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Anvisa Approves Wegovy Oral Tablet for Obesity

The regulator based its decision on phase 3 OASIS‑4 evidence of substantial weight loss, with pharmacy sales still contingent on CMED price approval before a commercial launch.

Overview

  • Anvisa approved the oral semaglutide tablet Wegovy on Wednesday, Nov. 4, 2026, marking the first oral GLP‑1 formulation authorized in Brazil for adult obesity and for adults with overweight plus a weight‑related condition.
  • The approval relied on the phase 3 OASIS‑4 program, which showed an average weight loss of about 13.6% at 64 weeks and included an analysis projecting roughly 17% reduction if treatment is maintained.
  • The treatment is a once‑daily fasting tablet given in stepped doses that start at 1.5 mg and increase through 4 mg and 9 mg to a 25 mg maintenance dose, and patients must wait at least 30 minutes after taking it before eating or taking other medicines.
  • Retail availability depends on Brazil's Câmara de Regulação do Mercado de Medicamentos (CMED) setting a maximum price, and Novo Nordisk has said it aims to begin sales in the first half of 2027 though no firm launch date or price is confirmed.
  • The approval expands options for patients who prefer pills over weekly injections, may affect storage and adherence patterns, and faces incoming competition because Eli Lilly’s oral GLP‑1 candidate Foundayo is under Anvisa review.