“For the first time in history, a pill achieves the potency of a high-efficacy injectable medication in the treatment of excess weight,” said Priscilla Mattar, vice president of Medical Affairs at Novo Nordisk Brazil, in a statement.
Brazil’s health regulator, Anvisa, approved the registration on Wednesday for an oral version of Wegovy, Novo Nordisk’s obesity drug, marking the first GLP-1 agonist in pill form cleared in the country for chronic weight management, InfoMoney reported. The decision, published in the Official Gazette through Resolution 4.249/2026, covers adults with obesity or overweight accompanied by comorbidities.
Daily 25 mg Tablet Requires Fasting and 30-Minute Wait Before Eating
The approved formulation is a 25 mg tablet taken once daily on an empty stomach with a small amount of water, with patients waiting at least 30 minutes before consuming food, beverages, or other medications, according to Agência Brasil. Dosing escalates gradually from 1.5 mg to 4 mg and 9 mg before reaching the 25 mg maintenance dose. Anvisa stated that semaglutide “acts on the regulation of appetite and food intake, promoting body weight reduction and improvement of metabolic parameters associated with obesity.”
OASIS 4 Trial Shows 13% Average Weight Loss Over 64 Weeks
The approval rests on the phase 3 OASIS 4 study, which tracked participants for 64 weeks and found that those taking the 25 mg oral dose lost an average of more than 13% of body weight, Agência Brasil reported. Nearly one-third of participants lost 20% or more of their weight, and the treatment improved several cardiometabolic health markers. For comparison, the injectable Wegovy achieved approximately 17.4% weight loss after 68 weeks in the STEP-4 trial, O Globo reported.
Novo Nordisk Targets 2027 Launch Pending CMED Price Ceiling
Novo Nordisk expects to begin selling the pill in Brazil in the first half of 2027, InfoMoney reported, though the company told the BBC that the product should reach pharmacies “in the coming quarters.” Before any sale can begin, the drug must receive a maximum price from the Câmara de Regulação do Mercado de Medicamentos (CMED), the federal body that sets price ceilings for medicines in Brazil, the BBC noted. In the United States, where the pill launched on January 5, out-of-pocket costs range from $149 to $299 per month depending on the dose, and more than 7 million prescriptions have been dispensed since launch, the BBC reported.
Goldman Sachs Projects R$ 353 Million in 2027 Semavy Sales Despite New Rival
The approval adds a competitor to the market where Hypera’s injectable Semavy has already gained traction, selling about 93,000 units in its first month. Goldman Sachs maintained a buy recommendation for Hypera with a 12-month target price of R$ 26, projecting Semavy sales of roughly R$ 353 million in 2027, equivalent to about 3.8% of the company’s gross revenue, InfoMoney reported. While Wegovy pills cost between $150 and $300 per month in the U.S., Semavy sells for an equivalent of roughly $60 to $85 monthly, which analysts say may preserve its competitiveness. The bank warned, however, that the oral version could slow Semavy’s growth in the medium term by capturing new patients who avoid injections.
Patent Fell in March, Opening Market to Generics
The pill arrives in a market already reshaped by the March 20 expiration of the semaglutide patent in Brazil. Since August, Anvisa has approved generic versions of injectable semaglutide, the BBC reported.
How to Take and Time the New Weight-Loss Drug
One 25 mg tablet daily on an empty stomach with a small amount of water, waiting at least 30 minutes before eating, drinking, or taking other medications, according to Agência Brasil.
Novo Nordisk expects commercialization in the first half of 2027, InfoMoney reported, after CMED sets a maximum price.
Participants in the OASIS 4 study lost an average of more than 13% of body weight over 64 weeks, and nearly one-third lost 20% or more, Agência Brasil reported.
“We see this as excellent news because, until very recently, we had very few options,” said Cynthia Valério, president-elect of the Brazilian Association for the Study of Obesity and Metabolic Syndrome (Abeso). “Access to obesity treatment as a chronic disease is essential, and we will fight for these new therapies to also be accessible through the SUS and supplementary health.”