What Was Approved?
On April 1, 2026, the U.S. Food and Drug Administration approved Foundayo (orforglipron) for chronic weight management in adults with:
- Obesity, or
- Overweight with at least one weight-related medical condition
Foundayo is used together with a reduced-calorie diet and increased physical activity.
What Is Foundayo?
Foundayo is an oral GLP-1 receptor agonist.
Unlike injectable GLP-1 medicines, Foundayo is taken as a tablet once daily. It may be taken with or without food.
How Is Foundayo Taken?
Treatment begins at 0.8 mg once daily.
The dose is gradually increased at intervals of at least 30 days to help reduce gastrointestinal side effects.
The maximum recommended dose is 17.2 mg once daily.
The tablet should be swallowed whole and should not be crushed, split, or chewed.
What Are the Common Side Effects?
Common adverse reactions include:
- Nausea
- Constipation
- Diarrhea
- Vomiting
- Indigestion
- Abdominal pain
- Headache
- Fatigue
- Bloating
- Reflux
- Gas
- Hair loss
Does Foundayo Have a Boxed Warning?
Yes.
Foundayo carries a boxed warning regarding the potential risk of thyroid C-cell tumors.
It is contraindicated in patients with:
- A personal or family history of medullary thyroid carcinoma
- Multiple Endocrine Neoplasia syndrome type 2, or MEN 2
What Other Safety Issues Are Important?
The FDA-approved label also includes warnings for:
- Acute pancreatitis
- Severe gastrointestinal reactions
- Acute kidney injury related to dehydration
- Hypoglycemia when used with certain diabetes medicines
- Serious hypersensitivity reactions
- Gallbladder disease
- Diabetic retinopathy complications in some patients with type 2 diabetes
- Pulmonary aspiration during general anesthesia or deep sedation
Foundayo is not recommended for use together with another GLP-1 receptor agonist.
Bottom Line
Foundayo (orforglipron) is a newly FDA-approved once-daily oral GLP-1 receptor agonist for chronic weight management in certain adults with obesity or overweight.
It should be used together with diet and physical activity, and treatment requires attention to important gastrointestinal, metabolic, and thyroid-related safety considerations.
Sources
- U.S. Food and Drug Administration (FDA) — FDA Approves First New Molecular Entity Under National Priority Voucher Program, April 1, 2026.
- U.S. Food and Drug Administration (FDA) — Foundayo (orforglipron) Prescribing Information, revised July 2026.
- U.S. Food and Drug Administration (FDA) — Novel Drug Approvals for 2026.