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FDA Approves Wegovy Weight-Loss Pill as First Oral GLP-1 for Obesity

A $149 starter offer alongside a January U.S. launch positions the daily tablet to broaden access.

Overview

  • The decision authorizes the first oral GLP-1 for chronic weight management in adults with obesity or overweight plus a related condition.
  • Novo Nordisk says U.S. availability begins in January, with a self-pay starting dose priced at $149 under a White House agreement.
  • A 64-week trial showed average weight loss of 16.6% on the 25 mg tablet, or about 13.6% with typical adherence, versus roughly 2% on placebo.
  • Dosing requires an empty stomach with a small amount of water and a 30-minute wait before food or other medicines, and gastrointestinal side effects were common with about 7% discontinuing due to adverse events.
  • Eli Lilly’s competing oral candidate, orforglipron, remains under FDA review with low‑teens weight loss and no food or water restrictions in trials, as analysts estimate pills could capture around 20% of the market by 2030.