Pipeline compound

    Brenipatide

    Brenipatide (LY3537031) is an investigational peptide that activates two incretin receptors, GIP and GLP-1, the same pair as tirzepatide. Unusually for this class, most of its registered trials are not in obesity or diabetes but in alcohol and opioid use, smoking relapse, mood disorders, schizophrenia and asthma. It has no marketing authorisation in any territory. This profile summarises its pharmacology and the clinical register for laboratory readers.

    Also known as
    LY3537031, LY-3537031
    Receptors
    GIP and GLP-1 (dual agonist)
    Highest phase, October 2026
    Phase 3
    CAS number and FDA UNII
    2408921-49-1, C3939LZT6J

    Mechanism

    GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) are the two incretin hormones released from the gut after a meal. Both act on class B G-protein-coupled receptors and both raise insulin release when glucose is high. A single peptide that activates both receptors is called a dual incretin agonist; tirzepatide is the best-known example, and brenipatide belongs to the same class.

    Its registered chemical name in the FDA Global Substance Registration System describes a synthetic peptide containing several non-natural amino acids, including D-tyrosine at the start of the chain, 2-aminoisobutyric acid and alpha-methylated leucine and tyrosine. These are standard design choices for resisting breakdown by enzymes. A C20 fatty diacid is attached to a lysine side chain through a linker; fatty acids of this kind bind albumin in the blood, which slows clearance. Phase 1 data presented at Psych Congress 2026 reported a half-life of 9 to 12 days, longer than the roughly 5 days reported for tirzepatide and 6 days for retatrutide.

    The reason for the unusual trial programme is the brain. GLP-1 receptors are found in areas involved in reward, and GLP-1 receptor agonists reduced alcohol intake in rodents and non-human primates. Human trials so far are small and mixed: in 127 people with alcohol use disorder, exenatide did not reduce heavy drinking days overall but did reduce alcohol cue reactivity on brain imaging, and in 48 adults, semaglutide reduced alcohol consumed in a laboratory session, drinks per drinking day and craving, but not the number of drinking days. The RENEW trials test whether a long-acting dual agonist changes these outcomes at scale. The contribution of GIP receptor activity to these effects is less studied.

    Clinical programme status

    • Investigational. Brenipatide has no marketing authorisation in the United Kingdom, European Union or United States, and no efficacy results from its trials have been published as of October 2026.
    • Phase 3: two trials, in moderate to severe alcohol use disorder (RENEW-ALC-1, about 1,100 participants) and in preventing relapse of major depressive disorder alongside standard care (RENEW-MDD-1, about 1,000 participants).
    • Phase 2: five trials, in relapse to smoking after quitting, opioid use disorder alongside buprenorphine, bipolar disorder, schizophrenia and uncontrolled moderate to severe asthma.
    • Phase 1: a completed single-ascending-dose study in 40 healthy participants (2020 to 2021) and a phase 1b study in people with overweight or obesity that measures body weight change at 29 weeks.
    • Phase 1 findings presented at Psych Congress 2026 in September reported gastrointestinal effects as the most common adverse events, at comparable rates on brenipatide and placebo.

    Registered trials

    From ClinicalTrials.gov, read 30 October 2026.

    • RENEW-ALC-1NCT07219966

      Alcohol use disorder, moderate to severe

      Phase 3 · Recruiting · Started Oct 2025

    • RENEW-MDD-1NCT07412756

      Major depressive disorder: delaying relapse, alongside standard care

      Phase 3 · Recruiting · Started Feb 2026

    • RENEW-Smk-1NCT07223840

      Relapse to smoking in adults who recently quit

      Phase 2 · Recruiting · Started Nov 2025

    • RENEW-Op-1NCT07420283

      Opioid use disorder, alongside buprenorphine

      Phase 2 · Recruiting · Started Feb 2026

    • RENEW-Bipolar-1NCT07286175

      Bipolar disorder: delaying relapse, alongside standard care

      Phase 2 · Recruiting · Started Nov 2025

    • RENEW-Scz-1NCT07410507

      Schizophrenia, alongside standard care

      Phase 2 · Recruiting · Started Feb 2026

    • RENEW-AsthmaNCT07219173

      Uncontrolled moderate to severe asthma

      Phase 2 · Recruiting · Started Oct 2025

    • Phase 1b studyNCT07476118

      Overweight or obesity

      Phase 1b · Active, not recruiting · Started Mar 2026

    • First-in-human studyNCT04648865

      Healthy participants, single doses

      Phase 1 · Completed · Started Dec 2020

    Published statements, quoted

    Reproduced verbatim from the sources named. Peptx makes no claim of its own on these points.

    “The purpose of this study is to see if brenipatide when compared to a placebo works and is safe for participants with moderate-to-severe Alcohol Use Disorder (AUD).”
    ClinicalTrials.gov record NCT07219966 (RENEW-ALC-1), brief summary.
    “This study evaluates the efficacy and safety of brenipatide when compared to placebo for reducing the risk of relapse to cigarette smoking in adults who have recently quit.”
    ClinicalTrials.gov record NCT07223840 (RENEW-Smk-1), brief summary.

    Not yet stocked

    Register interest

    Brenipatide is not currently supplied by Peptx. Leave an email address and we will notify you once verified reference material is available. No purchase, no obligation, and the address is used for this notice only.

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    Frequently asked questions

    What is brenipatide?
    Brenipatide (development code LY3537031) is an investigational peptide that activates both the GIP and GLP-1 receptors. As of October 2026 it is in phase 2 and phase 3 trials and is not approved in any country.
    Is brenipatide the same as tirzepatide?
    No. Both are dual GIP and GLP-1 receptor agonists, but they are different molecules. Brenipatide has a longer reported half-life (9 to 12 days in phase 1, against about 5 days for tirzepatide), and its trials focus on addiction, mood disorders, schizophrenia and asthma rather than diabetes and obesity.
    Why is brenipatide being studied in alcohol use disorder?
    GLP-1 receptors are present in brain areas involved in reward, and GLP-1 receptor agonists reduced alcohol intake in animal studies. Small human trials of exenatide and semaglutide gave mixed results, with some drinking measures improving and others not. The RENEW trials test the idea at a much larger scale.
    Has brenipatide been shown to work?
    Not yet. As of October 2026 the only reported human data are phase 1 safety and pharmacokinetic findings. The phase 2 and phase 3 trials are still recruiting and none has reported efficacy results.
    Does Peptx stock brenipatide?
    No. Brenipatide is not currently supplied by Peptx. You can register an email address on this page to be notified if verified reference material becomes available.

    Citations

    1. ClinicalTrials.gov registry search: brenipatide.
    2. FDA Global Substance Registration System: brenipatide, UNII C3939LZT6J.
    3. PubChem substance record SID 518139661: brenipatide (INN, USAN), CAS 2408921-49-1.
    4. Psychiatric Times, 18 September 2026: report of phase 1 brenipatide data presented at Psych Congress 2026.
    5. Klausen MK, et al. (2022). Exenatide once weekly for alcohol use disorder investigated in a randomized, placebo-controlled clinical trial. JCI Insight. PubMed 36066977.
    6. Hendershot CS, et al. (2025). Once-Weekly Semaglutide in Adults With Alcohol Use Disorder: A Randomized Clinical Trial. JAMA Psychiatry. PubMed 39937469.

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