Novo Nordisk files once-weekly semaglutide with FDA for type 2 diabetes

Novo Nordisk filed a New Drug Application with the FDA on Dec. 5, 2016, seeking approval of a once-weekly injectable form of semaglutide for adults with type 2 diabetes ^[1]. The drug was approved almost exactly one year later under the brand name Ozempic ^[1].

The application covered semaglutide as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes ^[1]. Semaglutide is a GLP-1 analog, a lab-made version of a hormone the body produces on its own. It binds to and activates the GLP-1 receptor, stimulating insulin release and lowering glucagon release when blood sugar is high ^[1].

Weekly dosing was the central feature of the filing. Semaglutide has an elimination half-life of about seven days and a duration of action of about 63.6 hours, which is what makes a once-weekly injection possible ^[2]. The approved Ozempic injection is given under the skin once a week, at any time of day, with or without meals ^[1]. An oral version was not part of the 2016 filing, and the oral route absorbs far less of the drug: oral bioavailability is 1 to 2 percent, compared with 89 percent for the injected form ^[2].

The FDA's outside advisers voted 16-0 in favor of approval on Oct. 18, 2017 ^[1]. The agency approved Ozempic injection for adults with type 2 diabetes on Dec. 5, 2017, one year to the day after the company filed ^[1].

Why it matters for patients

That 2016 filing is the starting point for a molecule that now reaches patients under several names: Ozempic (injection and tablets), Rybelsus, and Wegovy ^[1]. All of them are semaglutide ^[2]. Approved uses differ by product — Ozempic and Rybelsus for type 2 diabetes, Wegovy for weight reduction in obesity and overweight ^[1] — so the same molecule can show up under a brand name that matches the reason it was prescribed.

Patients also live with the safety profile that came with approval. Ozempic carries a boxed warning for thyroid C-cell tumors. Warnings and precautions include acute pancreatitis, diabetic retinopathy complications, hypoglycemia, acute kidney injury from volume depletion, severe gastrointestinal reactions, serious hypersensitivity reactions, acute gallbladder disease, and pulmonary aspiration during general anesthesia or deep sedation. In 5 percent or more of patients, common side effects include nausea, vomiting, diarrhea, abdominal pain, and constipation ^[1].

Whether the FDA granted a priority review, the launch price, and the complete trial results behind the application have not been reported.

What happened next

• Sept. 20, 2019: Rybelsus, an oral semaglutide tablet, approved for type 2 diabetes ^[1].
• Jan. 16, 2020: Ozempic approved to reduce the risk of major cardiovascular events in adults with type 2 diabetes and known heart disease ^[1].
• June 4, 2021: Wegovy injection approved for weight reduction in obesity and overweight ^[1].
• Mar. 28, 2022: a higher-dose Ozempic 2 mg approved for adults with type 2 diabetes ^[1].
• Jan. 28, 2025: Ozempic approved to reduce the risk of worsening kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease ^[1].
• Dec. 9, 2024: a reformulated oral semaglutide approved for type 2 diabetes under the Rybelsus name; that product was rebranded as Ozempic tablets on Jan. 30, 2026 ^[1].
• Dec. 22, 2025: Wegovy tablets approved for weight reduction in obesity and overweight ^[1].

The FDA review that began with the December 2016 filing took about 12 months, a timeline that the later approvals above stretched across diabetes, heart, kidney, and weight uses ^[1].