Q1 What is FOUNDAYO approved for?
FOUNDAYO (orforglipron) is 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; initial U.S. approval is 2026 per the prescribing highlights.
Q2 How does orforglipron (FOUNDAYO) work?
FOUNDAYO is described in the prescribing information as a GLP‑1 receptor agonist; the labeling notes that orforglipron is pharmacologically active at the human GLP‑1 receptor and contains nonclinical toxicology information relevant to rodent findings in the boxed warning and clinical pharmacology sections of the label.
Q3 What is the recommended dose of FOUNDAYO?
The FOUNDAYO prescribing highlights list a starting dosage of 0.8 mg once daily; after at least 30 days increase to 2.5 mg once daily, then after at least 30 days to 5.5 mg once daily, and the 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 response and tolerability, with a maximum dosage of 17.2 mg once daily (consult current prescribing information for full dosing guidance).
Q4 What are the side effects of FOUNDAYO and oral semaglutide in the trial data?
FOUNDAYO labeling names multiple safety concerns and lists most common adverse reactions reported in ≥5% of patients as nausea, constipation, diarrhea, vomiting, dyspepsia, abdominal pain, headache, abdominal distension, fatigue, eructation, gastroesophageal reflux disease, flatulence, and hair loss; the label also includes boxed warnings and named precautions including thyroid C‑cell tumors, acute pancreatitis, severe gastrointestinal reactions, acute kidney injury due to volume depletion, hypoglycemia with concomitant insulin or insulin secretagogues, hypersensitivity reactions, diabetic retinopathy complications in patients with type 2 diabetes, acute gallbladder disease, and pulmonary aspiration during general anesthesia or deep sedation. In OASIS 1 for oral semaglutide escalated to 50 mg, the primary publication reports adverse event findings and gastrointestinal adverse events compared with placebo (exact figures and detailed counts reported in the primary publication).
(consult current prescribing information for full dosing guidance)