Lixisenatide

Summary

Lixisenatide (CHEMBL2108336) is an approved protein (ATC A10BJ03) targeting GLP1R; indicated across 5 conditions including diabetes mellitus and type 2 diabetes mellitus.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Protein
• ATC class: A10BJ03
• Targets: 1 (GLP1R)
• Indications: 5 conditions
• Clinical trials: 56

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL2108336
Name	Lixisenatide
Type	Protein
Max phase	4
ATC	A10BJ03

Also known as: AVE 010, AVE-0010, AVE-010, AVE0010, Lixisenatida, Lixisenatide, Lixisenatide component of soliqua 100/33, Lyxumia, ZP 10, ZP-10, LIXISENATIDE

Targets

Targets

Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).

Gene	Target	Action	pAffinity	Cancer dependency	UniProt
GLP1R	GLP-1 receptor	Agonist	8.88	0.2%	P43220

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

Aggregated over 1 target gene(s): GLP1R.

Top Reactome pathways

3 total, by targets touching each:

Pathway	Targets	Genes
Glucagon-like Peptide-1 (GLP1) regulates insulin secretion	1	GLP1R
G alpha (s) signalling events	1	GLP1R
Glucagon-type ligand receptors	1	GLP1R

Dominant GO biological processes

GO term	Targets
cell surface receptor signaling pathway	1
adenylate cyclase-activating G protein-coupled receptor signaling pathway	1
activation of adenylate cyclase activity	1
positive regulation of cytosolic calcium ion concentration	1
learning or memory	1
regulation of heart contraction	1
post-translational protein targeting to membrane, translocation	1
negative regulation of blood pressure	1
positive regulation of blood pressure	1
hormone secretion	1
response to psychosocial stress	1
signal transduction	1
G protein-coupled receptor signaling pathway	1
regulation of biological quality	1
cellular response to glucagon stimulus	1

Indications & clinical

Indications

5 indications (2 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
diabetes mellitus	4	MONDO:0005015	EFO:0000400
type 2 diabetes mellitus	4	MONDO:0005148	MONDO:0005148
acute coronary syndrome	3	MONDO:0005542	EFO:0005672
Parkinson disease	2	MONDO:0005180	MONDO:0005180
type 1 diabetes mellitus	1	MONDO:0005147	MONDO:0005147

Clinical trials

Total trials: 56.

Phase distribution

Phase	Trials
PHASE3	31
PHASE4	11
PHASE1	6
PHASE2	5
Not specified	2
PHASE1/PHASE2	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT07117240	PHASE4	ENROLLING_BY_INVITATION	Evaluation of the Efficacy and Safety of GLP-1 Receptor Agonist Therapy In Steroid-Induced Diabetes
NCT01973231	PHASE4	COMPLETED	Efficacy and Safety of Liraglutide Versus Lixisenatide as add-on to Metformin in Subjects With Type 2 Diabetes
NCT02020629	PHASE4	COMPLETED	Study on Lixisenatide and Counterregulation to Hypoglycemia
NCT02049034	PHASE4	COMPLETED	Lixisenatide-The Effects on Glucose and Lipid Metabolism in Type 2 Diabetes
NCT02200991	PHASE4	COMPLETED	Effect of Lixisenatide on Postprandial Plasma Glucose Compared to Sitagliptin in Combination With Insulin Glargine
NCT02276196	PHASE4	COMPLETED	Effect of LIXIsenatide on the Renal System
NCT02767596	PHASE4	TERMINATED	Evaluation of Lixisenatide Efficacy in Diabetes Mellitus Type 2 With Failure of Other GLP-1 Analog
NCT02941367	PHASE4	COMPLETED	Safety Assessment of Lyxumia (Lixisenatide) and Sulfonylurea as Add-on Treatment to Basal Insulin in Uncontrolled Patients With Type 2 Diabetes Mellitus Who Elect to Fast During Ramadan
NCT03819790	PHASE4	COMPLETED	The Effect of Soliqua on Glucose Variability in Type 2 Patients Among South Asians
NCT05114590	PHASE4	COMPLETED	Effect of Soliqua 100/33 on Time in Range From Continuous Glucose Monitoring in Insulin-naive Patients With Very Uncontrolled Type 2 Diabetes Mellitus
NCT05804513	PHASE4	UNKNOWN	The Effect of Lixisenatide on the Effect of Pituitary Hormones
NCT00688701	PHASE3	COMPLETED	GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation in Monotherapy
NCT00707031	PHASE3	COMPLETED	GLP-1 Receptor Agonist Lixisenatide Versus Exenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin
NCT00712673	PHASE3	COMPLETED	GLP-1 Receptor Agonist Lixisenatide (Morning or Evening) in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin
NCT00713830	PHASE3	COMPLETED	GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Sulfonylurea
NCT00715624	PHASE3	COMPLETED	GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Basal Insulin
NCT00763451	PHASE3	COMPLETED	GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin
NCT00763815	PHASE3	COMPLETED	GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Pioglitazone
NCT00866658	PHASE3	COMPLETED	GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Basal Insulin +/- Sulfonylurea (GETGOAL-L-ASIA)
NCT00905255	PHASE3	COMPLETED	GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation in Monotherapy (GETGOAL-MONO Japan LTS)
NCT00975286	PHASE3	COMPLETED	24-week Treatment With Lixisenatide in Type 2 Diabetes Insufficiently Controlled With Metformin and Insulin Glargine
NCT00976937	PHASE3	COMPLETED	24-week Study Comparing Lixisenatide to Sitagliptin as add-on to Metformin in Obese Type 2 Diabetic Patients Younger Than 50 Years
NCT01147250	PHASE3	COMPLETED	Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With AVE0010 (Lixisenatide)
NCT01169779	PHASE3	COMPLETED	Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled by Metformin
NCT01517412	PHASE3	COMPLETED	Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin
NCT01632163	PHASE3	COMPLETED	Assessment of the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin +/- Metformin
NCT01768559	PHASE3	COMPLETED	Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients
NCT01798706	PHASE3	COMPLETED	Efficacy and Safety of Lixisenatide Versus Placebo on Top of Basal Insulin and/or Oral Antidiabetic Treatment in Older Type 2 Diabetic Patients
NCT01940965	PHASE3	COMPLETED	Safety and Tolerability of Lixisenatide in Combination With Oral Anti-Diabetic Treatment in Patients With Type 2 Diabetes
NCT01960179	PHASE3	COMPLETED	Safety And Tolerability Of Lixisenatide In Monotherapy In Patients With Type 2 Diabetes
NCT02058147	PHASE3	COMPLETED	Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination Compared to Insulin Glargine Alone and Lixisenatide Alone on Top of Metformin in Patients With T2DM
NCT02058160	PHASE3	COMPLETED	Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes
NCT02168491	PHASE3	COMPLETED	Feasibility of Once/Daily Administered GLP/1 Receptoragonist (Lixisenatide) in Combination With Basal Insulin
NCT02749890	PHASE3	COMPLETED	Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (LixiLan) to Lixisenatide on Top of Oral Anti-diabetic Drugs (OADs) With Type 2 Diabetes in Japan
NCT02752412	PHASE3	COMPLETED	Efficacy and Safety of LixiLan Versus Insulin Glargine Alone Both With Metformin in Japanese With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Drugs
NCT02752828	PHASE3	COMPLETED	Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (LixiLan) to Insulin Glargine Alone on Top of Oral Anti-diabetic Drugs (OADs) With Type 2 Diabetes in Japan
NCT03434119	PHASE3	TERMINATED	Efficacy and Safety of Soliqua Versus Lantus in Ethnically/Racially Diverse Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Agents
NCT03529123	PHASE3	COMPLETED	Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes (LixiLan-India)
NCT03767543	PHASE3	COMPLETED	Study Comparing the Efficacy and Safety of Insulin Glargine (Basal Insulin)/Lixisenatide (GLP-1 Receptor Agonist) Combination (Soliqua™) in Patients With Type 2 Diabetes Mellitus (T2DM)
NCT03798054	PHASE3	COMPLETED	Evaluation of Insulin Glargine/Lixisenatide Fixed Ratio Combination in Patients With Type 2 Diabetes Insufficiently Controlled With Oral Antidiabetic Drug(s)

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

Molecules sharing ≥1 of this drug’s curated primary targets, merged from two biobtree sources and ranked by shared-target count, then clinical phase: ChEMBL clinical-stage candidates (development phase ≥2) and PubChem drug-class bioactivity (approved / known drugs acting on the target). Deduplicated by drug name; the drug’s own salt forms are excluded. Note: for a drug with few primary targets a shared-target match can reflect off-target / promiscuous binding rather than the same therapeutic mechanism — the phase ordering surfaces bona-fide therapeutics first.

18 molecules share ≥1 primary target. Top 18 by shared-target count:

Molecule	Source	Status	Shared targets
LIRAGLUTIDE	ChEMBL + PubChem	Phase 4 (approved)	GLP1R
DIHYDROERGOTAMINE	ChEMBL	Phase 4 (approved)	GLP1R
ELAGOLIX	ChEMBL	Phase 4 (approved)	GLP1R
EXENATIDE	ChEMBL	Phase 4 (approved)	GLP1R
GLUCAGON	ChEMBL	Phase 4 (approved)	GLP1R
LOPERAMIDE	ChEMBL	Phase 4 (approved)	GLP1R
PERPHENAZINE	ChEMBL	Phase 4 (approved)	GLP1R
SECRETIN	ChEMBL	Phase 4 (approved)	GLP1R
SEMAGLUTIDE	ChEMBL	Phase 4 (approved)	GLP1R
TIRZEPATIDE	ChEMBL	Phase 4 (approved)	GLP1R
TOLVAPTAN	ChEMBL	Phase 4 (approved)	GLP1R
ORFORGLIPRON	ChEMBL	Phase 3	GLP1R
COTADUTIDE	ChEMBL	Phase 2	GLP1R
DANUGLIPRON	ChEMBL	Phase 2	GLP1R
DEVAZEPIDE	ChEMBL	Phase 2	GLP1R
GLP-1	ChEMBL	Phase 2	GLP1R
LOTIGLIPRON	ChEMBL	Phase 2	GLP1R
PF-06291874	ChEMBL	Phase 2	GLP1R