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Drug

Exenatide

Approved · EMA
ClassGlucagon-like peptide 1 receptor agonistActively researchedLate-stage developmentRising momentum
Also known as Bydureon, Byetta, Exendin 4, Exendin-4+3 more

Bydureon, Byetta, Exendin 4, Exendin-4, Exenatida, Exenatide synthetic, Synthetic exendin-4.

36
Research papers
3
Active clinical trials
Glucagon-like peptide 1 receptor
Primary target
3
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

Clinical trial2025-12-31Primary completion · ClinicalTrials.gov

Brain Systems and Behaviors Underlying Response to Obesity Treatment in Children

Clinical trial2025-08-21Primary completion · ClinicalTrials.gov

Approval: Bydureon (EMA)

Regulatory2011-06-17EMA

Approval: Byetta (EMA)

Regulatory2006-11-20EMA

Evidence confidence

1 claim

How strongly the incorporated evidence supports specific clinical claims about this treatment. A confidence figure is a current summary of evidence strength, not a permanent verdict.

Improves HbA1c in type 2 diabetes
64%Moderate confidence
Uncertainty ±5%Evidence coverage: PartialUpdated 9 April 2025

Evidence is mixed23 supporting evidence families · 5 well-powered no-effect results

Confidence is moderated by well-powered no-effect evidence and limited publication incorporation, despite broad trial support.

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Exenatide
Aliases & brands
BydureonByettaExendin 4Exendin-4ExenatidaExenatide syntheticSynthetic exendin-4
RxNorm CUI
60548
ChEMBL ID
CHEMBL414357
ATC codes
A10BJ01
UNII
9P1872D4OL
Primary mechanism
Glucagon-like peptide 1 receptor agonist
Regulatory jurisdictions
emamhra

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

AGONISTGlucagon-like peptide 1 receptor agonist

Regulatory timeline

3 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2006-11-20
Latest approval
2011-06-17
Authorities
EMA · MHRA
Total events
3
emaEuropean Medicines Agency· 2 events
2011-06-17Approval
Approval: Bydureon (EMA)
Indication: Bydureon is indicated in adults 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products whenShow full indication

Bydureon is indicated in adults 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products when the therapy in use, together with diet and exercise, does not provide adequate glycaemic control (see section 4.4, 4.5 and 5.1 for available data on different combinations). Bydureon is indicated for treatment of type 2 diabetes mellitus in combination with: Metformin Sulphonylurea Thiazolidinedione Metformin and sulphonylurea Metformin and thiazolidinedione in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies.

Evidence ↗
2006-11-20Approval
Approval: Byetta (EMA)
Indication: Byetta is indicated for treatment of type-2 diabetes mellitus in combination with: metformin; sulphonylureas; thiazolidinediones; metformin and a sulphonylurea; metformin and aShow full indication

Byetta is indicated for treatment of type-2 diabetes mellitus in combination with: metformin; sulphonylureas; thiazolidinediones; metformin and a sulphonylurea; metformin and a thiazolidinedione; in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies. Byetta is also indicated as adjunctive therapy to basal insulin with or without metformin and / or pioglitazone in adults who have not achieved adequate glycaemic control with these agents.

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2014-12-11Safety communicationSafety
Drug Safety Update: Exenatide (Byetta ▼): risk of severe pancreatitis and renal failure
Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

190 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
190
registered trials across all phases
LATEST COMPLETION 2024
3
Active studies
1
Recruiting
141
Late-stage (III+)
147
Completed
40
Discontinued
PHASE DISTRIBUTIONn = 190
Early Phase 11Phase 118Phase 1 / 25Phase 225Phase 2 / 37Phase 348Phase 466Phase N / A20

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

Research activity

36 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
19932025
Most influential
Recent papers
Major research themes8
Glucagon-Like Peptide-1 Receptor Agonists11Hypoglycemic Agents5Glucagon-Like Peptide 14Diabetes Mellitus, Type 23Exenatide3Receptors, Glucagon2Venoms2Alzheimer Disease1
Journals, researchers & institutions
Top journals
  • Diabetes4
  • Diabetes care2
  • Diabetes, obesity & metabolism2
  • Hepatology (Baltimore, Md.)2
  • Journal of diabetes investigation2
  • Acta neuropathologica communications1
Leading researchers
  • Trautmann M3
  • Cersosimo E2
  • Ciociaro D2
  • Daniele G2
  • DeFronzo R2
  • Drucker DJ2
  • Fox P2
  • Gastaldelli A2
Leading institutions
free-text, unnormalised
  • Graduate School of Medicine2
  • Institute of Clinical Physiology2
  • Lilly Research Laboratories Japan2
  • National Institute on Aging2
  • Beth Israel Deaconess Medical Center1
  • Brain and Cognition Discovery Foundation1

Related diseases

5 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Related drugs

8 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Acts on the same molecular target as Exenatide, with 11 overlapping disease areas.

11 shared diseasesShared target8 shared papers

Acts on the same molecular target as Exenatide, with 12 overlapping disease areas.

12 shared diseasesShared target3 shared papers

Acts on the same molecular target as Exenatide, with 8 overlapping disease areas.

Shared target8 shared diseases4 shared papers

Studied across 14 of the same disease areas as Exenatide in the shared literature.

14 shared diseases5 shared papers

Acts on the same molecular target as Exenatide, with an overlapping disease area.

Shared target1 shared disease1 shared paper

Studied across 9 of the same disease areas as Exenatide in the shared literature.

9 shared diseases2 shared papers

Studied across 8 of the same disease areas as Exenatide in the shared literature.

8 shared diseases1 shared paper

Studied across 6 of the same disease areas as Exenatide in the shared literature.

6 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.