Scientific deep-dive

Foundayo (Orforglipron): the First GLP-1 Pill for Weight

Approved 1 April 2026 as the first GLP-1 tablet for weight management, taken with or without food, no injection. It produced 11.1% weight loss at 72 weeks, below both injectable rivals. The label, the trials and the interactions.

By Ruth Calder · Enforcement Editor
Editorially reviewed (not clinically reviewed). Not medical advice · How we verify contentLast reviewed
9 min read·4 citations

Foundayo is the first GLP-1 pill approved for weight management, and it does something no injection can: you swallow it once a day, with or without food, and there is no needle involved at any point. Eli Lilly got it approved on 1 April 2026.[1] At its maximum dose it produced 11.1% weight loss over 72 weeks.[2]

Both halves of that matter. It is genuinely more convenient than anything else approved for this. It is also, on the numbers published so far, less effective than the injections it is being compared to — and that trade is the whole decision.

What was actually approved

Foundayo on Drugs@FDA
FieldRecord
ApplicationNDA 220934
SponsorEli Lilly and Company
Active ingredientOrforglipron calcium
Approved1 April 2026
FormFilm-coated tablet, once daily
StrengthsSix tablets: 0.8, 2.5, 5.5, 9, 14.5 or 17.2 mg

Who it is for, per the label: adults carrying obesity, or adults carrying excess weight who also have a condition connected to it. The approval covers both losing the weight and keeping it off over the long term, and it is explicitly conditioned on diet and exercise running alongside — the drug is approved as part of a program, not instead of one.[2] Stacking it with a second GLP-1 is not recommended.

Why this is not just “Rybelsus for weight”. Rybelsus is oral semaglutide — a peptide, approved for type 2 diabetes, and it barely survives the gut, which is why its label demands an empty stomach, a small sip of water and a wait before eating. Orforglipron is a non-peptide small molecule. It does not need protecting from your digestion, so the label simply says with or without food. That is the actual innovation here, and it is a chemistry story rather than a dosing one.

How well it works

Two placebo-controlled trials of 72 weeks each support the approval, and they were split by diabetes status. Trial 1 took 3,127 participants and deliberately excluded anyone with type 2 diabetes; Trial 2 enrolled the people Trial 1 turned away.[2] Running them separately is what makes the results readable, because diabetes changes how much weight these drugs shift.

Weight change from baseline after 72 weeks (intent-to-treat)
Daily doseTrial 1 (no diabetes)Trial 2 (type 2 diabetes)
Placebo−2.1%−2.5%
5.5 mg−7.4%−5.1%
9 mg−8.3%−7.0%
17.2 mg−11.1%−9.6%

Averages hide the spread, so the responder figure is the more useful one: on the top dose in Trial 1, 71.5% cleared the 5% threshold that counts as a clinically meaningful loss, where 26.8% did so on placebo.[2] The dose response is clean — more drug, more effect — and the benefit held across age, sex, race, ethnicity, starting BMI and blood sugar status.

Against the injections

Approved weight-management results, non-diabetic populations
DrugRouteWeight changeTrial
Orforglipron (Foundayo)Daily tablet−11.1% at 72 weeksTrial 1, n=3,127
Semaglutide (Wegovy)Weekly injection−14.9% at 68 weeksSTEP 1, n=1,961
Tirzepatide (Zepbound)Weekly injection−20.9% at 72 weeksSURMOUNT-1, n=2,539
⚠ These are three separate trials, not a head-to-head comparison. Different protocols, different sites, different years, different participants — so read the table as indicative rather than as a ranking anyone has actually measured. What makes it worth putting side by side at all is that all three enrolled people without type 2 diabetes, so the populations are at least comparable. Only a direct trial settles it, and none has reported.

With that caveat honored, the shape is hard to miss: the pill lands below both injections. If you want the largest average weight loss on the market, the evidence still points at tirzepatide. If you will not or cannot inject, this is the first approved option that respects that — and 11.1% is a real clinical result, not a consolation.

The boxed warning, read carefully

Foundayo carries the same boxed warning about thyroid C-cell tumors as the rest of the GLP-1 class, and it is worth reading rather than pattern-matching, because the label says something unusual.

“Orforglipron is not pharmacologically active in rats or mice and did not produce tumors in rodents… While orforglipron is pharmacologically active at the human GLP-1 receptor, the human relevance of GLP-1 receptor-dependent thyroid C-cell tumors observed in rodents has not been determined.”[2]
— FDA label, FOUNDAYO — Boxed Warning

The rodent tumors that generated this warning for the class were not produced by this molecule — it is not active in those species, so the experiment could not have produced them either way. The warning is retained because the human question behind it remains open, not because orforglipron failed a test. Two groups are ruled out entirely regardless: anyone whose own history or whose family’s includes medullary thyroid carcinoma, and anyone with MEN 2.

The interactions that are new

⛔ This is where being a small molecule cuts the other way, and it is the part most likely to be skipped. Injectable GLP-1s are peptides and largely sidestep liver enzyme interactions. Orforglipron does not — it runs through CYP3A4, so other drugs change its levels and it changes theirs.[2]

  • Strong CYP3A4 inhibitors — your ceiling becomes 9 mg a day rather than 17.2 mg. Ones that also block OATP1B should not be combined with it at all.
  • Strong CYP3A4 inducers — avoid. With moderate ones, the drug may simply work less well, so response needs watching and the dose may have to climb.
  • Simvastatin — capped at 20 mg once daily while you are on it.
  • Oral contraceptives — the label directs users onto a non-oral method, or onto an added barrier method. ★ Easy to miss, and expensive to miss.
  • Anything else you swallow — gastric emptying slows, and that can change how another tablet is taken up.
The contraception advice is not boilerplate. The label warns the drug can harm a developing fetus, and it tells you to discontinue it once you learn you are pregnant. Put those two facts together — a drug that must not continue into pregnancy, and a pill whose reliability it may undercut — and this becomes a conversation for before the first tablet rather than after. Our page on GLP-1s and hormonal birth control covers the mechanism, and pregnancy and trying to conceive covers the rest.

What people actually reported

Reported in at least 5% of people taking it: nausea, constipation, diarrhea, vomiting, dyspepsia, abdominal pain, headache, abdominal distension, fatigue, eructation, gastroesophageal reflux, flatulence — and hair loss.[2] Nausea ran 26–35% across the doses against 10% on placebo, and 5% of people stopped the drug because of gastrointestinal effects.

The label also warns on acute pancreatitis, severe gastrointestinal reactions (not recommended with severe gastroparesis), acute kidney injury from volume depletion, hypoglycemia when combined with insulin or an insulin secretagogue, hypersensitivity reactions, diabetic retinopathy progression, and acute gallbladder disease. Our pages on hair and muscle loss and pancreatitis and gallbladder risk go into those two in depth.

What it costs, and what it does not cost

Four sellers in this register currently list it: Found at $149 a month, ShedRx at $149, Sesame Care at $149 and Maximus at $199.99. That is a sample of four rather than a market, so treat it as a starting read rather than a median — we do not publish aggregate statistics below five recorded prices.

Disclosure. One of those four, Found, is a partner we earn a commission from. The other three are not. This article was written from the FDA record and the label, and the number that matters most in it — 11.1% against 14.9% and 20.9% — is not flattering to the drug. Our policy is at /disclosure.

Two things worth knowing beyond the cash price. Foundayo is one of the drugs covered under the Medicare GLP-1 Bridge, which means a $50 monthly copay for eligible beneficiaries. And there is no compounded version of it, nor should there be: it is a new, on-patent, commercially available drug with no shortage, so anything sold to you as compounded orforglipron is not a legitimate compounded product. Our guide to which GLP-1s can be compounded explains why that line exists.

Common questions

Frequently Asked Questions

The brand name for orforglipron, a once-daily GLP-1 tablet from Eli Lilly, cleared under NDA 220934 on 1 April 2026. It is the first pill in this class approved to treat weight rather than diabetes, and it is prescribed to people whose weight is high enough to qualify on its own or who carry a related condition alongside it.
Over 72 weeks, and it depends heavily on the dose you reach. Among participants without diabetes the top 17.2 mg dose averaged 11.1%, against 2.1% for placebo, and just under three quarters of that group cleared a 5% loss. The 9 mg dose managed 8.3% and the 5.5 mg dose 7.4%. Where type 2 diabetes was present the top-dose figure fell to 9.6%.
On the published numbers, no. Orforglipron reported 11.1%, semaglutide 14.9% in STEP 1 and tirzepatide 20.9% in SURMOUNT-1. Those are separate trials rather than a head-to-head comparison, so the gap is indicative rather than measured — but all three studied non-diabetic populations, and the ordering is consistent. What orforglipron offers instead is a tablet with no injection and no food restrictions.
No, and this is the practical advance over Rybelsus. Orforglipron is a non-peptide small molecule rather than a peptide, so it does not need to be shielded from digestion. The label says once daily with or without food. Swallow the tablet whole — do not break, crush or chew it — and never take more than one a day.
Slowly, and by design. You begin on the smallest tablet and hold there a full month before the next step, repeating that wait at every rung — six strengths in all, ending at 17.2 mg once daily. Whether you climb past the middle of the ladder depends on how you respond and what your stomach tolerates. The pace exists to blunt the nausea, which is why pushing it faster tends to backfire.
Because the unresolved question is about people, not rodents. The label is unusually explicit that this molecule is inactive in rats and mice and raised no tumors in them — but it does act on the human receptor, and whether the effect seen across the class carries over to humans has never been settled. The warning marks that gap rather than a failed study. Anyone with MEN 2, or with medullary thyroid carcinoma in their own or their family's history, is excluded from taking it.
More than the injectables do, and for a structural reason: it is a small molecule cleared through CYP3A4, so it sits in traffic the peptides drive around. Drugs that block that enzyme strongly pull your ceiling down to 9 mg; drugs that induce it strongly are off the table; simvastatin is held to 20 mg; and anyone relying on a contraceptive pill is steered onto a different method or told to add a barrier. Slower gastric emptying can also alter how other tablets are taken up. Hand your prescriber the full list, including anything over the counter.
No. It is newly approved, on patent, commercially available and not in shortage, so there is no lawful basis for compounding it. Anything marketed to you as compounded orforglipron is not a legitimate compounded preparation, whatever the seller calls it.

References

  1. 1.U.S. Food and Drug Administration Drugs@FDA record for FOUNDAYO (orforglipron calcium), NDA 220934, Eli Lilly and Company — approval date, dosage forms and strengths FDA Drugs@FDA. 2026. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220934
  2. 2.Eli Lilly and Company FOUNDAYO (orforglipron) tablets — prescribing information: indications, boxed warning, dosage and administration, drug interactions, adverse reactions and clinical studies DailyMed. 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ac446c5-feba-474f-a103-23facb9b5c62
  3. 3.Wilding JPH, Batterham RL, Calanna S, et al. Once-Weekly Semaglutide in Adults with Overweight or Obesity (STEP 1) N Engl J Med. 2021. PMID: 33567185.
  4. 4.Jastreboff AM, Aronne LJ, Ahmad NN, et al. Tirzepatide Once Weekly for the Treatment of Obesity (SURMOUNT-1) N Engl J Med. 2022. PMID: 35658024.

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No insurance needed · vetted by our editors

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5.7

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6.5

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8.4

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