Sodium oligomannate
Clinical data
Other namesSodium oligo-mannurarate; GV-971; GV971
Legal status
Legal status
  • Conditional approval in China; investigational elsewhere
Identifiers
CAS Number

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. 1 2 Syed YY (March 2020). "Sodium Oligomannate: First Approval". Drugs. 80 (4): 441–444. doi:10.1007/s40265-020-01268-1. PMID 32020555. S2CID 211027915.
  2. ↑ Servick K, Normile D (5 November 2019). "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.
  3. ↑ Rao Y (September 2020). "Omission of previous publications by an author should be corrected". Cell Research. 30 (9): 819. doi:10.1038/s41422-020-0344-3. PMC 7609295. PMID 32632254.
  4. ↑ Ye Y (July 9, 2020). "Neuroscientist Speaks Out Against Chinese Alzheimer's Drug, Again". Sixth Tone.
  5. ↑ 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. 1 2 "GV-971". Alzforum. 10 May 2021.
  7. ↑ Angus Liu (May 13, 2022). "Trial for controversial China-made Alzheimer's drug aborted as capital raise hits snag, COVID hurts sales". fiercepharma.com.
  8. ↑ Hu J, Geng M, Li J, Xin X, Wang J, Tang M, et al. (June 2004). "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. doi:10.1254/jphs.fpj04004x. PMID 15215650.
  9. ↑ Wang S, Li J, Xia W, Geng M (January 2007). "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. doi:10.1179/174313206X152483. PMID 17427283. S2CID 13359092.
  10. ↑ Liu M, Nie Q, Xin X, Geng M (2008). "Identification of AOSC-binding proteins in neurons". Chinese Journal of Oceanology and Limnology. 26 (4): 394–399. Bibcode:2008ChJOL..26..394L. doi:10.1007/s00343-008-0394-8. S2CID 84261464.
  11. ↑ Wang X, Sun G, Feng T, Zhang J, Huang X, Wang T, et al. (October 2019). "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. doi:10.1038/s41422-019-0216-x. PMC 6796854. PMID 31488882.
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