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Foundayo Dosage: What the FDA Label Says About Orforglipron Doses

Foundayo (orforglipron) dosage as the FDA label lists it: six tablet strengths from 0.8 mg to 17.2 mg, the 0.8 mg starting dose, dose escalation every 30 days or more, the 17.2 mg maximum, food and missed-dose rules, dose adjustments, and how the 3 to 36 mg trial capsule doses map to the tablets. A label summary, not medical advice.

Updated 8 November 2026 7 min read 8 primary sourcesHow we research

Key facts

  • The FDA label lists six once-daily tablet strengths: 0.8, 2.5, 5.5, 9, 14.5 and 17.2 mg of orforglipron.[1][2]
  • The label’s starting dose is 0.8 mg once daily, raised to 2.5 mg and then 5.5 mg, each after at least 30 days.[1]
  • Further steps to 9, 14.5 and 17.2 mg are optional, each after at least 30 days, based on response and tolerability; the maximum is 17.2 mg once daily.[1]
  • If 7 or more doses in a row are missed, the label says to restart escalation at a lower dose.[1]
  • Trial doses of 3, 6, 12 and 36 mg used an investigational capsule; the label shows them as 2.5, 5.5, 9 and 17.2 mg tablets.[1][5][7][8]

Foundayo Dosage at a Glance

The FDA label for Foundayo (orforglipron), revised 07/2026, lists a 0.8 mg once-daily starting dose, escalation in steps of at least 30 days, and a 17.2 mg once-daily maximum.[1]

This page summarises the FDA prescribing information for Foundayo for information only. It is not medical advice and not a dosing plan. Anyone taking Foundayo should follow their prescriber’s instructions.

Foundayo is a prescription medicine from Eli Lilly. It is not sold in this shop, and this page is not a guide to obtaining it. For what orforglipron is, how it works and its full trial results, see what is orforglipron.

Foundayo Tablet Strengths

Foundayo comes as six film-coated tablets of 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg and 17.2 mg of orforglipron, each supplied in bottles of 30.[1][2]

Tablet strengths and appearance, FDA label sections 3 and 16.1.
StrengthAppearanceDebossingPack
0.8 mgPink, round"L" / "G1"Bottle of 30[1]
2.5 mgLight yellow, round"L" / "G2"Bottle of 30[1]
5.5 mgGreyish purple, round"L" / "G3"Bottle of 30[1]
9 mgPink, modified oval"Lilly" / "G4"Bottle of 30[1]
14.5 mgLight yellow, modified oval"Lilly" / "G5"Bottle of 30[1]
17.2 mgGreyish purple, modified oval"Lilly" / "G6"Bottle of 30[1]

The mg figure refers to orforglipron itself. Each tablet holds the drug as orforglipron calcium, so a 17.2 mg tablet contains 17.57 mg of the calcium salt.[1] The label lists storage at 20 to 25 °C, with short excursions allowed between 15 and 30 °C.[1]

Foundayo Starting Dose and Dose Escalation Schedule

The label’s starting dose is 0.8 mg once daily for at least 30 days, then 2.5 mg for at least 30 days, then 5.5 mg, with optional further steps to 9, 14.5 and 17.2 mg.[1]

Escalation as set out in FDA label section 2.1. Earliest day is simple arithmetic from the 30-day minimum, not label wording.
StepDaily doseLabel instructionEarliest day at this dose
10.8 mgStarting dose; stay at least 30 daysDay 1[1]
22.5 mgAfter at least 30 days on 0.8 mg; stay at least 30 daysDay 31[1]
35.5 mgAfter at least 30 days on 2.5 mgDay 61[1]
49 mgMay increase after at least 30 days on 5.5 mg, based on response and tolerabilityDay 91[1]
514.5 mgMay increase after at least 30 days on 9 mg, based on response and tolerabilityDay 121[1]
617.2 mgMay increase after at least 30 days on 14.5 mg; maximum doseDay 151[1]
  • Why it starts low. The label says to follow the starting dose and escalation to reduce the risk of gastrointestinal adverse reactions.[1]
  • The first two steps are fixed. The label says to increase from 0.8 mg to 2.5 mg and from 2.5 mg to 5.5 mg. Steps above 5.5 mg “may” be taken, depending on response and tolerability.[1]
  • At least 30 days, not exactly 30. Each interval in the label is a minimum, so a slower pace is consistent with it.[1]
  • Trials used four-week steps. In ACHIEVE-2, ACHIEVE-3 and ACHIEVE-5, everyone started at 0.8 mg and went up every four weeks; reaching 17.2 mg passed through 0.8, 2.5, 5.5, 9 and 14.5 mg.[3] ACHIEVE-4 also started at 0.8 mg and rose every four weeks to the highest tolerated dose, up to 17.2 mg.[4]

Foundayo Maintenance Doses and Maximum Dose

The label sets the maximum at 17.2 mg once daily and names no single maintenance dose; 5.5 mg is the last fixed step, and the obesity trials kept people on 5.5 mg, 9 mg or 17.2 mg.[1]

  • Maximum: 17.2 mg once daily. The label also says not to take more than one tablet a day.[1]
  • Lower ceiling with some medicines. With a strong CYP3A4 inhibitor, the label’s maximum is 9 mg once daily (see dose adjustments below).[1]
  • Doses studied long term. In the 72-week ATTAIN-1 and ATTAIN-2 trials, people were randomised to stay on 5.5 mg, 9 mg or 17.2 mg once daily after escalation.[1]
  • 14.5 mg in the trials. In the studies Lilly describes, 14.5 mg was a step on the way to 17.2 mg rather than a randomised dose arm.[3]

How to Take Foundayo: Food, Water and Time of Day

The label says to take one tablet by mouth once daily, with or without food, swallowed whole and not broken, crushed or chewed.[1]

  • Food. With or without food. In a food-effect study, taking orforglipron with food lowered exposure (AUC) by 19% and peak level by 26%, which the label calls not clinically relevant.[1]
  • Water. The label gives no instruction about water. Lilly describes Foundayo as a pill that can be taken without restrictions on food and water intake.[1][3]
  • Time of day. The label does not name a time of day. Lilly says it can be taken any time of the day.[1][3]
  • One tablet only. No more than one tablet a day; the Medication Guide adds that it is used with a reduced-calorie diet and more physical activity.[1]
  • How long it stays. The label gives a half-life of about 29 to 49 hours, with steady state after about one week of daily dosing.[1]

What If You Miss a Dose of Foundayo?

The label says to take a missed dose as soon as possible and not to double up, and to restart escalation at a lower dose after 7 or more missed doses in a row.[1]

Missed-dose wording from FDA label section 2.3 and the Medication Guide.
SituationWhat the label lists
One dose missedTake it as soon as possible[1]
Next doseDo not double up; the Medication Guide says not to take 2 doses in the same day[1]
7 or more consecutive doses missedRestart dose escalation at a lower dosage, to reduce the risk of GI adverse reactions; the Medication Guide says to call the healthcare provider about how to restart[1]
Too much takenCall the healthcare provider or Poison Help line (1-800-222-1222), or go to the nearest emergency room[1]

The label does not say which lower dose to restart on after a break of 7 days or more. That is left to the prescriber.[1]

Foundayo Dose Adjustments

The label caps Foundayo at 9 mg once daily alongside a strong CYP3A4 inhibitor and lists no dose change for kidney impairment or for mild to moderate liver impairment.[1]

Dose-related instructions in FDA label sections 2.2, 5, 7 and 8.
SituationWhat the label lists
Strong CYP3A4 inhibitorMaximum Foundayo dose 9 mg once daily[1]
Strong CYP3A4 inhibitor that also inhibits OATP1B (e.g. ritonavir)Avoid the combination[1]
Strong CYP3A4 inducerAvoid the combination[1]
Moderate CYP3A4 inducerMonitor effectiveness and escalate the Foundayo dose as needed[1]
SimvastatinDo not exceed simvastatin 20 mg once daily[1]
Insulin or a sulfonylureaReducing the dose of insulin or the sulfonylurea may be necessary (low blood sugar risk)[1]
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 increase[1]
Kidney impairment, including end-stageNo dose change[1]
Mild or moderate liver impairment (Child-Pugh A or B)No dose change[1]
Severe liver impairment (Child-Pugh C)Not recommended[1]
Severe gastroparesisNot recommended[1]
Another GLP-1 receptor agonistUse together not recommended[1]

The label gives no separate dosing for older adults: in the two weight trials, 13% of people on Foundayo were 65 or older, with no overall differences in safety or effectiveness. Safety and effectiveness in children have not been established.[1]

Foundayo Tablet mg vs Trial Capsule mg (3 to 36 mg)

The trials published doses of 3, 6, 12 and 36 mg of an investigational capsule, which correspond to the 2.5, 5.5, 9 and 17.2 mg Foundayo tablets; 36 mg capsule equals 17.2 mg tablet.[8][5][7][1]

Capsule doses as published in trial papers, matched to the tablet doses the label and Lilly report for the same trials.
Trial capsule doseFoundayo tablet doseHow it is matched
3 mg2.5 mgACHIEVE-2 paper reports 3, 12 and 36 mg; Lilly reports the same trial as 2.5, 9 and 17.2 mg[7][3]
6 mg5.5 mgATTAIN-1 paper reports 6, 12 and 36 mg; the label reports the same trial (NCT05869903) as 5.5, 9 and 17.2 mg[5][1]
12 mg9 mgATTAIN-1 and ACHIEVE-2, as above[5][7][1]
36 mg17.2 mgStated directly in the ACHIEVE-4 paper: “up to 36 mg capsule [equivalent to 17.2 mg tablet]”[8]
  • The label explains that the pivotal trials used an investigational orforglipron formulation and presents the results as equivalent doses of once-daily Foundayo.[1]
  • Lilly’s releases use the same convention: the ACHIEVE trials “were conducted using an investigational formulation of Foundayo at dosages equivalent to Foundayo tablets”.[3]
  • Because the two formulations differ, the mg numbers are not interchangeable: a 17.2 mg tablet is the marketed equivalent of the 36 mg trial capsule, not half the dose.[8][1]
  • ACHIEVE-1 also published 3, 12 and 36 mg arms, matching the same three tablet doses.[6]

Foundayo Doses in the ATTAIN-1 Trial

ATTAIN-1 randomised 3,127 adults without diabetes to 5.5 mg, 9 mg or 17.2 mg once daily or placebo, and after 72 weeks weight fell by 7.4%, 8.3% and 11.1% against 2.1% on placebo.[1]

ATTAIN-1: mean weight change at 72 weeks by Foundayo dose
Placebo2.1%5.5 mg7.4%9 mg8.3%17.2 mg11.1%

FDA label Table 6, intent-to-treat, treatment-regimen estimand. The NEJM paper reports 7.5%, 8.4% and 11.2% for the 6, 12 and 36 mg capsule arms.

ATTAIN-1 (Trial 1) results by dose at week 72, FDA label Table 6.
MeasurePlacebo5.5 mg9 mg17.2 mg
People randomised949723725730
Mean weight change-2.1%-7.4%-8.3%-11.1%
Lost at least 5%26.8%59.6%63.1%71.5%
Lost at least 10%13%32.5%39.8%54.5%
Lost at least 15%6%14.3%20.1%35.9%
Lost at least 20%2.9%5.9%8.9%18.4%
Stopped trial drug30%22%22%24%[1]

The randomisation ratio was 3:3:3:4, and all doses were reached through the escalation in label section 2.1.[1] In ATTAIN-2, in adults with type 2 diabetes, the same three doses gave 5.1%, 7.0% and 9.6% weight loss against 2.5% on placebo.[1] For side effects by dose and the other phase 3 trials, see what is orforglipron; for other options, see GLP-1 alternatives.

Frequently Asked Questions

What is the starting dose of Foundayo?

The FDA label lists a starting dose of 0.8 mg once daily. After at least 30 days on 0.8 mg, the label says to increase to 2.5 mg once daily. The prescriber sets the actual plan.

How do you increase Foundayo dose?

The label sets out steps of at least 30 days each: 0.8 mg, then 2.5 mg, then 5.5 mg. After that the dose may go up to 9 mg, 14.5 mg and 17.2 mg, one step at a time with at least 30 days on each, based on response and tolerability. Clinical trials used four-week steps.

What is the maximum dose of Foundayo?

17.2 mg once daily, according to the FDA label, and no more than one tablet a day. The label lowers the maximum to 9 mg once daily for people also taking a strong CYP3A4 inhibitor.

Can you take Foundayo with food?

Yes. The label says to take Foundayo once daily with or without food, swallowed whole. Food lowered exposure by 19% in a study, which the label calls not clinically relevant. The label sets no time of day, and Lilly says it can be taken any time without food or water restrictions.

What if I miss a dose of Foundayo?

The label says to take the missed dose as soon as possible and not to double up or take two doses on the same day. If 7 or more doses in a row are missed, the label says to restart escalation at a lower dose, and the Medication Guide says to call the healthcare provider about how to restart.

Foundayo 17.2 mg vs 36 mg?

They are the same dose level in different formulations. Trials published a 36 mg dose of an investigational capsule, and the ACHIEVE-4 paper states that 36 mg capsule is equivalent to the 17.2 mg Foundayo tablet. There is no 36 mg Foundayo tablet; 17.2 mg is the highest strength.

Sources

  1. FDA. FOUNDAYO (orforglipron) tablets prescribing information and Medication Guide, revised 07/2026 (NDA 220934, supplement 3)
  2. FDA. Drugs@FDA, NDA 220934 (Foundayo) products and approval history
  3. Eli Lilly press release, 8 Jun 2026: ACHIEVE-2, ACHIEVE-3 and ACHIEVE-5 results (via PR Newswire)
  4. Eli Lilly press release, 30 Sep 2026: detailed ACHIEVE-4 results (via PR Newswire)
  5. Wharton S, et al. Orforglipron, an oral small-molecule GLP-1 receptor agonist for obesity treatment (ATTAIN-1). N Engl J Med 2025;393(18):1796-1806. DOI 10.1056/NEJMoa2511774
  6. Rosenstock J, et al. Orforglipron in early type 2 diabetes (ACHIEVE-1). N Engl J Med 2025;393(11):1065-1076. DOI 10.1056/NEJMoa2505669
  7. Welch M, et al. Orforglipron compared with dapagliflozin in type 2 diabetes (ACHIEVE-2). The Lancet 2026;408(10550):125-140. DOI 10.1016/S0140-6736(26)00800-7
  8. Klein KR, et al. Cardiovascular safety of orforglipron versus insulin glargine (ACHIEVE-4). The Lancet 2026;408(10564):1557-1570. DOI 10.1016/S0140-6736(26)01865-9

For research use only. Not for human or veterinary consumption. This guide summarises published research for information only. It is not medical advice and does not describe any use of products sold on this site.

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