AM1476

AM1476 is a first-in-class, orally administered small molecule that acts as a highly selective antagonist of the peripheral serotonin 5-HT2B receptor. Developed by AnaMar, AM1476 is designed to modulate key fibrotic pathways, including TGF-β and Wnt signaling, by blocking 5-HT2B receptor activity. This mechanism reduces myofibroblast and macrophage activation and TGF-β production—processes central to fibrosis development—while minimizing side effects and drug interactions. AM1476 has demonstrated efficacy in both in vitro and in vivo models of fibrosis, showing the ability to halt or reverse established skin and lung fibrosis. It has completed Phase I clinical trials with favorable safety and pharmacokinetic profiles, leading to orphan drug designation from both the FDA and EMA for systemic sclerosis (SSc). The drug is being advanced into Phase II trials for SSc but also shows potential across a range of fibrotic diseases such as interstitial lung disease