BYETTA (exenatide synthetic)
BYETTA (exenatide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to improve glycemic control in adults with type 2 diabetes mellitus. It is used as an adjunct to diet and exercise in this patient population. The medication is not recommended for coadministration with other products containing exenatide. Its therapeutic role is to reduce both fasting and postprandial glucose concentrations.
How BYETTA Works
BYETTA functions by binding to and activating the human GLP-1 receptor, which enhances glucose-dependent insulin synthesis and secretion from pancreatic beta cells. The drug also suppresses inappropriately elevated glucagon secretion and slows the rate of gastric emptying. These combined actions lead to a reduction in blood glucose levels. These effects are mediated through intracellular signaling pathways involving cyclic AMP.
Development Insights
Details
- Status
- Discontinued
- First Approved
- 2005-04-28
- Routes
- SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
BYETTA Approval History
What BYETTA Treats
1 indicationsBYETTA is approved for 1 conditions since its original approval in 2005. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Type 2 diabetes mellitus
BYETTA Target & Pathway
ProTarget
A hormone released after eating that stimulates insulin secretion, suppresses glucagon, slows gastric emptying, and promotes satiety. GLP-1 receptor agonists mimic these effects, improving blood sugar control and promoting weight loss in diabetes and obesity.
BYETTA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in BYETTA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications BYETTA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to BYETTA
3 of 6FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
87 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02860923 CRANIOEXE | CHUBX 2012/17 2013-004755-21 | Ph 3 | completed | Efficacy and Safety of Exenatide in the Treatment of Hypothalamic Obesity After Craniopharyngioma Therapy |
| NCT05482789 | STUDY22070080 | Ph 4 | recruiting | Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes |
| NCT06252623 | H-52307 | Ph 1 | withdrawn | Exenatide For Reducing the Reinforcing Effects of Cocaine |
| NCT02586831 DIPIT | 20150856 | Ph 1, Ph 2 | withdrawn | Diabetes Islet Preservation Immune Treatment |
| NCT01524705 FLAT-SUGAR results posted | 42178 | Ph 4 | completed | FLuctuATion Reduction With inSULin and Glp-1 Added togetheR (FLAT-SUGAR) |
| NCT03331289 results posted | HSC20170582H R01DK107680 | Ph 4 | completed | Can Exenatide Prevent Increase in EGP in Response to Dapagliflozin-induced Increase in Glucosuria |
| NCT02981069 results posted | HSC20160597H | Ph 4 | completed | Effect of Chronic Exenatide Therapy on Beta Cell Function and Insulin Sensitivity in T2DM |
| NCT02302976 | 1409014655 1R21DA040914-01A1 | Ph 1 | completed | GLP-1 Agonism for Blocking Cocaine Euphoria and Self-Administration |
| NCT03456687 | IRB201703187 - N R01NS052318, OCR17539 | Ph 1 | completed | Effects of Exenatide on Motor Function and the Brain |
| NCT02794402 Combat-JUDO | 2015-001628-45 | Ph 2 | completed | Double-blinded, 6 Months Study With Bydureon® or Placebo in Adolescents With Obesity to Explore Changes in BMI |
| NCT02664441 ECHO results posted | R01DK104936-01A1 | Ph 3 | completed | Energy Balance & Weight Loss in Craniopharyngioma-related or Other Hypothalamic Tumors in Hypothalamic Obesity |
| NCT03007329 EXENDA | ESR-15-10882 | Ph 4 | completed | Effects of Combined Dapagliflozin and Exenatide Versus Dapagliflozin and Placebo on Ectopic Lipids in Patients With Uncontrolled Type 2 Diabetes Mellitus. |
| NCT04969627 | 2020PS624K | Ph 4 | completed | Effects of GLP-1 Analogue Combined With Metformin and Metformin on Gonadal and Metabolic Profiles in Chinese Overweight/Obese PCOS Patients With Hyperandrogenemia. |
| NCT02787551 LixiLan-G results posted | EFC13794 2014-004850-32, U1111-1168-4639 | Ph 3 | completed | Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) Versus GLP-1 Receptor Agonist in Patients With Type 2 Diabetes, With a FRC Extension Period |
| NCT03645408 results posted | H-38015 R21AA027332-01 | Ph 1 | terminated | The Effects of Exenatide, a GLP-1 Agonist, on Alcohol Self-Administration in Heavy Drinkers |
| NCT02417142 results posted | 13T-005 | Ph 4 | completed | Exenatide Weekly Injections as an Adjunctive Treatment in Patients With Schizophrenia |
| NCT01269034 results posted | 2010-435 3R01DK077166-05S1 | Ph 4 | completed | New Onset Type 1 Diabetes: Role of Exenatide |
| NCT01590433 results posted | 2011P000310 | Ph 4 | completed | Weight Loss With Exenatide Treatment |
| NCT03361098 DECREASE | DC2017DECREASE01 | Ph 4 | completed | DECREASE: Dapagliflozin Plus Exenatide on Central REgulation of Appetite in diabeteS typE 2 |
| NCT02685852 | 1503M65841 | Ph 1 | completed | Evaluating Exenatide for the Treatment of Postprandial Hyperinsulinemic Hypoglycemia |
| NCT02432976 ExeQOL | 09/503 | Ph 2, Ph 3 | completed | Impact of Perioperative Exenatide Infusion on Quality of Life in Cardiac Surgery Patients |
| NCT02975297 results posted | HSC-MS-17-0802 CCTS Research Scholar Award | Ph 1, Ph 2 | completed | Exenatide Once Weekly for Smoking Cessation |
| NCT00658021 results posted | D5550C00002 H8O-MC-GWBQ | Ph 3 | completed | Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes |
| NCT02404376 COMBAT-MI | COMBAT-MI | Ph 3 | completed | COMBinAtion Therapy in Myocardial Infarction: The COMBAT-MI Trial |
| NCT02793154 results posted | 204879 | Ph 4 | terminated | An Exploratory Study on the Effects of Repeat Doses of Albiglutide Compared to Exenatide on Gastric Myoelectrical Activity and Gastric Emptying in Type 2 Diabetes Mellitus Subjects |
| NCT00799435 results posted | 613 1K01HL092585, 1K01HL092585-01 | Ph 4 | terminated | Evaluating the Use of Exenatide in People With Type 2 Diabetes and Diastolic Heart Failure |
| NCT02690883 | ESR-14-10425 | Ph 4 | completed | Effect of Exenatide on 24h-UAER in Patients With Diabetic Nephropathy |
| NCT01061775 results posted | 0903-028 | Ph 1, Ph 2 | completed | Effects of Exenatide on Hypothalamic Obesity |
| NCT03352869 | [2017]077 | Ph 4 | completed | Research of Exenatide for Overweight/Obese PCOS Patients With IGR |
| NCT02303730 | ESR-14-10096 | Ph 4 | completed | Exenatide Compared With Insulin Glargine to Change Liver Fat Content in Type 2 Diabetes |
| NCT03017352 MAG1C | Eudract-nr.: 2016-001365-92 | Ph 2 | completed | Meal-time Administration of Exenatide for Glycaemic Control in Type 1 Diabetic Cases |
| NCT02455076 results posted | IRB00080596 | Ph 4 | completed | Exenatide Inpatient Trial: A Randomized Controlled Pilot Trial on the Safety and Efficacy of Exenatide (Byetta®) Therapy for the Inpatient Management of Patients With Type 2 Diabetes |
| NCT01885208 SUSTAIN™ 3 results posted | NN9535-3624 2012-004826-92, U1111-1135-8647 | Ph 3 | completed | Efficacy and Safety of Semaglutide Once-weekly Versus Exenatide ER 2.0 mg Once-weekly as add-on to 1-2 Oral Antidiabetic Drugs (OADs) in Subjects With Type 2 Diabetes |
| NCT02229383 results posted | D5553C00002 2014-003502-33 | Ph 3 | completed | Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus |
| NCT01676116 DUAL™ III results posted | NN9068-3851 2012-000209-63, U1111-1127-1321 | Ph 3 | completed | The Efficacy of Insulin Degludec/Liraglutide in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and OAD Therapy |
| NCT02449603 | ESR-14-10319 | Ph 4 | completed | Comparison of Exenatide vs. Biphasic Insulin Aspart 30 on Glucose Variability in Type 2 Diabetes |
| NCT02058940 results posted | 13-1391 Astra Zeneca Pharmaceuticals, Medtronic MiniMed, Inc | Ph 4 | completed | Intravenous Exenatide in Patients With Acute Brain Injury |
| NCT02104739 results posted | HSC-MS-13-0791 | Ph 4 | completed | Effects of Antidiabetic Medications on the Postprandial State in Prediabetes |
| NCT00845507 results posted | Exenatide | Ph 4 | completed | Exenatide for the Treatment of Weight Gain Associated With Olanzapine in Obese Adults |
| NCT01269047 results posted | 2010 -436 R01DK077166 | Ph 4 | completed | Use of Exenatide and Pramlintide to Decrease Post-prandial Hyperglycemia |
| NCT02735031 | ESR-15-10862 | Ph 2, Ph 3 | completed | Exenatide and Impaired Hypoglycaemic Awareness in Type 1 Diabetes |
| NCT02092597 SAFEGUARD | HEALTH-282521-CUNI | Ph 4 | completed | Safety Evaluation of Adverse Reactions in Diabetes |
| NCT01588418 results posted | 233-GAS-08 | Ph 4 | completed | Acute Effect of Exenatide on Brain Glucose Metabolism |
| NCT01501084 | 11-002316 | Ph 1 | completed | Effects of the GLP-1 Exenatide on Satiety in Lean and Obese Women |
| NCT01857895 | 200016 | Ph 1 | completed | Feasibility Study of Exenatide by Continuous Subcutaneous Infusion |
| NCT01969149 ExSTRESS | API/2009/10 | Ph 2, Ph 3 | completed | Exenatide for Stress Hyperglycemia |
| NCT01573806 PEPS | PEPS-SCH-001 | Ph 1, Ph 2 | withdrawn | Pharmacology of Exenatide in Pediatric Sepsis |
| NCT01381926 CMBD results posted | F100929001 | Ph 4 | terminated | Changes in Bone Turnover With Exposure to a GLP-1 Receptor Agonist |
| NCT01484873 results posted | 111185 | Ph 2 | completed | Weight Loss Study for Patients With Obesity Due to Craniopharyngioma or Other Brain Tumor |
| NCT02325960 | ISSEXEN0034 | Ph 4 | completed | A Comparison of Exenatide and Insulin Glargine |
Showing 50 of 87 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BYETTA FDA Label Details
Indications & Usage
FDA Label (PDF)BYETTA is indicated for the treatment of Type 2 diabetes mellitus.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment