Status checked on October 6, 2026 dailymed.nlm.nih.gov
Orforglipron, the small-molecule GLP-1 pill: FDA approved for weight as Foundayo (April 2026), investigational for diabetes, ATTAIN-1 and ACHIEVE-1 results.
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.
Brands with this active ingredient
| Brand | Route | How often | Approved uses | Status | Manufacturer |
|---|---|---|---|---|---|
| Foundayo (orforglipron): status, uses and what is confirmed | Pill (tablet) | Daily | Reduce excess body weight and maintain weight reduction long term (with reduced-calorie diet and increased physical activity) | FDA approved for weight managementPrescriptionPill | Eli Lilly |
Key takeaways
- Orforglipron is FDA approved only as Foundayo, since April 1, 2026, for chronic weight management in adults; treating type 2 diabetes is not an approved use.[3]
- It is a small, non-peptide GLP-1 receptor agonist that the label says can be taken with or without food.[1]
- In ATTAIN-1, the highest dose led to an average weight change of -11.2% at 72 weeks, versus -2.1% on placebo.[4]
- In ACHIEVE-1, orforglipron lowered HbA1c in early type 2 diabetes over 40 weeks, an investigational use.[5]
In short: Orforglipron is a small-molecule GLP-1 receptor agonist taken as a daily pill. It is FDA approved only under the brand name Foundayo, since April 1, 2026, for chronic weight management in adults with obesity, or overweight with at least one weight-related condition. It has also been studied for type 2 diabetes (the ACHIEVE trials), but treating diabetes is not an approved use: for that purpose it remains investigational (FDA records checked on 2026-10-06).
This page is about the molecule: what makes it different from semaglutide, what the trials found and where its status stands. For prescribing details, prices and the label in full, see the Foundayo page.
Current status, from FDA records
| Use | Status (checked 2026-10-06) | FDA source |
|---|---|---|
| Chronic weight management in adults with obesity, or overweight with a weight-related condition | FDA approved as Foundayo, April 1, 2026 | Drugs@FDA NDA 220934; DailyMed label |
| Treatment of type 2 diabetes (blood sugar control) | Investigational: not in the FDA label | DailyMed label lists weight management only |
| Children and teens | Not approved | DailyMed label (adults only) |
Status can change. Our status badges guide explains what “FDA approved” and “investigational” mean, and we re-check this record against FDA sources at least every 90 days.
What makes orforglipron different
Semaglutide and tirzepatide are peptides: chains of amino acids modeled on gut hormones. The label of the semaglutide pill requires taking it on an empty stomach with little water. Orforglipron is a small, non-peptide molecule designed to activate the same GLP-1 receptor. According to the Foundayo label, it can be taken once a day with or without food, and the label lists no fixed waiting time before eating. The effect on appetite and fullness is similar in kind to other GLP-1 medications, and so are the digestive side effects.
One curiosity in the label: orforglipron is not pharmacologically active in rats or mice and did not produce thyroid tumors in rodent studies. It still carries the class boxed warning about thyroid C-cell tumors, because other GLP-1 receptor agonists caused them in rodents and human relevance is not determined, and it is still not used by people with a personal or family history of medullary thyroid carcinoma or with MEN 2.
What the trials showed
ATTAIN-1 (obesity, no diabetes). Published in the New England Journal of Medicine in 2025, this 72-week trial randomized 3,127 adults with obesity to one of three orforglipron doses or placebo, with diet and activity support. Average weight change was -7.5%, -8.4% and -11.2% from the lowest to the highest dose, versus -2.1% on placebo. At the highest dose, 54.6% lost 10% or more of their weight, compared with 12.9% on placebo. Waist size, blood pressure and some blood fats also improved. Between 5.3% and 10.3% stopped because of side effects, versus 2.7% on placebo.
Note that the paper names its doses 6, 12 and 36 mg, while the Foundayo label expresses tablet strengths differently (up to 17.2 mg, as orforglipron base). Do not compare the numbers directly; the label’s own table reports the highest dose at -11.1% versus -2.1%, in line with the paper.
Weight in type 2 diabetes. The label also describes a 72-week trial in 1,613 adults with obesity or overweight and type 2 diabetes, with an average change of -9.6% at the highest dose versus -2.5% on placebo. In these label trials, the average loss was smaller in adults with diabetes than in adults without it.
ACHIEVE-1 (early type 2 diabetes). In this 40-week trial, also published in 2025, orforglipron lowered HbA1c more than placebo at every dose, and body weight fell by 4.5% to 7.6% depending on dose, versus 1.7% with placebo. No severe low blood sugar was reported. These are trial results for an unapproved use; they do not make orforglipron a diabetes treatment until the FDA approves that indication.
Orforglipron vs oral semaglutide
Both are daily GLP-1 pills approved for weight in adults. Oral semaglutide (the Wegovy pill) is a peptide taken on an empty stomach with up to 4 ounces of water and a 30-minute wait; in OASIS 4, the 25 mg dose led to -13.6% at 64 weeks versus -2.2% on placebo. Orforglipron is a non-peptide pill without food rules in its label; in ATTAIN-1, -11.2% at 72 weeks at the highest dose. The trials enrolled different people over different periods, so they cannot settle which works better for anyone. Our oral GLP-1 guide compares the pills side by side, and injections vs pills compares them with the weekly shots.
Side effects
Digestive effects lead the list in the Foundayo label: nausea, constipation, diarrhea, vomiting, indigestion and abdominal pain, plus headache, bloating, fatigue, burping, reflux, gas and hair loss. Warnings cover pancreatitis, severe digestive reactions, kidney injury from dehydration, low blood sugar, allergic reactions, diabetic eye complications, gallbladder disease and aspiration during anesthesia. The label also advises a non-oral or added barrier contraceptive for 30 days after starting and after each dose increase. See GLP-1 side effects.
Where it fits
Orforglipron joins injectable semaglutide and tirzepatide, oral semaglutide and older pills as an option to discuss with a clinician. Our medications hub lists them all with status badges, the weight-loss pills hub separates prescription pills from supplements, and newer drugs still in trials are on the emerging medications page.
FDA status and approved uses
| Indication | Labeled population | For weight | Approved | Source |
|---|---|---|---|---|
| Reduce excess body weight and maintain weight reduction long term (Foundayo) | Adults with obesity, or overweight with 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)
Once daily by mouth, swallowed whole, with or without food (Foundayo label). The label describes a starting dose and increases at least 30 days apart. 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 |
|---|---|---|---|
| ATTAIN-1 NCT05869903 | 3,127 adults with obesity, no diabetes | 72 weeks | -7.5%, -8.4%, -11.2% by dose vs -2.1% placebo; 54.6% vs 12.9% lost 10% or more at the highest dose.[4] |
| ACHIEVE-1 NCT05971940 | Adults with early type 2 diabetes | 40 weeks | HbA1c reduced vs placebo at all doses; weight -4.5% to -7.6% vs -1.7% placebo; no severe hypoglycemia (investigational use).[5] |
| Label Trial 2 (type 2 diabetes, weight) | 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% (highest dose) vs 10% placebo (Foundayo label) |
| Vomiting | 24% vs 4% placebo |
| Diarrhea | 25% vs 11% placebo |
| Constipation | 24% vs 9% placebo |
Serious risks
- Thyroid C-cell tumors (class boxed warning)
- Acute pancreatitis
- Severe gastrointestinal reactions
- Acute kidney injury
- Hypoglycemia
- Acute gallbladder disease
- Pulmonary aspiration during anesthesia or deep sedation
Warnings and who should not use it
Boxed warning
Class boxed warning (Foundayo): 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 not determined. Contraindicated with a personal or family history of medullary thyroid carcinoma or 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 excipients
Interactions, pregnancy and breastfeeding
| Drug or class | What the label says |
|---|---|
| Oral hormonal contraceptives | Non-oral or added barrier method for 30 days after starting and after each dose increase (label). |
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
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- Is a daily pill like orforglipron a reasonable option for me compared with weekly injections?
- If I have type 2 diabetes, how does that change what I can expect and which medicines fit?
- Is there anything in my thyroid or family history that rules out GLP-1 medicines?
- How should I handle contraception while the dose is being increased?
- How will we judge whether it is working, and what happens if I stop?
Frequently asked questions
Is orforglipron FDA approved?
Yes, for one use: as Foundayo, approved April 1, 2026, for chronic weight management in adults with obesity, or overweight with a weight-related condition. Other uses, such as treating type 2 diabetes, are not approved as of 2026-10-06.
What is the difference between orforglipron and Foundayo?
Orforglipron is the active ingredient; Foundayo is the brand name of the approved Eli Lilly tablet.
Is orforglipron a peptide like semaglutide?
No. It is a small, non-peptide molecule that activates the GLP-1 receptor. That is why its label does not require taking it on an empty stomach.
How much weight did people lose on orforglipron?
In ATTAIN-1, average weight change at 72 weeks was -7.5% to -11.2% depending on dose, versus -2.1% with placebo. Individual results vary.
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
- Rosenstock J, Hsia S, Nevarez Ruiz L, et al.. Orforglipron, an Oral Small-Molecule GLP-1 Receptor Agonist, in Early Type 2 Diabetes (ACHIEVE-1). New England Journal of Medicine, 2025. doi:10.1056/NEJMoa2505669 · PMID 40544435 · NCT05971940 (accessed October 6, 2026) Randomized trial
- Wharton S, Lingvay I, Bogdanski P, et al.. Oral Semaglutide at a Dose of 25 mg in Adults with Overweight or Obesity (OASIS 4). New England Journal of Medicine, 2025. doi:10.1056/NEJMoa2500969 · PMID 40934115 · NCT05564117 (accessed October 6, 2026) Randomized trial
- 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.