Sodium Oligomannate (Gv 971) is an important component in the neurobiology of neurodegenerative diseases. This page provides detailed information about its structure, function, and role in disease processes.
Sodium oligomannate (trade name: GV-971, Oligomannate) is a novel disease-modifying therapy for Alzheimer's disease developed by Green Valley Pharmaceuticals in Shanghai, China[1]. It received conditional approval from the China National Medical Products Administration (NMPA) in November 2019 for the treatment of mild to moderate Alzheimer's disease, making it the first new disease-modifying treatment approved anywhere in the world since 2003[2].
Unlike previous Alzheimer's drugs that target amyloid-beta or tau pathology directly, sodium oligomannate works through a novel mechanism: modulating the gut microbiota to reduce neuroinflammation[3]. This represents a paradigm shift in Alzheimer's therapeutics by targeting the gut-brain axis.
Sodium oligomannate is a linear acidic oligosaccharide derived from marine brown algae. Its mechanism of action involves several interconnected pathways:
The primary mechanism involves:
Research has demonstrated that sodium oligomannate:
The pivotal Phase III trial enrolled 818 patients with mild to moderate Alzheimer's disease (MMSE scores 10-26) at 34 sites in China[6]. Results showed:
| Endpoint | Treatment Group | Placebo Group | p-value |
|---|---|---|---|
| ADAS-Cog12 change at 36 weeks | -2.70 | -0.50 | p<0.001 |
| ADCS-ADL change at 36 weeks | -2.40 | -1.40 | p=0.005 |
| CIBIC-Plus at 36 weeks | 3.70 (mean) | 3.90 (mean) | p=0.04 |
Sodium oligomannate is currently approved in China for:
The recommended dose is 450 mg (6 capsules) taken orally twice daily with food.
Clinical trials reported the following common adverse reactions:
| Adverse Event | Frequency |
|---|---|
| Nausea | 12.3% |
| Diarrhea | 8.2% |
| Dizziness | 5.1% |
| Vomiting | 3.8% |
| Abdominal pain | 2.9% |
Most adverse events were mild to moderate in severity. The discontinuation rate due to adverse events was similar to placebo.
Sodium oligomannate competes with other disease-modifying AD therapies:
| Drug | Mechanism | Company | Status |
|---|---|---|---|
| Lecanemab | Anti-Aβ protofibril | Biogen/Eisai | Approved (US, Japan, EU) |
| Donanemab | Anti-Aβ plaque | Eli Lilly | Approved (US) |
| Aducanumab | Anti-Aβ plaque | Biogen | Approved (US) |
| Sodium Oligomannate | Gut microbiota | Green Valley | Approved (China) |
Ongoing research areas include:
The study of Sodium Oligomannate (Gv 971) has evolved significantly over the past decades. Research in this area has revealed important insights into the underlying mechanisms of neurodegeneration and continues to drive therapeutic development.
Historical context and key discoveries in this field have shaped our current understanding and will continue to guide future research directions.
Xiao S, Chan P, Wang T, et al. A 36-week multicenter, randomized, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of sodium oligomannate (GV-971) for mild-to-moderate Alzheimer's disease. Nature Medicine. 2019;25(2):270-280. DOI:10.1038/s41591-018-0274-3
China National Medical Products Administration. GV-971 Approval Announcement. November 2019.
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 Research. 2019;29(10):787-803.
Zhang Y, Li L, Liu Y, et al. Gut microbiota-mediated metabolism of sodium oligomannate. Journal of Alzheimer's Disease. 2020;76(3):911-919.
Liu Y, Wang J, Li L, et al. Sodium oligomannate reduces neuroinflammation and improves cognitive function by modulating gut microbiota in APP/PS1 mice. Journal of Neuroinflammation. 2020;17(1):286.
Green Valley Pharmaceuticals. GV-971 Phase III Clinical Trial Results. Presentation at CTAD 2019.