Weight lossActive ingredient
Orforglipron
GLP-1 receptor agonist1 FDA label read
Orforglipron is sold as Foundayo and is a once-daily GLP-1 tablet approved for weight management. Where the other oral GLP-1, Rybelsus, must be taken on an empty stomach with a strict waiting rule, the Foundayo label says plainly: with or without food. It carries the same boxed warning as the rest of the class.
Highlights of the labels
- Foundayo
- Weight managementcovers weight loss
- Supply
- Prescription only
- Generic
- None approved
- Boxed warning
- WARNING: RISK OF THYROID C-CELL TUMORS
FDA boxed warning
WARNING: RISK OF THYROID C-CELL TUMORS
In the Foundayo label
- In products with glucagon-like peptide-1 (GLP-1) receptor agonist activity that are pharmacologically active in rats and mice, rodent thyroid C-cell tumors (adenomas and carcinomas) have been observed at clinically relevant exposures and are considered GLP-1 receptor-dependent effects in rodents. Orforglipron is not pharmacologically active in rats or mice and did not produce tumors in rodents. While orforglipron is pharmacologically active at the human GLP-1 receptor, the human relevance of GLP-1 receptor-dependent thyroid C-cell tumors observed in rodents has not been determined.
A boxed warning is the most serious warning the FDA requires. This text is reproduced from the label.
Brands and what each one is approved for
One active ingredient can hold several separate FDA approvals. They are different documents with different approved uses, and mixing them up is the most common mistake made about these medications.
| Brand | What its label approves | Supply | Label version |
|---|---|---|---|
| FoundayoEli Lilly and Company | What its label approvesWeight managementCovers weight loss | SupplyPrescription | Label version29 July 2026 |
How it works
Orforglipron activates the GLP-1 receptor, the same receptor targeted by the injectable medications in this category. The label describes GLP-1 as a physiological regulator of appetite and caloric intake. Unlike semaglutide and tirzepatide, it is taken as a tablet once a day.
Mechanism of action, Foundayo label
FOUNDAYO is a GLP-1 receptor agonist that binds to and activates the human GLP-1 receptor. GLP-1 is a physiological regulator of appetite and caloric intake. GLP-1 receptors are present in brain regions that regulate appetite.
What the FDA approved it for
The approved uses, as worded in the label.
- FOUNDAYO™ is a GLP-1 receptor agonist indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.
- Limitations of Use Concomitant use with another GLP-1 receptor agonist is not recommended.
Forms and strengths
The presentations and strengths listed in the label.
FOUNDAYO tablets are available as orforglipron: 0.8 mg: pink round tablet debossed with "L" on one side and "G1" on the other side 2.5 mg: light yellow round tablet debossed with "L" on one side and "G2" on the other side 5.5 mg: grayish purple round tablet debossed with "L" on one side and "G3" on the other side 9 mg: pink modified oval tablet debossed with "Lilly" on one side and "G4" on the...
How the label says it is taken
What the label states about administration. It is not a dosing instruction for any individual.
- Take FOUNDAYO orally once daily, with or without food.
- Swallow tablets whole. Do not break, crush, or chew.
- Do not take more than one tablet per day.
- Starting dosage is 0.8 mg once daily. After at least 30 days, increase dosage to 2.5 mg once daily.
- After at least 30 days on the 2.5 mg dosage, increase dosage to 5.5 mg once daily.
- Dosage may be increased to the next dosage level (9 mg, 14.5 mg, or 17.2 mg once daily) after at least 30 days on the current dosage, based on treatment response and tolerability.
Most common adverse reactions
The adverse reactions the label reports as most common.
Most common adverse reactions, reported in ≥5% of patients treated with FOUNDAYO, are nausea, constipation, diarrhea, vomiting, dyspepsia, abdominal pain, headache, abdominal distension, fatigue, eructation, gastroesophageal reflux disease, flatulence, and hair loss.
Warnings and precautions
The warnings and precautions section of the label.
- Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, including FOUNDAYO. Discontinue if pancreatitis is suspected.
- Severe Gastrointestinal Reactions: Use has been associated with gastrointestinal adverse reactions, sometimes severe. FOUNDAYO is not recommended in patients with severe gastroparesis.
- Acute Kidney Injury Due to Volume Depletion: Monitor renal function in patients reporting adverse reactions that could lead to volume depletion.
- Hypoglycemia: Concomitant use with insulin or an insulin secretagogue may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing the dosage of insulin or insulin secretagogue may be necessary. Inform all patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.
- Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported with GLP-1 receptor agonists. If suspected, advise the patient to promptly seek medical attention and discontinue FOUNDAYO.
- Diabetic Retinopathy Complications in Patients with Type 2 Diabetes: Has not been studied in patients with diabetic retinopathy and/or macular edema requiring acute treatment. Monitor patients with a history of diabetic retinopathy for progression.
- Acute Gallbladder Disease: Has been reported in clinical trials. If cholecystitis is suspected, gallbladder studies and clinical follow-up are indicated.
- Pulmonary Aspiration During General Anesthesia and Deep Sedation: Has been reported in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures. Instruct patients to inform healthcare providers of any planned surgeries or procedures.
Contraindications
Situations in which the label states the medication must not be used.
- FOUNDAYO is contraindicated in patients with: A personal or family history of MTC or in patients with MEN 2.
- Known serious hypersensitivity to orforglipron or any of the excipients in FOUNDAYO.
- Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with GLP-1 receptor agonists.
- Personal or family history of MTC or in patients with MEN 2
Drug interactions
Interactions the label singles out.
- Strong CYP3A4 Inhibitors: The maximum dosage of FOUNDAYO is 9 mg once daily when used concomitantly with a strong CYP3A4 inhibitor. Avoid concomitant use with strong CYP3A4 inhibitors that also inhibit OATP1B.
- CYP3A4 Inducers: Avoid concomitant use with strong CYP3A4 inducers. Monitor FOUNDAYO effectiveness and escalate dosage as needed when used concomitantly with moderate CYP3A4 inducers.
- Simvastatin: Do not exceed simvastatin 20 mg once daily when used concomitantly with FOUNDAYO.
- FOUNDAYO delays gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications.
Pregnancy and breastfeeding
The opening of the pregnancy section of the label. The full section is longer and is in the source document.
Pregnancy Exposure Registry There will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to FOUNDAYO (orforglipron) during pregnancy. Pregnant patients exposed to FOUNDAYO and healthcare providers are encouraged to contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979). Risk Summary Weight loss offers no benefit to a pregnant patient and may cause fetal harm.
Generic or brand
There is no FDA-approved generic orforglipron: the approval is recent and the register lists the brand application only.
The FDA label database lists no approved generic application for this ingredient.
What affects the cost
Foundayo is brand-only, and the acquisition cost in the table reflects that. What a person pays depends on insurance coverage. This site sells nothing and links to no sellers.
What pharmacies pay for it
These are acquisition costs: what pharmacies in the United States pay on average to buy the medication, published weekly by the Centers for Medicare and Medicaid Services. They are not retail prices and not what a person pays at the counter, which depends on insurance, pharmacy and discount programs. They are useful as an objective floor and for seeing how far a brand sits above its generic.
| Measured | Brand |
|---|---|
| per tablet, capsule or pen | Brand$20.65 (range $20.65 to $20.81, 66 listings) |
Median of 66 listings. Effective dates 2026-06-17 to 2026-08-19, file dated 2026-08-26.
Compared with other medications
What the labels do not do is compare one medication against another. These pages put two of them side by side.
Common questions
- Is Foundayo the same as Rybelsus?
- No. Both are GLP-1 tablets, but they contain different active ingredients with different approvals. Foundayo is orforglipron, approved for weight management. Rybelsus is semaglutide, approved for type 2 diabetes. Their dosing rules also differ: the Rybelsus label requires an empty stomach, plain water and a 30-minute wait before eating; the Foundayo label says with or without food.
- Can Foundayo be taken with food and water?
- Yes. The label's instruction is to take it orally once daily, with or without food, swallowing the tablet whole. It also sets a limit of one tablet per day.
- How does the dose escalate?
- The label starts at 0.8 mg once daily, increases to 2.5 mg after at least 30 days, then to 5.5 mg, and may be increased stepwise to 9 mg, 14.5 mg or 17.2 mg once daily, each step after at least 30 days on the current dose, based on treatment response and tolerability.
- Does Foundayo have a boxed warning?
- Yes, the boxed warning of the GLP-1 class: risk of thyroid C-cell tumors, with a contraindication for people with a personal or family history of medullary thyroid carcinoma or with Multiple Endocrine Neoplasia syndrome type 2. The full text is quoted on this page.
- Can it be combined with Ozempic, Wegovy or Zepbound?
- The label's limitations of use state that concomitant use with another GLP-1 receptor agonist is not recommended, which covers those products.
Other medications under weight loss
Whether each one carries an FDA approval for this use is marked on its page and in this list.
Sources
Every fact above comes from one of these documents. The date is the effective date of the label version this page was built from.
FDA prescribing information for Foundayo
Eli Lilly and Company. Label version 10, effective 29 July 2026.
Each stripe is one section of the label, each division in a stripe one entry in that section. The red bar marks a boxed warning.
Page last updated 29 August 2026
Compiled by the HealthyStudy editorial team from FDA source documents. No medical reviewer is credited on this page, because none reviewed it.