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Adlyxin (LIXISENATIDE)
Adlyxin works by mimicking the action of the GLP-1 hormone to help regulate blood sugar levels.
Adlyxin (Lixisenatide) is a small molecule GLP-1 Receptor Agonist developed by Sanofi-Aventis US LLC. It targets the glucagon-like peptide 1 receptor to treat type 2 diabetes mellitus. Adlyxin was FDA-approved in 2016 and is currently owned by Sanofi-Aventis US LLC. The commercial status of Adlyxin is patented, and key safety considerations include potential gastrointestinal side effects and increased risk of pancreatitis. Adlyxin works by mimicking the action of the GLP-1 hormone, which helps regulate blood sugar levels.
At a glance
| Generic name | LIXISENATIDE |
|---|---|
| Sponsor | Sanofi-Aventis Us Llc |
| Drug class | Insulin Analog [EPC] |
| Target | Glucagon-like peptide 1 receptor |
| Modality | Recombinant protein |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2016 |
Mechanism of action
Lixisenatide is GLP-1 receptor agonist. Lixisenatide increases glucose-dependent insulin release, decreases glucagon secretion, and slows gastric emptying.
Approved indications
- Diabetes mellitus type 2
Common side effects
- Nausea
- Vomiting
- Headache
- Diarrhea
- Dizziness
- Hypoglycemia
- Gastrointestinal adverse reactions
- Injection site reactions
- Anaphylaxis
- Allergic reactions
- Dyspepsia
- Constipation
Key clinical trials
- iGlarLixi CGM Study in Chinese T2D Individuals After OADs (PHASE4)
- Regimen Transition After Short-Term Intensive Insulin Therapy in Type 2 Diabetes (PHASE4)
- A Study to Investigate Safety and Efficacy of iGlarLixi in Adult Patients With Type 2 Diabetes Mellitus (PHASE4)
- Efficacy and Safety of iGlarLixi Versus Standard of Care in a Real-world Adult China Population With Uncontrolled Type 2 Diabetes on Oral Agents (PHASE4)
- Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study
- Study to Evaluate the Effect of Lixisenatide in Patient With Parkinson's Disease (PHASE2)
- iGlarLixi vs IDegAsp in Chinese Participants After OAD(s) (PHASE3)
- Using 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)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Adlyxin CI brief — competitive landscape report
- Adlyxin updates RSS · CI watch RSS
- Sanofi-Aventis Us Llc portfolio CI