Abstract
Sodium oligomannate (九期一®; GV-971) is a marine algae-derived oral oligosaccharide being developed by Shanghai Green Valley Pharmaceuticals for the treatment of Alzheimer’s disease (AD). Sodium oligomannate received its first approval in November 2019 in China for the treatment of mild to moderate AD to improve cognitive function. This article summarizes the milestones in the development of sodium oligomannate leading to this first approval for AD.
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24 February 2020
The first sentence, which currently reads: “Sodium oligomannate is produced by depolymerizing propylene glycol alginate sodium sulfate followed by oxidation, leaving carboxyl group at the reduced end [11].”
References
Dong Y, Li X, Cheng J, et al. Drug development for Alzheimer’s disease: microglia induced neuroinflammation as a target? Int J Mol Sci. 2019;20(3):558.
Panza F, Lozupone M, Logroscino G, et al. A critical appraisal of amyloid-beta-targeting therapies for Alzheimer disease. Nat Rev Neurol. 2019;15(2):73–88.
Seo DO, Boros BD, Holtzman DM. The microbiome: a target for Alzheimer disease? Cell Res. 2019;29(10):779–80.
Wang X, Sun G, Feng T, et al. Sodium oligomannate therapeutically remodels gut microbiota and suppresses gut bacterial amino acids-shaped neuroinflammation to inhibit Alzheimer’s disease progression. Cell Res. 2019;29(10):787–803.
Shanghai Green Valley Pharmaceuticals. Milestones of oligomannate (GV-971) development. 2019. https://www.greenvalleypharma.com. Accessed 28 Nov 2019.
Shanghai Green Valley Pharmaceuticals. Green Valley announces NMPA approval of oligomannate for mild to moderate Alzheimer’s disease [media release]. 2019. https://www.prnewswire.com.
Reuters. China gives conditional OK to its first self-developed Alzheimer’s drug [media release]. 2019. https://www.reuters.com.
Shanghai Green Valley Pharmaceuticals Co., Ltd. Sodium oligomannate capsules: Chinese prescribing information. 2019. https://www.greenvalleypharma.com/En/Index/listView/catid/81.html. Accessed 15 Jan 2020.
China approves Alzheimer’s drug [news article]. Science. 2019;366(6466):668.
Shanghai Institute of Materia Medica. China focus: China’s new Alzheimer’s drug completes phase 3 clinical trial. 2018. http://english.simm.cas.cn/. Accessed 28 Nov 2019.
Gao Y, Zhang L, Jiao W. Chapter Seven: Marine glycan-derived therapeutics in China. Prog Mol Biol Transl Sci. 2019;163:113–4.
Jiang RW, Du XG, Zhang X, et al. Synthesis and bioassay of beta-(1,4)-D-mannans as potential agents against Alzheimer’s disease. Acta Pharmacol Sin. 2013;34(12):1585–91.
Xiao S. A phase II clinical trial on GV-971 in patients with Alzheimer’s [abstract no. OC 3]. J Prev Alz Dis. 2014;1(3):214–96.
Shi-fu X. A 36-week multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3 clinical trial of sodium oligomannate for mild-to-moderate Alzheimer disease [abstract]. Chin J Pharmacol Toxicol. 2019;6(6):403.
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The preparation of this review was not supported by any external funding.
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During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Yahiya Syed is a salaried employee of Adis International Ltd/Springer Nature, is responsible for the article content and declares no relevant conflicts of interest.
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Enhanced material for this AdisInsight Report can be found at https://doi.org/10.6084/m9.figshare.11290541. This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch and beyond.
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Syed, Y.Y. Sodium Oligomannate: First Approval. Drugs 80, 441–444 (2020). https://doi.org/10.1007/s40265-020-01268-1
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DOI: https://doi.org/10.1007/s40265-020-01268-1