HDIT101

HDIT101 is a first-in-class humanized monoclonal antibody developed for the treatment of herpes simplex virus (HSV) infections, including both HSV-1 and HSV-2. It targets a highly conserved epitope on glycoprotein B (gB), which is essential for viral infectivity. The drug exhibits a dual mechanism of action by neutralizing circulating HSV particles and inhibiting direct cell-to-cell spread of the virus, thereby preventing infection of neighboring cells. Preclinical studies demonstrated high efficacy in both immunocompetent and immunocompromised animal models, with favorable safety profiles confirmed in phase 1 clinical trials involving healthy volunteers. HDIT101 has been evaluated in phase 2 clinical trials for chronic recurrent orolabial herpes (HSV-1) via topical application and chronic recurrent genital herpes (HSV-2) via intravenous infusion. The drug was developed by Heidelberg ImmunoTherapeutics.