Chemistry:Sodium oligomannate
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| Other names | Sodium oligo-mannurarate; GV-971; GV971 |
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Sodium oligomannate (development code GV-971) is a mixture of oligosaccharides isolated from the marine algae Ecklonia kurome that is used in China as a treatment for Alzheimer's disease (AD).[1]
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]
References
- ↑ 1.0 1.1 "Sodium Oligomannate: First Approval". Drugs 80 (4): 441–444. March 2020. doi:10.1007/s40265-020-01268-1. PMID 32020555.
- ↑ "Alzheimer's experts greet China's surprise approval of a drug for brain disease with hope and caution". Science Magazine. American Association for the Advancement of Science. 5 November 2019. https://www.science.org/content/article/alzheimer-s-experts-greet-china-s-surprise-approval-drug-brain-disease-hope-and-caution.
- ↑ "Omission of previous publications by an author should be corrected". Cell Research 30 (9): 819. September 2020. doi:10.1038/s41422-020-0344-3. PMID 32632254.
- ↑ "Neuroscientist Speaks Out Against Chinese Alzheimer's Drug, Again". Sixth Tone. July 9, 2020. https://www.sixthtone.com/news/1005912/neuroscientist-speaks-out-against-chinese-alzheimers-drug%2C-again.
- ↑ 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
- ↑ 6.0 6.1 "GV-971". Alzforum. 10 May 2021. https://www.alzforum.org/therapeutics/gv-971.
- ↑ Angus Liu (May 13, 2022). "Trial for controversial China-made Alzheimer's drug aborted as capital raise hits snag, COVID hurts sales". https://www.fiercepharma.com/pharma/controversial-china-made-alzheimers-drug-aborts-global-clinical-trial-capital-raise-hits.
- ↑ "Acidic oligosaccharide sugar chain, a marine-derived acidic oligosaccharide, inhibits the cytotoxicity and aggregation of amyloid beta protein". Journal of Pharmacological Sciences 95 (2): 248–55. June 2004. doi:10.1254/jphs.fpj04004x. PMID 15215650.
- ↑ "A marine-derived acidic oligosaccharide sugar chain specifically inhibits neuronal cell injury mediated by beta-amyloid-induced astrocyte activation in vitro". Neurological Research 29 (1): 96–102. January 2007. doi:10.1179/174313206X152483. PMID 17427283.
- ↑ "Identification of AOSC-binding proteins in neurons". Chinese Journal of Oceanology and Limnology 26 (4): 394–399. 2008. doi:10.1007/s00343-008-0394-8. Bibcode: 2008ChJOL..26..394L.
- ↑ "Sodium oligomannate therapeutically remodels gut microbiota and suppresses gut bacterial amino acids-shaped neuroinflammation to inhibit Alzheimer's disease progression". Cell Research 29 (10): 787–803. October 2019. doi:10.1038/s41422-019-0216-x. PMID 31488882.
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