What Is Foundayo?

1. What Was Approved

FDA approved Foundayo on April 1, 2026, the first new molecular entity under its national priority voucher program. The indication is an adjunct to a reduced-calorie diet and increased physical activity to reduce excess body weight in adults with obesity, or with overweight and at least one weight-related comorbid condition. It is not approved for type 2 diabetes, and the label’s limitations of use say not to combine it with another GLP-1 receptor agonist.

2. The Dose Ladder

Steps beyond 5.5 mg are taken based on treatment response and tolerability, not on a fixed calendar. Because orforglipron reaches steady state in about a week, each 30-day step is well past the point where the level has settled. The titration schedule generator does not yet model Foundayo; the label’s own table is the reference.

Taking it. One tablet once daily, with or without food, swallowed whole; do not break, crush, or chew, and do not take more than one tablet a day. There is no water limit and no waiting period, which is the practical difference from the semaglutide tablets.

Missed dose. Take it as soon as possible and do not double the next one. After 7 or more consecutive missed doses, restart escalation at a lower dosage to limit gastrointestinal side effects.

3. Drug Interactions

Peptide GLP-1 drugs are cleared by proteolysis and have almost no metabolic interactions. Orforglipron is metabolised by CYP3A4, the enzyme behind many common drug interactions, so the label has a dosage-modification section:

• With a strong CYP3A4 inhibitor, the maximum Foundayo dose is 9 mg once daily.
• Strong CYP3A4 inducers are to be avoided; with a moderate inducer, the label says to monitor effectiveness and escalate the dose as needed.
• Simvastatin is limited to 20 mg once daily alongside Foundayo.
• Like all GLP-1 agonists, Foundayo delays gastric emptying and can change the absorption of other oral medicines, with the usual caution for drugs that need a threshold concentration or have a narrow therapeutic index.

Anyone on a long medication list should have it checked against these sections before starting.

4. The Evidence

The trial papers report doses of 6, 12, and 36 mg; the marketed tablets are 5.5, 9, and 17.2 mg. They are the same arms in a different formulation labelled by a different dose convention, and Lilly’s later analyses use the marketed numbers: in the post hoc analysis of adults 65 and older, 17.2 mg produced 13.0% in ATTAIN-1 and 12.2% in ATTAIN-2 against 1.6% and 2.3% on placebo. Blood pressure and lipids improved alongside the weight change. For where these numbers sit against injected drugs and the semaglutide tablet, see the orforglipron page and Foundayo vs Rybelsus.

5. Safety

The label opens with the class boxed warning on thyroid C-cell tumors, with a wording specific to this drug: GLP-1 agonists that are pharmacologically active in rats and mice caused C-cell tumors in those species, orforglipron is not active in rodents and did not produce tumors in them, and the human relevance of the rodent finding is unknown. The contraindication is the same as the rest of the class, a personal or family history of medullary thyroid carcinoma or MEN 2, plus known serious hypersensitivity to orforglipron.

Warnings cover acute pancreatitis, severe gastrointestinal reactions, acute kidney injury from dehydration, hypoglycemia with insulin or a sulfonylurea, hypersensitivity reactions, diabetic retinopathy complications in people with type 2 diabetes, acute gallbladder disease, and pulmonary aspiration under anesthesia. The most common adverse reactions, at 5% or more, are nausea, constipation, diarrhea, vomiting, dyspepsia, abdominal pain, headache, abdominal distension, fatigue, eructation, reflux, flatulence, and hair loss.

6. Tracking a Daily Tablet

A daily tablet is the simplest GLP-1 record: product, date, milligrams, and any side effect. What the log is for here is the ladder and the misses. A 30-day step is easy to lose count of, and the 7-missed-doses rule only works if the misses are written down. How GLP-1 tracking works covers the fields; for the route question in general, see oral vs injectable GLP-1.

7. Foundayo FAQ

• What is Foundayo approved for?

  As an adjunct to a reduced-calorie diet and increased physical activity to reduce excess body weight in adults with obesity, or with overweight and at least one weight-related condition. It is not approved for type 2 diabetes, and the label says not to use it with another GLP-1 receptor agonist.

• How is Foundayo taken?

  One tablet once daily, with or without food, swallowed whole. The label starts at 0.8 mg for at least 30 days, then 2.5 mg for at least 30 days, then 5.5 mg, and may step to 9, 14.5, or 17.2 mg after at least 30 days on each dose, depending on response and tolerability. The maximum is 17.2 mg.

• What if I miss a Foundayo dose?

  Take it as soon as possible, and do not double the next dose. If 7 or more consecutive doses are missed, the label says to restart dose escalation at a lower dosage to reduce gastrointestinal side effects.

• Does Foundayo interact with other medicines?

  Yes, in a way peptide GLP-1 drugs do not. Orforglipron is metabolised by CYP3A4, so the maximum dose is 9 mg with a strong CYP3A4 inhibitor, strong inducers are to be avoided, and simvastatin is capped at 20 mg a day. Like every GLP-1 agonist it also slows gastric emptying, which can change absorption of other oral medicines.

• How much weight do people lose on Foundayo?

  In ATTAIN-1, 3,127 adults with obesity lost 7.5%, 8.4%, and 11.2% on the three trial doses over 72 weeks, against 2.1% on placebo. In ATTAIN-2, adults with obesity and type 2 diabetes lost up to 9.6% against 2.5%. Those are trial averages, not predictions.

8. Sources