At a glance
- Lixisenatide is an FDA-approved drug, marketed as Adlyxin, Soliqua (first approval: July 27, 2016).
- PubMed lists 738 publications mentioning it, including 95 randomized controlled trials and 37 animal-only studies.
- ClinicalTrials.gov lists 77 registered studies testing it (8 active).
- FDA's adverse event system (FAERS) holds 4,055 reports mentioning it; 1,089 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
| Application | Product | Status | First approval | Sponsor |
|---|---|---|---|---|
| BLA208471 | ADLYXIN | Approved, marketed | July 27, 2016 | SANOFI-AVENTIS US |
| BLA208673 | SOLIQUA 100/33 | Approved, marketed | November 21, 2016 | SANOFI-AVENTIS US |
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- Editorial Expression of Concern: Drugs developed to treat diabetes, liraglutide and lixisenatide, cross the blood brain barrier and enhance neurogenesis.
- Glucagon-Like Peptide-1 Receptor Agonists and Risk of Arrhythmias: A Network Meta-Analysis.
- Patient-Reported Outcomes Following Initiation or Simplification of Treatment With iGlarLixi in Adults With Type 2 Diabetes: A Narrative Review.
- Development and validation of qualitative methods for the detection of GLP-1 receptor agonists in serum and dried blood spots by LC-HRMS/MS for doping control purposes.
- Audiovestibular adverse event reporting profiles of GLP-1 receptor agonists: A case-case pharmacovigilance study using FDA AEMS data.
- GLP-1 Receptor Agonists Are Associated With Lower Early Revision Risk Compared to Bariatric Surgery Following Total Hip Arthroplasty: A Retrospective Cohort Study.
- Glucagon-like peptide-1 receptor agonists in hidradenitis suppurativa: A nationwide cohort study.
- Tirzepatide safety in EudraVigilance: descriptive and disproportionality analysis of preferred terms related to suboptimal treatment outcomes and drug-use-related issues.
- Suitability of the ICH S1B(R1) weight-of-evidence framework to evaluate glucagon-like protein-1 receptor agonist (GLP-1RA) carcinogenicity risk.
- iGlarlixi for the simplification of more complex insulin regimens in type 2 diabetes patients with good glycaemic control.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 77
- Active
- 8
- With posted results
- 27
Conditions studied
Show 40 more studies
All 77 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 4,055
- Serious
- 1,089
- With death outcome
- 74
Most reported reactions
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
FDA prescribing information
Official US prescribing information. Dosing sections are intentionally not shown.
Source: DailyMed / openFDA
Change history
No changes since monitoring began on October 30, 2026.