Novo Nordisk files oral semaglutide with the FDA

Novo Nordisk filed an application with the U.S. Food and Drug Administration on March 26, 2019, seeking approval of an oral tablet form of semaglutide ^[1]. The company sought approval for two uses: helping adults with type 2 diabetes control blood sugar, and reducing cardiovascular risk in adults with type 2 diabetes who face a high chance of heart attack, stroke, or cardiovascular death ^[1].

Semaglutide belongs to a class of drugs called GLP-1 receptor agonists. These drugs copy the action of a natural hormone called glucagon-like peptide-1, which tells the body to release insulin and reduce a hormone called glucagon when blood sugar is high ^[1]. Until this filing, semaglutide was only available as an injection, sold under the brand name Ozempic, which the FDA had approved in December 2017 ^[1].

The tablet form described in the filing used an absorption enhancer designed to help the drug survive passage through the stomach, since peptide-based drugs like semaglutide are normally broken down by stomach acid before they can be absorbed ^[1]. This engineering challenge is one reason an oral version of semaglutide took years longer to develop than the injectable form.

The FDA approved the application about six months later, on September 20, 2019, clearing the tablet for sale under the brand name Rybelsus ^[1]. At approval, Rybelsus was authorized only to improve blood sugar control in adults with type 2 diabetes, taken once daily by mouth on an empty stomach ^[1]. It initially came in tablet strengths of 3 mg, 7 mg, and 14 mg ^[1]. The cardiovascular risk reduction use that Novo Nordisk originally requested in its 2019 filing was not approved until years later, according to the drug's FDA history, which lists an October 17, 2025 approval specifically for cardiovascular risk reduction in high-risk adults with type 2 diabetes ^[1].

Why it matters for patients

Before this filing, anyone using semaglutide had to inject it. An oral tablet gave people with type 2 diabetes and needle aversion, or those who preferred pills, another way to take the same medicine ^[1]. Common side effects reported for Rybelsus include nausea, abdominal pain, diarrhea, decreased appetite, vomiting, and constipation, similar to what's seen with other GLP-1 drugs ^[1]. The FDA also flagged warnings for acute pancreatitis, complications from diabetic eye disease, low blood sugar when combined with certain other diabetes drugs, kidney injury from dehydration, and severe stomach or intestinal reactions ^[1].

It's worth noting that Rybelsus, as an oral tablet, is a different medicine formulation than Wegovy, the injectable semaglutide product approved in 2021 specifically for weight loss in people with obesity or who are overweight ^[1]. Rybelsus was approved for type 2 diabetes management, not primarily for weight loss, though weight changes can occur with GLP-1 drugs.

What happens next

According to the drug's approval history, Rybelsus received a label update in January 2023 allowing it to be used as a first-line treatment option for adults with type 2 diabetes, rather than only after other drugs had been tried ^[1]. A second tablet formulation, described as the R2 formulation with 1.5 mg, 4 mg, and 9 mg strengths, was approved on December 9, 2024 ^[1]. That same R2-formulation tablet was later renamed from Rybelsus to Ozempic tablets, per an FDA approval dated January 30, 2026 ^[1]. The sources do not explain in detail why Novo Nordisk chose to consolidate the Rybelsus and Ozempic tablet naming, so that reasoning is not yet known from the available material.