Evidence review: Open Peptide Project (verified against primary PubMed, ClinicalTrials.gov & FDA records) · Last checked 2026-10-27. ← Back to Evidence Library

Lixisenatide (Adlyxin): what the evidence says

Name: Lixisenatide (Adlyxin)
Published: 2026-10-27

At a glance

What it is: a once-daily injected GLP-1 receptor agonist built on the exendin-4 backbone. FDA approved it as Adlyxin in 2016; the application is now listed as BLA 208471. ^R1 Sanofi stopped selling Adlyxin in the US; the Purple Book lists it as discontinued. ^R2 It is still sold in the US inside the insulin combination Soliqua. ^R3

What the evidence says: in ELIXA (6,068 people with type 2 diabetes and a recent heart attack or unstable angina), it neither raised nor lowered heart events (HR 1.02). ^R4 In LIXIPARK (156 people with early Parkinson's), motor scores worsened less over 12 months than with placebo. ^R5

Biggest risks: nausea (46%) and vomiting (13%) in the Parkinson's trial. ^R5

Rating


Human Human evidence	Strong for diabetes; neutral heart outcomes (n = 6,068) ^R4; limited for Parkinson's (one phase 2, n = 156) ^R5
Animal Animal / lab evidence	Mouse neuroprotection data cited in the Parkinson's trial background ^R5
Regulatory	FDA-approved (BLA 208471), US brand discontinued ^{R1, R2} · not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page ^{R6, R7, R8} · not named by WADA ^R9
Established human dose	Yes, label dose (see Study details for trial amounts)

Evidence verdict: Type 2 diabetes glucose control: Strong (FDA-approved) · Heart safety: Strong (neutral outcomes trial) · Parkinson's disease: Limited (one phase 2 trial)

This page reports what studies used. It is not dosing advice.

Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source

About the evidence: the diabetes and heart data come from large randomized trials. The Parkinson's result is one 12-month phase 2 trial with a small difference (about 3 points on the motor scale) and needs confirmation.

What is it?

Lixisenatide is a 44-amino-acid peptide related to exenatide. UNVERIFIED the exact residue count against the label. Related pages: Exenatide, Liraglutide, Semaglutide.

Does it work?

Human Heart outcomes (ELIXA): primary events 13.4% vs 13.2% with placebo, so no benefit and no harm. ^R4
Human Parkinson's (LIXIPARK, phase 2): at 12 months, motor scores changed by −0.04 points with lixisenatide vs +3.04 with placebo. ^{R5, R10} UNVERIFIED the exact change values; they come from the full text, not the abstract.
Unknown Weight loss or anti-aging in people without diabetes: no data.

Is it safe?

Human Stomach side effects are common: nausea 46% and vomiting 13% in LIXIPARK. ^R5
Human ELIXA found no rise in heart events over a median 25 months. ^R4

Gray-market vials: extra risks

A gray-market vial has no quality control and no guarantee of identity, strength or sterility. We test retail vials blind under the Open Peptide Standard; see /tests/. A passing test covers one batch on one date and does not mean the compound is safe.

Is it legal?

US: FDA-approved, but the Adlyxin brand is discontinued ^{R1, R2}; still available in Soliqua. ^R3
Compounding: not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page. ^{R6, R7, R8}
Sport: not named on WADA's 2026 Prohibited List. ^R9

Study details

These are amounts researchers used, not recommendations.

Study	People / model	Route	Amount used	Follow-up	Reported	Citation
ELIXA 2015	6,068 adults, T2D + recent ACS	SC daily	Label dose	Median 25 months	MACE HR 1.02	PMID 26630143
LIXIPARK 2024	156 adults, early Parkinson's	SC daily	Per trial protocol	12 months + 2-month washout	Less motor worsening	PMID 38598572

Full reference list (PubMed, CT.gov, FDA and WADA checked Oct 26, 2026)

^R1 Drugs@FDA, Adlyxin (lixisenatide), application BLA 208471 (deemed BLA; originally NDA 208471) (openFDA drugsfda record checked Oct 26, 2026). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=BLA 208471 (deemed BLA; originally NDA 208471)
^R2 FDA Purple Book, BLA 208471 Adlyxin, both strengths listed as discontinued (checked Oct 26, 2026). https://purplebooksearch.fda.gov/index.cfm?blaNo=208471&event=productdetails
^R3 Drugs@FDA, Soliqua 100/33 (insulin glargine and lixisenatide), application BLA 208673 (openFDA drugsfda record checked Oct 26, 2026). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=BLA 208673
^R4 Pfeffer MA, et al. N Engl J Med. 2015. PMID 26630143
^R5 Meissner WG, et al. N Engl J Med. 2024. PMID 38598572
^R6 FDA, 503A bulk drug substances categories list (updated May 14, 2026). https://www.fda.gov/media/94155/download
^R7 FDA, 503B bulk drug substances categories list (updated Mar 21, 2025). https://www.fda.gov/media/94164/download
^R8 FDA, Certain bulk drug substances for use in compounding that may present significant safety risks (content current Apr 22, 2026). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
^R9 WADA. The 2026 Prohibited List, full list checked; compound not named. https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf
^R10 ClinicalTrials.gov NCT03439943, LIXIPARK phase 2 Parkinson's trial (CT.gov API v2, checked Oct 26, 2026). https://clinicaltrials.gov/study/NCT03439943

Disclaimer

This page is for education and harm reduction, not medical advice or a recommendation to use Lixisenatide (Adlyxin). This is a prescription medicine. Use it only under the care of a licensed clinician; do not buy it from research-chemical or gray-market sellers. Report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).