BYDUREON
LOE ApproachingNDASUBCUTANEOUSFOR SUSPENSION, EXTENDED RELEASE
Approved
Jan 2012
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
4
Data completeness
3/8 — Basic
Drug data last refreshed 21h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BYDUREON is an extended-release subcutaneous suspension for Type 2 Diabetes Mellitus and obesity, approved in 2012. It is a small-molecule GLP-1 receptor agonist delivered as a once-weekly injection designed to improve glycemic control and weight management. The mechanism of action involves stimulating insulin secretion in response to elevated glucose levels while suppressing glucagon secretion.
LOE Approaching2.4 years to LOE
Product faces imminent loss of exclusivity (2028) with moderate competitive pressure (15 competitors), indicating team downsizing and shift toward managed care and retention strategies.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (4)
A 12/24-weeks, Open, Multi-centre, Phase IV Study on Safety and Efficacy of 2mg Exenatide Once Weekly (Bydureon) in T2DM Patients.
Started Jan 2016
110 enrolled
Type 2 Diabetes Mellitus
Study to Evaluate the Effect of BYDUREON on 24-hour Glucose Control in Metformin Treated Patients With Type 2 Diabetes.
Started Dec 2014
239 enrolled
Type 2 Diabetes
Specific Clinical Experience Investigation for Long-term Use of Bydureon.
Started Oct 2013
1,137 enrolled
Type 2 Diabetes
Pilot Study of Bydureon to Treat Diabetes in HIV-infected Adults
Started Mar 2013
6 enrolled
Human Immunodeficiency Virus InfectionDiabetes Mellitus
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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.