Medicine profile
Semaglutide
Once-weekly injectable and daily oral GLP-1 receptor agonist, marketed for weight management, type 2 diabetes and cardiovascular risk reduction under several brands.
- Generic name
- Semaglutide
- Also known as
- Wegovy, Ozempic, Rybelsus, Wegovy pill, oral semaglutide
- Sponsor and licensing
- Novo Nordisk (originator)
- Mechanism
- GLP-1 receptor agonist
- Molecular type
- Peptide (mechanism and molecular type are recorded separately: GLP-1 activity does not make a medicine a peptide)
Brands, routes and formulations
Wegovy
subcutaneous 路 once-weekly injection
- United States: Chronic weight management (4 Jun 2021)
- United States: Cardiovascular risk reduction (8 Mar 2024)
- United Kingdom: Cardiovascular risk reduction (23 Jul 2024)
Ozempic
subcutaneous 路 once-weekly injection
- United States: Type 2 diabetes (glycaemic control) (5 Dec 2017)
Rybelsus
oral 路 once-daily tablet
- United States: Type 2 diabetes (glycaemic control) (20 Sep 2019)
Regulatory status by jurisdiction
Authorisation, launch and funded access are three different things and are shown separately. "Not recorded" means GLPInfo has not verified an event, not that nothing has happened.
| United States (FDA) | United Kingdom (MHRA) | European Union (EMA / EC) | |
|---|---|---|---|
| Regulatory authorisation | 5 Dec 2017 路 OzempicType 2 diabetes (glycaemic control)20 Sep 2019 路 RybelsusType 2 diabetes (glycaemic control)4 Jun 2021 路 WegovyChronic weight management8 Mar 2024 路 WegovyCardiovascular risk reduction | 23 Jul 2024 路 WegovyCardiovascular risk reduction | Not recorded |
| Commercial launch | Not recorded | Not recorded | Not recorded |
| Funded access | Not recorded | Not recorded | Not recorded |
Development timeline
Semaglutide
Dashed line: today, 13 Sep 2026. Future windows are conditional. Approval, launch and funded access are separate milestones.
Select a marker to open its record in the pipeline view, which has the detail panel and the accessible list.
Next milestone and forecast rationale
No forecast is published for Semaglutide. Approved medicines only carry forecasts for new indications or jurisdictions when a filing anchor exists.
Trial evidence
| Trial | Phase | Population | Duration | Results |
|---|---|---|---|---|
| PIONEER 1Novo Nordisk 路 oral, once daily | 3 | 703 adults with type 2 diabetes | 26 weeks | On file from the research workbook; withheld until the primary publication or registry record is attached. |
| STEP 1Novo Nordisk 路 subcutaneous, once weekly | 3 | 1,961 adults without diabetes; BMI 30 or more, or 27 or more with at least one weight-related condition | 68 weeks | On file from the research workbook; withheld until the primary publication or registry record is attached. |
| SUSTAIN-1Novo Nordisk 路 subcutaneous, once weekly | 3 | 388 adults with type 2 diabetes not recently on glucose-lowering medication | 30 weeks | On file from the research workbook; withheld until the primary publication or registry record is attached. |
GLPInfo does not rank unrelated trials against each other or quote "weight loss per week": populations, durations and methods differ and weight change is not linear. Results appear here per trial and dose arm, with comparator, endpoint and source, once cited.
Known limitations and official labels
This profile is assembled from the regulatory records and sponsor statements GLPInfo has verified; it is not a complete review of Semaglutide. The current official label in each jurisdiction is the authority on indications, populations and safety. Official records read for this profile: Drugs@FDA: NDA 215256 Wegovy (semaglutide) approval history; Drugs@FDA: NDA 209637 Ozempic (semaglutide) approval history; Drugs@FDA: NDA 213051 Rybelsus (oral semaglutide) approval history.
Review date and correction history
Records last checked 13 Sep 2026. No corrections have been made to the records on this profile; every record is at version 1. Report a correction.
Related news
Wegovy's cardiovascular indication: what the US, UK and EU each decided in 2024
In 2024 the same trial, SELECT, produced three different regulatory outcomes for semaglutide (Wegovy): a new indication in the US on 8 March, a new indication in the UK on 23 July, and a product-information update in the EU. Here is what each one means.
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