What Is Foundayo? The New Once-Daily GLP-1 Weight-Loss Pill
Foundayo is Eli Lilly's brand name for orforglipron, a once-daily GLP-1 pill the FDA approved on April 1, 2026 for weight management. In trials, people who stayed on the highest dose lost an average of 12.4% of body weight (27.3 lbs) at 72 weeks.
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Foundayo is the brand name for orforglipron, a once-daily GLP-1 pill made by Eli Lilly and Company that the FDA approved on April 1, 2026 for chronic weight management in adults [1][2][7]. Unlike Ozempic, it is not an injection, and unlike Rybelsus, it is not a peptide squeezed into a tablet. Orforglipron is a small molecule. The FDA label says to take it once daily, with or without food [1], and both Lilly and the UK’s MHRA state it can be taken at any time of day with no food or water restrictions [2][5]. Lilly markets it as the only GLP-1 pill for weight loss that can be taken any time of day without food or water restrictions [2].
In the pivotal ATTAIN-1 trial, people taking the highest dose who stayed on treatment lost an average of 12.4% of body weight (27.3 lbs) at 72 weeks by the efficacy estimand, compared with 0.9% (2.2 lbs) on placebo [2][8]. Here is what the drug is, what it is approved for, how it works, and how it compares with the injections and the other GLP-1 tablet.
Is Foundayo the same thing as orforglipron?
Yes. Orforglipron is the molecule, the active ingredient; Foundayo is the brand name Lilly put on the finished tablet [1][2]. Lilly gives the pronunciation as “fown-DAY-oh” [2].
The molecule has a research history: it was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018 [2][4]. In the scientific literature it appears under the research codes LY3502970 and OWL833 [3]. Its structure bound to the GLP-1 receptor was published in PNAS in 2020 (doi 10.1073/pnas.2014879117) [3].
Is Foundayo a pill or an injection, and is it a GLP-1?
It is a pill, and it is a GLP-1. The FDA label classifies Foundayo as a GLP-1 receptor agonist in tablet form, taken orally once daily [1][7]. FDA’s drug review center described it as “a GLP-1 receptor partial agonist pill which does not need to be taken on an empty stomach” [7].
The chemistry is what sets it apart. Foundayo is a once-daily small molecule (non-peptide) oral GLP-1 receptor agonist [1][2]. The injectable GLP-1s on the market, including exenatide, liraglutide, dulaglutide and semaglutide, are peptide-based drugs that require administration by subcutaneous injection [3]. Orforglipron is not a peptide, so it comes as a swallowed tablet [1][2][3].
In preclinical work, orforglipron acted as a partial agonist at the human GLP-1 receptor, biased toward G protein activation over β-arrestin recruitment, with no activity at other class B GPCRs. It was inactive at the mouse GLP-1 receptor, which is why early animal studies used mice engineered to carry the human receptor [3].
What did the FDA approve it for?
The FDA approved Foundayo, 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 who have at least one weight-related comorbid condition [1][7].
The label carries limitations. Concomitant use with another GLP-1 receptor agonist is not recommended, and it is not known whether Foundayo is safe and effective in children [1][2].
Foundayo is not FDA-approved for type 2 diabetes in the US. Lilly said on April 16, 2026 that it planned to submit Foundayo for type 2 diabetes to the FDA by the end of the second quarter of 2026 under the Commissioner’s National Priority Review Voucher [4]. Beyond weight and diabetes, Lilly lists orforglipron as under study for obstructive sleep apnea, osteoarthritis knee pain, hypertension, peripheral artery disease and stress urinary incontinence [2][4]. Lilly has submitted orforglipron for weight management and/or type 2 diabetes in more than 40 countries [2].
How does Foundayo work?
Orforglipron activates the human GLP-1 receptor [1][5]. GLP-1 is a hormone the body releases after eating; the drug mimics it. It acts on areas of the brain that regulate appetite, helping people feel fuller for longer, reducing hunger and decreasing food cravings, so people eat less [5].
Like other GLP-1s, Foundayo also delays gastric emptying, which means it can affect how other oral medications are absorbed [1]. The label identifies only the GLP-1 receptor as its target; it does not claim a second receptor [1]. In people with type 2 diabetes, orforglipron also lowers blood sugar when sugar levels are high [5].
How is Foundayo different from Rybelsus, the other GLP-1 tablet?
The difference comes down to chemistry and the dosing rules it forces. Rybelsus is oral semaglutide, a peptide. To get a peptide through the stomach, it is coformulated with an absorption enhancer, sodium N-(8-[2-hydroxybenzoyl]amino) caprylate, and even then its oral bioavailability is less than 1% [3]. Because absorption is so fragile, the tablet must be taken after an overnight fast, with a prescribed volume of water, at least 30 minutes before breakfast or any other medicine [3].
Orforglipron, as a small molecule, does not need any of that. The label says to take it once daily with or without food [1], and both Lilly and the UK’s MHRA state it can be taken at any time of day with no food or water restrictions [2][5].
Food does change orforglipron absorption somewhat, but not in a way the researchers considered clinically meaningful. In two phase 1 crossover studies, AUC was 23.7% lower and Cmax 23.2% lower when a single 3 mg dose was taken fed rather than fasted; with multiple 16 mg doses, AUC was 17.6% lower and Cmax 20.9% lower fed versus fasted. Time to peak concentration and half-life were comparable between fed and fasted states, and the authors concluded the differences were unlikely to contribute to clinically meaningful differences in efficacy [6]. Those trials were registered as NCT03929744 and NCT05110794 [6].
| Foundayo (orforglipron) | Rybelsus (oral semaglutide) | |
|---|---|---|
| Drug type | Small molecule, non-peptide [1][2] | Peptide with absorption enhancer [3] |
| Oral bioavailability | Not stated in the label excerpt | Less than 1% [3] |
| Food and water rules | Any time of day, with or without food, no water restriction [1][2][5] | After overnight fast, prescribed water volume, 30+ min before food or other medicines [3] |
| Approved use (US) | Chronic weight management in adults [1][7] | — |
One more point from the scientific literature: the approved doses of oral semaglutide do not reach the drug exposures needed to match the glucose- and weight-lowering efficacy of injectable semaglutide [3].
Why was it approved so quickly?
Foundayo was the fifth approval under the FDA’s Commissioner’s National Priority Voucher (CNPV) pilot program and the first new molecular entity approved under it. The decision came 50 days after filing, 294 days before the application’s PDUFA date of January 20, 2027, making it the fastest approval of a new molecular entity since 2002 [7].
The CNPV pilot launched in 2025 to speed up applications addressing critical national health priorities. As of April 1, 2026, the FDA had awarded 18 vouchers and issued six decisions, with a target decision timeline of two months [7].
Outside the US, the UK’s MHRA authorized orforglipron (Foundayo) on August 10, 2026, making the UK the first country in Europe to approve it. The UK authorization covers both weight management and blood sugar control in type 2 diabetes, for adults with a BMI of 30 or above, or a BMI of 27 to 30 with at least one weight-related comorbidity. It was not available on the NHS at the time of authorization, with a NICE evaluation to follow [5].
What are the tablet strengths and the dose schedule?
Foundayo tablets come in six strengths: 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg and 17.2 mg [1][5][7]. The FDA label lays out an escalation ladder, and every step requires at least 30 days at the current dose:
| Step | Dose (once daily) | Label requirement |
|---|---|---|
| Starting dose | 0.8 mg | — |
| After at least 30 days | 2.5 mg | Increase from 0.8 mg [1][7] |
| After at least 30 days on 2.5 mg | 5.5 mg | Increase from 2.5 mg [1][7] |
| After at least 30 days at each level | 9 mg, 14.5 mg or 17.2 mg | Based on treatment response and tolerability [1][7] |
| Maximum | 17.2 mg | — [1][7] |
The MHRA phrases the same schedule as a minimum of one month at each dose level [5]. The label also says to swallow tablets whole, not to break, crush or chew them, and not to take more than one tablet per day [1]. It includes a separate section (2.3) on what to do about a missed dose [1].
Two dose caps apply with other medicines: the maximum dose is 9 mg once daily when Foundayo is used with a strong CYP3A4 inhibitor, and simvastatin should not exceed 20 mg once daily when taken with Foundayo [1].
Dosing decisions belong with a prescriber; the schedule above is only what the FDA label states.
Why do trial reports mention 36 mg when the top tablet is 17.2 mg?
Because the trials used capsules, not the commercial tablets. In the Phase 3 ATTAIN-1 trial, doses were reported as 6 mg, 12 mg and 36 mg [8]. Lilly’s ACHIEVE-4 release explains the conversion: a 1 mg capsule corresponds to a 0.8 mg tablet, and the top trial dose of a 36 mg capsule corresponds to a 17.2 mg tablet [4]. In ACHIEVE-4, participants started at the 1 mg capsule equivalent and increased the dose every four weeks until reaching a maximum tolerated dose [4].
How much weight did people lose in the trials?
ATTAIN-1 (NCT05869903) was a Phase 3, 72-week, randomized, double-blind, placebo-controlled trial that enrolled 3,127 adults with obesity, or overweight with at least one comorbidity, who did not have diabetes [2][8]. Participants started at an average of 103.2 kg (227.5 lbs) with a BMI of 37.0 [8]. Results were published in The New England Journal of Medicine and presented at the EASD Annual Meeting on September 16, 2025 [8].
The results depend on which statistical method, called an estimand, is used. Using the efficacy estimand, people on the highest dose lost an average of 12.4% of body weight (12.4 kg, or 27.3 lbs) at 72 weeks, versus 0.9% (2.2 lbs) on placebo [2][8]. Using the treatment-regimen estimand, which counts everyone randomized regardless of trial completion, the highest dose produced 11.2% (25.0 lbs) versus 2.1% (5.3 lbs) on placebo [8]. Lilly’s April 2026 release describes the latter as an average of 25 pounds (11.1%) regardless of trial completion versus 5.3 pounds (2.1%) for placebo [2].
| ATTAIN-1 result at 72 weeks | Highest dose | Placebo |
|---|---|---|
| Weight change, efficacy estimand | −12.4% (−27.3 lbs) | −0.9% (−2.2 lbs) [2][8] |
| Weight change, treatment-regimen estimand | −11.2% (−25.0 lbs) | −2.1% (−5.3 lbs) [8] |
| Lost ≥5% of body weight (efficacy estimand) | 77.1% | 22.1% [8] |
| Lost ≥10% of body weight | 59.6% | — [8] |
| Lost ≥15% of body weight | 39.6% | — [8] |
The lower doses lost less: 7.8% at 6 mg and 9.3% at 12 mg by the efficacy estimand [8]. Among the 1,127 participants who had prediabetes at the start, up to 91% of those on orforglipron reached near-normal blood sugar levels versus 42% on placebo [8]. In a pre-specified exploratory analysis, the highest dose reduced hsCRP, a marker of inflammation, by 47.7% [8]. The trial also showed improvements in non-HDL cholesterol, systolic blood pressure, triglycerides and waist circumference [2][8].
The broader ATTAIN program enrolled more than 4,500 people across two global registration trials; ATTAIN-2 (NCT05872620) enrolled more than 1,600 adults with obesity or overweight and type 2 diabetes [2].
What did the diabetes and heart study show?
ACHIEVE-4 (NCT05803421), announced April 16, 2026, was a Phase 3, event-driven, randomized, open-label trial comparing Foundayo with insulin glargine in 2,749 adults with type 2 diabetes and obesity or overweight at increased cardiovascular risk, across 15 countries [4].
The trial met its primary endpoint: non-inferiority for major adverse cardiovascular events (MACE-4), with a hazard ratio of 0.84 (95% CI 0.59 to 1.20, p = 0.336), meeting the prespecified criterion that the upper confidence limit stay below 1.8 [4]. MACE-3 showed a hazard ratio of 0.77 (95% CI 0.52 to 1.13, p = 0.181), which Lilly’s release headline describes as a 23% lower risk [4]. All-cause death showed a hazard ratio of 0.43 (95% CI 0.25 to 0.75, p = 0.002), but this analysis was not controlled for type 1 error, so it should be read as exploratory [4].
On metabolic measures at 52 weeks from a baseline A1C of 8.22%, Foundayo lowered A1C by 1.6% versus 1.0% for insulin glargine, a treatment difference of −0.66. Body weight fell 8.8% (17.9 lbs) on Foundayo from a baseline of 90.9 kg (200.4 lbs), while the insulin group gained 1.7% (3.1 lbs) [4]. During the 52-week minimum treatment period, 10.6% of patients discontinued Foundayo due to adverse events, and the trial’s liver-injury analyses found no hepatic safety signal [4]. Across seven Phase 3 studies, more than 11,000 patients have been enrolled [4].
What are the side effects and warnings?
The label carries a boxed warning about the risk of thyroid C-cell tumors. It notes that orforglipron is not pharmacologically active in rats or mice and did not produce tumors in rodents, and that the human relevance of the rodent tumors seen with other GLP-1s has not been determined [1][7].
Foundayo is contraindicated in people with a personal or family history of medullary thyroid carcinoma, in people with Multiple Endocrine Neoplasia syndrome type 2, and in anyone with serious hypersensitivity to orforglipron or the tablet’s ingredients [1][2].
The most common adverse reactions, reported in at least 5% of patients, are nausea, constipation, diarrhea, vomiting, dyspepsia, abdominal pain, headache, abdominal distension, fatigue, eructation, gastroesophageal reflux disease, flatulence and hair loss [1][7].
The label’s warnings and precautions include acute pancreatitis, severe gastrointestinal reactions (it is not recommended in severe gastroparesis), acute kidney injury from volume depletion, hypoglycemia when combined with insulin or an insulin secretagogue, hypersensitivity reactions including anaphylaxis and angioedema, diabetic retinopathy complications, acute gallbladder disease, and pulmonary aspiration during general anesthesia or deep sedation [1].
Other label points: Foundayo may cause fetal harm and should be discontinued when pregnancy is recognized; people using oral contraceptives are advised to switch to a non-oral method or add a barrier method for 30 days after starting and for 30 days after each dose increase; it is not recommended in severe hepatic impairment; and strong CYP3A4 inducers should be avoided, with monitoring of effectiveness if moderate inducers are used [1]. The label was revised in July 2026 [1].
How much does it cost, and how do you get it?
Foundayo became available through LillyDirect with free home delivery, with prescriptions accepted on April 1, 2026 and shipping beginning April 6, 2026, followed shortly by broad availability through US retail pharmacies and telehealth providers [2].
Foundayo’s share of new patients has grown since launch. Lilly reported that new starts for Foundayo were at nearly one in four in the oral obesity category at its early-August earnings, and the company’s CEO said on September 21, 2026 that the pill now accounts for about one out of three new starts in that category [13]. The same day, Lilly broke ground on a $6.5 billion manufacturing facility on roughly 240 acres in Houston, Texas, where it plans to make the active ingredient for Foundayo, among other small-molecule medicines; the company expects the plant to be operational by 2030 [13][14].
Self-pay pricing starts at $149 per month for the lowest dose [2]. Eligible people with commercial insurance may pay as little as $25 per month with the Foundayo savings card, and eligible Medicare Part D individuals may be able to get it for $50 per month beginning as soon as July 1, 2026 [2]. The $25 and $50 figures are savings-card and Medicare program tiers with eligibility conditions, not cash prices.
Foundayo is a prescription-only medicine. The MHRA cautions that buying GLP-1 medicines from unregulated sellers carries serious health risks [5]. Lilly cites that fewer than 1 in 10 people who could benefit from a GLP-1 are currently taking one [2], and calls Foundayo its second FDA-approved obesity medicine [2].
Whether Foundayo fits a particular person is a question for a prescriber, who can weigh the eligibility criteria, the dose schedule and the warnings against an individual’s health history.
Sources
- Eli Lilly and Company. FOUNDAYO (orforglipron) tablets, for oral use. Initial U.S. Approval: 2026.
- Eli Lilly and Company. FDA approves Lilly’s Foundayo (orforglipron), the only GLP-1 pill for weight loss that can be taken any time of day without food or water restrictions. April 1, 2026.
- PNAS. Structural basis for GLP-1 receptor activation by LY3502970, an orally active nonpeptide agonist.
- Eli Lilly and Company. ACHIEVE-4, the longest Phase 3 study of Lilly’s Foundayo (orforglipron) to date, reaffirmed its cardiovascular and overall safety profile. April 16, 2026.
- GOV.UK. UK first in Europe to authorise orforglipron for weight management and type 2 diabetes.
- Diabetes Therapy. Effect of Food Consumption on the Pharmacokinetics, Safety, and Tolerability of Once-Daily Orally Administered Orforglipron (LY3502970), a Non-peptide GLP-1 Receptor Agonist. February 24, 2024.
- U.S. Food and Drug Administration. FDA Approves First New Molecular Entity Under National Priority Voucher Program. April 1, 2026.
- Eli Lilly and Company. Lilly’s oral GLP-1, orforglipron, demonstrated meaningful weight loss and cardiometabolic improvements in complete ATTAIN-1 results published in The New England Journal of Medicine. September 16, 2025.
- Eli Lilly and Company. Foundayo (orforglipron), Lilly’s new oral GLP-1 pill for weight loss, now available in the U.S. April 9, 2026.
- LillyDirect. Foundayo (orforglipron): Now available.
- PR Newswire. Lilly reports second-quarter 2026 financial results, raises full-year guidance, and highlights continued growth and pipeline progress.
- Eli Lilly and Company. How much should I expect to pay for Foundayo (orforglipron)? Foundayo cost information.
- cnbc.com. Eli Lilly CEO offers investors 3 more reasons to stick with the stock. September 21, 2026.
- cnbc.com. Lilly is ramping up future manufacturing for Foundayo obesity pill. September 21, 2026.
Frequently asked questions
Is Foundayo the same thing as orforglipron?
Yes. Orforglipron is the active molecule and Foundayo is the brand name Eli Lilly gave the tablet. In research papers the molecule also appears under the codes LY3502970 and OWL833. Lilly pronounces the brand name "fown-DAY-oh".
Is Foundayo a pill or an injection, and is it a GLP-1?
It is a once-daily pill and it is a GLP-1 receptor agonist. Unlike injectable GLP-1s such as semaglutide, which are peptide-based drugs requiring subcutaneous injection, Foundayo is a small molecule (non-peptide) tablet. FDA's drug center described it as a GLP-1 receptor partial agonist pill.
Can Foundayo be taken with food or at night?
The label says to take it orally once daily, with or without food. Lilly and the UK's MHRA both state it can be taken at any time of day with no food or water restrictions. Food lowers absorption modestly, but study authors concluded the difference is unlikely to be clinically meaningful.
How is Foundayo different from Rybelsus (oral semaglutide)?
Rybelsus is a peptide tablet with an absorption enhancer and under 1% oral bioavailability, so it must be taken after an overnight fast with a set amount of water, at least 30 minutes before food or other medicines. Foundayo is a non-peptide small molecule with no such restrictions.
Is Foundayo approved for type 2 diabetes in the US?
No. The FDA approval on April 1, 2026 covers chronic weight management only. Lilly said on April 16, 2026 that it planned to submit a type 2 diabetes application to the FDA by the end of Q2 2026. The UK's MHRA did authorize it for both weight management and type 2 diabetes blood sugar control on August 10, 2026.
How much weight did people lose on it in trials?
In ATTAIN-1, a 72-week trial of 3,127 adults without diabetes, the highest dose produced an average loss of 12.4% (27.3 lbs) by the efficacy estimand versus 0.9% (2.2 lbs) on placebo. By the treatment-regimen estimand, the highest dose averaged 11.2% (25.0 lbs) versus 2.1% (5.3 lbs) on placebo.
What are the available tablet strengths and how long does escalation take?
Tablets come in 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg and 17.2 mg. The label starts at 0.8 mg once daily and requires at least 30 days at each level before increasing, with 17.2 mg as the maximum. Dosing decisions rest with a prescriber.
What are the most common side effects?
The label lists nausea, constipation, diarrhea, vomiting, dyspepsia, abdominal pain, headache, abdominal distension, fatigue, eructation, GERD, flatulence and hair loss as the most common reactions, each reported in at least 5% of patients. The label also carries a boxed warning about thyroid C-cell tumors.
This article summarizes FDA labeling, published research and company information current as of October 18, 2026. It is not medical advice and does not replace a conversation with your own healthcare provider. How we research and verify.