Lixisenatide

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

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
The Effect of Lixisenatide on the Effect of Pituitary Hormones	2023/04/07	NCT05804513	Phase 4	Recruiting	University of Tartu
INSULIN THERAPY DE-INTENSIFICATION WITH iGlarLixi	2021/06/30	NCT04945070	Phase 4	UNKNOWN	Institute for Clinical and Experimental Medicine
Efficacy and Safety of iGlarLixi Versus Insulin Glargine Plus Dulaglutide in Patients With Type 2 Diabetes	2021/05/19	NCT04893148	Phase 4	UNKNOWN	Chungbuk National University Hospital
Durability of Combination of Insulin and GLP-1 Receptor Agonist or SGLT-2 Inhibitors Versus Basal Bolus Insulin Regimen in Type 2 Diabetes (BEYOND)	2019/12/12	NCT04196231	Phase 4	Completed	University of Campania "Luigi Vanvitelli"
Effects of Insulin Glargine and Lixisenatide on the Brain	2019/03/20	NCT03881995	Phase 4	Terminated	University Hospital Tuebingen
Evaluation of Insulin Glargine/Lixisenatide Fixed Ratio Combination in Patients With Type 2 Diabetes Insufficiently Controlled With Oral Antidiabetic Drug(s)	2019/01/09	NCT03798054	Phase 3	Completed	Sanofi
Study to Evaluate the Effect of Lixisenatide in Patient With Parkinson's Disease	2018/02/20	NCT03439943	Phase 2	Completed	University Hospital, Toulouse
Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IGlarLixi	2017/04/26	NCT03130426	Phase 3	Completed	Population Health Research Institute
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	2016/10/21	NCT02941367	Phase 4	Completed	Sanofi
A Study on Safety, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Pediatric Patients With Type 2 Diabetes Mellitus (T2DM)	2016/06/17	NCT02803918	Phase 1	Completed	Sanofi

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Soliqua 100/33	sanofi-aventis U.S. LLC	0024-5761	SUBCUTANEOUS	33 ug in 1 mL	9/30/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Suliqua	Sanofi Winthrop Industrie,82 Avenue Raspail,94250 Gentilly,FRANCE	Authorised	1/11/2017
Lyxumia	Sanofi Winthrop Industrie,82 Avenue Raspail,94250 Gentilly,FRANCE	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	Sanofi-Aventis Deutschland GmbH	SIN15540P	INJECTION, SOLUTION	50 μg/mL	9/20/2018
SOLIQUA SOLUTION FOR INJECTION IN A PRE-FILLED PEN 100UNITS/ML + 33MCG/ML	Sanofi-Aventis Deutschland GmbH	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	Sanofi Winthrop Industrie	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	Sanofi Winthrop Industrie	1161157002	SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Not Commercialized
LYXUMIA 10 MICROGRAMOS SOLUCION INYECTABLE	Sanofi Winthrop Industrie	12811001	SOLUCIÓN INYECTABLE	Medicamento Sujeto A Prescripción Médica	Not Commercialized
LYXUMIA 20 MICROGRAMOS SOLUCION INYECTABLE	Sanofi Winthrop Industrie	12811003	SOLUCIÓN INYECTABLE	Medicamento Sujeto A Prescripción Médica	Not Commercialized
LYXUMIA 10 MICROGRAMOS + 20 MICROGRAMOS SOLUCION INYECTABLE	Sanofi Winthrop Industrie	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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