First Generic GLP-1 RA Approved for Weight Management in the US: Daily Dose

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On August 29, 2025, we reported on the US approval and launch of the first generic version of liraglutide injection (Saxenda), making the glucagon-like peptide-1 receptor agonist (GLP-1) formulation the first in its class specifically indicated for weight loss in the US.

The approval

The FDA originally awarded approval of liraglutide as Saxenda to Novo Nordisk, on December 23, 2014, for chronic weight management in adults with obesity or overweight, in conjunction with a reduced-calorie diet and increased physical activity. In December 2020, the agency expanded the indication to include adolescents (ages 12–17 years) with obesity and a minimum weight of 60 kg. Liraglutide’s approval was based on robust clinical trial data demonstrating its efficacy in both adults and adolescents for long-term weight management.

The GLP-1's clinical benefits for obesity and weight management were established in several large-scale phase III trials. In non-diabetic obese adults, liraglutide (3.0 mg) resulted in an average weight loss of approximately 3.4 kg more than placebo over 56 weeks. Additionally, 25.2% of study participants reached weight loss of more than 10% with liraglutide, compared to 6.7% with placebo. Across premarketing studies, liraglutide also demonstrated improvements other metabolic parameters associated with obesity and overweight, including body mass index (BMI), waist circumference, and blood pressure.

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