Last reviewed 2026-04-23 · How we verify

Exenatide infusion

Amsterdam UMC, location VUmc · Phase 3 active Small molecule

Exenatide infusion is a GLP-1 receptor agonist Small molecule drug developed by Amsterdam UMC, location VUmc. It is currently in Phase 3 development for Type 2 diabetes mellitus (investigational infusion formulation).

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 is a GLP-1 receptor agonist that mimics glucagon-like peptide-1 to stimulate insulin secretion and reduce blood glucose in response to meals. Used for Type 2 diabetes mellitus (investigational infusion formulation).

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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 infusion
Sponsor	Amsterdam UMC, location VUmc
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 reduction in patients with type 2 diabetes.

Approved indications

Type 2 diabetes mellitus (investigational infusion formulation)

Common side effects

Nausea
Vomiting
Diarrhea
Hypoglycemia
Headache

Key clinical trials

Diabetes Islet Preservation Immune Treatment (PHASE1, PHASE2)
Effect of Glucagon and Glucagon-like Peptide-1 Co-agonism on Cardiac Function and Metabolism in Overweight Participants with Type 2 Diabetes (PHASE4)
GLP-1 and Hyperoxia for Organ Protection in Heart Surgery (NA)
Haemodynamic Effects of GLP-1 and Glucagon in Healthy Male Volunteers (NA)
Intravenous Exenatide (Byetta) During Surgery (PHASE1, PHASE2)
Impact of Perioperative Exenatide Infusion on Quality of Life in Cardiac Surgery Patients (PHASE2, PHASE3)
Gut Hormones in Obesity, Nicotine and Alcohol Dependence (EARLY_PHASE1)
Intravenous Exenatide in Patients With Acute Brain Injury (PHASE4)

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 infusion CI brief — competitive landscape report
Exenatide infusion updates RSS · CI watch RSS
Amsterdam UMC, location VUmc portfolio CI

Frequently asked questions about Exenatide infusion

What is Exenatide infusion?

Exenatide infusion is a GLP-1 receptor agonist drug developed by Amsterdam UMC, location VUmc, indicated for Type 2 diabetes mellitus (investigational infusion formulation).

How does Exenatide infusion work?

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.

What is Exenatide infusion used for?

Exenatide infusion is indicated for Type 2 diabetes mellitus (investigational infusion formulation).

Who makes Exenatide infusion?

Exenatide infusion is developed by Amsterdam UMC, location VUmc (see full Amsterdam UMC, location VUmc pipeline at /company/amsterdam-umc-location-vumc).

What drug class is Exenatide infusion in?

Exenatide infusion belongs to the GLP-1 receptor agonist class. See all GLP-1 receptor agonist drugs at /class/glp-1-receptor-agonist.

What development phase is Exenatide infusion in?

Exenatide infusion is in Phase 3.

What are the side effects of Exenatide infusion?

Common side effects of Exenatide infusion include Nausea, Vomiting, Diarrhea, Hypoglycemia, Headache.

What does Exenatide infusion target?

Exenatide infusion targets GLP-1R and is a GLP-1 receptor agonist.

Drug class: All GLP-1 receptor agonist drugs
Target: All drugs targeting GLP-1R
Manufacturer: Amsterdam UMC, location VUmc — full pipeline
Therapeutic area: All drugs in Diabetes
Indication: Drugs for Type 2 diabetes mellitus (investigational infusion formulation)

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing