Clinical Trials

Exendin-4 has been evaluated across numerous clinical trials investigating its therapeutic potential and diagnostic utility in metabolic and endocrine disorders. These studies primarily focus on conditions such as type 2 diabetes mellitus, gestational diabetes, overweight status, insulinoma, and nesidioblastosis. Investigations span Early Phase 1 through Phase 3 trials (e.g., NCT00082407 and NCT06254014), encompassing clinical evaluations of novel formulations, pharmacokinetic comparisons, and beta-cell imaging in bariatric surgery candidates. Trials have been supported by diverse sponsors, including academic medical centers like Radboud University Medical Center and global pharmaceutical companies such as AstraZeneca and Sanofi. The recruitment landscape reflects a range of statuses, including completed studies as well as active, non-recruiting, and ongoing recruiting protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06257966 ACTIVE_NOT_RECRUITING
Type2 Diabetes Mellitus
Beijing Dongfang Biotech Co., Ltd.
 2024-07-17 PHASE3
NCT06254014 ACTIVE_NOT_RECRUITING
Type 2 Diabetes Mellitus
Beijing Dongfang Biotech Co., Ltd.
 2024-07-10 PHASE3
NCT03182296 UNKNOWN
Gestational Diabetes
Radboud University Medical Center
 2016-11-10
NCT04979611 UNKNOWN
Insulinoma
First Affiliated Hospital of Fujian Medical University
 2020-08-01 PHASE1
NCT05662189 RECRUITING
Type1diabetes; Type2diabetes; Pre Diabetes; Hyperinsulinism
Azienda Ospedaliero-Universitaria di Parma
 2022-03-15
NCT04615910 UNKNOWN
Diabetes Mellitus
Radboud University Medical Center
 2021-07-01 PHASE2
NCT03182192 UNKNOWN
Hypoglycemia
Radboud University Medical Center
 2016-04-01 PHASE1
NCT06247748 COMPLETED
Diabetes Mellitus, Type 2; Overweight
Beijing Dongfang Biotech Co., Ltd.
 2023-10-19 PHASE1
NCT03923114 COMPLETED
Diabetes Mellitus, Type 2
Radboud University Medical Center
 2019-05-23
NCT05622123 UNKNOWN
Type 1 Diabetes
Radboud University Medical Center
 2023-02-23 PHASE2
NCT03182231 UNKNOWN
Diabetes Mellitus, Type 2; Bariatric Surgery Candidate
Radboud University Medical Center
 2016-10-07 PHASE1; PHASE2
NCT05034783 UNKNOWN
Insulinoma
Peking Union Medical College Hospital
 2021-10-01 EARLY_PHASE1
NCT04733508 UNKNOWN
Diabetes Mellitus; Diabetes Mellitus, Type 2
Radboud University Medical Center
 2019-11-01
NCT03189953 COMPLETED
Insulinoma
Radboud University Medical Center
 2015-04 PHASE1; PHASE2
NCT04185350 UNKNOWN
Insulinoma
Nanjing First Hospital, Nanjing Medical University
 2019-05-05 EARLY_PHASE1
NCT03350191 COMPLETED
Type 2 Diabetes Mellitus
Sanofi
 2017-12-20 PHASE1
NCT02541734 COMPLETED
Diabetes Mellitus, Non-Insulin-Dependent; Diabetes Mellitus
Radboud University Medical Center
 2015-08 PHASE1; PHASE2
NCT03199261 COMPLETED
Type 2 Diabetes
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
 2016-12-23 PHASE1
NCT02560376 UNKNOWN
Insulinoma; Nesidioblastosis
Peking Union Medical College Hospital
 2014-02 EARLY_PHASE1
NCT01255163 TERMINATED
Alzheimer's Disease; Mild Cognitive Impairment
National Institute on Aging (NIA)
 2010-11-21 PHASE2
NCT01988545 UNKNOWN
Healthy
Zealand University Hospital
 2013-11
NCT01174810 UNKNOWN
Parkinson's Disease
University College, London
 2010-07 PHASE2
NCT00082407 COMPLETED
Diabetes Mellitus, Type 2
AstraZeneca
 2003-11 PHASE3
NCT00082381 COMPLETED
Diabetes Mellitus, Type 2
AstraZeneca
 2003-06 PHASE3
NCT00064714 COMPLETED
Diabetes Mellitus
AstraZeneca
 2003-07 PHASE2

(data from https://clinicaltrials.gov, updated on 2025-09-17)

Check the Exendin-4 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Exendin-4 acts as a long-acting agonist of the glucagon-like peptide-1 receptor, selectively binding the target to stimulate adenylate cyclase activity and intracellular cyclic adenosine monophosphate accumulation. This signaling cascade triggers glucose-dependent insulin secretion and suppresses glucagon release from pancreatic islet cells, thereby lowering blood glucose levels to improve glycemic control in patients with type 2 diabetes mellitus.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.