Dosing schedules
Foundayo dosing schedule: the dose chart from the FDA label
- 6 sources
- No vendors
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
| Item | Value | Source |
|---|---|---|
| Starting dose | 0.8 mg once daily for at least 30 days | Eli Lilly, Jul 29, 2026 |
| Required escalation steps | 0.8 → 2.5 → 5.5 mg once daily, at least 30 days on each | Eli Lilly, Jul 29, 2026 |
| Optional higher steps | 9, 14.5 or 17.2 mg once daily, at least 30 days apart, based on response and tolerability | Eli Lilly, Jul 29, 2026 |
| Maximum dose | 17.2 mg once daily | Eli Lilly, Jul 29, 2026 |
| Tablet strengths | 0.8, 2.5, 5.5, 9, 14.5 and 17.2 mg film-coated tablets, bottles of 30 | Eli Lilly, Jul 29, 2026 |
| Food and water | With or without food; the label has no water-volume or timing rule | Eli Lilly, Jul 29, 2026 |
| Missed dose | Take as soon as possible; do not double the next dose | Eli Lilly, Jul 29, 2026 |
| 7 or more consecutive doses missed | Restart escalation at a lower dosage | Eli Lilly, Jul 29, 2026 |
| With other strong CYP3A4 inhibitors | Maximum 9 mg once daily | Eli Lilly, Jul 29, 2026 |
| Half-life | Approximately 29 to 49 hours after an oral dose | Eli Lilly, Jul 29, 2026 |
| Time to steady state | About 1 week of daily dosing | Eli Lilly, Jul 29, 2026 |
| Storage | 20°C to 25°C (68°F to 77°F); excursions 15°C to 30°C permitted | Eli Lilly, Jul 29, 2026 |
| FDA approval | Apr 1, 2026, NDA 220934, adults with obesity or overweight plus a weight-related condition | FDA, 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.
| Step | Daily dose | Label rule | Earliest days (30-day steps) |
|---|---|---|---|
| 1 | 0.8 mg | Starting dose | Days 1–30 |
| 2 | 2.5 mg | After at least 30 days on 0.8 mg | Days 31–60 |
| 3 | 5.5 mg | After at least 30 days on 2.5 mg | Days 61–90 |
| 4 (optional) | 9 mg | After at least 30 days at the current dose | No earlier than day 91 |
| 5 (optional) | 14.5 mg | After at least 30 days at the current dose | No earlier than day 121 |
| 6 (optional, maximum) | 17.2 mg | After at least 30 days at the current dose | No 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
| Situation | What the label says |
|---|---|
| One dose missed | Take it as soon as possible |
| Next scheduled dose | Do not double it to make up for the missed one |
| 7 or more consecutive doses missed | Restart 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.
| Other medicine | What the label says |
|---|---|
| Strong CYP3A4 inhibitors that also inhibit OATP1B | Avoid use together |
| Other strong CYP3A4 inhibitors | Maximum Foundayo dose is 9 mg once daily |
| Strong CYP3A4 inducers | Avoid use together |
| Simvastatin | Do not exceed 20 mg/day of simvastatin |
| Oral hormonal contraceptives | Switch 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 agonist | Use 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).
| Measure | Label value |
|---|---|
| Half-life | Approximately 29 to 49 hours after an oral dose |
| Time to peak level (Tmax) | 4 to 8 hours |
| Time to steady state | About 1 week |
| Absolute bioavailability | 77% (0.8 mg dose) |
| Protein binding | More than 99% |
| Main metabolic route | CYP3A4 |
| Excretion | 87% recovered in feces, less than 1% in urine |
| Food effect | Not 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).
| Arm | Trial 1 mean change | Trial 1 ≥5% loss | Trial 2 mean change | Trial 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
| Milestone | Date or detail |
|---|---|
| NDA 220934 received by FDA | Jan 20, 2026 |
| FDA approval | Apr 1, 2026 |
| FDA’s stated time from filing | 50 days (FDA’s figure; from NDA receipt on Jan 20 to approval on Apr 1 is 71 days, our arithmetic) |
| Original PDUFA goal date | Jan 20, 2027 (294 days later) |
| Advisory committee | Not referred to one |
| LillyDirect shipping began | Apr 6, 2026 |
| Retail pharmacy availability | Apr 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).
Related schedules
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
- 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.
- NDA 220934 approval letter (FOUNDAYO orforglipron tablets). U.S. Food and Drug Administration, Apr 1, 2026. Accessed Oct 21, 2026.
- 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.
- 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.
- 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.
- 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.