Status checked on October 6, 2026 dailymed.nlm.nih.gov
Foundayo (orforglipron) was FDA approved on April 1, 2026 for chronic weight management: label facts, trials, side effects, boxed warning and dated prices.
Fact-checked against FDA labels and official sources; not yet reviewed by a licensed clinician. This page is education, not medical advice. Talk to your doctor before starting, stopping or changing any treatment.
Key facts
- Active ingredient
- Orforglipron: the small-molecule GLP-1 pill and its current status
- Class
- GLP-1 receptor agonist
- Route
- Pill (tablet)
- How often
- Daily
- Manufacturer
- Eli Lilly
- Approved for weight
- Yes
- First approved
- 2026
- Generic available
- No
- Controlled substance
- No
- Official label
- Prescribing information
Key takeaways
- Foundayo (orforglipron) was FDA approved on April 1, 2026 for chronic weight management in adults with obesity, or overweight with a weight-related condition.[3]
- The label says the once-daily tablet can be taken with or without food.[1]
- In the label trial of adults without diabetes, the highest dose led to an average weight change of -11.1% at 72 weeks, versus -2.1% on placebo.[1]
- Regular self-pay prices were $149 to $349 a month by dose, with temporary lower prices through December 31, 2026, checked on 2026-10-06.[5]
In short: Foundayo is FDA approved. It is Eli Lilly’s brand of orforglipron, a once-daily GLP-1 pill approved on April 1, 2026, together with a reduced-calorie diet and more physical activity, to reduce excess body weight and keep it off long term in adults with obesity, or adults with overweight plus at least one weight-related condition. According to its label it can be taken with or without food. It is not approved for type 2 diabetes treatment or for children (status checked on DailyMed and Drugs@FDA on 2026-10-06).
Foundayo is new, so this page sticks to what is confirmed: the FDA approval, the label, the trials in the label and the manufacturer’s published prices. It is general information to prepare for a conversation with your clinician, not medical advice.
Foundayo at a glance
- April 1, 2026FDA approval as a new molecular entity (NDA 220934)Drugs@FDA
- 11.1%average weight loss at 72 weeks on the highest dose in adults without diabetes (placebo 2.1%)Foundayo label, section 14
- 6 strengthsfrom a 0.8 mg starting tablet to a 17.2 mg maximum, raised at least 30 days apartFoundayo label, section 2.1
- With or without foodno empty-stomach routine, unlike oral semaglutideFoundayo label, section 2.1
Checked on October 6, 2026
What is confirmed about its FDA status
Drugs@FDA lists Foundayo (orforglipron calcium) tablets under NDA 220934, approved on April 1, 2026 as a new molecular entity. The FDA’s announcement that day said it was the first new molecular entity approved under the Commissioner’s National Priority Voucher pilot program, issued 50 days after filing. The prescribing information on DailyMed was revised in July 2026, and a Medication Guide update was approved in August 2026. Anything beyond that, such as approvals for other conditions, is not confirmed and is not on this page.
What Foundayo is
The active ingredient, orforglipron, is a GLP-1 receptor agonist, the same receptor targeted by semaglutide, but it is a small molecule rather than a peptide. Our orforglipron page explains what that means. Practically, the label does not require the empty-stomach routine that oral semaglutide does. The label says it should not be combined with another GLP-1 receptor agonist. For the wider class, see GLP-1 medications.
Who it is labeled for
Adults with obesity, and adults with overweight in the presence of at least one weight-related comorbid condition, always alongside diet and activity changes. These are the label’s words; whether Foundayo is suitable for a particular person is something only a clinician who knows their history can judge.
How it is taken, in general
One tablet once a day, swallowed whole, with or without food. The label describes a low starting dose and increases at intervals of at least 30 days to a maintenance dose, with six tablet strengths in all. The label also advises people who use oral hormonal contraceptives to switch to a non-oral method, or add a barrier method, for 30 days after starting and for 30 days after each dose increase. Your prescriber sets the dose and pace.
How the label describes starting Foundayo, in general
- First 30 daysA low starting tablet, chosen to reduce stomach side effects.
- Next stepsAt least 30 days on each strength before the next increase, through three set steps.
- MaintenanceFurther increases are optional, based on how well it works and is tolerated, up to the maximum.
- Missed dosesTake a missed tablet as soon as possible, never two at once; after 7 or more missed days in a row, the dose is restarted lower.
Tablets are swallowed whole, never split, crushed or chewed, and only one is taken per day. They are stored at room temperature. Because orforglipron is broken down by the liver enzyme CYP3A4, some medicines change its levels; the label caps the dose when it is combined with a strong CYP3A4 inhibitor and advises avoiding strong CYP3A4 inhibitors that also block a liver transporter called OATP1B (ritonavir is the label’s example) and strong CYP3A4 inducers. It also raises levels of simvastatin, so the label says not to exceed simvastatin 20 mg a day with Foundayo. Bring every medicine, including supplements, to your prescriber and pharmacist.
What the trials in the label showed
The label describes two 72-week placebo-controlled trials. Trial 1 enrolled 3,127 adults without type 2 diabetes; at the highest dose, average weight change was -11.1% compared with -2.1% on placebo. Trial 2 enrolled 1,613 adults with type 2 diabetes; at the highest dose, average change was -9.6% versus -2.5%. Lower doses produced smaller average losses. Trial 1 corresponds to ATTAIN-1, published in the New England Journal of Medicine in 2025, which also reported improvements in waist size, blood pressure and some blood fats compared with placebo.
| Item | Foundayo | Placebo |
|---|---|---|
| Trial 1, no diabetes, 5.5 mg | 7.4% | 2.1% |
| Trial 1, 9 mg | 8.3% | 2.1% |
| Trial 1, 17.2 mg | 11.1% | 2.1% |
| Trial 2, type 2 diabetes, 5.5 mg | 5.1% | 2.5% |
| Trial 2, 9 mg | 7% | 2.5% |
| Trial 2, 17.2 mg | 9.6% | 2.5% |
Intention-to-treat. Doses are shown as the equivalent Foundayo tablet strengths.
Source: Foundayo prescribing information, section 14 (DailyMed, revised July 2026) (checked on October 6, 2026)
| Item | Foundayo 17.2 mg | Placebo |
|---|---|---|
| Lost 5% or more | 71.5% | 26.8% |
| Lost 10% or more | 54.5% | 13% |
| Lost 15% or more | 35.9% | 6% |
| Lost 20% or more | 18.4% | 2.9% |
Source: Foundayo prescribing information, section 14 (DailyMed) (checked on October 6, 2026)
Changes beyond weight in Trial 1, on the highest dose: waist size fell 10 cm versus 3.1 cm on placebo, systolic blood pressure 6.4 versus 1.4 mmHg and triglycerides 20% versus 4%, while resting pulse rose about 4.6 beats per minute. In Trial 2 (adults with type 2 diabetes), HbA1c fell 1.7 points versus 0.4 from a baseline of about 8.1%. These averages are smaller than the weight loss seen with injectable semaglutide or tirzepatide in their own trials, but trials differ and were not head to head.
Side effects
The label lists nausea, constipation, diarrhea, vomiting, indigestion, abdominal pain, headache, bloating, fatigue, burping, reflux, gas and hair loss as the most common side effects (in 5% or more). At the highest dose in the label’s table, nausea was reported by 35% of people versus 10% on placebo and vomiting by 24% versus 4%. In ATTAIN-1, 5.3% to 10.3% of people on orforglipron stopped because of side effects, versus 2.7% on placebo. Warnings include acute pancreatitis, severe digestive reactions, kidney injury from dehydration, low blood sugar, allergic reactions, diabetic eye complications in people with type 2 diabetes, gallbladder disease and aspiration during anesthesia or deep sedation. See GLP-1 side effects for how these are recognized.
| Item | Foundayo 17.2 mg | Placebo |
|---|---|---|
| Nausea | 35% | 10% |
| Diarrhea | 25% | 11% |
| Constipation | 24% | 9% |
| Vomiting | 24% | 4% |
| Abdominal pain | 14% | 7% |
| Indigestion | 13% | 4% |
| Headache | 9% | 7% |
| Fatigue | 9% | 4% |
| Bloating | 8% | 3% |
| Burping | 8% | 1% |
| Reflux (GERD) | 7% | 2% |
| Gas | 6% | 2% |
| Hair loss | 5% | 2% |
Percent reporting each reaction at least once in up to 72 weeks.
Source: Foundayo prescribing information, Table 1 (DailyMed) (checked on October 6, 2026)
Digestive reactions overall were reported by 60% to 69% of people on Foundayo versus 37% on placebo; most were mild (60%) or moderate (36%), and 4% were severe. In total, 8% stopped Foundayo because of side effects (6% at 5.5 mg, 9% at 9 mg, 10% at 17.2 mg) versus 3% on placebo.
Less common risks, with the label numbers
- Fast heart rate: reported by 3% versus 0.9%; average pulse rose 4 to 5 beats per minute.
- Low blood pressure: 2% versus 0.5%, and 4% in people taking blood-pressure medicines.
- Pancreatitis: 0.14 versus 0.04 patients per 100 years of exposure.
- Kidney injury: 0.2% versus 0.05%.
- Gallbladder: gallstones 1% versus 0.7%; acute gallbladder inflammation 0.4% versus 0.3%.
- Low blood sugar in type 2 diabetes: 2% versus 0.2%, and 7% in people also taking a sulfonylurea.
- Hair loss: 7% of women versus 0.9% of men on Foundayo.
Boxed warning and who should not use it
Foundayo carries the class boxed warning about thyroid C-cell tumors, which other GLP-1 receptor agonists caused in rodents. The label notes that orforglipron is not pharmacologically active in rats or mice and did not produce tumors in rodents, and that the relevance for humans is not determined. It must not be used by people with a personal or family history of medullary thyroid carcinoma or with MEN 2, or with a serious allergy to orforglipron or the tablet’s ingredients.
Pregnancy and breastfeeding
The label says to discontinue Foundayo when a pregnancy is recognized and that it is not recommended while breastfeeding. A pregnancy exposure registry exists. Talk with your clinician before starting if either applies to you.
The label explains that there are no data on orforglipron in human breast milk, but in rats it reached milk at about three times the blood level, which is why it is not recommended for nursing women. Because orforglipron can make birth-control pills less reliable, the label advises a non-oral method, or adding a barrier method, for 30 days after starting and after each dose increase. Orforglipron clears faster than semaglutide: its elimination half-life is about 29 to 49 hours.
Cost and coverage
Checked on 2026-10-06 on Lilly’s Foundayo site: regular self-pay prices are $149 a month for 0.8 mg, $199 for 2.5 mg, $299 for 5.5 mg and 9 mg, and $349 for 14.5 mg and 17.2 mg. Through December 31, 2026, 2.5 mg is temporarily $149 and 5.5 mg $199, and the two highest doses are $299 when each refill is bought within 45 days of the previous one. With commercial insurance that covers Foundayo, the savings card brings a fill to as little as $25 (card ends December 31, 2026). Medicare’s GLP-1 Bridge includes Foundayo for weight management with a $50 copay for those who meet its criteria, from July 1, 2026 to December 31, 2027. Our GLP-1 cost comparison puts these next to other options.
How it compares and where to go next
The other approved GLP-1 pill for weight is the Wegovy pill (oral semaglutide), which must be taken on an empty stomach. Our oral GLP-1 guide compares the pills, Wegovy vs Foundayo compares injection and pill, and the weight-loss pills hub separates prescription pills from supplements. The medications hub lists every option with its status badge.
Side by side, according to the two labels checked on 2026-10-06:
- Routine: Foundayo, any time with or without food; Wegovy tablets, morning, empty stomach, up to 4 ounces of water and a 30-minute wait.
- Molecule: Foundayo is a small molecule (orforglipron); the Wegovy pill is a peptide (semaglutide) with an absorption enhancer.
- Main trial result: Foundayo 11.1% versus 2.1% at 72 weeks (highest dose); Wegovy tablets 13.6% versus 2.4% at 64 weeks. Different trials, not head to head.
- Uses: Foundayo, weight management only; Wegovy tablets, weight management and heart-risk reduction.
- Self-pay starting price: $149 a month for both starting strengths.
- Interactions: Foundayo has CYP3A4 and simvastatin rules; the Wegovy pill has the empty-stomach rule and a levothyroxine effect.
Injections remain an option too: Zepbound and Wegovy produced larger average weight loss in their own trials. The best fit depends on health history, routine and coverage.
Before you start
InstaTuck does not sell or prescribe medicine. Foundayo is prescription only and new, so long-term experience outside trials is still limited. A licensed clinician should review your history first: the boxed warning and “do not use” rules (a personal or family history of medullary thyroid carcinoma or MEN 2, or a serious allergy to orforglipron), any past pancreatitis or gallbladder disease, severe gastroparesis (the label does not recommend Foundayo for it), a fast heart rate, low blood pressure, diabetes medicines, statins and other medicines that interact through CYP3A4. Read GLP-1 side effects for how the common effects are managed, our obesity medicine guide for finding a qualified prescriber, and the GLP-1 cost comparison for price context.
FDA status and approved uses
| Indication | Labeled population | For weight | Approved | Source |
|---|---|---|---|---|
| Reduce excess body weight and maintain weight reduction long term (with reduced-calorie diet and increased physical activity) | Adults with obesity, or adults with overweight in the presence of at least one weight-related comorbid condition | Yes | April 1, 2026 | Source |
From the FDA label. Who a medicine is labeled for is not the same as whether it fits you; only a clinician can decide that.
How it is taken (in general)
One tablet once daily, swallowed whole (not broken, crushed or chewed), with or without food. The label describes a starting dose and increases at least 30 days apart to a maintenance dose. Follow your prescriber.
This is what the label describes in general, never a personal dose or schedule. Follow your prescriber.
What studies showed
| Trial | Population | Duration | Outcome as reported |
|---|---|---|---|
| Label Trial 1 (ATTAIN-1) NCT05869903 | 3,127 adults with obesity or overweight, no type 2 diabetes | 72 weeks | Highest dose -11.1% vs -2.1% placebo (label); published paper -11.2% vs -2.1%.[1] |
| Label Trial 2 | 1,613 adults with obesity or overweight and type 2 diabetes | 72 weeks | Highest dose -9.6% vs -2.5% placebo.[1] |
Average results from trials; individual results vary. Results from different trials cannot be compared directly.
Side effects
| Common side effect | How often (label) |
|---|---|
| Nausea | 35% (17.2 mg) vs 10% placebo |
| Diarrhea | 25% vs 11% placebo |
| Constipation | 24% vs 9% placebo |
| Vomiting | 24% vs 4% placebo |
| Abdominal pain | 14% vs 7% placebo |
| Dyspepsia (indigestion) | 13% vs 4% placebo |
Serious risks
- Thyroid C-cell tumors (class boxed warning)
- Acute pancreatitis
- Severe gastrointestinal reactions
- Acute kidney injury due to volume depletion
- Hypoglycemia
- Hypersensitivity reactions
- Diabetic retinopathy complications in type 2 diabetes
- Acute gallbladder disease
- Pulmonary aspiration during general anesthesia or deep sedation
Warnings and who should not use it
Boxed warning
Risk of thyroid C-cell tumors: other GLP-1 receptor agonists caused thyroid C-cell tumors in rodents; orforglipron is not pharmacologically active in rats or mice and did not produce tumors in rodents. Human relevance has not been determined. Foundayo is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Who should not use it (per the label)
- Personal or family history of medullary thyroid carcinoma (MTC) or MEN 2
- Known serious hypersensitivity to orforglipron or any excipients
Interactions, pregnancy and breastfeeding
| Drug or class | What the label says |
|---|---|
| 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 increase (label). |
| Other GLP-1 receptor agonists | Concomitant use is not recommended (label). |
Pregnancy and breastfeeding
The label advises discontinuing Foundayo when pregnancy is recognized and states it is not recommended for women who are breastfeeding. A pregnancy exposure registry is available.
Cost, insurance and savings
| Price | Amount | Basis | Checked on |
|---|---|---|---|
| Self-pay / cash | 149 USD | per month, 0.8 mg (2.5 mg also $149 through 2026-12-31; regular $199) | October 6, 2026 |
| Self-pay / cash | 299 USD | per month, 5.5 mg and 9 mg regular price (5.5 mg $199 through 2026-12-31) | October 6, 2026 |
| Self-pay / cash | 349 USD | per month, 14.5 mg and 17.2 mg regular price ($299 with refills within 45 days) | October 6, 2026 |
| With savings program | 25 USD | per 1- to 3-month fill with commercial coverage (card ends 2026-12-31) | October 6, 2026 |
Prices change often and depend on pharmacy, plan and location. Insurance can change what you pay. Every price shows the date we checked it.
Savings programs
- Foundayo Savings Card: Commercial insurance; ends 2026-12-31 (checked October 6, 2026)
- Foundayo Self-Pay Journey: Valid prescription; refill within 45 days for the $299 offer on 14.5 mg and 17.2 mg (checked October 6, 2026)
- Medicare GLP-1 Bridge: Eligible Part D enrollees for weight management, $50 copay, July 1, 2026 to December 31, 2027 (checked October 6, 2026)
Stopping and keeping results
Trials show that weight often returns after these medicines are stopped. Plan any change with your prescriber. Stopping a GLP-1: what trials show and how people keep results
Compounded and counterfeit versions
Compounded semaglutide and tirzepatide are not FDA approved: the FDA does not review them for safety, quality or effectiveness. Counterfeit pens and "research peptides" sold online have caused harm. Buy only from a licensed pharmacy with a prescription.
Same class
FDA approved for weight managementPrescriptionInjectionLiraglutide: the daily GLP-1 (Saxenda, Victoza) and genericsInjection · Daily
FDA approved for weight managementPrescriptionPillOrforglipron: the small-molecule GLP-1 pill and its current statusPill (tablet) · Daily
FDA approved for weight managementPrescriptionInjectionSaxenda (liraglutide 3 mg): uses, side effects and costLiraglutide: the daily GLP-1 (Saxenda, Victoza) and generics · Injection · Daily
FDA approved for weight managementPrescriptionInjectionSemaglutide: one ingredient, several brandsInjection · Daily, Weekly
FDA approved for weight managementPrescriptionInjectionWegovy (semaglutide): uses, side effects, cost and FDA statusSemaglutide: one ingredient, several brands · Injection · Weekly
FDA approved for weight managementPrescriptionInjectionWegovy HD (semaglutide 7.2 mg): what the higher dose is, results and statusSemaglutide: one ingredient, several brands · Injection · WeeklyCompare with
Non-drug approaches
FDA approved for weight managementPrescriptionPillWegovy Pill (oral semaglutide): status, how it is taken, how it comparesSemaglutide: one ingredient, several brands · Pill (tablet) · DailyFDA approved for weight managementPrescriptionInjectionWegovy (semaglutide): uses, side effects, cost and FDA statusSemaglutide: one ingredient, several brands · Injection · Weekly
FDA approved for weight managementPrescriptionInjectionZepbound (tirzepatide): uses, side effects, cost and FDA statusTirzepatide: how the dual GIP/GLP-1 drug works (Zepbound, Mounjaro) · Injection · Weekly
FDA approved for weight managementPrescriptionPillQsymia (phentermine/topiramate): uses, risks and REMSCapsule · DailyCost and coverage
Research mentioning it
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- Is a daily pill like Foundayo a reasonable option for me compared with an injection?
- Is there anything in my thyroid or family history that would rule it out?
- How should I handle birth control during the first months and after each dose change?
- What side effects should make me call you, and how do we manage nausea?
- What will it cost me with my insurance, and how long might I take it?
Frequently asked questions
Is Foundayo FDA approved?
Yes. The FDA approved Foundayo (orforglipron) on April 1, 2026 (NDA 220934) for chronic weight management in adults with obesity, or overweight with at least one weight-related condition.
Is Foundayo approved for type 2 diabetes?
No. As of 2026-10-06 its only approved use is weight reduction and maintenance. Adults with type 2 diabetes were studied for weight, but treating diabetes itself is not an approved use.
Do I need to take Foundayo on an empty stomach?
According to the label, no: it can be taken with or without food. The tablet should be swallowed whole.
How is Foundayo different from the Wegovy pill?
Foundayo contains orforglipron, a small-molecule GLP-1 receptor agonist; the Wegovy pill contains semaglutide and must be taken on an empty stomach with little water. Their trials were separate, so results cannot be compared directly.
How much weight do people lose on Foundayo?
In the label's Trial 1, adults without diabetes lost an average of 11.1% of their weight at 72 weeks on the highest dose versus 2.1% on placebo, and 54.5% lost at least 10%. In adults with type 2 diabetes the average was 9.6% versus 2.5%.
Do I need to take Foundayo on an empty stomach?
No. The label says Foundayo can be taken once daily with or without food. The tablet must be swallowed whole.
Does Foundayo interact with other medicines?
Yes. Strong CYP3A4 inhibitors raise its levels (the label caps the dose and says to avoid those that also block OATP1B, such as ritonavir), strong CYP3A4 inducers lower them, and it doubles simvastatin acid exposure, so simvastatin should not exceed 20 mg a day. It can also reduce how well birth-control pills work.
What if I miss Foundayo doses?
Take a missed dose as soon as possible and do not double up. If 7 or more doses in a row are missed, the label says to restart at a lower dose to reduce stomach side effects.
Is Foundayo approved for type 2 diabetes?
Not as of 2026-10-06. Its only approved use is chronic weight management in adults; a trial in people with type 2 diabetes is in the label as part of the weight indication.
Official sources
References
- FOUNDAYO (orforglipron) tablets: prescribing information. Eli Lilly and Company, via DailyMed, 2026. (accessed October 7, 2026) Drug label
- Drugs@FDA: Foundayo, NDA 220934. U.S. Food and Drug Administration. (accessed October 7, 2026) Government page
- FDA Approves First New Molecular Entity Under National Priority Voucher Program. U.S. Food and Drug Administration, 2026. (accessed October 7, 2026) Government page
- Wharton S, Aronne LJ, Stefanski A, et al.. Orforglipron, an Oral Small-Molecule GLP-1 Receptor Agonist for Obesity Treatment (ATTAIN-1). New England Journal of Medicine, 2025. doi:10.1056/NEJMoa2511774 · PMID 40960239 · NCT05869903 (accessed October 6, 2026) Randomized trial
- Foundayo coverage and savings. Eli Lilly and Company. (accessed October 6, 2026) Other
- Medicare GLP-1 Bridge: information for providers. Centers for Medicare and Medicaid Services. (accessed October 7, 2026) Government page
- WEGOVY (semaglutide) injection and tablets: prescribing information. Novo Nordisk, via DailyMed, 2026. (accessed October 7, 2026) Drug label
Facts checked on October 6, 2026
Educational information, not medical advice. Talk with a qualified healthcare professional about your own situation. In an emergency call 911.