Last reviewed 2026-05-25 · How we verify

Exenatide Microspheres for Injection

Xiangya Hospital of Central South University · Phase 3 active Small molecule Under review

Exenatide Microspheres for Injection is a GLP-1 receptor agonist Small molecule drug developed by Xiangya Hospital of Central South University. It is currently in Phase 3 development for Type 2 diabetes mellitus. Also known as: Bydureon.

Exenatide is a GLP-1 receptor agonist that stimulates insulin secretion and reduces glucagon in response to elevated blood glucose.

Exenatide Microspheres for Injection is a treatment being studied for obesity. The mechanism of action of Exenatide Microspheres for Injection is unknown.

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 Microspheres for Injection
Also known as	Bydureon
Sponsor	Xiangya Hospital of Central South University
Drug class	GLP-1 receptor agonist
Target	GLP-1R
Modality	Small molecule
Therapeutic area	Diabetes
Phase	Phase 3

Mechanism of action

Exenatide mimics glucagon-like peptide-1 (GLP-1), an incretin hormone that enhances glucose-dependent insulin secretion from pancreatic beta cells and suppresses glucagon release from alpha cells. The microsphere formulation provides sustained, extended-release delivery over weeks to months, improving glycemic control with less frequent dosing than immediate-release formulations. This mechanism helps reduce postprandial and fasting blood glucose levels in patients with type 2 diabetes.

Approved indications

Type 2 diabetes mellitus

Common side effects

Nausea
Vomiting
Diarrhea
Hypoglycemia
Injection site reactions

Key clinical trials

Effects of GLP-1 RAs on Weight and Metabolic Indicators in Obese Patients (PHASE3)

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 Microspheres for Injection CI brief — competitive landscape report
Exenatide Microspheres for Injection updates RSS · CI watch RSS
Xiangya Hospital of Central South University portfolio CI

Frequently asked questions about Exenatide Microspheres for Injection

What is Exenatide Microspheres for Injection?

Exenatide Microspheres for Injection is a GLP-1 receptor agonist drug developed by Xiangya Hospital of Central South University, indicated for Type 2 diabetes mellitus.

How does Exenatide Microspheres for Injection work?

Exenatide is a GLP-1 receptor agonist that stimulates insulin secretion and reduces glucagon in response to elevated blood glucose.

What is Exenatide Microspheres for Injection used for?

Exenatide Microspheres for Injection is indicated for Type 2 diabetes mellitus.

Who makes Exenatide Microspheres for Injection?

Exenatide Microspheres for Injection is developed by Xiangya Hospital of Central South University (see full Xiangya Hospital of Central South University pipeline at /company/xiangya-hospital-of-central-south-university).

Is Exenatide Microspheres for Injection also known as anything else?

Exenatide Microspheres for Injection is also known as Bydureon.

What drug class is Exenatide Microspheres for Injection in?

Exenatide Microspheres for Injection 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 Microspheres for Injection in?

Exenatide Microspheres for Injection is in Phase 3.

What are the side effects of Exenatide Microspheres for Injection?

Common side effects of Exenatide Microspheres for Injection include Nausea, Vomiting, Diarrhea, Hypoglycemia, Injection site reactions.

What does Exenatide Microspheres for Injection target?

Exenatide Microspheres for Injection 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: Xiangya Hospital of Central South University — full pipeline
Therapeutic area: All drugs in Diabetes
Indication: Drugs for Type 2 diabetes mellitus
Also known as: Bydureon

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