Exenatide

Generic Name: Exenatide

Brand Names: Bydureon, Byetta

Drug Type: Biotech

CAS Number: 141758-74-9

Unique Ingredient Identifier: 9P1872D4OL

Background: Exenatide is a glucagon-like peptide-1 (GLP-1) analog. It activates the GLP-1 receptor and increases insulin secretion, decreases glucagon secretion, and slows gastric emptying to improve glycemic control. Exenatide was given FDA approval on April 28, 2005. It is available as immediate- and extended-release formulations. Bydureon, the brand name product of extended-release exenatide in an injectable suspension, was discontinued in 2021. Bydureon BCise, an auto-injector extended-release formulation, remains available.

Indication: Exenatide is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. An extended-release formulation is available which is indicated in patients ≥10 years old, while the immediate-acting formulation is approved only for adult patients.

Associated Conditions: Type 2 Diabetes Mellitus

Clinical Trials

A Phase 3 Study to Evaluate the Efficacy of JY09 Compared With Dulaglutide in Combination Therapy Diabetes Mellitus Type 2 Patients With Metformin

Phase 3

Recruiting

Conditions: Type2 Diabetes Mellitus

Interventions: Drug: Exendin-4 Fc fusion protein injection(1.2mg）
Drug: Exendin-4 Fc fusion protein injection（2.4mg）
Drug: Dulaglutide
Drug: Metformin

First Posted Date: 2024-02-14

Last Posted Date: 2024-08-22

Lead Sponsor: Beijing Dongfang Biotech Co., Ltd.

Target Recruit Count: 600

Registration Number: NCT06257966

Locations: 🇨🇳
Peking University First Hospital, Beijing, Beijing, China

A Phase 3 Study to Evaluate the Efficacy of JY09 Compared With Placebo in T2DM Patients

Phase 3

Recruiting

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Exendin-4 Fc fusion protein injection
Drug: Placebo

First Posted Date: 2024-02-12

Last Posted Date: 2024-08-20

Lead Sponsor: Beijing Dongfang Biotech Co., Ltd.

Target Recruit Count: 270

Registration Number: NCT06254014

Locations: 🇨🇳
Peking University People's Hospital, Beijing, Beijing, China

Exenatide For Reducing the Reinforcing Effects of Cocaine

Phase 1

Recruiting

Conditions: Cocaine Use Disorder

Interventions: Drug: Exenatide
Drug: Placebo

First Posted Date: 2024-02-12

Last Posted Date: 2025-02-14

Lead Sponsor: Christopher D. Verrico

Target Recruit Count: 44

Registration Number: NCT06252623

Locations: 🇺🇸
Michael E. DeBakey VA Medical Center, Houston, Texas, United States

Influence of JY09 on Pharmacokinetics of Metformin , Rosuvastatin , and Digoxin and the QT Interval Study in Overweight Chinese Subjects

Phase 1

Completed

Conditions: Overweight
Diabetes Mellitus, Type 2

Interventions: Drug: Exendin-4 Fc fusion protein (JY09) injection
Drug: Metformin Hydrochloride tablet
Drug: Rosuvastatin calcium tablets
Drug: Digoxin tablet

First Posted Date: 2024-02-08

Last Posted Date: 2024-08-21

Lead Sponsor: Beijing Dongfang Biotech Co., Ltd.

Target Recruit Count: 28

Registration Number: NCT06247748

Locations: 🇨🇳
Peking University Third Hospital drug clinical trial Institute, Beijing, Beijing, China

Pharmacogenomics of GLP1 Receptor Agonists

Phase 1

Terminated

Conditions: Type 2 Diabetes

Interventions: Drug: Exenatide Injection
Drug: Saline injection

First Posted Date: 2023-03-10

Last Posted Date: 2023-03-10

Lead Sponsor: University of Maryland, Baltimore

Target Recruit Count: 78

Registration Number: NCT05762744

Locations: 🇺🇸
Amish Research Clinic, Lancaster, Pennsylvania, United States

Assessment of Safety, Tolerability and Drug Levels of Exenatide Implant

Phase 1

Active, not recruiting

Conditions: Overweight and Obesity
Type2diabetes

Interventions: Drug: Semaglutide, 1.0 mg/mL
Combination Product: Exenatide Implant
Drug: Bydureon BCise (exenatide extended release)

First Posted Date: 2023-01-04

Last Posted Date: 2025-02-17

Lead Sponsor: Vivani Medical, Inc

Target Recruit Count: 24

Registration Number: NCT05670379

Locations: 🇦🇺
CMax, Adelaide, Australia

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

Recruiting

Conditions: Pancreatic Cancer

Interventions: Drug: Non-GLP-1 RA based glucose lowering drugs
Drug: Exenatide

First Posted Date: 2022-12-23

Last Posted Date: 2025-05-14

Lead Sponsor: AstraZeneca

Target Recruit Count: 24000

Registration Number: NCT05663515

Locations: 🇬🇧
Research Site, London, United Kingdom

Exenatide for Smoking Cessation and Prevention of Weight Gain

Phase 2

Recruiting

Conditions: Weight Gain
Smoking Cessation

Interventions: Drug: Exenatide 2 milligram (mg) Injection
Drug: Placebo
Drug: Nicotine patch
Behavioral: Smoking Cessation Counseling

First Posted Date: 2022-11-09

Last Posted Date: 2024-12-11

Lead Sponsor: The University of Texas Health Science Center, Houston

Target Recruit Count: 216

Registration Number: NCT05610800

Locations: 🇺🇸
Michael E. DeBakey VA Medical Center, Houston, Texas, United States
🇺🇸
The University of Texas Health Science Center at Houston, Houston, Texas, United States