RYBELSUS
PeakNDAORALTABLET
Approved
Jan 2020
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
3/8 — Basic
RYBELSUS by Novo Nordisk is glp-1 analogue with 94% sequence homology to human glp-1. First approved in 2020.
Drug data last refreshed 16h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RYBELSUS (semaglutide) is an oral GLP-1 receptor agonist approved by the FDA in January 2020 for the treatment of type 2 diabetes. It works by stimulating insulin secretion and inhibiting glucagon secretion in a glucose-dependent manner, with a long half-life achieved through albumin binding and DPP-4 stabilization. The drug also produces a minor delay in gastric emptying, contributing to blood glucose control.
Peak
Product is at peak commercial maturity with moderate competitive pressure (30/100), indicating stable sales team size and established brand infrastructure.
Mechanism of Action
GLP-1 analogue with 94% sequence homology to human GLP-1. Semaglutide acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for native GLP-1. GLP-1 is a physiological hormone that has multiple actions on glucose, mediated by the GLP-1 receptors. The…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
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 Jan 2027
600 enrolled
Diabetes Mellitus, Type 2
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
Clinical Trial of Rybelsus (Semaglutide) Among Adults With Alcohol Use Disorder (AUD)
Started Jan 2024
50 enrolled
Alcohol Use Disorder
Trial to Learn About the Study Medicine (PF-07081532) and Rybelsus in People With Type 2 Diabetes and Separately PF-07081532 in People With Obesity
Started Oct 2022
902 enrolled
Diabetes MellitusObesity
A Research Study Comparing RYBELSUS® to Other Blood Sugar Lowering Tablets in People Living in America With Type 2 Diabetes (REALYSE)
Started Sep 2021
1,018 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.