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Rybelsus
Rybelsus is a brand of semaglutide from Novo Nordisk, first approved by the FDA on 2019-09-20 under applications NDA213051, NDA213182, authorised in the EU as Rybelsus, with 3 presentations flagged to be discontinued.
Rybelsus is Novo Nordisk's brand of semaglutide, covering 2 FDA applications. The same molecule is also sold as Ozempic, Wegovy — a separate application with its own approved uses and its own supply record, which is why the two are tracked apart here rather than merged. Its current FDA label, effective 2026-01-30, covers cardiovascular disease, type 2 diabetes. 3 presentations are flagged for discontinuation. It is also authorised in the EU, which does not always follow the US indication wording.
Rybelsus and Ozempic, Wegovy are the same molecule. They are marketed under separate FDA applications with different approved indications, so they are distinct products on the regulatory record even though the active ingredient is identical. Compare the applications below. Side by side: Rybelsus vs Ozempic · Rybelsus vs Wegovy.
- Active ingredient
- semaglutide
- Sponsor
- Novo Nordisk
- FDA applications
- NDA213051, NDA213182
- First FDA action
- 2019-09-20
- Most recent FDA action
- 2026-01-30
- FDA actions on file
- 14
- EU authorisation
- Rybelsus
- Active trials of semaglutide
- 203
Approved indications
Quoted from the current FDA label for each application. This is what the drug is approved to treat in the US — separate from the conditions it is being studied in.
RYBELSUS and OZEMPIC tablets are indicated: • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. • to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events. RYBELSUS and OZEMPIC tablets are glucagon-like peptide-1 (GLP-1) receptor agonists indicated: • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) • 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 mellitus who are at high risk for these events. ( 1 )
FDA record
Every approved submission filed under this brand, newest first, from Drugs@FDA: original approval, efficacy supplements, labeling changes and manufacturing updates. New safety language usually arrives in a labeling supplement.
| Date | Action | Application |
|---|---|---|
| 2026-01-30 | Labeling | NDA213051 · label |
| 2025-10-17 | Labeling | NDA213051 · label |
| 2025-10-17 | Labeling | NDA213051 · label |
| 2025-10-17 | Efficacy | NDA213051 · label |
| 2024-12-09 | Labeling | NDA213051 · label |
| 2024-12-09 | Efficacy | NDA213051 · label |
| 2024-11-01 | Labeling | NDA213051 · label |
| 2024-01-24 | Labeling | NDA213051 · label |
| 2023-01-12 | Labeling | NDA213051 · label |
| 2022-06-10 | Labeling | NDA213051 · label |
| 2021-04-30 | Manufacturing (CMC) | NDA213051 · label |
| 2020-01-16 | Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval original | NDA213182 · label |
| 2020-01-16 | Labeling | NDA213051 · label |
| 2019-09-20 | Type 3 - New Dosage Form original | NDA213051 · label |
Supply records
FDA Drug Shortage Database entries naming this brand.
| Updated | Status | Presentation | FDA note |
|---|---|---|---|
| 06/04/2026 | To Be Discontinued | Rybelsus, Tablet, 3 mg (NDC 0169-4303-30) | Discontinuation of the manufacture of the drug. These products will be replaced by Ozempic (semaglutide) tablets. |
| 06/04/2026 | To Be Discontinued | Rybelsus, Tablet, 7 mg (NDC 0169-4307-30) | Discontinuation of the manufacture of the drug. These products will be replaced by Ozempic (semaglutide) tablets. |
| 06/04/2026 | To Be Discontinued | Rybelsus, Tablet, 14 mg (NDC 0169-4314-30) | Discontinuation of the manufacture of the drug. These products will be replaced by Ozempic (semaglutide) tablets. |
For the molecule behind this brand — every trial, every indication under study and the full research record — see semaglutide.