Foundayo (orforglipron, Eli Lilly) is the first FDA-approved oral non-peptide GLP-1 receptor agonist, cleared on April 1, 2026 for chronic weight management. It is a once-daily tablet taken at any time of day, with or without food and water — no fasting window. The FDA prescribing information lays out a six-step ladder: 0.8 mg → 2.5 mg → 5.5 mg → 9 mg → 14.5 mg → 17.2 mg, with approximately four weeks at each step. The 0.8 mg starter is a tolerability lead-in and is not a therapeutic dose.
Dose ladder (FDA label)
| Step | Weeks | Dose (once-daily oral) | Notes |
|---|---|---|---|
| 1 (lead-in) | Weeks 1–4 | 0.8 mg | Tolerability dose. Not a therapeutic dose — advance after about 4 weeks if tolerated. |
| 2 | Weeks 5–8 | 2.5 mg | First therapeutic step. Hold longer if GI symptoms (nausea, vomiting, diarrhea) are intolerable. |
| 3 | Weeks 9–12 | 5.5 mg | Mid-ladder step. Advance only after at least 4 weeks on 2.5 mg. |
| 4 | Weeks 13–16 | 9 mg | Mid-high step. Some patients stabilize here if higher doses are not tolerated. |
| 5 | Weeks 17–20 | 14.5 mg | Penultimate step toward the maintenance dose. Holding here is acceptable if tolerated and effective. |
| 6 (ceiling) | Week 21+ | 17.2 mg | Maintenance dose used in the ATTAIN-1 Phase 3 trial. Do not exceed 17.2 mg/day. |
Source: DailyMed Foundayo SPL, SetID 8ac446c5-feba-474f-a103-23facb9b5c62.
Quick facts
- No food or water restriction. Unlike Rybelsus (oral semaglutide), Foundayo can be taken at any time of day, with or without food, and does not require a 30-minute fasting window.
- Once daily, same time each day. Pick a time that fits the patient’s routine and stick to it.
- ~4 weeks per step. The label allows roughly four weeks at each dose before escalating. Holding a step longer is acceptable if GI symptoms have not resolved.
- Holding a dose is allowed. Patients who tolerate and respond well to 9 mg or 14.5 mg can remain at that dose; the 17.2 mg ceiling is the maximum, not a required target.
- 17.2 mg is the ATTAIN-1 maintenance dose. The Phase 3 ATTAIN-1 obesity trial used 17.2 mg/day as the top maintenance dose; this is the FDA-approved ceiling.
- Tablet, not injection. Foundayo is the first oral non-peptide GLP-1 receptor agonist to reach the U.S. market — no needles, no refrigeration.
- Swallow whole. Do not split, crush, or chew the tablet.
Missed-dose protocol
Because Foundayo is a daily oral tablet, the missed-dose logic is different from weekly subcutaneous GLP-1s like Wegovy or Zepbound (which use a 96-hour window).
- If you remember the same day: take the missed dose as soon as you remember, then resume the normal once-daily schedule.
- If it is already the next day: skip the missed dose and take the next scheduled dose at the usual time. Do not double up.
- Never take two doses in one day. Doubling the dose increases the risk of nausea, vomiting, and dehydration without added benefit.
- For weekly injectable GLP-1s, the rules are entirely different — see the GLP-1 missed-dose guide.
Red-flag side effects (pause escalation or call the prescriber)
- Severe, persistent abdominal pain radiating to the back — possible acute pancreatitis. Stop dosing and seek evaluation.
- Right-upper-quadrant pain, fever, or jaundice — possible gallbladder disease (cholelithiasis or cholecystitis), a known GLP-1 class adverse reaction.
- Signs of severe dehydration from prolonged vomiting or diarrhea — acute kidney injury has been reported across the GLP-1 class. Hold the next dose, hydrate, and contact the prescriber.
- A new neck lump, hoarseness, or trouble swallowing — per the boxed warning on thyroid C-cell tumors, evaluate promptly. A personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) is a contraindication.
- Symptomatic hypoglycemia — especially in patients on concomitant insulin or a sulfonylurea. Those agents may need dose reduction.
- Severe allergic reaction — rash, urticaria, swelling of the face/tongue/throat, or anaphylaxis. Discontinue and seek emergency care.
What this cheat sheet does not cover
- Pricing. Foundayo is rolling out through late 2025 and into 2026; cash-pay tiers and insurance coverage are still being finalized. Check the live Foundayo drug page for current pricing.
- Pregnancy guidance. Like the rest of the GLP-1 class, Foundayo is not recommended in pregnancy. Discontinue at least two months before a planned pregnancy. See the full DailyMed label for specifics.
- Type 2 diabetes indication. The ACHIEVE-1 Phase 3 program in T2D is pending; this cheat sheet covers only the chronic-weight-management label cleared April 1, 2026.
- Head-to-head with Rybelsus. Both are oral GLP-1s, but Rybelsus is a peptide (semaglutide) requiring a fasting window and Foundayo is a non-peptide with no food restriction. See the Foundayo vs Rybelsus verdict page for the side-by-side.
Related on Weight Loss Rankings
- Foundayo drug page — full label, indications, side effects, current pricing.
- Foundayo vs Rybelsus — the only two oral GLP-1s on the U.S. market, compared head-to-head.
- Top retatrutide studies — PubMed-curated list of next-generation GLP-1 / GIP / glucagon trials.
- GLP-1 trial results dashboard — weight-loss outcomes across the SURMOUNT, STEP, ATTAIN, and ACHIEVE programs.
- GLP-1 titration planner — interactive week-by-week ladder across the major GLP-1s.