Short answer

The Foundayo label (revised 7/2026) starts at 0.8 mg once daily, then 2.5 mg and 5.5 mg, each after at least 30 days. Prescribers may continue to 9, 14.5 and 17.2 mg, the maximum, again at least 30 days apart. Example: held exactly 30 days per step, 5.5 mg starts on day 61. As of Oct 21, 2026.

On this page11 sections
  1. How to take Foundayo, per the label
  2. Missed doses: the 7-dose rule
  3. Interactions that change the dose
  4. Pharmacokinetics: what a daily pill with a 1- to 2-day half-life means
  5. Who the label covers
  6. Trial results in the label
  7. Storage
  8. Approval timeline
  9. Related schedules
  10. FAQ
  11. Sources
Key facts (as of Oct 21, 2026)
ItemValueSource
Starting dose0.8 mg once daily for at least 30 daysEli Lilly, Jul 29, 2026
Required escalation steps0.8 → 2.5 → 5.5 mg once daily, at least 30 days on eachEli Lilly, Jul 29, 2026
Optional higher steps9, 14.5 or 17.2 mg once daily, at least 30 days apart, based on response and tolerabilityEli Lilly, Jul 29, 2026
Maximum dose17.2 mg once dailyEli Lilly, Jul 29, 2026
Tablet strengths0.8, 2.5, 5.5, 9, 14.5 and 17.2 mg film-coated tablets, bottles of 30Eli Lilly, Jul 29, 2026
Food and waterWith or without food; the label has no water-volume or timing ruleEli Lilly, Jul 29, 2026
Missed doseTake as soon as possible; do not double the next doseEli Lilly, Jul 29, 2026
7 or more consecutive doses missedRestart escalation at a lower dosageEli Lilly, Jul 29, 2026
With other strong CYP3A4 inhibitorsMaximum 9 mg once dailyEli Lilly, Jul 29, 2026
Half-lifeApproximately 29 to 49 hours after an oral doseEli Lilly, Jul 29, 2026
Time to steady stateAbout 1 week of daily dosingEli Lilly, Jul 29, 2026
Storage20°C to 25°C (68°F to 77°F); excursions 15°C to 30°C permittedEli Lilly, Jul 29, 2026
FDA approvalApr 1, 2026, NDA 220934, adults with obesity or overweight plus a weight-related conditionFDA, Apr 1, 2026

Foundayo (orforglipron) is a once-daily GLP-1 tablet from Eli Lilly, approved by FDA on Apr 1, 2026 for chronic weight management in adults (FDA, Apr 1, 2026). Its dose ladder climbs in steps of at least 30 days. This page quotes the prescribing information revised 7/2026, the version on DailyMed when we checked on Oct 21, 2026 (Eli Lilly, Jul 29, 2026). It is a reference, not a plan: talk to your prescriber before starting, changing or restarting a dose.

Foundayo dose chart, label section 2.2 (prescribing information revised 7/2026). Day ranges are the earliest possible schedule, if each step lasts exactly 30 days; the label says at least 30 days. (Eli Lilly, Jul 29, 2026)
StepDaily doseLabel ruleEarliest days (30-day steps)
10.8 mgStarting doseDays 1–30
22.5 mgAfter at least 30 days on 0.8 mgDays 31–60
35.5 mgAfter at least 30 days on 2.5 mgDays 61–90
4 (optional)9 mgAfter at least 30 days at the current doseNo earlier than day 91
5 (optional)14.5 mgAfter at least 30 days at the current doseNo earlier than day 121
6 (optional, maximum)17.2 mgAfter at least 30 days at the current doseNo earlier than day 151

The label states: “Starting dosage is 0.8 mg once daily. After at least 30 days, increase dosage to 2.5 mg once daily.” The step to 5.5 mg follows after at least 30 days on 2.5 mg. Above 5.5 mg the label says the dose may be increased to the next level, depending on treatment response and tolerability, and “Maximum dosage is 17.2 mg once daily” (Eli Lilly, Jul 29, 2026).

Two things the label does not do. It names no separate maintenance dose, and it gives no fixed calendar: “at least 30 days” is a floor, so any step can last longer. The day numbers in the last column are arithmetic on that floor, not a schedule anyone must follow.

Each strength is its own film-coated tablet, sold in bottles of 30 (Eli Lilly, Jul 29, 2026). For what each bottle costs at each step, see the Foundayo savings card guide; this page does not list prices.

How to take Foundayo, per the label

The administration section is short (Eli Lilly, Jul 29, 2026):

  • Once daily, by mouth. “Take FOUNDAYO orally once daily, with or without food.”
  • Swallow whole. Do not break, crush or chew the tablet.
  • One tablet a day. Take no more than one tablet per day.
  • No water or timing rule. The label sets no minimum or maximum amount of water and no waiting period before or after food. It does not tie the dose to a particular time of day.

Lilly’s approval release describes Foundayo as a pill that can be taken any time of day without food or water restrictions (Eli Lilly, Apr 1, 2026). For a side-by-side of the two pills, see Foundayo vs the Wegovy pill.

Missed doses: the 7-dose rule

Foundayo missed-dose rules, label section 2.3 (prescribing information revised 7/2026) (Eli Lilly, Jul 29, 2026)
SituationWhat the label says
One dose missedTake it as soon as possible
Next scheduled doseDo not double it to make up for the missed one
7 or more consecutive doses missedRestart escalation at a lower dosage

The label does not name which lower dose to restart on. That choice belongs to your prescriber, who can weigh how long the gap was and how the earlier steps were tolerated.

For comparison, the Wegovy injection label sets its restart threshold at 2 or more consecutive missed weekly doses (Novo Nordisk, Jun 18, 2026). In both cases, after a long enough gap, escalation starts again from a lower step rather than at the old dose. The full Wegovy rules are on the Wegovy dosing schedule page.

Interactions that change the dose

Orforglipron is metabolized mainly by the liver enzyme CYP3A4, and the label builds several dose limits around that (Eli Lilly, Jul 29, 2026). Two of the terms below need a definition. A CYP3A4 inhibitor is a drug that slows that enzyme, which can raise orforglipron levels; an inducer speeds it up, which can lower them. OATP1B is a liver transporter that some of the same drugs also block.

Foundayo drug-interaction dose rules, label sections 1, 2.2 and 7 (prescribing information revised 7/2026) (Eli Lilly, Jul 29, 2026)
Other medicineWhat the label says
Strong CYP3A4 inhibitors that also inhibit OATP1BAvoid use together
Other strong CYP3A4 inhibitorsMaximum Foundayo dose is 9 mg once daily
Strong CYP3A4 inducersAvoid use together
SimvastatinDo not exceed 20 mg/day of simvastatin
Oral hormonal contraceptivesSwitch to a non-oral method, or add a barrier method, for 30 days after starting and for 30 days after each dose escalation
Another GLP-1 receptor agonistUse together is not recommended

The contraceptive rule repeats with every step. On the earliest possible schedule, that means backup contraception during days 1–30, 31–60 and 61–90, and again for 30 days after any move to 9, 14.5 or 17.2 mg. The 9 mg cap also means that a patient on a qualifying strong CYP3A4 inhibitor would not use the 14.5 or 17.2 mg tablets. If you take any of these medicines, talk to your prescriber and pharmacist before starting Foundayo or changing a dose.

Pharmacokinetics: what a daily pill with a 1- to 2-day half-life means

Pharmacokinetics describes how a drug is absorbed, spread through the body and cleared. The label’s figures are below (Eli Lilly, Jul 29, 2026).

Foundayo pharmacokinetics, label section 12.3 (prescribing information revised 7/2026) (Eli Lilly, Jul 29, 2026)
MeasureLabel value
Half-lifeApproximately 29 to 49 hours after an oral dose
Time to peak level (Tmax)4 to 8 hours
Time to steady stateAbout 1 week
Absolute bioavailability77% (0.8 mg dose)
Protein bindingMore than 99%
Main metabolic routeCYP3A4
Excretion87% recovered in feces, less than 1% in urine
Food effectNot clinically relevant; with an investigational 37.5 mg tablet, food lowered AUC by 19% and Cmax by 26%

A half-life of 29 to 49 hours is about 1.2 to 2 days. Because each tablet arrives while a good share of the earlier ones is still present, levels build up over the first days at a new dose; the label puts steady state at about 1 week. Absolute bioavailability of 77% means most of the swallowed dose reaches the bloodstream.

Weekly injections work on a different time scale. Semaglutide, the drug in Wegovy, has an elimination half-life of about 1 week (Novo Nordisk, Jun 18, 2026), so a single dose covers the whole week and levels change slowly. With Foundayo, the daily tablet does that job, and the shorter half-life means levels respond to a change, or a gap, within days rather than weeks. That is a qualitative comparison: we have not modeled orforglipron, and our plotting tools cover only the weekly injectable compounds. For the weekly side, see the semaglutide half-life guide.

Who the label covers

The approved use is narrow (FDA, Apr 1, 2026) (Eli Lilly, Jul 29, 2026):

  • Indication. An adjunct to a reduced-calorie diet and increased physical activity “to reduce excess body weight and maintain weight reduction long term.”
  • Adults only. Adults with obesity, or adults with overweight and at least one weight-related comorbid condition. The indication text gives no BMI thresholds; BMI cut-offs appear only as trial entry criteria.
  • Not for type 2 diabetes. Type 2 diabetes is not an approved indication. It appears in the label as a trial population and in warnings.
  • Not for children. “Safety and effectiveness of FOUNDAYO have not been established in pediatric patients.” FDA deferred studies for ages 12 to under 18 (final report due Dec 2028) and 6 to under 12 (final report due Feb 2032), and waived them for ages 0 to under 6.

The label carries a boxed warning about the risk of thyroid C-cell tumors. It also notes that orforglipron is not pharmacologically active in rats or mice, did not cause tumors in rodents, and that the relevance to humans is undetermined. Foundayo is contraindicated in people with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN 2), and in people with a known serious hypersensitivity to orforglipron or any ingredient (Eli Lilly, Jul 29, 2026).

Trial results in the label

Label section 14 reports two 72-week, placebo-controlled trials. Trial 1 is ATTAIN-1, in participants without diabetes (n=3,127). Trial 2 is ATTAIN-2, in participants with type 2 diabetes and a BMI of at least 27 (n=1,613) (Eli Lilly, Jul 29, 2026) (Eli Lilly, Apr 1, 2026).

Mean body-weight change and share reaching at least 5% loss at week 72, label section 14 Trials 1 and 2 (the label’s figures: treatment-regimen estimand, intent-to-treat population; prescribing information revised 7/2026) (Eli Lilly, Jul 29, 2026)
ArmTrial 1 mean changeTrial 1 ≥5% lossTrial 2 mean changeTrial 2 ≥5% loss
Placebo−2.1%26.8%−2.5%26.8%
5.5 mg−7.4%59.6%−5.1%47.4%
9 mg−8.3%63.1%−7.0%54.7%
17.2 mg−11.1%71.5%−9.6%67.0%

These are the label’s numbers, which is why they can differ from figures in news coverage. Lilly’s headline “12.4%” for the highest dose is the efficacy estimand, which estimates the result if everyone had stayed on treatment. By the treatment-regimen estimand, which counts everyone randomized whether or not they kept taking the drug, the figure is 11.1%, the same value the label shows for 17.2 mg in Trial 1 (Eli Lilly, Apr 1, 2026).

In the label’s figures, Trial 2 participants (type 2 diabetes) had smaller mean changes than Trial 1 participants at every dose. These are separate trials, so that comparison needs the same care as any cross-trial comparison, including with Wegovy or other drugs: trials differ in population, duration and analysis.

Storage

The label says: “Store FOUNDAYO at room temperature 20°C to 25°C (68°F to 77°F).” Excursions between 15°C and 30°C are permitted (Eli Lilly, Jul 29, 2026). The approval letter sets expiry dating at 24 months from manufacture when stored at 20–25°C (FDA, Apr 1, 2026).

Approval timeline

Foundayo regulatory and launch milestones (FDA approval letter, FDA bulletin and Lilly releases) (FDA, Apr 1, 2026) (FDA, Apr 1, 2026) (Eli Lilly, Apr 1, 2026) (Eli Lilly, Apr 9, 2026)
MilestoneDate or detail
NDA 220934 received by FDAJan 20, 2026
FDA approvalApr 1, 2026
FDA’s stated time from filing50 days (FDA’s figure; from NDA receipt on Jan 20 to approval on Apr 1 is 71 days, our arithmetic)
Original PDUFA goal dateJan 20, 2027 (294 days later)
Advisory committeeNot referred to one
LillyDirect shipping beganApr 6, 2026
Retail pharmacy availabilityApr 9, 2026

Foundayo was the first new molecular entity approved under the Commissioner’s National Priority Voucher pilot, and FDA called it “the fastest approval of an NME since 2002” (FDA, Apr 1, 2026). The launch dates come from Lilly’s releases (Eli Lilly, Apr 1, 2026) (Eli Lilly, Apr 9, 2026). Orforglipron is a small-molecule, non-peptide drug that Chugai discovered and licensed to Lilly in 2018 (Eli Lilly, Apr 1, 2026).

The Wegovy dosing schedule covers the weekly semaglutide injection and the once-daily Wegovy tablet, and the semaglutide dosage chart puts every semaglutide product on one page. For a direct comparison of the two GLP-1 pills, read Foundayo vs the Wegovy pill. For costs at each Foundayo step, see the Foundayo savings card guide.

Frequently asked questions

What is the Foundayo dosing schedule?

Per the Foundayo prescribing information (revised 7/2026), treatment starts at 0.8 mg once daily. After at least 30 days the dose goes to 2.5 mg, and after at least 30 more days to 5.5 mg. From there the dose may go up to 9 mg, 14.5 mg and 17.2 mg, each after at least 30 days, depending on response and tolerability. If every step lasted exactly 30 days, 5.5 mg would start on day 61. Your prescriber sets the actual pace.

What is the maximum dose of Foundayo?

The label says the maximum dosage is 17.2 mg once daily, and no more than one tablet should be taken per day. The label does not name a separate maintenance dose. If a patient also takes a strong CYP3A4 inhibitor that does not inhibit OATP1B, the label caps the dose at 9 mg. Talk to your prescriber about which step fits.

Can you take Foundayo with food?

Yes. The label says to take Foundayo orally once daily, with or without food, and to swallow the tablet whole without breaking, crushing or chewing it. The label sets no rule about how much water to drink or how long to wait before eating. The label calls the food effect not clinically relevant.

What happens if I miss a dose of Foundayo?

The label says to take a missed dose as soon as possible and not to take two doses to make up for it. If 7 or more consecutive doses are missed, the label says to restart dose escalation at a lower dosage rather than resume the old dose. It does not name the restart dose, so call your prescriber for a restart plan.

How long does Foundayo stay in your system?

The label gives a half-life of approximately 29 to 49 hours after an oral dose, or about 1.2 to 2 days, and says steady state is reached in about 1 week of daily dosing. The label does not state a washout time. By the common 5-half-life rule of thumb, most of the drug would be gone about 6 to 10 days after the last tablet; that is arithmetic on the label range, not a label statement.

Is Foundayo approved for type 2 diabetes?

No. As of Oct 21, 2026, the FDA approval of Apr 1, 2026 covers chronic weight management in adults only: obesity, or overweight with at least one weight-related condition. Type 2 diabetes appears in the label as a trial population (Trial 2) and in warnings, not as an indication. The label also says safety and effectiveness have not been established in children.

Sources

  1. FOUNDAYO (orforglipron) tablets, for oral use - Full Prescribing Information (Revised 7/2026). Eli Lilly and Company / National Library of Medicine DailyMed, Jul 29, 2026. Accessed Oct 21, 2026.
  2. NDA 220934 approval letter (FOUNDAYO orforglipron tablets). U.S. Food and Drug Administration, Apr 1, 2026. Accessed Oct 21, 2026.
  3. FDA Approves First New Molecular Entity Under National Priority Voucher Program (FDA bulletin). U.S. Food and Drug Administration, Apr 1, 2026. Accessed Oct 21, 2026.
  4. 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. Eli Lilly and Company, Apr 1, 2026. Accessed Oct 21, 2026.
  5. Foundayo (orforglipron), Lilly's new oral GLP-1 pill for weight loss, now available at retail pharmacies. Eli Lilly and Company, Apr 9, 2026. Accessed Oct 21, 2026.
  6. WEGOVY (semaglutide) injection, for subcutaneous use; WEGOVY (semaglutide) tablets, for oral use - Full Prescribing Information (SPL, Revised 6/2026). Novo Nordisk / National Library of Medicine DailyMed, Jun 18, 2026. Accessed Oct 19, 2026.