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Ozempic
Ozempic is a brand of semaglutide from Novo Nordisk, first approved by the FDA on 2017-12-05 under applications NDA209637, NDA213051, authorised in the EU as Ozempic, with no open FDA supply records.
Ozempic is Novo Nordisk's brand of semaglutide, covering 2 FDA applications. The same molecule is also sold as Rybelsus, 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. Nothing under this name is currently on the FDA shortage list. It is also authorised in the EU, which does not always follow the US indication wording.
Ozempic and Rybelsus, 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: Ozempic vs Rybelsus · Ozempic vs Wegovy.
- Active ingredient
- semaglutide
- Sponsor
- Novo Nordisk
- FDA applications
- NDA209637, NDA213051
- First FDA action
- 2017-12-05
- Most recent FDA action
- 2026-08-27
- FDA actions on file
- 28
- EU authorisation
- Ozempic
- 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.
OZEMPIC is 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 events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease. • to reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease. OZEMPIC is a glucagon-like peptide 1 (GLP-1) receptor agonist 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 in adults with type 2 diabetes mellitus and established cardiovascular disease. ( 1 ) • to reduce the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease. ( 1 )
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 |
|---|---|---|
| 2026-08-27 | Labeling | NDA209637 · label |
| 2026-06-01 | Labeling | NDA209637 · label |
| 2026-01-30 | Labeling | NDA213051 · label |
| 2025-10-17 | Labeling | NDA213051 · label |
| 2025-10-17 | Labeling | NDA213051 · label |
| 2025-10-17 | Efficacy | NDA213051 · label |
| 2025-10-14 | Labeling | NDA209637 · label |
| 2025-10-14 | Labeling | NDA209637 · label |
| 2025-01-28 | Efficacy | NDA209637 · label |
| 2024-12-09 | Labeling | NDA213051 · label |
| 2024-12-09 | Efficacy | NDA213051 · label |
| 2024-11-01 | Labeling | NDA213051 · label |
| 2024-11-01 | Labeling | NDA209637 · label |
| 2024-01-24 | Labeling | NDA213051 · label |
| 2023-09-22 | Labeling | NDA209637 · label |
| 2023-09-22 | Labeling | NDA209637 · label |
| 2023-01-12 | Labeling | NDA213051 · label |
| 2022-10-06 | Labeling | NDA209637 · label |
| 2022-06-10 | Labeling | NDA213051 · label |
| 2022-03-28 | Efficacy | NDA209637 · label |
| 2021-04-30 | Manufacturing (CMC) | NDA213051 · label |
| 2021-04-12 | Labeling | NDA209637 · label |
| 2020-01-16 | Labeling | NDA213051 · label |
| 2020-01-16 | Efficacy | NDA209637 · label |
| 2019-11-27 | Labeling | NDA209637 · label |
| 2019-09-20 | Type 3 - New Dosage Form original | NDA213051 · label |
| 2019-04-09 | Labeling | NDA209637 · label |
| 2017-12-05 | Type 1 - New Molecular Entity original | NDA209637 · label |
For the molecule behind this brand — every trial, every indication under study and the full research record — see semaglutide.