Novo beats Lilly to first FDA-approved GLP-1RA pill for obesity

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Source: Pharmaceutical Technology

Original: https://www.pharmaceutical-technology.com/news/novo-beats-lilly-to-first-fda-app...

Published: Tue, 23 Dec 2025 10:37:23 +0000

Novo Nordisk has received FDA approval for Wegovy's first oral GLP-1RA pill (semaglutide 25 mg once daily) for the treatment of obesity.The drug has outperformed competitor Eli Lilly and is designed to reduce excess weight and maintain reduced weight in adults who are obese or overweight and have at least one comorbid condition.The approval follows the OASIS and SELECT study program.[In the OASIS 4 trial, oral semaglutide 25 mg achieved a mean weight loss of 16.6% in adult participants with obesity or overweight and comorbidities while adhering to treatment.4 Wegovy pill is the first oral GLP-1 receptor agonist approved for weight management.[Novo Nordisk plans to launch the pill in the U.S. market in early January 2026.The company has also submitted an application for approval of oral semaglutide 25 mg to the European Medicines Agency (EMA) and other regulatory authorities in the second half of 2025.4 The company has submitted an application for approval of oral semaglutide 25 mg to the European Medicines Agency (EMA) and other regulatory authorities in the second half of 2025.[4]