Drug

Lixisenatide

Regulatory activity · EMA

ClassGlucagon-like peptide 1 receptor agonistEmerging researchLate-stage development

Also known as Adlyxin, DesPro38Exendin-4(1-39)-Lys6-NH2, Soliqua, des-38-proline-exendine-4 (Heloderma suspectum)-(1-39)-peptidylpenta-L-lysyl-L-lysinamide+2 more

Adlyxin, DesPro38Exendin-4(1-39)-Lys6-NH2, Soliqua, des-38-proline-exendine-4 (Heloderma suspectum)-(1-39)-peptidylpenta-L-lysyl-L-lysinamide, Lixisenatida, Lixisénatide.

RxNorm1440051 ChEMBLCHEMBL2108336 ATCA10BJ03UNII74O62BB01U

Research papers

Glucagon-like peptide 1 receptor

Primary target

Regulatory events

Latest activity

beta

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

Market withdrawal: Lyxumia (EMA)

Regulatory2025-12-18EMA

Multicenter, Randomised, Placebo-controlled, Double Blinded, Parallel Arm Proof-of-concept Trial of Lixisenatide in Patients With Early Parkinson's Disease

Clinical trial2021-04-15Completed · ClinicalTrials.gov

A Randomized, 24 Week, Active-controlled, Open-label, 3-arm, Parallel-group Multicenter Study Comparing the Efficacy and Safety of iGlarLixi to Insulin Glargine and Lixisenatide in Type 2 Diabetes Mellitus Patients Insufficiently Controlled With Oral Antidiabetic Drug(s)

Clinical trial2021-03-01Completed · ClinicalTrials.gov

Randomized, Double-blind, Placebo-controlled, Dose Escalation, Study on Safety, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Pediatric Patients With Type 2 Diabetes Mellitus Not Adequately Controlled With Metformin and/or Basal Insulin

Clinical trial2020-01-27Completed · ClinicalTrials.gov

Effects of Victoza® (Liraglutide) Versus Lyxumia® (Lixisenatide) on Gastroesophageal Reflux, Gastric Emptying and Gastric Acid Secretion

Clinical trial2018-07-23Terminated · ClinicalTrials.gov

A Randomized, Active-controlled, Open Label, 2-treatment Arm, and Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/Lixisenatide Combination to Lixisenatide on Top of OADs in Japanese Patients With Type 2 DM With an Extension Period

Clinical trial2018-05-01Completed · ClinicalTrials.gov

International, Randomized, Open Label Study to Compare the Safety and Efficacy of Lixisenatide vs. Sulfonylurea on Top of Basal Insulin Treatment in Type 2 Diabetes Mellitus Subjects Who Elect to Fast During Ramadan

Clinical trial2017-08-04Completed · ClinicalTrials.gov

A Randomized, 30 Week, Active-controlled, Open-label, 3-treatment Arm, Parallel-group Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination to Insulin Glargine Alone and to Lixisenatide Alone on Top of Metformin in Patients With Type 2 Diabetes Mellitus (T2DM)

Clinical trial2017-05-09Results posted · ClinicalTrials.gov

Feasibility of Once-daily Administered GLP-1 Receptoragonist (Lixisenatide) in Combination With Basal Insulin in Patients With Type-2 Diabetes Mellitus Not Achieving Therapeutic Targets With Premixed Insulin

Clinical trial2017-05-09Results posted · ClinicalTrials.gov

A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter, 24 Week Study Assessing the Safety and Efficacy of Lixisenatide in Older Patients With Type 2 Diabetes Inadequately Controlled on Their Current Diabetes Treatment Regimen

Clinical trial2017-04-18Results posted · ClinicalTrials.gov

A Pilot Single-Arm Open-Label Study to Evaluate the Efficacy of Treatment With Lixisenatide in Diabetes Mellitus Type 2 Patients With Failure of Other GLP-1 Analog

Clinical trial2017-02-21Terminated · ClinicalTrials.gov

Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome.

Research2015-12-01The New England journal of medicine

Profile

Identifiers & mechanism

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

Canonical name

Lixisenatide

Aliases & brands

AdlyxinDesPro38Exendin-4(1-39)-Lys6-NH2Soliquades-38-proline-exendine-4 (Heloderma suspectum)-(1-39)-peptidylpenta-L-lysyl-L-lysinamideLixisenatidaLixisénatide

RxNorm CUI

1440051

ChEMBL ID

CHEMBL2108336

ATC codes

A10BJ03

UNII

74O62BB01U

Primary mechanism

Glucagon-like peptide 1 receptor agonist

Regulatory jurisdictions

ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Glucagon-like peptide 1 receptor

GLP1R · P43220

AGONISTGlucagon-like peptide 1 receptor agonist

Regulatory timeline

1 event

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.

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2025-12-18Market withdrawalMarket

Market withdrawal: Lyxumia (EMA)

Indication: Lyxumia is indicated for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with oral glucose lowering medicinal products and/or… Show full indication

Lyxumia is indicated for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with oral glucose lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control.

Evidence ↗

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