FDA-Approved Indications for Ozempic (Semaglutide)
Ozempic is FDA-approved for two specific indications: (1) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, and (2) to reduce the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes mellitus and established cardiovascular disease. 1
Primary Indication: Glycemic Control in Type 2 Diabetes
- Ozempic (subcutaneous semaglutide) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus 1
- The medication is administered as a once-weekly subcutaneous injection, starting at 0.25 mg for 4 weeks, then increasing to 0.5 mg, with further titration to 1 mg or 2 mg as needed for optimal glycemic control 2
- Semaglutide was approved by the FDA for treatment of type 2 diabetes, with the SUSTAIN-6 trial serving as the initial regulatory approval study 3
Secondary Indication: Cardiovascular Risk Reduction
- Ozempic is specifically indicated to reduce the risk of major adverse cardiovascular events (including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease 1
- This cardiovascular indication is based on the SUSTAIN-6 trial, which demonstrated that semaglutide reduced the primary composite outcome (cardiovascular death, nonfatal MI, or nonfatal stroke) from 8.9% in the placebo group to 6.6% in the semaglutide group (HR 0.74; 95% CI 0.58-0.95) 3
- The cardiovascular benefit was demonstrated in patients with type 2 diabetes at high cardiovascular risk or with established cardiovascular disease 3
Critical Limitations and Contraindications
Important limitations that clinicians must recognize:
- Ozempic has not been studied in patients with a history of pancreatitis, and another antidiabetic therapy should be considered in these patients 1
- It is not indicated for use in type 1 diabetes mellitus or for treatment of diabetic ketoacidosis 1
- Ozempic is contraindicated in patients with a personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia syndrome type 2 (MEN2) based on animal studies showing thyroid C-cell tumors 3, 2
What Ozempic is NOT FDA-Approved For
A critical distinction: While subcutaneous semaglutide at 2.4 mg (marketed as Wegovy) was FDA-approved for chronic weight management in obesity in 2021 3, Ozempic itself is not FDA-approved for obesity treatment 1. The formulation, dosing, and indication differ between these products, even though they contain the same active ingredient.