At a glance
- Exenatide is an FDA-approved drug, marketed as Byetta (first approval: October 30, 2009).
- PubMed lists 4,940 publications mentioning it, including 392 randomized controlled trials and 1,386 animal-only studies.
- ClinicalTrials.gov lists 380 registered studies testing it (21 active).
- FDA's adverse event system (FAERS) holds 84,435 reports mentioning it; 20,670 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
| Application | Product | Status | First approval | Sponsor |
|---|---|---|---|---|
| NDA021773 | BYETTA | Approved, discontinued | April 28, 2005 | ASTRAZENECA AB |
| NDA021919 | BYETTA | Approved, marketed | October 30, 2009 | AMYLIN |
| NDA022200 | BYDUREON, BYDUREON PEN | Approved, discontinued | January 27, 2012 | ASTRAZENECA AB |
| NDA209210 | BYDUREON BCISE | Approved, discontinued | October 20, 2017 | ASTRAZENECA AB |
| ANDA206697 | EXENATIDE SYNTHETIC | Approved, discontinued | November 19, 2024 | AMNEAL |
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- Comparative Effects of Pharmacological Treatment on Heart Failure with Mildly Reduced or Preserved Ejection Fraction: A Systematic Review and Network Meta-analysis of Randomized Controlled Trials.
- Reproductive and Gynecologic Effects of Glucagon-Like Peptide-1 Receptor Agonists in Women With Polycystic Ovary Syndrome: A Scoping Review.
- Pancreatic δ cells are resistant to auto- and paracrine inhibition in human type-2 diabetes.
- Beyond Weight Loss and Glycemic Control: Molecular Mechanisms and Hypothesis-Generating Therapeutic Potential of Incretin-Based Therapies Against Peritoneal Fibrosis in Peritoneal Dialysis.
- 6-Gingerol Potentiates β-Cell Insulin Secretion Without Acting as an L-Cell GLP-1 Secretagogue.
- Signature Definition Shapes Associations Between Exenatide-Related Transcriptional Programs and Macrophage Senescence Scores in Colorectal Cancer.
- Oral Health-Related Adverse Events of GLP-1 Receptor Agonists.
- Skeletal effects of GLP-1 receptor agonist therapy in adults with overweight or obesity: a systematic review.
- Intestinal Macrophage-Mediated Exosomal Repackaging Establishes Bioactive Reservoirs for Long-Acting Oral Peptide Therapy.
- Occult Abdominal Para-Aortic Ectopic Insulinoma Localized by 18F-NOTA-Exendin-4 PET/CT.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 380
- Active
- 21
- With posted results
- 128
Conditions studied
Show 40 more studies
All 380 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 84,435
- Serious
- 20,670
- With death outcome
- 2,220
Most reported reactions
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
FDA prescribing information
Official US prescribing information. Dosing sections are intentionally not shown.
Source: DailyMed / openFDA
Change history
No changes since monitoring began on October 30, 2026.