Ozempic reached US pharmacies in 2018, months after its December 2017 FDA approval

Ozempic (semaglutide) reached US pharmacies in 2018, a few months after the FDA approved it on December 5, 2017 for adults with type 2 diabetes ^[1][2]. It was Novo Nordisk's once-weekly injectable GLP-1, and it arrived in a drug class that had already been in clinical use for more than a decade ^[1][2].

The approval path was not overnight. Novo Nordisk filed for FDA approval of once-weekly semaglutide on December 5, 2016, and an FDA advisory committee voted 16-0 in favor of approval on October 18, 2017 ^[2]. The initial label covered use as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes ^[2]. The approved 0.25 mg and 0.5 mg pen delivered the starting doses; a 1 mg pen followed in the same 4 mg/3 mL format, and a 2 mg dose was approved on March 28, 2022 ^[2].

Ozempic's label has widened well beyond blood sugar. The FDA approved it on January 16, 2020 to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and known heart disease, and on January 28, 2025 to reduce the risk of worsening kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease ^[2]. The drug carries a boxed warning for thyroid C-cell tumors, and its warnings include acute pancreatitis, diabetic retinopathy complications, hypoglycemia, acute kidney injury from volume depletion, severe gastrointestinal reactions, gallbladder disease and pulmonary aspiration during general anesthesia or deep sedation ^[2]. The most common side effects, reported in at least 5 percent of patients, are nausea, vomiting, diarrhea, abdominal pain and constipation ^[2].

The same molecule later reached the market under other labels and doses. Rybelsus, the oral form, was approved September 20, 2019; Wegovy, semaglutide at weight-management doses up to 2.4 mg, was approved June 4, 2021; and a Wegovy tablet was approved December 22, 2025 ^[2]. A reformulated oral semaglutide first approved December 9, 2024 was rebranded as Ozempic tablets on January 30, 2026 ^[2]. The broader GLP-1 class started earlier still: exenatide (Byetta) was the first approved GLP-1 receptor agonist in 2005, and liraglutide (Victoza) followed in 2010 ^[1].

Why it matters for patients

People starting a GLP-1 often want to know how well the risks are understood, and the class timeline is the more useful number than the brand timeline. GLP-1 receptor agonists have been in clinical use since 2005, which means the gastrointestinal profile, the pancreatitis and gallbladder signals, and the thyroid C-cell warning carried over from rodent studies have been tracked across roughly two decades and millions of patient-years ^[1]. Semaglutide specifically has also been through large outcome trials since approval, including SELECT, which followed more than 17,000 people and reported cardiovascular benefit ^[1].

Two caveats are worth keeping in view. The highest doses used for weight management — semaglutide 2.4 mg and tirzepatide up to 15 mg — are newer than the diabetes doses, so the longest-term data at those doses is still accumulating, and tirzepatide has a shorter record overall because it only arrived in 2022 ^[1]. Drugs now generating headlines, such as retatrutide, orforglipron and CagriSema, are not approved at all ^[1].

Practical details also differ by product. Ozempic injection is given subcutaneously once weekly at any time of day, with or without meals, while Ozempic tablets are taken orally once daily in the morning on an empty stomach ^[2].

How quickly doctors began discussing weight loss among patients taking Ozempic for diabetes after the 2018 launch has not been documented in the approval records reviewed here, and no specific figures for that early period have been reported.

What happens next

Novo Nordisk introduced an Ozempic pill and said it would be available in the US in the second quarter of 2026 ^[2]. The company also announced a significant reduction in US list prices for Wegovy, Ozempic and Rybelsus on February 24, 2026, after lowering Ozempic's cost to $499 per month for self-paying patients in August 2025 ^[2].