Is Lixisenatide registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Lixisenatide.

Is Lixisenatide approved by the US FDA?

Drugs@FDA lists 1 application product line for Lixisenatide, including ADLYXIN (Prescription).

Is Lixisenatide authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Lixisenatide.

Are there safety signals or safety updates for Lixisenatide?

EMA PRAC: 11 entries; US FDA: 2 entries (latest 2026-03-12).

Active substance

Lixisenatide

SFDA 3
US FDA 1
EMA 1
Safety 13

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
LYXUMIA 10µg Solution for Injection	10 µg	Solution for injection · Subcutaneous use	1 Pre-filled pen	SAR 155.00	Biological · Prescription	SANOFI AVENTIS GROUPE	Withdrawn by MAH · Not Marketed
LYXUMIA 20µg Solution for Injection	20 µg	Solution for injection · Subcutaneous use	1 Pre-filled pen	SAR 155.00	Biological · Prescription	SANOFI AVENTIS GROUPE	Withdrawn by MAH · Not Marketed
LYXUMIA 20µg Solution for Injection	20 µg	Solution for injection · Subcutaneous use	2 Pre-filled pen	SAR 293.60	Biological · Prescription	SANOFI AVENTIS GROUPE	Withdrawn by MAH · Not Marketed

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
ADLYXIN	0.15MG/3ML (0.05MG/ML); 0.3MG/3ML (0.1MG/ML)	solution · subcutaneous	SANOFI-AVENTIS US	Prescription	27 Jul 2016

EMA European Union — centrally authorised medicines

Lyxumia Sanofi Winthrop Industrie · Withdrawn · authorised 31 Jan 2013 · ATC A10BJ03

Therapeutic indication (EMA)

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.

Safety signals and safety-related labeling changes

US FDA 12 Mar 2026 ADLYXIN — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 12 Mar 2026 SOLIQUA 100/33 — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 11 Jul 2024 PRAC signal: Aspiration and pneumonia aspiration
Action for MAH: update of the product information: Yes
EMA PRAC 11 Apr 2024 PRAC signal: Thyroid cancer
Action for MAH: update of the product information: No
EMA PRAC 7 Mar 2024 PRAC signal: Aspiration and pneumonia aspiration
Action for MAH: update of the product information: No
EMA PRAC 30 Nov 2023 PRAC signal: Suicidal ideation and self-injurious ideation
Action for MAH: update of the product information: No
EMA PRAC 26 Oct 2023 PRAC signal: Thyroid cancer
Action for MAH: update of the product information: No
EMA PRAC 28 Sep 2023 PRAC signal: Aspiration and pneumonia aspiration
Action for MAH: update of the product information: No
EMA PRAC 6 Jul 2023 PRAC signal: Suicidal ideation and self-injurious ideation
Action for MAH: update of the product information: No
EMA PRAC 14 Apr 2023 PRAC signal: Thyroid cancer
Action for MAH: update of the product information: No
EMA PRAC 13 Jan 2023 PRAC signal: Thyroid cancer
Action for MAH: update of the product information: No
EMA PRAC 14 Jun 2019 PRAC signal: Increased risk of cholangiocarcinoma in adults with type 2 diabetes
Action for MAH: update of the product information: No
EMA PRAC 17 Jan 2019 PRAC signal: Increased risk of cholangiocarcinoma in adults with type 2 diabetes
Action for MAH: update of the product information: No

All safety entries for lixisenatide →

Combinations containing Lixisenatide

Insulin glargine + lixisenatide

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.