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Lixisenatide

Written by The Peptide Record editorialClinical review not yet completedLast reviewed 15 September 2026

Lixisenatide (Adlyxin) is a real, FDA-approved once-daily GLP-1 agonist, discontinued in the US in 2023 for commercial reasons — its own cardiovascular-outcomes trial was a genuinely neutral result, neither harmful nor beneficial, unlike the positive trials behind dulaglutide and albiglutide.

On this page
  1. The approval
  2. The ELIXA trial: a neutral result
  3. The US discontinuation
  4. Current status

In brief

Should you care? Only if you're researching the GLP-1 class broadly — this drug is no longer sold in the US.

The short version

  • Approved July 2016 as a once-daily prandial GLP-1 agonist for type 2 diabetes.
  • ELIXA trial: a genuinely neutral cardiovascular result — non-inferior to placebo, but no benefit either (HR 1.02, p=0.81 for superiority).
  • Discontinued in the US around January 2023 for commercial reasons, remains marketed elsewhere (e.g., as Lyxumia in Europe).

The approval

The FDA approved lixisenatide (as Adlyxin) on 27 July 2016, a once-daily prandial GLP-1 agonist for type 2 diabetes, based on the 13-trial, 5,000-plus-patient "GetGoal" clinical program. Marketed by Sanofi.

The ELIXA trial: a neutral result

Lixisenatide's cardiovascular-outcomes trial, ELIXA (Pfeffer et al., N Engl J Med 2015, PMID 26630143), is worth reading precisely because it's the least dramatic of the three GLP-1 cardiovascular trials on this site. In 6,068 patients with type 2 diabetes and a recent acute coronary syndrome event, followed for a median of 25 months, the composite outcome (cardiovascular death, MI, stroke, or hospitalization for unstable angina) occurred in 13.4% of the lixisenatide group versus 13.2% on placebo (HR 1.02, 95% CI 0.89-1.17) — meeting the FDA's bar for cardiovascular safety (non-inferiority, p<0.001) but showing no benefit at all (p=0.81 for superiority). Heart-failure hospitalization and death were similarly unchanged. Set against dulaglutide's REWIND and albiglutide's HARMONY Outcomes — both genuinely positive — ELIXA is the honest reminder that "passed its cardiovascular safety trial" and "improves cardiovascular outcomes" are two different claims, and this drug only supports the first one.

The US discontinuation

Sanofi discontinued US sales of Adlyxin around January 2023, citing business and competitive reasons — newer once-weekly GLP-1 drugs had taken over most of the market — not a safety concern. Lixisenatide remains marketed outside the US, including as Lyxumia in Europe and other markets.

Current status

No longer sold in the US as of this review. No FDA warning letter names lixisenatide as a grey-market "research peptide" — consistent with it being a discontinued, non-obesity-indicated, brand-only drug with little grey-market demand.

References

  1. Pfeffer MA, Claggett B, Diaz R, et al. (ELIXA Investigators), "Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome," N Engl J Med 2015;373(23):2247-2257, PMID 26630143, DOI: 10.1056/NEJMoa1509225.
  2. FDA approval history for Adlyxin (lixisenatide), 27 July 2016. Sanofi US discontinuation, reported around January 2023.