Metabolic · FDA Approved
Exenatide (Byetta/Bydureon)
FDA-approved
01 · Overview
A synthetic version of exendin-4, a 39-amino acid peptide originally isolated from the venom of the Gila monster lizard (Heloderma suspectum) (PMID 1313797). Exenatide shares roughly 50% homology with human GLP-1 and stimulates the GLP-1 receptor for prolonged periods (PMID 20152707), enhancing glucose-dependent insulin secretion, suppressing glucagon and slowing gastric emptying.
Bydureon and Bydureon BCise are listed as discontinued in FDA records.
02 · Research summary & key findings
FDA-approved in 2005 (Byetta, twice daily); the extended-release once-weekly formulation (Bydureon) was approved in 2012. In DURATION-1, once-weekly exenatide produced greater HbA1c improvement than twice-daily dosing with similar weight reduction (PMID 18782641), and clinical trials consistently report weight loss (PMID 20152707). The EXSCEL cardiovascular outcomes trial showed noninferiority for safety but no significant reduction in major adverse cardiovascular events (PMID 28910237).
03 · Regulatory status
Exenatide (Byetta/Bydureon) has received FDA approval and is available for clinical use under appropriate medical supervision. Consult a qualified healthcare provider for prescribing information.
Exenatide (Byetta/Bydureon) is an FDA-approved medicine prescribed for the conditions on its label. It is not part of our intake, so we do not propose protocols for it. If you think it may be relevant to you, talk to your own doctor. How to ask your doctor.
Looking for a lawful, clinician-prescribed option for metabolic health and weight?
Exenatide (Byetta/Bydureon) is prescribed for the conditions on its label, and it is not part of our intake. If you are working on metabolic health and weight, a licensed clinician can tell you at a free consultation whether an FDA-approved or lawfully compounded treatment fits you, or whether nothing does.
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04 · Administration routes
- Subcutaneous injection (twice daily or weekly extended-release)
References
- [1]Isolation and characterization of exendin-4, an exendin-3 analogue, from Heloderma suspectum venom. Further evidence for an exendin receptor on dispersed acini from guinea pig pancreas J Biol Chem, 1992. PMID 1313797
- [2]Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, non-inferiority study Lancet, 2008. PMID 18782641
- [3]Exenatide and weight loss Nutrition, 2010. PMID 20152707
- [4]Effects of Once-Weekly Exenatide on Cardiovascular Outcomes in Type 2 Diabetes N Engl J Med, 2017. PMID 28910237
Primary literature
- PubMed: "Exenatide"
Peer-reviewed literature indexed by the National Library of Medicine.
- ClinicalTrials.gov: "Exenatide"
Registered interventional and observational studies, including status and phase.
- PubChem: "Exenatide"
Chemical structure, molecular properties, and bioactivity data.
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