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Exenatide Once Weekly
Exenatide Once Weekly is a GLP-1 receptor agonist Small molecule drug developed by AstraZeneca. It is currently in Phase 3 development for Type 2 diabetes mellitus. Also known as: BYDUREON, long_acting glucagon-like peptide-1 receptor agonist.
Exenatide is a GLP-1 receptor agonist that mimics glucagon-like peptide-1 to stimulate insulin secretion, suppress glucagon, and slow gastric emptying in response to blood glucose levels.
Exenatide is a GLP-1 receptor agonist that mimics glucagon-like peptide-1 to stimulate insulin secretion, suppress glucagon, and slow gastric emptying in response to blood glucose levels. Used for Type 2 diabetes mellitus.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
AstraZeneca is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Exenatide Once Weekly |
|---|---|
| Also known as | BYDUREON, long_acting glucagon-like peptide-1 receptor agonist |
| Sponsor | AstraZeneca |
| Drug class | GLP-1 receptor agonist |
| Target | GLP-1R |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 3 |
Mechanism of action
Exenatide binds to and activates GLP-1 receptors on pancreatic beta cells, enhancing glucose-dependent insulin secretion. It also inhibits glucagon secretion when blood glucose is elevated and delays gastric emptying, reducing postprandial glucose spikes. The once-weekly formulation uses extended-release microsphere technology to provide sustained drug delivery over seven days.
Approved indications
- Type 2 diabetes mellitus
Common side effects
- Nausea
- Vomiting
- Diarrhea
- Constipation
- Injection site reactions
- Hypoglycemia
Key clinical trials
- Exenatide for Smoking Cessation and Prevention of Weight Gain (PHASE2)
- Exenatide For Reducing the Reinforcing Effects of Cocaine (PHASE1)
- GLP-1 Analogue in Preventing Progression of Small Vessel Disease (GAPP-SVD) (PHASE2)
- Extended Release Exenatide Versus Placebo In Diabetic Patients With Type 4 Cardiorenal Syndrome (PHASE3)
- Diabetes Islet Preservation Immune Treatment (PHASE1, PHASE2)
- Brain Activation and Satiety in Children 2 (PHASE3)
- A Phase 3 Study to Evaluate the Efficacy of JY09 Compared With Dulaglutide in Combination Therapy Diabetes Mellitus Type 2 Patients With Metformin (PHASE3)
- Exenatide Once-weekly as a Treatment for Multiple System Atrophy (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Exenatide Once Weekly CI brief — competitive landscape report
- Exenatide Once Weekly updates RSS · CI watch RSS
- AstraZeneca portfolio CI
Frequently asked questions about Exenatide Once Weekly
What is Exenatide Once Weekly?
How does Exenatide Once Weekly work?
What is Exenatide Once Weekly used for?
Who makes Exenatide Once Weekly?
Is Exenatide Once Weekly also known as anything else?
What drug class is Exenatide Once Weekly in?
What development phase is Exenatide Once Weekly in?
What are the side effects of Exenatide Once Weekly?
What does Exenatide Once Weekly target?
Related
- Drug class: All GLP-1 receptor agonist drugs
- Target: All drugs targeting GLP-1R
- Manufacturer: AstraZeneca — full pipeline
- Therapeutic area: All drugs in Diabetes
- Indication: Drugs for Type 2 diabetes mellitus
- Also known as: BYDUREON, long_acting glucagon-like peptide-1 receptor agonist
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing