Novo Nordisk files oral semaglutide with FDA for type 2 diabetes

On March 26, 2019, Novo Nordisk filed an application with the US Food and Drug Administration for an oral tablet form of semaglutide, intended for blood sugar control and cardiovascular risk reduction in adults with type 2 diabetes ^[1]. The agency approved the drug about six months later, on September 20, 2019, under the brand name Rybelsus, which was described at the time as the first oral GLP-1 analog treatment for adults with type 2 diabetes ^[1].

Rybelsus (semaglutide) is an oral glucagon-like peptide-1 (GLP-1) receptor agonist ^[1]. Its approved uses are as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, and to reduce the risk of major adverse cardiovascular events — cardiovascular death, non-fatal myocardial infarction or non-fatal stroke — in adults with type 2 diabetes who are at high risk for those events ^[1].

Semaglutide is an analog of the naturally occurring hormone GLP-1 and selectively binds to and activates the GLP-1 receptor, according to the Rybelsus approval history ^[1]. It lowers blood glucose by stimulating insulin secretion and reducing glucagon secretion, so that when blood glucose is high, insulin release is stimulated and glucagon release is inhibited ^[1]. The tablets are taken orally once daily in the morning on an empty stomach ^[1]. Rybelsus was first approved in 3 mg, 7 mg and 14 mg strengths ^[1].

The 2019 filing sought both blood sugar control and cardiovascular risk reduction ^[1]. The cardiovascular risk reduction indication for Rybelsus was not approved until October 17, 2025 ^[1].

Labeled warnings and precautions for Rybelsus include acute pancreatitis, diabetic retinopathy complications, hypoglycemia when used with insulin secretagogues or insulin, acute kidney injury due to volume depletion, severe gastrointestinal adverse reactions, hypersensitivity reactions, and pulmonary aspiration during general anesthesia or deep sedation ^[1]. Common adverse reactions, occurring in at least 5 percent of patients, include nausea, abdominal pain, diarrhea, decreased appetite, vomiting and constipation ^[1].

Several changes followed the initial approval. On January 12, 2023, the FDA approved a label update allowing Rybelsus to be used as a first-line option for adults with type 2 diabetes ^[1]. A second version, known as the R2 formulation and sold as 1.5 mg, 4 mg and 9 mg tablets, was approved on December 9, 2024 ^[1]. On January 30, 2026, the FDA approved a supplemental application changing the name of that R2 product from Rybelsus to Ozempic tablets, and Novo Nordisk introduced the Ozempic pill on February 4, 2026, with US availability expected in the second quarter of 2026 ^[1].

On December 22, 2025, the FDA approved Wegovy tablets, in 1.5 mg, 4 mg, 9 mg and 25 mg strengths, for weight reduction in obesity and overweight and to reduce the risk of major adverse cardiovascular events in that population ^[1]. On February 24, 2026, Novo Nordisk announced a significant reduction in US list prices for Wegovy, Ozempic and Rybelsus ^[1].

Why it matters for patients

For adults with type 2 diabetes who wanted to avoid injections, the 2019 filing was the first step toward an oral GLP-1 option in the United States. Before Rybelsus, semaglutide was available only as the injectable Ozempic, first approved on December 5, 2017 ^[1]. The same molecule is now sold in several forms for different uses: injectable Ozempic, Ozempic tablets and Rybelsus for type 2 diabetes, and injectable Wegovy and Wegovy tablets for weight reduction in obesity and overweight ^[1].

The oral product is not taken the way most daily pills are. It is taken once daily in the morning on an empty stomach ^[1], a schedule that shapes a patient's morning routine and can interact with other medicines taken at the same time. The most common side effects are gastrointestinal ^[1], and the labeled warnings include serious risks such as pancreatitis and acute kidney injury from volume depletion ^[1]. The list price reductions announced in February 2026 apply to the semaglutide medicines, and the approval history does not state dollar amounts ^[1].

What happens next

The next dated milestone for the oral form is US availability of Ozempic tablets, expected in the second quarter of 2026 ^[1]. In April 2026, Novo Nordisk reported that oral semaglutide showed potential to be the first oral GLP-1 receptor agonist therapy for children and adolescents with type 2 diabetes ^[1]; no regulatory decision on that use has been reported. Whether the 2019 filing's original cardiovascular goal influenced the later 2025 approval has not been disclosed ^[1].