It was conditionally approved in China by the
National Medical Products Administration in 2019 for mild to moderate AD to improve cognitive function.[1] However, the clinical data supporting its potential benefits have been received skeptically elsewhere[2][3][4] and are considered insufficient for approval in other countries. Therefore, it is still undergoing
Phase III clinical trials necessary for regulatory approval in the United States and Europe.[5][6] In 2022, Green Valley Pharmaceuticals, the company conducting Phase III clinical trials for the purpose of obtaining FDA approval in the United States, ended the trials early and suspended further development of the drug.[7]
The
mechanism by which sodium oligomannate may function is unclear and several possibilities have been proposed,[6] including
amyloid beta disaggregation,[8] mediation of inflammatory responses to
amyloid plaques,[9] protein binding inside neurons,[10] and alteration of intestinal bacteria.[11]
^Clinical trial number NCT04520412 for "A Study of Sodium Oligomannate (GV-971) in Participants With Mild to Moderate Alzheimer's Disease (GREEN MEMORY)" at
ClinicalTrials.gov