FDA
FDA approves oral GLP-1 Foundayo for weight loss
Brand name: Foundayo
Generic name: orforglipron
Manufacturer: Eli Lilly and Company
Approval date: April 1, 2026
Foundayo (orforglipron), an oral GLP-1 receptor agonist that can be taken any time of day without food or water restrictions, is indicated to reduce excess body weight and maintain weight reduction long term in adults with obesity or overweight in the presence of at least one weight-related comorbid condition. It is to be used in combination with a reduced-calorie diet and increased physical activity.
“Individuals who are overweight or obese now have an additional option to help with weight loss — a GLP-1 receptor partial agonist pill which does not need to be taken on an empty stomach,” said Acting Center for Drug Evaluation and Research (CDER) Director Tracy Beth Hoeg, MD, PhD, in an FDA statement.
Efficacy
Approval was based on two randomized, double-blind, placebo-controlled, 72-week trials. ATTAIN-1 enrolled 3,127 adult patients with obesity (BMI ≥30 kg/m2), or overweight (BMI 27 to <30 kg/m2) and at least one weight-related comorbid condition, such as dyslipidemia, hypertension, obstructive sleep apnea, or cardiovascular disease; patients with type 2 diabetes were excluded. Participants were randomized in a 3:3:3:4 ratio to Foundayo 5.5 mg, 9 mg, 17.2 mg, or placebo, once daily. At baseline, mean age was 45 years (range, 18-88 years), mean body weight was 103.2 kg, and mean BMI was 37 kg/m2; 64% of patients were female, 56% were White, 28% were Asian, 9% were Black or African American, and 0.4% were American Indian/Alaska Native; 38% were Hispanic or Latino ethnicity.
ATTAIN-2 enrolled 1,613 adult patients with BMI ≥27 kg/m2 and type 2 diabetes. The study included patients with a baseline HbA1c of 7% to 10% who were being treated with either diet and exercise alone, or any oral anti-hyperglycemic agent except DPP-4 inhibitors or GLP-1 receptor agonists; patients on injectable GLP-1s or pramlintide were excluded. Participants were randomized in 1:1:1:2 ratio to Foundayo 5.5 mg, 9 mg, 17.2 mg, or placebo, once daily. At baseline, mean age was 57 years (range, 20-92 years), mean body weight was 101.4 kg, mean BMI was 35.6 kg/m2, and mean HbA1c was 8%; 47% of patients were female, 71% were White, 17% were Asian, 7% were Black or African American, and 0.3% were American Indian/Alaska Native; 30% were Hispanic or Latino ethnicity.
In both trials, the primary endpoint was mean percent change in body weight from baseline to week 72. Results showed statistically significant reductions in body weight after 72 weeks in the Foundayo-treated groups vs. placebo groups (ATTAIN-1: 5.5 mg, -7.4%; 9 mg, -8.3%; 17.2 mg, -11.1%; placebo, -2.1%; ATTAIN-2: 5.5 mg, -5.1%; 9 mg, -7%; 17.2 mg, -9.6%; placebo, -2.5%). Reduction in body weight was observed with Foundayo regardless of age, sex, race, ethnicity, baseline BMI, and glycemic status.
Safety
Most common adverse reactions (≥5%) were nausea, constipation, diarrhea, vomiting, dyspepsia, abdominal pain, headache, abdominal distension, fatigue, eructation, GERD, flatulence, and hair loss.
Across the two trials, 8% of Foundayo-treated patients (5.5 mg, 6%; 9 mg, 9%; 17.2 mg, 10%) permanently discontinued treatment as a result of adverse reactions vs. 3% in the placebo group, with GI-related reactions being the most common reason.
The Foundayo prescribing information includes a boxed warning for thyroid C-cell tumors, as well as warnings and precautions regarding acute pancreatitis, severe GI reactions, acute kidney injury due to volume depletion, hypoglycemia, hypersensitivity reactions, diabetic retinopathy complications in patients with type 2 diabetes, acute gallbladder disease, and pulmonary aspiration during general anesthesia and deep sedation.
Source: FDA news release. (2026, April 1). FDA Approves First New Molecular Entity Under National Priority Voucher Program