FDA approves Wegovy for obesity in teens aged 12 and older

On Dec. 23, 2022, the FDA approved once-weekly Wegovy (semaglutide) injection for the treatment of obesity in teenagers aged 12 and older, according to the drug's approval history ^[1]. It was the first time a GLP-1 medicine was cleared for weight management in adolescents ^[1].

Wegovy is made by Novo Nordisk. The adult version was first approved on June 4, 2021 ^[1]. The pediatric approval came about 18 months later and rests on the STEP TEENS trial in adolescents aged 12 and older with obesity ^[1].

What the label says

The approved pediatric indication is to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged 12 years and older with obesity ^[1]. Like the adult use, it is indicated in combination with a reduced calorie diet and increased physical activity ^[1].

Wegovy injection is given once a week under the skin of the abdomen, thigh or upper arm, with or without meals ^[1]. The doses available in the single-dose pen are 0.25 mg, 0.5 mg, 1 mg, 1.7 mg, 2.4 mg, and a higher-dose Wegovy HD 7.2 mg ^[1].

The label carries a boxed warning for an increased risk of thyroid C-cell tumors ^[1]. Other warnings and precautions include acute pancreatitis, acute gallbladder disease, low blood sugar, acute kidney injury, hypersensitivity reactions, diabetic retinopathy complications in patients with type 2 diabetes, increased heart rate, suicidal behavior and ideation, and pulmonary aspiration during general anesthesia or deep sedation ^[1].

Common side effects, listed as occurring in 5% or more of adults or pediatric patients aged 12 and older, include nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, indigestion, dizziness, abdominal bloating, belching, low blood sugar in patients with type 2 diabetes, gas, gastroenteritis, gastroesophageal reflux disease and nasopharyngitis ^[1].

Using Wegovy injection or tablets together with other semaglutide-containing products or any other GLP-1 receptor agonist is not recommended ^[1].

Why it matters for patients

Before this approval, adolescents with obesity had no GLP-1 medicine specifically cleared for weight management ^[1]. Families considering treatment now have an option with a defined pediatric indication, a fixed weekly injection schedule and a label that spells out the warnings and the most common side effects for this age group ^[1].

The approval applies to the injection, not the pills. Wegovy tablets are indicated for weight reduction in adults with obesity, or adults with overweight plus at least one weight-related condition — pediatric patients are not included in the tablet indication ^[1]. So for a teenager, the approved Wegovy product is the once-weekly injection.

Some practical questions are not answered in the approval record. The specific weight-loss results and side-effect rates from STEP TEENS have not been disclosed in the approval history ^[1], and it does not state whether insurers cover the pediatric indication or what the cost is for adolescents. Those details have not been reported.

What happens next

Every later Wegovy approval recorded since December 2022 has been for adults ^[1]. Those include cardiovascular risk reduction in adults with established cardiovascular disease and obesity or overweight on March 8, 2024; accelerated approval for noncirrhotic MASH with moderate to advanced liver fibrosis on Aug. 15, 2025; and the oral Wegovy tablet for weight loss in adults on Dec. 22, 2025 ^[1]. The MASH approval is accelerated, meaning continued approval may depend on a confirmatory trial ^[1].

No further adolescent indications for Wegovy have been reported since the December 2022 decision ^[1]. Adults and pediatric patients taking the medicine are advised to stay in contact with a healthcare provider about whether the label information applies to their situation ^[1].