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Ozempic reaches US pharmacies

Ozempic reached US pharmacies in 2018, months after its December 2017 FDA approval for type 2 diabetes, setting up years of off-label weight-loss use before Wegovy arrived.

By the Semaglutides news desk··Ozempic
Ozempic reaches US pharmacies
Image: doselogapp.com

Ozempic, the brand name for the drug semaglutide, was approved by the US Food and Drug Administration on December 5, 2017, and became available to patients in US pharmacies in early 2018 [1][2]. It was approved only for adults with type 2 diabetes, to be used along with diet and exercise to improve blood sugar control [2]. The drug is made by Novo Nordisk and is given as a once-weekly injection [1][2].

Ozempic works by mimicking a hormone called GLP-1, which helps the body release insulin when blood sugar is high and slows the release of a hormone called glucagon [2]. That mechanism also tends to slow digestion and reduce appetite, which is why some patients taking it for diabetes lost weight as a side effect of treatment, even though the drug was not approved for that purpose at the time [1][2].

The FDA label for Ozempic carries a boxed warning about thyroid C-cell tumors, a risk identified in animal studies, along with warnings about acute pancreatitis, gallbladder disease, kidney injury from fluid loss, and serious gastrointestinal reactions [2]. The most common side effects reported in at least 5 percent of patients are nausea, vomiting, diarrhea, abdominal pain, and constipation [2].

Ozempic's approval was one step in a broader class history. The first GLP-1 receptor agonist, exenatide (Byetta), was approved in 2005, and liraglutide (Victoza) followed in 2010 [1]. Novo Nordisk later brought an oral form of semaglutide to market as Rybelsus in September 2019, and then won approval for semaglutide at higher, weight-management doses under the brand name Wegovy in June 2021 [1][2]. Ozempic itself later gained additional approved uses: reducing cardiovascular risk in adults with type 2 diabetes and known heart disease in January 2020, a higher 2 mg dose in March 2022, and reducing the risk of worsening kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease in January 2025 [2].

Why it matters for patients

The 2018 arrival of Ozempic marks the starting point for the drug's real-world track record in the United States. By the time of the most recent reporting, semaglutide had roughly eight years of use in US pharmacies, on top of the clinical trial years that came before approval [1]. That history matters because it means the drug's known risks, including the thyroid warning and the gastrointestinal and gallbladder effects listed on its label, have been observed across a large number of patients over time [2].

It also explains why Ozempic became widely known as a weight-loss drug even though it was never approved for that use. Patients taking it for diabetes lost weight, and Novo Nordisk later developed and won separate FDA approval for a higher-dose version, Wegovy, specifically for weight management in 2021 [1][2]. Anyone taking Ozempic today is taking a drug approved for type 2 diabetes, not weight loss, and its label reflects that intended use [2].

What happens next

Semaglutide's approved uses have continued to expand well beyond the original 2017 diabetes indication. Rybelsus was approved in 2019, Wegovy in 2021, an added cardiovascular risk-reduction indication for Ozempic in 2020, a higher Ozempic dose in 2022, and a chronic kidney disease indication in January 2025 [2]. The sources reviewed here do not describe any specific upcoming milestones for Ozempic beyond that January 2025 approval.

Images from the sources

How long has Ozempic been on the market? A short timeline
doselogapp.com
How long has Ozempic been on the market? A short timeline
doselogapp.com

Sources

  1. https://www.doselogapp.com/blog/how-long-has-ozempic-been-available
  2. https://www.drugs.com/history/ozempic.html

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