Orforglipron (Foundayo): The First Oral Small-Molecule GLP-1
Every other GLP-1 approved for weight management is a peptide. This one is not, and that single fact explains the tablet, the price, and most of what makes it different.
- Not a peptideA small molecule that reaches the same receptor, so it survives being swallowed
- −11.1%Average body weight change at 72 weeks on the highest dose, from the FDA label
- $149–299Lilly’s own self-pay price per month, depending on strength
- 17.2 mgThe highest approved strength — reports of a 36 mg dose describe something else
Regulatory status
Orforglipron is FDA-approved and available on prescription, sold as Foundayo under NDA 220934, with an initial United States approval of 2026. It carries a boxed warning about thyroid C-cell tumours. There is no approved generic and no legitimate route to buy it without a prescription.
The short version
Semaglutide and tirzepatide are peptides — chains of amino acids, which the digestive system is built to break apart. That is why they are injected, and why the oral versions that do exist need heavy formulation work to survive the stomach at all. Orforglipron is a small molecule that happens to activate the same receptor. It was never a peptide, so it did not need rescuing from digestion.
The practical consequences are a tablet rather than an injection, no refrigeration, and — unlike the oral semaglutide products — no fasting window, since the label states it is taken with or without food. It is also the cheapest way to buy a GLP-1 directly from its manufacturer, which is covered further down.
What it does not appear to be is more effective. On the FDA label’s own figures it produces less weight reduction than the injected drugs it competes with, which is the trade the rest of this page tries to make legible.
What it is approved for
Read from the approved prescribing information rather than from the announcement. The label indicates Foundayo, alongside a reduced-calorie diet and increased physical activity, to reduce excess body weight and maintain that reduction long term in adults with obesity, or adults with overweight who also have at least one weight-related condition.
- Foundayo — tablet. NDA 220934. Eli Lilly and Company. Initial United States approval 2026. Weight management only; this is not a diabetes approval, and orforglipron is not currently sold under a second brand name the way semaglutide and tirzepatide are.
- Approved strengths. Six tablet strengths exist, from 0.8 mg up to a maximum of 17.2 mg once daily. Which strength applies to a given person, and how anyone moves between them, is set by the prescribing information and the prescriber — not by this page.
- A limitation of use. The label states that taking it alongside another GLP-1 receptor agonist is not recommended. That is worth knowing for anyone considering moving across from an injection.
- The boxed warning has an unusual footnote. Like the rest of the class it carries a boxed warning about thyroid C-cell tumours. But the label also records that orforglipron is not pharmacologically active in rats or mice and did not produce tumours in rodents. The warning is retained because the human relevance of the rodent finding has not been determined, not because this drug reproduced it.
Why the trial doses do not match the tablet you can buy
Coverage of the trial results frequently quotes doses of 6 mg, 12 mg and 36 mg. The highest strength you can actually be prescribed is 17.2 mg. Both numbers are correct, and the reason they differ is stated plainly in the label.
The trials were run using what the label calls an investigational orforglipron formulation. The marketed tablet is a different formulation, and the same quantity of drug does not behave identically in the two. So the label restates the trial results as equivalent dosages of the product that is actually sold: the trial arms appear as 5.5 mg, 9 mg and 17.2 mg once daily.
Why this matters
An article reporting that “the 36 mg dose produced the best results” describes a tablet strength that does not exist and cannot be bought. Read as a shopping instruction, it points at nothing. The equivalent marketed strength is 17.2 mg, and that is the number on the price list.
What the trials actually showed
Two randomised, double-blind, placebo-controlled trials support the approval, both running 72 weeks with weight change as the primary measure. Trial 1 (NCT05869903) enrolled 3,127 adults with obesity, or overweight plus a weight-related condition, and excluded people with type 2 diabetes. Trial 2 (NCT05872620) enrolled 1,613 adults with a BMI of 27 or above who did have type 2 diabetes.
Figures below are the label’s, not the manufacturer’s press release. Every participant in both trials also received diet and physical activity counselling from the first dose onward, so the placebo column is not “no treatment”.
| Trial 1 — obesity, no diabetes | Placebo | 5.5 mg | 9 mg | 17.2 mg |
|---|---|---|---|---|
| Average body weight change | −2.1% | −7.4% | −8.3% | −11.1% |
| Lost 10% or more | 13% | 32.5% | 39.8% | 54.5% |
| Lost 15% or more | 6% | 14.3% | 20.1% | 35.9% |
| Lost 20% or more | 2.9% | 5.9% | 8.9% | 18.4% |
Against placebo, the 17.2 mg difference in Trial 1 was 9 percentage points, with a 95% confidence interval running from 8.1 to 10 — a narrow interval, meaning the effect is measured precisely rather than merely being statistically significant.
| Trial 2 — with type 2 diabetes | Placebo | 5.5 mg | 9 mg | 17.2 mg |
|---|---|---|---|---|
| Average body weight change | −2.5% | −5.1% | −7.0% | −9.6% |
| Lost 10% or more | 9.2% | 22.5% | 31.1% | 45.6% |
Weight reduction is consistently smaller in people with type 2 diabetes. That pattern is not unique to this drug — it shows up across the class — but it means the headline figure from Trial 1 is not the one to expect if you have diabetes.
What is not yet known
A substantial number of participants had no weight measurement at week 72 — 24% of the placebo group in Trial 1, and 14% to 16% of those on the drug. Those gaps were filled statistically rather than measured, which the label states openly. Published figures higher than the ones above generally come from a different analysis that counts only people who stayed on treatment; the label’s more conservative numbers are what is reproduced here. There is also no published trial yet comparing orforglipron head to head against semaglutide or tirzepatide, so any ranking against them is inference across separate trials, not a direct result.
What it costs without insurance
Lilly sells it direct through its own self-pay pharmacy, and publishes a price for every strength. These are the manufacturer’s own figures, not an aggregator’s estimate.
| Strength | Self-pay price, per month |
|---|---|
| 0.8 mg | $149 |
| 2.5 mg | $149 until 31 December 2026 |
| 5.5 mg | $199 until 31 December 2026 |
| 9 mg | $299 |
| 14.5 mg | $299 |
| 17.2 mg | $299 |
Two conditions are attached. The 2.5 mg and 5.5 mg prices are described as temporarily reduced and run only to 31 December 2026. On the two highest strengths, the $299 rate depends on refilling within 45 days; miss that window and the regular price applies instead — the same structure Lilly uses on Zepbound.
The arithmetic, with the right number of months
Foundayo’s terms define a month as 30 days, so a year is about 12.2 fills — roughly $3,640 at the top strength. Zepbound’s terms define a month as 28 days, which is about 13 fills, not 12: roughly $5,850 a year at $449. The gap between the pill and the injection is therefore around $2,200 a year, wider than comparing the monthly prices alone suggests.
Lilly also advertises a rate as low as $25 a month for people who are commercially insured with coverage for the drug, and a separate route for eligible Medicare Part D patients. Both carry eligibility conditions we have not verified. Our GLP-1 cost comparison sets the self-pay prices for every product side by side.
What we have looked at in detail
- Orforglipron side effects. Every reaction the label reports in 5% or more of patients, dose by dose and against placebo, plus how many people stopped taking it, how severe the reactions were, and the drug interactions that come with being a small molecule rather than a peptide.
- Wegovy pill vs Foundayo. The two oral GLP-1s side by side. They cost the same at maintenance, so what separates them is effectiveness, a daily fasting window, and your other medicines.
- Cost without insurance. Foundayo’s published self-pay prices set beside Wegovy’s and Zepbound’s, with the annual arithmetic that monthly comparisons miss.
Where it sits against the injections
The comparison people want is against semaglutide and tirzepatide, and it has to be made carefully: these are separate trials with different populations, not a head-to-head contest. Read that way, orforglipron produces less weight reduction than either injected drug, at a materially lower price, without needles.
Whether that trade is worth making is not a question this page can answer for you. It depends on how much weight reduction you need, how you feel about injecting, and what you can sustain paying for something intended to be taken long term. What we can say is that the choice is now genuinely three-way, which it was not before 2026.
Worth knowing
“Oral GLP-1” now covers two different things. Rybelsus and the Wegovy tablet are peptides formulated to survive being swallowed, and come with instructions about food and water. Orforglipron never was a peptide, and its label puts no fasting window around the dose. Same receptor, different problem solved.
What this site will not tell you
- How to move between strengths, or how long to spend on each. The label sets that out for prescribers, and reproducing it here would function as instruction however it were worded.
- Whether you should switch from an injection. The label advises against taking two GLP-1 receptor agonists together, which makes any change a clinical decision rather than a shopping one.
- Where to buy orforglipron without a prescription. It is prescription-only, it is too new to have a generic, and anything advertised otherwise is not this drug.
Sources and method
- Approval, indication, strengths, boxed warning and all trial figures. The approved prescribing information for Foundayo (orforglipron), NDA 220934, read in full from the FDA’s own document archive. The weight-change and responder percentages are taken from the clinical studies section of that label.
- Trial registrations. NCT05869903 and NCT05872620, the two trials the label identifies as supporting the approval.
- Self-pay pricing and the refill condition. LillyDirect — Foundayo, read directly from the manufacturer’s own pharmacy pages rather than from a price-comparison site.
- What we could not verify. Eligibility for the insured and Medicare routes, whether additional dispensing or shipping fees apply at checkout, and how long the temporarily reduced strengths stay at their current price beyond the stated date. We have not reproduced the full adverse-reaction tables from the label; anyone weighing this drug up should read them with a prescriber.
- Method. Where the label and the manufacturer’s announcement disagree, the label wins — which is why the weight-change figures here are lower than several widely republished ones. Annual costs multiply the monthly price by the number of fills each manufacturer’s own definition of a month actually produces in a year, rather than assuming twelve.
GLP-1 medications → Cost without insurance → How we source and verify →
FDA label and LillyDirect pricing read 5 September 2026. We recheck this page when the label is revised, when the dated prices expire, or when a head-to-head trial against another GLP-1 is published.