manganese chloride tetrahydrate

Manganese chloride tetrahydrate (ACE-MBCA, proposed trade name Orviglance, formerly Mangoral) is an orally administered, manganese-based, liver-specific magnetic resonance imaging (MRI) contrast agent. It is developed by Ascelia Pharma specifically for patients with known or suspected focal liver lesions (such as liver metastases or primary liver cancer) who also suffer from severe renal impairment. Because standard gadolinium-based contrast agents (GBCAs) carry a black-box warning for patients with severe kidney disease due to the risk of Nephrogenic Systemic Fibrosis (NSF), these patients are typically imaged without contrast (unenhanced MRI), which reduces diagnostic accuracy. Manganese chloride tetrahydrate is absorbed from the small intestine and selectively taken up by normal hepatocytes via the portal circulation, causing healthy liver tissue to appear bright on T1-weighted MR images, while lesions and metastases remain dark. In July 2026, the FDA issued a Complete Response Letter (CRL) requesting additional clinical data and product documentation, and Ascelia Pharma is currently evaluating the regulatory path forward in the U.S. without planning a new clinical study.

Brand names

MangoralOrviglance

Other names

manganese chloridemanganese dichloride tetrahydrate