Sodium Oligomannate (GV-971) for Alzheimer's Disease

Sodium Oligomannate (GV-971) for Alzheimer's Disease

Overview

Sodium Oligomannate (GV-971) for Alzheimer's Disease

Overview

<table class="infobox infobox-therapeutic">
<tr>
<th class="infobox-header" colspan="2">Sodium Oligomannate (GV-971) for Alzheimer's Disease</th>
</tr>
<tr>
<td class="label">Parameter</td>
<td>Details</td>
</tr>
<tr>
<td class="label">Dosage</td>
<td>450 mg twice daily (900 mg total daily)</td>
</tr>
<tr>
<td class="label">Route</td>
<td>Oral</td>
</tr>
<tr>
<td class="label">Formulation</td>
<td>Capsule</td>
</tr>
<tr>
<td class="label">Duration</td>
<td>Chronic, long-term treatment</td>
</tr>
<tr>
<td class="label">Food Interaction</td>
<td>Take with or without food</td>
</tr>
<tr>
<td class="label">Region</td>
<td>Status</td>
</tr>
<tr>
<td class="label">China (NMPA)</td>
<td>Approved (conditional)</td>
</tr>
<tr>
<td class="label">US (FDA)</td>
<td>Fast Track Designation</td>
</tr>
<tr>
<td class="label">US (FDA)</td>
<td>Phase 3 planned</td>
</tr>
<tr>
<td class="label">EU (EMA)</td>
<td>Not yet filed</td>
</tr>
<tr>
<td class="label">Feature</td>
<td>GV-971</td>
</tr>
<tr>
<td class="label">Target</td>
<td>Gut-brain axis</td>
</tr>
<tr>
<td class="label">Type</td>
<td>Disease-modifying</td>
</tr>
<tr>
<td class="label">Route</td>
<td>Oral</td>
</tr>
<tr>
<td class="label">Approval</td>
<td>China</td>
</tr>
<tr>
<td class="label">Mechanism</td>
<td>Microbiome modulation</td>
</tr>
</table>

Sodium Oligomannate (GV-971, trade name: Oligomannate) is a disease-modifying therapy for Alzheimer's disease developed by Green Valley Pharmaceuticals (Shanghai, China). 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[@xing2021][@china2019].

GV-971 is a marine-derived acidic oligosaccharide extracted from brown algae (Ascophyllum nodosum). Unlike previous Alzheimer's drugs that target [amyloid-beta](/proteins/amyloid-beta) or [tau](/proteins/tau) pathology directly, GV-971 takes a novel approach by modulating the [gut-brain axis](/entities/gut-brain-axis) through alteration of gut microbiota composition["@wang2019"].

Mechanism of Action

Gut Microbiota Modulation

GV-971 operates through a distinctive gut-brain axis mechanism:

Key Molecular Targets

• Gut microbiota: Reduces Escherichia/Shigella populations
• Peripheral cytokines: Decreases IL-1β, IL-6, TNF-α
• Brain [microglia](/cell-types/microglia-neuroinflammation): Modulates microglial activation states
• Amyloid-beta: Reduces plaque burden in AD models

Clinical Evidence

Phase 3 Trial (Green Memory Study)

The pivotal Phase 3 trial (NCT02293915) enrolled 818 patients with mild to moderate Alzheimer's disease (MMSE score 10-26) in China[@xiao2021]:

• Study Design: 36-week, randomized, double-blind, placebo-controlled
• Dosage: 450 mg twice daily (900 mg total daily)
• Primary Endpoint: Change from baseline in ADAS-Cog score at week 36

• Significant improvement in cognitive function vs. placebo (difference: -2.15 points on ADAS-Cog at week 36, p=0.0004)
• Benefits observed as early as week 4
• Good safety profile with mostly mild adverse events

Supporting Studies

• Phase 2 Trial: Showed dose-dependent cognitive benefits with good tolerability[@zhang2018]
• Post-hoc Analyses: Suggested benefits in patients with mild to moderate AD
• Real-world Data: Chinese real-world studies have reported continued use and monitoring[@green]

Dosing and Administration

Safety and Adverse Effects

Common Adverse Events

• Nausea (most common)
• Diarrhea
• Dizziness
• Headache
• Fatigue

Safety Profile

GV-971 demonstrated a favorable safety profile in clinical trials:

• No major organ toxicity
• Low rates of serious adverse events
• No significant differences in discontinuation rates vs. placebo
• Drug-related adverse events were mostly mild to moderate

Regulatory Status

The FDA Fast Track designation was granted in 2020 to facilitate development and expedite review[@fda2020]. Green Valley has been conducting additional clinical trials to meet international regulatory requirements.

Comparison with Other AD Therapies

Research Pipeline

Ongoing Studies

• Global Phase 3 Trials: Planning or recruiting for international trials
• Combination Therapy: Studies exploring GV-971 combined with standard AD treatments
• Biomarker Studies: Investigating predictive biomarkers for treatment response
• Mechanism Studies: Further elucidation of gut-brain signaling pathways

Future Directions

See Also

• [Sodium Oligomannate (GV-971) — Drug Overview](/therapeutics/sodium-oligomannate)
• [Alzheimer's Disease](/diseases/alzheimers-disease)
• [Gut-Brain Axis in Neurodegeneration](/mechanisms/gut-brain-axis)
• [Amyloid Hypothesis](/mechanisms/amyloid-cascade)
• [Neuroinflammation in AD](/mechanisms/neuroinflammation)

Allen Brain Atlas Resources

• [Allen Brain Atlas - Gene Expression](https://human.brain-map.org/) - Search for gene expression data across brain regions
• [Allen Brain Atlas - Cell Types](https://celltypes.brain-map.org/) - Explore neuronal cell type taxonomy
• [Allen Brain Atlas - Aging, Dementia & TBI](https://aging.brain-map.org/) - Data on aging and traumatic brain injury

External Links

• [ClinicalTrials.gov - GV-971 Studies](https://clinicaltrials.gov/search?cond=Alzheimer+Disease&intr=GV-971)
• [Green Valley Pharmaceuticals](https://www.greenvalleypharma.com/)
• [Alzheimer's Association - Drug Treatments](https://www.alz.org/alzheimers_dementia_treatments.asp)

References

Pathway Diagram

The following diagram shows the key molecular relationships involving Sodium Oligomannate (GV-971) for Alzheimer's Disease discovered through SciDEX knowledge graph analysis: