AMZ004

AMZ004 is a transdermal gel formulation of an FDA-approved serotonin 5-HT3 receptor antagonist being developed by Amzell for the treatment of severe nausea and vomiting in pregnancy (NVP) and hyperemesis gravidarum. The drug acts as a small molecule antiemetic by antagonizing the 5-HT3 receptor, thereby preventing nausea and vomiting. AMZ004 is designed as an odorless, skin-friendly gel to provide a patient-friendly delivery route, particularly for those who cannot tolerate oral medications. The product has received Orphan Drug Designation for hyperemesis gravidarum and is being developed via the 505(b)(2) regulatory pathway. It is currently in the preclinical/pre-IND stage of development.