.7% of their weight loss on orforglipron versus 49.2% on placebo; those switched from semaglutide kept 79.3% versus 37.6%.

Foundayo vs the Wegovy pill

There are now two GLP-1 weight-loss pills, and the practical difference is the morning routine. No trial has compared them head to head for obesity, so the table sets out what each label says.

These are separate trials with different lengths, so read the weight row as a rough guide. The semaglutide guide covers the Wegovy pill in detail.

What are the side effects of Foundayo?

The common side effects are gastrointestinal, as with every GLP-1 drug. The label pools ATTAIN-1 and ATTAIN-2 (3,155 people on Foundayo, 1,576 on placebo, up to 72 weeks):

Across both trials, 8% of people on Foundayo stopped because of side effects (6% on 5.5 mg, 9% on 9 mg, 10% on 17.2 mg) versus 3% on placebo, mostly for stomach problems. The label says nausea, vomiting and diarrhea were higher during dose escalation and decreased over time.

Other label findings:

• Heart rate. Average heart rate rose by 4 to 5 beats per minute versus 0.5 on placebo. Tachycardia (a fast heart rate) was reported in 3% versus 0.9%.
• Low blood pressure. 2% versus 0.5%, and 4% in people also taking blood pressure medicine.
• Low blood sugar. In ATTAIN-2, glucose below 54 mg/dL occurred in 2% on Foundayo versus 0.2% on placebo, and in 7% of those also taking a sulfonylurea.
• Pancreatitis. Six confirmed cases on Foundayo versus one person on placebo in the pooled trials.
• Gallbladder. Gallstones in 1% versus 0.7%; acute cholecystitis in 0.4% versus 0.3%.
• Hair loss was linked to weight loss and was more common in women (7%) than men (0.9%).

The boxed warning, and its unusual wording

Like every GLP-1 drug, Foundayo carries a boxed warning about thyroid C-cell tumors, and it is contraindicated in anyone with a personal or family history of medullary thyroid carcinoma or with Multiple Endocrine Neoplasia syndrome type 2. Its wording differs from the peptide labels. The label explains that GLP-1 drugs active in rats and mice caused these tumors in rodents, but that “orforglipron is not pharmacologically active in rats or mice and did not produce tumors in rodents.” In other words, the rodent test that flagged the peptides could not test orforglipron, so the human relevance remains undetermined and the warning stays. Symptoms worth reporting are a lump in the neck, trouble swallowing, shortness of breath or persistent hoarseness.

The label’s other warnings are the class set: acute pancreatitis, severe gastrointestinal reactions (not recommended in severe gastroparesis), acute kidney injury from dehydration, low blood sugar with insulin or sulfonylureas, serious allergic reactions, diabetic eye complications in people with type 2 diabetes, acute gallbladder disease, and food entering the lungs during anesthesia or deep sedation. Weight loss offers no benefit in pregnancy and the label says to stop Foundayo when pregnancy is recognized. It is not recommended while breastfeeding.

The label’s patient information says to stop and call right away for severe stomach pain that will not go away, sometimes reaching the back, and to get medical help for swelling of the face, lips, tongue or throat or trouble breathing.

How much does Foundayo cost?

Lilly’s self-pay prices run from $149 to $349 a month by dose, and the list price is $649.

Prices are for a 30-day supply, from Lilly’s self-pay terms (dated August 2026, checked November 2, 2026). The list price is what Lilly charges wholesalers. With commercial insurance that covers Foundayo, Lilly’s savings card can bring the cost to as little as $25 for a one-, two- or three-month fill, with savings capped at $100 a month and $1,000 a year; the card excludes Medicare, Medicaid and other government plans and expires December 31, 2026. Lilly also lists a $50-a-month price for eligible Medicare Part D patients under the Medicare GLP-1 Bridge program. Terms change, so check Lilly’s pages before relying on any number. The cheapest GLP-1 without insurance page compares Foundayo with the other options.

Foundayo is a brand-name prescription drug. It needs a prescription from a licensed prescriber and is dispensed by a licensed pharmacy, including Lilly’s own LillyDirect pharmacy. No generic exists. Tablets or powders sold online as “orforglipron” outside that chain are not the approved product.

Who should be cautious

The label contraindicates Foundayo for anyone with a personal or family history of medullary thyroid carcinoma or MEN 2, and for anyone with a known serious allergy to orforglipron or its ingredients. It flags for prescriber judgment: a history of pancreatitis, severe gastroparesis, diabetic retinopathy, use of insulin or a sulfonylurea, oral contraceptives, simvastatin above 20 mg, and medicines that strongly affect the CYP3A4 liver enzyme. It should not be combined with another GLP-1 drug, and it is not for children.

Questions to ask a prescriber

• Does a pill fit better than a weekly shot for me, given the smaller average weight loss?
• Do any of my medicines interact with it, especially statins, birth control pills or drugs that affect CYP3A4?
• If I use birth control pills, what backup should I use and for how long?
• How far up the ladder do I need to go, and how will we judge whether it is working?
• If I switch from an injection to this pill to keep weight off, what should I expect?