Oral semaglutide: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Oral semaglutide appears in the FDA drug-label database. Marketed as OZEMPIC, RYBELSUS.
- Drug class
- GLP-1 Receptor Agonist (FDA established pharmacologic class)
- Mechanism of action
- Glucagon-like Peptide-1 (GLP-1) Agonists (as stated on the FDA label)
- Boxed warning
- The FDA label for Oral semaglutide carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
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 )
Phase breakdown
Conditions being studied
| Condition | Trials |
|---|---|
| Type 2 Diabetes | 2 |
| Genetic Predisposition | 1 |
| Glaucoma | 1 |
| Hypertension | 1 |
| Metabolic Diseases | 1 |
| Obesity | 1 |
| Open-Angle Glaucoma | 1 |
| Primary Open Angle Glaucoma (POAG) | 1 |
| Type 2 Diabetes Mellitus (T2DM) | 1 |
Recruiting trials involving Oral semaglutide
- A Study Investigating Oral Semaglutide in People with Open-Angle Glaucoma
- Effect of Early Combination Antihyperglycemic Treatment on Metabolic Control in Individuals With Type 2 Diabetes
- Examination of How the Duration of Fasting and Temporary Stopping of GLP-1 Medications Affect the Amount of Food Left in the Stomach in People Using Liraglutide (Injected), Semaglutide (Taken by Mouth) or Semaglutide (Injected)
- GLUCOSE-MGH: Genetic Links Understood Through Challenge With Oral Semaglutide Exposure at MGH
Common questions
Is Oral semaglutide FDA-approved?
Yes, marketed as OZEMPIC, RYBELSUS. Its FDA label carries a boxed warning.
How many recruiting trials involve Oral semaglutide?
4 recruiting trials across 9 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.