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semaglutide
FDA-approved since 2017 and marketed in the US as Ozempic, Rybelsus, Wegovy, authorised in the EU as Ozempic, Rybelsus, Wegovy, with 3 presentations flagged to be discontinued. 203 active trials, the next due to complete 2026-10-15.
GLP-1 agonist, SC/oral, from Novo Nordisk. Every figure below is taken directly from ClinicalTrials.gov, Drugs@FDA, the FDA Drug Shortage Database, the EMA register or Europe PMC, and re-checked every four hours.
- Status
- marketed
- Target
- GLP-1
- Route
- SC/oral
- Sponsor
- Novo Nordisk
- First FDA approval
- 2017-12-05
- EU authorisation
- Ozempic (2018), Rybelsus (2020), Wegovy (2021)
- Active trials
- 203 (72 in phase 3)
- Participants enrolled
- 94,274
- Trials with a reporting date
- 76
- Approved FDA submissions
- 51
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 )
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 )
WEGOVY is indicated in combination with a reduced calorie diet and increased physical activity: • to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight. • to reduce excess body weight and maintain weight reduction long term in: o Adults and pediatric patients aged 12 years and older with obesity o Adults with overweight in the presence of at least one weight-related comorbid condition. Limitations of Use • WEGOVY contains semaglutide. Coadministration with other semaglutide-containing products or with any other GLP-1 receptor agonist is not recommended. WEGOVY is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated in combination with a reduced calorie diet and increased physical activity: • to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight (1) . • to reduce excess body weight and maintain weight reduction long term in: o Adults and pediatric patients aged 12 years and older with obesity o Adults with overweight in the presence of at least one weight-related comorbid condition (1) . Limitations of Use: • Coadministration with other semaglutide-containing products or with any other GLP-1 receptor agonist is not recommended (1).
Supply status
| 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. |
Recent changes
When these trials report
Next 30 of 76 active trials by estimated primary completion.
Regulatory history
| Date | Action | Brands | Application |
|---|---|---|---|
| 2026-08-27 | Labeling | OZEMPIC | NDA209637 · label |
| 2026-06-18 | Manufacturing (CMC) | WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD | NDA215256 · label |
| 2026-06-18 | Labeling | WEGOVY | NDA218316 · label |
| 2026-06-01 | Labeling | OZEMPIC | NDA209637 · label |
| 2026-05-05 | Manufacturing (CMC) | WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD | NDA215256 · label |
| 2026-05-05 | Labeling | WEGOVY | NDA218316 · label |
| 2026-03-19 | Efficacy | WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD | NDA215256 · label |
| 2026-03-19 | Labeling | WEGOVY | NDA218316 · label |
| 2026-02-25 | Labeling | WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD | NDA215256 · label |
| 2026-02-25 | Labeling | WEGOVY | NDA218316 · label |
| 2026-01-30 | Labeling | OZEMPIC, RYBELSUS | NDA213051 · label |
| 2026-01-29 | Labeling | WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD | NDA215256 · label |
| 2026-01-29 | Labeling | WEGOVY | NDA218316 · label |
| 2025-12-22 | Type 3 - New Dosage Form original | WEGOVY | NDA218316 · label |
| 2025-11-21 | Efficacy | WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD | NDA215256 · label |
| 2025-10-17 | Labeling | OZEMPIC, RYBELSUS | NDA213051 · label |
| 2025-10-17 | Labeling | OZEMPIC, RYBELSUS | NDA213051 · label |
| 2025-10-17 | Efficacy | OZEMPIC, RYBELSUS | NDA213051 · label |
| 2025-10-14 | Labeling | WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD | NDA215256 · label |
| 2025-10-14 | Labeling | OZEMPIC | NDA209637 · label |
| 2025-10-14 | Labeling | OZEMPIC | NDA209637 · label |
| 2025-08-15 | Efficacy | WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD | NDA215256 · label |
| 2025-01-28 | Efficacy | OZEMPIC | NDA209637 · label |
| 2024-12-09 | Labeling | OZEMPIC, RYBELSUS | NDA213051 · label |
| 2024-12-09 | Efficacy | OZEMPIC, RYBELSUS | NDA213051 · label |
Indications under study
ASCVD; Acute Ischemic Stroke; Acute Myocardial Infarction With ST Elevation; Addiction; Adult Obesity; Adults With Overweight/Obesity and Type 2 Diabetes; Aging; Albuminuria; Alcohol; Alcohol Use Disorder; Alcohol Use Disorder (AUD); Alzheimer Disease; Alzheimer Disease (AD); Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Anesthesia; Antipsychotic-induced Weight Gain; Aortic Stenosis; Appetite Regulation; Arthritis; Asthma; Atrial Fibrillation; Atrial Fibrillation (AF); Atypical Endometrial Hyperplasia; Atypical Endometrial Hyperplasia and Endometrial Carcinoma Stage I; Autism Spectrum Disorder; BMI>40; Bipolar I Disorder; Bipolar II Disorder; Blood Pressure Monitoring; Bone Density; Bone Strength; Caloric Restriction; Cannabis Abuse; Cannabis Addiction; Cannabis Dependence; Cannabis Use Disorder; Cannabis Use Disorders; Cardiometabolic Risk Factors.