04/11/2026
FDA Approves First New Molecular Entity for Weight Loss
The U.S. Food and Drug Administration (FDA) has approved the first new molecular entity (NME) approved under the Commissioner's National Priority Voucher (CNPV) pilot program for weight loss. Foundayo (orforglipron) is a glucagon-like peptide-1 (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. Foundayo (orforglipron) is administered as an oral tablet.
The safety and efficacy of Foundayo (orforglipron) was evaluated in a pool of two randomized, double-blind, placebo-controlled trials that included 3155 adult patients with obesity or overweight treated with FOUNDAYO once daily for up to 72 weeks and a 2-week off-drug follow-up period (Trial 1 and Trial 2).
Warnings and precautions for Foundayo (orforglipron) include a Boxed Warning for thyroid C-cell tumors. Foundayo (orforglipron) should not be used in patients with a personal or family history of medullary thyroid cancer or in patients with Multiple Endocrine Neoplasia syndrome type 2. Other warnings and precautions for Foundayo (orforglipron) include pancreatitis, severe gastrointestinal reactions, acute kidney injury due to volume depletion, hypoglycemia, hypersensitivity, diabetic retinopathy in patients with type 2 diabetes mellitus, acute gallbladder disease, and pulmonary aspiration during general anesthesia or deep sedation. Foundayo (orforglipron) should not be used in combination with another GLP-1 receptor agonist.
The most common adverse reactions for Foundayo (orforglipron) include nausea, constipation, diarrhea, vomiting, dyspepsia, abdominal pain, headache, abdominal distension, fatigue, burping, gastroesophageal reflux disease, gas, and hair loss.
View the FDA’s announcement here:
https://www.fda.gov/news-events/press-announcements/fda-approves-first-new-molecular-entity-under-national-priority-voucher-program