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FDA Approves First Oral Wegovy for Weight Management as Novo Prepares January U.S. Launch

The once-daily pill could expand access to GLP-1 therapy for patients who avoid injections.

Overview

  • Regulators cleared the oral semaglutide tablet after phase 3 OASIS 4 results showed about 13%–16% mean weight loss versus roughly 2%–3% with placebo.
  • Novo Nordisk plans a U.S. rollout in early January 2026, offering a $149 per month starter dose (1.5 mg) with savings offers and stating it has ample supply.
  • The tablet must be taken on an empty stomach, and common GLP-1 side effects such as nausea, diarrhea, and vomiting were observed, highlighting potential adherence challenges.
  • Eli Lilly has filed for FDA approval of its oral orforglipron after positive phase 3 data, and Novo says it has also sought approvals in Europe.
  • Global pricing pressure is mounting, with reported roughly 50% Wegovy list-price cuts in Chinese provinces ahead of generic competition, while Novo’s shares rose about 8%–9% on the approval news.