Overview
Lixisenatide is a glucagon-like peptide-1 (GLP-1) receptor agonist used in the treatment of type II diabetes mellitus (T2DM). It is sold by Sanofi-Aventis under the brand name Adlyxin in the US and Lyxumia in the EU. Adlyxin recieved FDA approval July 28, 2016.
Indication
Lixisenatide is indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type II diabetes mellitus. It is also available in combination with insulin glargine for the same indication.
Associated Conditions
- Type 2 Diabetes Mellitus
Research Report
Lixisenatide (DB09265): A Comprehensive Pharmacological and Clinical Monograph
Executive Summary
[Lixisenatide is a synthetic, short-acting glucagon-like peptide-1 (GLP-1) receptor agonist, administered once daily via subcutaneous injection for the management of type 2 diabetes mellitus (T2DM). Structurally derived from exendin-4, its unique molecular design, featuring six C-terminal lysine residues, confers resistance to dipeptidyl peptidase-4 (DPP-4) degradation while maintaining a short plasma half-life of approximately 3 hours. This pharmacokinetic profile defines its pharmacodynamic character as a "prandial" agent, exerting its primary therapeutic effect through a potent, dose-dependent slowing of gastric emptying. This mechanism leads to a pronounced reduction in postprandial glucose (PPG) excursions, a key contributor to overall glycemic control.]
[The extensive GetGoal clinical trial program established the efficacy and safety of lixisenatide across the spectrum of T2DM care—as monotherapy, as an add-on to oral antidiabetic drugs, and, most notably, in combination with basal insulin. Its ability to target PPG effectively complements the fasting plasma glucose (FPG)-lowering effect of basal insulins, a synergistic relationship that became the cornerstone of its therapeutic strategy and led to its inclusion in the fixed-ratio combination product Soliqua 100/33.]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/04/07 | Phase 4 | Recruiting | |||
2021/06/30 | Phase 4 | UNKNOWN | Institute for Clinical and Experimental Medicine | ||
2021/05/19 | Phase 4 | UNKNOWN | |||
2019/12/12 | Phase 4 | Completed | |||
2019/03/20 | Phase 4 | Terminated | |||
2019/01/09 | Phase 3 | Completed | |||
2018/02/20 | Phase 2 | Completed | |||
2017/04/26 | Phase 3 | Completed | |||
2016/10/21 | Phase 4 | Completed | |||
2016/06/17 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Sanofi-Aventis U.S. LLC | 0024-5761 | SUBCUTANEOUS | 33 ug in 1 mL | 7/28/2025 | |
| sanofi-aventis U.S. LLC | 0024-5761 | SUBCUTANEOUS | 33 ug in 1 mL | 7/28/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 1/11/2017 | ||
Authorised | 1/31/2013 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| SOLIQUA SOLUTION FOR INJECTION IN A PRE-FILLED PEN 100UNITS/ML + 50MCG/ML | SIN15540P | INJECTION, SOLUTION | 50 μg/mL | 9/20/2018 | |
| SOLIQUA SOLUTION FOR INJECTION IN A PRE-FILLED PEN 100UNITS/ML + 33MCG/ML | SIN15542P | INJECTION, SOLUTION | 33μg/mL | 9/20/2018 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| SOLIQUA | sanofi-aventis canada inc | 02478293 | Solution - Subcutaneous | 33 MCG / ML | 9/12/2018 |
| ADLYXINE | sanofi-aventis canada inc | 02464284 | Solution - Subcutaneous | 20 MCG / ACT | 9/12/2017 |
| ADLYXINE | sanofi-aventis canada inc | 02464349 | Solution
,
Kit - Subcutaneous | 0.05 MG / ML | 9/12/2017 |
| ADLYXINE | sanofi-aventis canada inc | 02464349 | Solution
,
Kit - Subcutaneous | 0.1 MG / ML | 9/12/2017 |
| ADLYXINE | sanofi-aventis canada inc | 02464276 | Solution - Subcutaneous | 10 MCG / ACT | 9/12/2017 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| SULIQUA 100 UNIDADES/ML + 33 MICROGRAMOS/ML SOLUCION INYECTABLE EN PLUMA PRECARGADA | 1161157004 | SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Not Commercialized | |
| SULIQUA 100 UNIDADES/ML + 50 MICROGRAMOS/ML SOLUCION INYECTABLE EN PLUMA PRECARGADA | 1161157002 | SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Not Commercialized | |
| LYXUMIA 10 MICROGRAMOS SOLUCION INYECTABLE | 12811001 | SOLUCIÓN INYECTABLE | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| LYXUMIA 20 MICROGRAMOS SOLUCION INYECTABLE | 12811003 | SOLUCIÓN INYECTABLE | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| LYXUMIA 10 MICROGRAMOS + 20 MICROGRAMOS SOLUCION INYECTABLE | 12811005 | SOLUCIÓN INYECTABLE | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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