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Histamine H3 Receptor as a target for alcohol use disorder: challenging the predictability of animal models for clinical translation in drug development

by Ligneau, Xavier , Boileau, Isabelle , Sabioni, Pamela , Perrin, David , Lecomte, Jeanne-Marie , Finance, Olivier , Naassila, Mickael , Chavarria, Jesus , Berrebi-Bertrand, Isabelle , Le Foll, Bernard , Schwartz, Jean Charles , Hendershot, Christian S. , Di Ciano, Patricia , Uguen, Marilyne , Calmels, Thierry , Rusjan, Pablo M. , Robert, Philippe , Jeanblanc, Jérôme , Krief, Stéphane , Capet, Marc

in 59/78 / 631/154 / 631/378 / 692/699/476 / 692/699/476/5 / Alcohol withdrawal / Alcoholism - drug therapy / Animals / Behavioral Sciences / Biological Psychology / Brain - drug effects / Brain - metabolism / Disease Models, Animal / Drug Development / Ethanol / Extinction / Females / Histamine / Histamine Agonists - pharmacology / Histamine H3 Antagonists - pharmacology / Histamine H3 Antagonists - therapeutic use / Human health and pathology / Humans / Life Sciences / Medicine / Medicine & Public Health / Neurosciences / Pharmacokinetics / Pharmacotherapy / Psychiatrics and mental health / Psychiatry / Receptors, Histamine H3 - drug effects / Receptors, Histamine H3 - metabolism / Translational Research, Biomedical

2026

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Histamine H3 Receptor as a target for alcohol use disorder: challenging the predictability of animal models for clinical translation in drug development

2026

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Histamine H3 Receptor as a target for alcohol use disorder: challenging the predictability of animal models for clinical translation in drug development

2026

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Journal Article

Histamine H3 Receptor as a target for alcohol use disorder: challenging the predictability of animal models for clinical translation in drug development

Ligneau, Xavier,

Boileau, Isabelle,

Sabioni, Pamela,

Perrin, David,

Lecomte, Jeanne-Marie,

Finance, Olivier,

Naassila, Mickael,

Chavarria, Jesus,

Berrebi-Bertrand, Isabelle,

Le Foll, Bernard,

Schwartz, Jean Charles,

Hendershot, Christian S.,

Di Ciano, Patricia,

Uguen, Marilyne,

Calmels, Thierry,

Rusjan, Pablo M.,

Robert, Philippe,

Jeanblanc, Jérôme,

Krief, Stéphane,

Capet, Marc

2026

Overview

There is an important need to advance medication development for alcohol use disorder (AUD). BP1.3656B, a highly potent and selective histamine H3 receptor inverse agonist/antagonist, has been developed. Preclinical studies revealed high affinity, good pharmacokinetic profile, good brain penetration, and favorable safety. BP1.3656B reduced alcohol drinking and alcohol-seeking behavior in rodents. Phase I studies revealed good tolerability/pharmacokinetic in humans. Positron emission tomography revealed high brain occupancy in humans. Based on this favorable profile, two trials were conducted in subjects with AUD. In non-treatment seekers, BP1.3656B had no impact on intravenous alcohol self-administration (IV-ASA). A randomized clinical trial testing three doses of BP1.3656B versus placebo in treatment-seekers with AUD showed no reduction of heavy drinking days. Collective results illustrate the challenges inherent to clinical translation of AUD therapies, and reinforce the use of Phase IIa human laboratory paradigms as an important tool to de-risk translation of innovative drug targets for AUD.

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Publisher

Nature Publishing Group UK,Nature Publishing Group,Nature Pub. Group

Subject

59/78

/ 631/154

/ 631/378

/ 692/699/476

/ 692/699/476/5

/ Alcohol withdrawal

/ Alcoholism - drug therapy