Novo Nordisk filed semaglutide 2.4 mg for chronic weight management in December 2020

In December 2020, Novo Nordisk submitted semaglutide 2.4 mg to the FDA for chronic weight management. The agency approved the application on June 4, 2021, under the brand name Wegovy ^[1].

The filing covered a once-weekly subcutaneous injection. The company reported in March 2021 that adults with obesity treated with semaglutide 2.4 mg achieved and maintained what the study described as a significant amount of weight loss in a 68-week trial ^[1]. The injection is supplied in single-dose pens that deliver 0.25 mg, 0.5 mg, 1 mg, 1.7 mg and 2.4 mg ^[1].

Semaglutide is a GLP-1 receptor agonist. The same molecule is also sold under the brand names Ozempic and Rybelsus ^[2]. Given by injection, semaglutide is about 89 percent bioavailable and has an elimination half-life of about seven days; taken by mouth, its bioavailability is 1 to 2 percent ^[2].

What the approved label says

Wegovy injection is indicated, along with a reduced-calorie diet and increased physical activity, to reduce excess body weight and maintain weight reduction long term in adults with obesity, or in adults who are overweight and have at least one weight-related condition. Pediatric use was added later, for patients aged 12 and older ^[1].

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

Common side effects, reported in 5 percent or more of adults or of patients aged 12 and older, include nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distension, belching, flatulence, gastroenteritis, gastroesophageal reflux disease and nasopharyngitis, plus hypoglycemia in people with type 2 diabetes ^[1].

The label says Wegovy should not be used with another semaglutide-containing product or with any other GLP-1 receptor agonist ^[1]. The average weight-loss percentage from the trial that supported the December 2020 filing is not stated in the approval history, which describes the result only as a significant amount of weight loss over 68 weeks ^[1].

Why it matters for patients

Before June 2021, semaglutide had no FDA-approved version labeled for chronic weight management ^[1]. The approval created a weight-specific brand of a molecule patients and clinicians already knew from the Ozempic and Rybelsus names ^[2].

It also set the shape of the treatment as it is used now: one injection a week on top of diet and exercise changes, with a boxed warning, a long list of possible side effects, and a rule against combining it with other GLP-1 drugs ^[1].

Cost and access have changed repeatedly since. Novo Nordisk lowered the cost of all doses of FDA-approved Wegovy to $499 a month through its NovoCare Pharmacy in March 2025 ^[1], and in February 2026 the company announced a significant reduction in the US list price of Wegovy, Ozempic and Rybelsus ^[1].

What came after

Regulators later added indications and new forms to the same drug. The FDA cleared Wegovy for teens aged 12 and older in December 2022, for cardiovascular risk reduction in adults with established cardiovascular disease and either obesity or overweight in March 2024, and for noncirrhotic MASH with moderate to advanced liver fibrosis in August 2025 under accelerated approval ^[1]. An oral version, Wegovy tablets, was approved in December 2025, and a higher-dose Wegovy HD injection, 7.2 mg, was approved in March 2026 ^[1].