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Exenatide (AC2993)
Exenatide (AC2993) 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: Byetta.
Exenatide is a GLP-1 receptor agonist that mimics glucagon-like peptide-1 to stimulate insulin secretion and reduce blood glucose in response to meals.
Exenatide, also known as AC2993, is a GLP-1 receptor agonist used in the treatment of Type 2 Diabetes Mellitus. It has also been studied for its potential benefits in myocardial infarction and myocardial protection during reperfusion.
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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 (AC2993) |
|---|---|
| Also known as | Byetta |
| 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 slows gastric emptying and promotes satiety, contributing to improved glycemic control and weight loss. The drug is derived from exendin-4, a peptide found in Gila monster venom.
Approved indications
- Type 2 diabetes mellitus
Common side effects
- Nausea
- Vomiting
- Diarrhea
- Hypoglycemia
- Headache
- Injection site reactions
Key clinical trials
- Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis (PHASE2)
- Exenatide for Smoking Cessation and Prevention of Weight Gain (PHASE2)
- A Pan-European Post-Authorisation Safety Study: Risk of Pancreatic Cancer Among Type 2 Diabetes Patients Who Initiated Exenatide as Compared With Those Who Initiated Other Non-Glucagon-Like Peptide 1 Receptor Agonists Based Glucose Lowering Drugs
- 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)
- Identification and Clinical Relevance of an Oxytocin Deficient State (GLP1 Study) (PHASE4)
- A Single-Center, Open-Label, Single Ascending Dose Study of Exenatide Circular RNA-Lipid Nanoparticle Injection (CR059) in Chinese Subjects With Type 2 Diabetes Mellitus (EARLY_PHASE1)
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 (AC2993) CI brief — competitive landscape report
- Exenatide (AC2993) updates RSS · CI watch RSS
- AstraZeneca portfolio CI
Frequently asked questions about Exenatide (AC2993)
What is Exenatide (AC2993)?
How does Exenatide (AC2993) work?
What is Exenatide (AC2993) used for?
Who makes Exenatide (AC2993)?
Is Exenatide (AC2993) also known as anything else?
What drug class is Exenatide (AC2993) in?
What development phase is Exenatide (AC2993) in?
What are the side effects of Exenatide (AC2993)?
What does Exenatide (AC2993) 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: Byetta
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing