First *ORAL* GLP-1 receptor agonist for obesity/overweight

In December of 2025, the US Food and Drug Administration (FDA) approved ORAL semaglutide 25 mg tablets (Wegovy^®) for the following indication (emphasis in red added by us, source Prescribing Information).

Note: CV is an abbreviation for cardiovascular

“in combination with a reduced calorie diet and increased physical activity:

• To reduce the risk of major adverse CV events (CV death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established CV disease and either obesity or overweight.
• To reduce excess body weight and maintain weight reduction long term in adults with obesity, or in adults with overweight in the presence of at least one weight-related comorbid condition. “

So, now, semaglutide is available as:

– Tablets under two DIFFERENT brand names that have DIFFERENT FDA indications

– Injection under the SAME brand name

It’s all very confusing!

Wegovy^® versus Wegovy^®

How are the FDA indications for semaglutide tablets versus semaglutide injection—both of which carry the brand name Wegovy^®—different?

Semaglutide injection has the same indications as semaglutide 25 mg tablets, PLUS the following:

1. The indication “To reduce excess body weight and maintain weight reduction long term…” also extends to pediatric patients 12 years or older with obesity, though NOT to pediatric patients with overweight.

2. “For the treatment of noncirrhotic metabolic dysfunction associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH), with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) in adults.”

Didn’t we already have oral semaglutide?

Yes, we did. Oral semaglutide has been available since 2017 as brand name Rybelsus^®. So, what’s the difference?

1. The FDA indications for semaglutide tablets (Rybelsus^®) are related to type 2 diabetes mellitus and not obesity/ overweight (Prescribing Information).

2. The available dosage strengths are different; for semaglutide tablets (Rybelsus^®), they only go up to a maximum of 14 mg tablets, while semaglutide tablets (Wegovy^®) are available in dosage strengths up to 25 mg.