Brenipatide (LY-3537031) is an investigational dual GLP-1/GIP peptide from Eli Lilly, engineered for once-monthly dosing. Its lead trial targets alcohol use disorder, not obesity. It is not FDA-approved and not available to buy, compound, or prescribe today.
Brenipatide is not FDA-approved for any use. Eli Lilly is studying it in clinical trials — most prominently a Phase 3 program in moderate-to-severe alcohol use disorder. It isn't sold through pharmacies, compounders, or peptide suppliers.
This summary is based on public company disclosures, the ClinicalTrials.gov registry, and published research — it isn't an official FDA determination, and no efficacy results have been published yet.
Brenipatide is an investigational medicine from Eli Lilly, developed under the code name LY-3537031. It's a dual agonist of the GLP-1 and GIP receptors — the same two targets as tirzepatide — but engineered to be given once a month instead of once a week. It's still in clinical trials and has not been approved by the FDA.
This page explains what brenipatide is, what it's being studied for, how it's thought to work, and exactly where it stands with regulators. It's written to help people understand the drug — not to sell it, and not as medical advice.
The list below is what brenipatide is being studied for in clinical trials — not uses the FDA has approved. No efficacy results have been published yet, so this describes the research program, not a proven effect.
None of these uses is FDA-approved. Conditions like alcohol use disorder, depression, and IBS-D need care from a licensed professional — not a self-directed peptide.
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Earliest possible FDA decision: not before ~2028, assuming Phase 3 succeeds.
Lilly has also reported a bipolar disorder program in its pipeline; no public registry identifier was available at time of writing.
"Compounded" drugs aren't approved by the FDA — a pharmacy or outsourcing facility prepares them instead of the manufacturer, under one of two legal pathways.
After tirzepatide (Lilly's Mounjaro/Zepbound) was approved, a supply shortage — added to FDA's shortage list in December 2022 — opened the door for 503A pharmacies to legally compound copies, and a wave of 503B facilities and telehealth clinics followed. At its peak in 2024, compounded GLP-1s reportedly made up around 30% of the U.S. supply.7
That window closed once supply caught up: FDA declared the tirzepatide shortage resolved in October 2024, ended 503B enforcement discretion for it in March 2025, and in April 2026 proposed formally excluding it from the 503B bulks list altogether.4
Anything sold online today as "brenipatide" for research or personal use is unauthorized, unregulated, and not verified to be the same molecule studied in Lilly's trials.