NDAORALTABLETPriority Review
Approved
Sep 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
Priority Review
RYBELSUS (oral semaglutide) by Novo Nordisk is glucagon-like peptide-1 (glp-1) agonists [moa]. Approved for glp-1 receptor agonist [epc]. First approved in 2019.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RYBELSUS is an oral formulation of semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist developed by Novo Nordisk and approved by the FDA in September 2019. It is indicated for the treatment of type 2 diabetes mellitus and works by enhancing insulin secretion and reducing glucagon levels in response to elevated blood glucose. As the first oral GLP-1 agonist, RYBELSUS represents a significant advancement over injectable alternatives by offering improved patient convenience and adherence.
$1.7BPart D
12.7 years to LOEMechanism of Action
Glucagon-like Peptide-1 (GLP-1) Agonists
Pharmacologic Class:
GLP-1 Receptor Agonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Efficacy and Safety of QLG1091 vs Rybelsus as add-on to Metformin in Subjects With Type 2 Diabetes
Started May 2026
478 enrolled
Type 2 Diabetes
Regulatory Post Marketing Surveillance (rPMS) Study of Rybelsus (Oral Semaglutide) to Evaluate Safety and Effectiveness in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in Korea
Started Dec 2025
600 enrolled
Diabetes Mellitus, Type 2
A Research Study to See if Two Different Formulations of Oral Semaglutide Are Equally Safe and Effective in Reducing the Blood Sugar Level in Japanese People With Type 2 Diabetes
Started Dec 2025
264 enrolled
Type 2 Diabetes
SEMA-CardioDiab HUNGARY: A Research Study to Understand the Effects of Oral Semaglutide on Blood Sugar Levels, Weight, and Cardiovascular Risk in People With Type 2 Diabetes Patients in Hungary
Started Sep 2024
470 enrolled
Type 2 Diabetes
Real World Effectiveness of Oral Semaglutide in Thailand Participants With Type 2 Diabetes
Started Sep 2024
209 enrolled
Diabetes Mellitus, Type 2
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.