Friday, July 10, 2026

Drug profile · INN

lixisenatide

lixisenatide (LYXUMIA) is a glucagon-like peptide 1 receptor agonist. Route of administration: subcutaneous. Current US regulatory status: approved.

FDA: approved EMA: withdrawn PMDA: approved Alimentary tract and metabolism (A10) A10BJ03
US status approved
Patents linked 0
Pipeline programs 4
News articles 0
Drug details — lixisenatide
US status
approved
Class
Alimentary tract and metabolism (A10)
Route
SUBCUTANEOUS
Patents
0
Programs
4
Data quality
0.84

Quick answer

lixisenatide (LYXUMIA) is a glucagon-like peptide 1 receptor agonist. Route of administration: subcutaneous. Current US regulatory status: approved.

Key facts

INN lixisenatide
Brand LYXUMIA
Mechanism Glucagon-like peptide 1 receptor agonist
Target Glucagon-like peptide 1 receptor
Therapeutic class Alimentary tract and metabolism (A10)
Route SUBCUTANEOUS
Formulation SOLUTION
ATC code A10BJ03

Mechanism of action

Glucagon-like peptide 1 receptor agonist

Primary target: Glucagon-like peptide 1 receptor

Approval history

Authority Status Date
FDA approved
EMA withdrawn
PMDA approved

Pipeline programs

  1. Insulin glargine/Lixisenatide (HOE901/AVE0010) Phase 3 · Sanofi Pasteur MSD · Type 2 Diabetes Mellitus
  2. Lixisenatide (AVE0010) Phase 3 · Sanofi Pasteur MSD · Acute Coronary Syndrome
  3. lixisenatide AVE0010 Phase 3 · Sanofi Pasteur MSD · Type 2 Diabetes Mellitus
  4. Lixisenatide (AVE0010) Approved · Sanofi Pasteur MSD · Diabetes Mellitus, Type 2

Related & competitor drugs

  1. agalsidase alfa Alimentary tract and metabolism (A16)
  2. alogliptin Alimentary tract and metabolism (A10)
  3. alogliptin benzoate Alimentary tract and metabolism (A10)
  4. aprepitant Alimentary tract and metabolism (A04)
  5. budesonide Alimentary tract and metabolism (A07)
  6. canagliflozin Alimentary tract and metabolism (A10)

Frequently asked questions

What is lixisenatide?

lixisenatide (LYXUMIA) is a glucagon-like peptide 1 receptor agonist. Route of administration: subcutaneous. Current US regulatory status: approved.

What is the brand name for lixisenatide?

LYXUMIA is a marketed brand name for lixisenatide. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of lixisenatide?

lixisenatide has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.