DATABASE · 2,000+ PEER-REVIEWED CITATIONS INDEXEDCOMPOUND LIBRARY · 100+ EVIDENCE-GRADED RECORDSGRADE A EVIDENCE · 45 COMPOUNDS WITH MULTIPLE HUMAN RCTSHUMAN EVIDENCE · 97 COMPOUNDS WITH HUMAN STUDY DATAVENDOR DIRECTORY · 11 RESEARCH VENDORS TRACKEDCLINIC DIRECTORY · 10 TELEHEALTH PROVIDERS VETTEDCOA RECORDS · 7 BATCH CERTIFICATES ON FILELIVE DATABASE · UPDATED 2D AGODATABASE · 2,000+ PEER-REVIEWED CITATIONS INDEXEDCOMPOUND LIBRARY · 100+ EVIDENCE-GRADED RECORDSGRADE A EVIDENCE · 45 COMPOUNDS WITH MULTIPLE HUMAN RCTSHUMAN EVIDENCE · 97 COMPOUNDS WITH HUMAN STUDY DATAVENDOR DIRECTORY · 11 RESEARCH VENDORS TRACKEDCLINIC DIRECTORY · 10 TELEHEALTH PROVIDERS VETTEDCOA RECORDS · 7 BATCH CERTIFICATES ON FILELIVE DATABASE · UPDATED 2D AGO
Home/Compounds/Lixisenatide
GLP-1 agonistFDA approvedRx required

Lixisenatide

Also known as: Adlyxin · Lyxumia
Brands: Adlyxin · Lyxumia

Short-acting GLP-1 receptor agonist with strong postprandial glucose effect.

A
Grade A
Multiple human RCTs
Human studies26
PubMed citations29
Routesubcutaneous
Regulatory (US)FDA approved · Rx
Last verified2 days ago

Mechanism of action

Exendin-4 derivative with six additional C-terminal lysines. Once-daily dosing; strong effect on gastric emptying and postprandial glucose.

Evidence summary

26
Human studies
29
PubMed citations
25
Clinical trials
A
Evidence grade

GetGoal trial program. ELIXA was the first dedicated cardiovascular outcomes trial for a GLP-1 RA.

Dosing protocols

Educational information only. Consult a licensed provider before using any peptide.
Administration routes
subcutaneous

Side effects & safety

From the FDA label
Source
abdominal painacute kidney injuryconstipationdecreased appetitediabetic retinopathydiarrheadyspepsiagastroesophageal reflux diseaseheadachehypoglycemianauseapancreatitispruritusurticariavomiting

Terms pulled directly from the referenced source. We don't fabricate frequencies — when a label doesn't publish a percentage, we don't either.

Interactions

No documented drug interactions on file.

Regulatory status

United States
FDA approved

FDA approved for type 2 diabetes (Adlyxin). US distribution discontinued in 2023; product still approved.

Compounding
Not permitted

Not available via 503A/503B compounding pharmacies.

Regulatory data last verified 4/19/2026

Clinical trials

NCT06716424Multicentre Phase IV Single Arm Clinical Trial to Evaluate the Safety and Efficacy of a Fixed Ratio Combination of Insulin Glargine and Lixisenatide in Adult Patients With Type 2 Diabetes Who Are Sub Optimally Controlled on Oral Anti-hyperglycemic Drugs and/or Basal Insulin/GLP-1 RAActive Not Recruiting · Phase 4 · Type 2 Diabetes · n=105NCT06671587A 20-week, Multicenter, Prospective, Parallel-group Treatment, Open-label, 2-Arm, Phase 4, Randomized Study to Evaluate the Efficacy of iGlarLixi Versus Gla-100 on Glycemic Time in Range (TIR) From Continuous Glucose Monitoring (CGM) in Chinese Insulin Naïve Patients With Type 2 Diabetes (T2D) Inadequately Controlled With Oral AntidiabeticsRecruiting · Phase 4 · Type 2 Diabetes (T2D) · n=678NCT07173712Regimen Transition After Short-Term Intensive Insulin Therapy in Type 2 Diabetes Mellitus Patients With Inadequate Glycemic Control on Oral Hypoglycemic Agents: A Multicenter, Open-Label, Randomized Controlled StudyNot Yet Recruiting · Phase 4 · Type 2 Diabetes · n=324NCT07307235Efficacy and Safety of iGlarLixi Versus Standard of Care in a Real-world Adult China Population With Uncontrolled Type 2 Diabetes on Oral Agents-a Pragmatic Randomized Controlled TrialNot Yet Recruiting · Phase 4 · Type 2 Diabetes · n=1316NCT05220917Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes StudyActive Not Recruiting · Cardiovascular Events · n=781430NCT03439943Multicenter, Randomised, Placebo-controlled, Double Blinded, Parallel Arm Proof-of-concept Trial of Lixisenatide in Patients With Early Parkinson's DiseaseCompleted · Phase 2 · Parkinson Disease · n=156NCT05413369A Randomized, 24 Weeks, Active-controlled, Open-label, 2-arm Multicenter Study Comparing the Efficacy and Safety of iGlarLixi to IDegAsp in Chinese Type 2 Diabetes Mellitus Participants Insufficiently Controlled With Oral Antidiabetic Drug(s)Completed · Phase 3 · Type 2 Diabetes Mellitus · n=582NCT07188545Using Secondary Data to Evaluate Sex-based Heterogeneity of GLP-1 Agonists and SGLT2 Inhibitors on Cardiovascular-Kidney-Metabolic Health (CKMH) Outcomes in Real-world Settings (DASH-CKMH)Active Not Recruiting · Cardiovascular Kidney Metabolic Syndrome · n=23280000NCT07117240Efficacy of Treatment Strategies for Steroid-induced Diabetes - a Comparison of GLP-1 Receptor Agonist Plus Basal Insulin With Intensive Insulin TherapyEnrolling By Invitation · Phase 4 · Steroid-Induced Diabetes · n=100NCT05114590A 16-week, Multicenter, Prospective, Open-label, Single-arm, Phase 4 Study to Evaluate the Effect of Soliqua™ 100/33 on the Percentage of Time in Range (TIR) From Continuous Glucose Monitoring (CGM) in Insulin-naïve Patients With Very Uncontrolled Type 2 Diabetes MellitusCompleted · Phase 4 · Type 2 Diabetes Mellitus · n=124NCT03492580Comparison of Canagliflozin vs. Alternative Antihyperglycemic Treatments on Risk of Heart Failure Hospitalization and Amputation for Patients With Type 2 Diabetes Mellitus and the Subpopulation With Established Cardiovascular DiseaseCompleted · Diabetes Mellitus, Type 2 · n=714582NCT02049034The Effect of Lixisenatide on Postprandial Lipid and Glucose Metabolism in Patients with Type 2 DiabetesCompleted · Phase 4 · Type 2 Diabetes · n=8

Showing 12 of 25 indexed studies. View all on ClinicalTrials.gov →

Citations

PMID 40172827West J, Li M et al. · Are Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists Central Nervous System (CNS) Penetrant: A Narrative Review.Neurology and therapy (2025)HumanPMID 40344943Zhou ZD, Yi L et al. · Glucagon-like peptide-1 receptor agonists in neurodegenerative diseases: Promises and challenges.Pharmacological research (2025)HumanPMID 40145958Sun S, Huang L et al. · Neuroprotective effects of lixisenatide against propagation of α-synuclein pathology in Parkinson's disease.Neural regeneration research (2025)PMID 40042613Himmerich H · [Glucagon-like peptide-1 receptor agonists: a new pharmacological treatment option for psychiatric illnesses?].Der Nervenarzt (2025)HumanPMID 39425661Luo ZY, Li X et al. · Ocular adverse events associated with GLP-1 receptor agonists: a real-world study based on the FAERS database and network pharmacology.Expert opinion on drug safety (2025)HumanPMID 38612620Kalinderi K, Papaliagkas V et al. · GLP-1 Receptor Agonists: A New Treatment in Parkinson's Disease.International journal of molecular sciences (2024)HumanPMID 38677445Hölscher C · Glucagon-like peptide-1 class drugs show clear protective effects in Parkinson's and Alzheimer's disease clinical trials: A revolution in the making?Neuropharmacology (2024)HumanPMID 38598572Meissner WG, Remy P et al. · Trial of Lixisenatide in Early Parkinson's Disease.The New England journal of medicine (2024)HumanPMID 38746639Liang Y, Doré V et al. · Clinical Evidence for GLP-1 Receptor Agonists in Alzheimer's Disease: A Systematic Review.Journal of Alzheimer's disease reports (2024)PMID 37821008Watanabe JH, Kwon J et al. · Trends in glucagon-like peptide 1 receptor agonist use, 2014 to 2022.Journal of the American Pharmacists Association : JAPhA (2024)HumanPMID 38288136Alharbi SH · Anti-inflammatory role of glucagon-like peptide 1 receptor agonists and its clinical implications.Therapeutic advances in endocrinology and metabolism (2024)HumanPMID 38795152Salazar CE, Patil MK et al. · Rare cutaneous adverse reactions associated with GLP-1 agonists: a review of the published literature.Archives of dermatological research (2024)HumanPMID 37423944Oezer K, Kolibabka M et al. · The effect of GLP-1 receptor agonist lixisenatide on experimental diabetic retinopathy.Acta diabetologica (2023)HumanPMID 37828829Tsukamoto S, Tanaka S et al. · Effect of tirzepatide on glycaemic control and weight loss compared with other glucagon-like peptide-1 receptor agonists in Japanese patients with type 2 diabetes mellitus.Diabetes, obesity & metabolism (2023)HumanPMID 36691309Amaro A, Sugimoto D et al. · Efficacy and safety of semaglutide for weight management: evidence from the STEP program.Postgraduate medicine (2023)HumanPMID 33767808Trujillo JM, Nuffer W et al. · GLP-1 receptor agonists: an updated review of head-to-head clinical studies.Therapeutic advances in endocrinology and metabolism (2021)PMID 33068776Nauck MA, Quast DR et al. · GLP-1 receptor agonists in the treatment of type 2 diabetes - state-of-the-art.Molecular metabolism (2021)HumanPMID 30270723Yang T, Cutshall BT et al. · Combined Insulin and GLP-1 Receptor Agonists: Simplifying Treatment or Adding Obstacles?Journal of pharmacy practice (2020)HumanPMID 30610613Perreault L, Rodbard H et al. · Optimizing Fixed-Ratio Combination Therapy in Type 2 Diabetes.Advances in therapy (2020)HumanPMID 32755557Salameh TS, Rhea EM et al. · Brain uptake pharmacokinetics of incretin receptor agonists showing promise as Alzheimer's and Parkinson's disease therapeutics.Biochemical pharmacology (2020)Human

Showing 20 of 29 papers. View all on PubMed →