GLP-1 drug approvals: A breakdown
As of Sept. 10, the FDA has approved more than a dozen glucagon-like peptide-1 receptor agonists for diabetes, weight loss, cardiovascular disease and other indications.
The approved indications for brand-name GLP-1s:
Adlyxin (lixisenatide)
- Type 2 diabetes in adults
Bydureon (exenatide)
- Type 2 diabetes in patients ages 10 years and older
Byetta (exenatide)
- Type 2 diabetes in adults
Mounjaro (tirzepatide)
- Type 2 diabetes in adults
Ozempic (semaglutide)
- Type 2 diabetes in adults
- To reduce the risk of major adverse cardiovascular events in diabetic adults with cardiovascular disease
- To reduce the risk of worsening kidney disease in diabetic adults with chronic kidney disease
Rybelsus (semaglutide)
- Type 2 diabetes in adults
Saxenda (liraglutide)
- Chronic weight management in obese patients ages 12 years and older
- Chronic weight management in overweight adults with at least one weight-related comorbid condition, such as hypertension, Type 2 diabetes or dyslipidemia
Soliqua (lixisenatide and insulin glargine)
- Type 2 diabetes in adults
Trulicity (dulaglutide)
- Type 2 diabetes in patients ages 10 years and older
- To reduce the risk of major adverse cardiovascular events in diabetic adults with cardiovascular disease or multiple cardiovascular risk factors
Victoza (liraglutide)
- Type 2 diabetes in patients ages 10 years and older
- To reduce the risk of major adverse cardiovascular events in diabetic adults with cardiovascular disease
Wegovy (semaglutide)
- Long-term weight loss in obese patients ages 12 years and older
- Long-term weight loss in overweight adults with at least one weight-related comorbid condition
- To reduce the risk of major adverse cardiovascular events in adults with cardiovascular disease and are either obese or overweight
- To treat noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis
Xultophy (liraglutide and insulin degludec)
- Type 2 diabetes in adults
Zepbound (tirzepatide)
- Long-term weight loss in obese or overweight adults with at least one weight-related comorbid condition
- To treat moderate to severe obstructive sleep apnea in obese adults
The approved indications for generic GLP-1s:
- Amneal Pharmaceuticals’ exenatide, a therapeutical equivalent for Novo Nordisk’s Byetta, is approved to improve glycemic control in adults with Type 2 diabetes
- Hikma Pharmaceuticals’ liraglutide, a therapeutical equivalent for Novo Nordisk’s Victoza, is approved to improve glycemic control in patients ages 10 years and older with Type 2 diabetes
- Teva Pharmaceuticals’ liraglutide, a therapeutical equivalent for Novo Nordisk’s Victoza, is approved to improve glycemic control in patients ages 10 years and older with Type 2 diabetes
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