Nine Phase One (mannote sodium) / Shanghai Greenvalley - LARVOL DELTA

Beyond the Pancreas: The Gut Microbiota in Acute Pancreatitis - From Mechanisms to Therapeutic Perspectives. (PubMed, Clin Exp Gastroenterol) - "GV-971 is currently supported predominantly by preclinical experimental data...At present, microbiota-oriented management should prioritize evidence-based supportive measures, particularly early oral or enteral nutrition and rational antimicrobial use. Future studies should combine clinical outcomes with standardized microbiome, metabolome, barrier, and resistance endpoints to determine whether direct microbiota modulation can become a safe and reproducible component of personalized therapy."

Journal • Review • Inflammation • Metabolic Disorders • Pancreatitis • Transplantation

Multitargeted drug strategies for Alzheimer's and Parkinson's diseases. (PubMed, Z Naturforsch C J Biosci) - "A few potential candidates, such as GV-971, Prasinezumab, Huperzine A, curcumin derivatives, and hybrids of MAO-B inhibitors, have shown neuroprotective and cognitive effects in preclinical and clinical studies. However, there are still major obstacles to be overcome, such as the ability to cross the blood-brain barrier, optimizing the pharmacokinetics, the difficulties of transferring from the animal to the human model, and the complexity of the regulatory process. New strategies based on nanomedicine, biomarker-driven trials, personalized medicine, and drug repurposing will enhance therapeutic precision and clinical success."

Journal • Review • Alzheimer's Disease • CNS Disorders • Inflammation • Metabolic Disorders • Movement Disorders • Parkinson's Disease

Evaluating the cognitive efficacy of marine-derived drugs in Alzheimer's disease: A systematic review and Bayesian network meta-analysis. (PubMed, Ther Adv Neurol Disord) - "GV-971 and tramiprosate improved ADAS-Cog scores, while rifampicin therapy showed a possible MMSE benefit. However, no intervention was consistently superior across cognitive outcomes, and the antibiotic finding was based on a single small trial. Current evidence is therefore insufficient to identify the optimal marine-derived therapy for AD, highlighting the need for larger, adequately powered RCTs."

Journal • Retrospective data • Alzheimer's Disease • CNS Disorders • Dementia

Sodium oligomannate reduces cerebral infarction and improves neurological function through microbiota remodeling in MCAO/R rats. (PubMed, Front Pharmacol) - "On day 42, Barnes maze test results indicated that GV-971 treatment reduced the time required to locate the target hole from 76.45±17.41s to 31.03±20.75 s and 33.37±19.30 s for pre- and co-treatment, respectively. Taken together, GV-971 demonstrated neuroprotective potential in experimental ischemic stroke."

Journal • Preclinical • Alzheimer's Disease • Cardiovascular • CNS Disorders • Cognitive Disorders • Inflammation • Ischemic stroke • Transplantation

GV-971 remodels the gut microbiota-bile acid-FXR axis to ameliorate obesity and metabolic dysfunction. (PubMed, Cell Discov) - "Mechanistically, inhibition of intestinal FXR promoted thermogenic gene expression and white adipose tissue browning, thus enhancing systemic energy expenditure. These findings uncover a bacterium-metabolite-host signaling pathway underlying the effects of GV-971 and establish microbiota-directed FXR modulation as a promising therapeutic approach for obesity and metabolic disease."

Journal • Genetic Disorders • Metabolic Disorders • Obesity

Efficacy And Safety Of Sodium Oligomannate And AChEIs In Alzheimer's Disease: A Meta-analysis With Meta-regression And TSA (AAIC 2026) - No abstract available

Retrospective data • Alzheimer's Disease • CNS Disorders

GV-971 Ameliorates Chronic Restraint Stress-Induced Depression-like Phenotypes Accompanied by Reshaping of the Microbiota-Gut-Brain Axis. (PubMed, Mar Drugs) - "Fecal microbiota transplantation (FMT) from GV-971-treated donors partially recapitulated the antidepressant and gut-protective effects in CRS recipients, confirming a causal role for the remodeled microbiota. Collectively, GV-971 exerts antidepressant effects by coordinately remodeling the gut microbiota, normalizing tryptophan and SCFA metabolism, restoring gut barrier integrity, and dampening central neuroinflammation, supporting its potential as a novel gut-brain axis-targeted therapy for depression."

Journal • CNS Disorders • Depression • Inflammation • Mood Disorders • Psychiatry • Transplantation

Network meta-analysis of the efficacy of nine drugs for cognitive function in patients with Alzheimer's disease. (PubMed, J Alzheimers Dis Rep) - "We systematically searched randomized controlled trials published up to May 2025 that evaluated aducanumab, lecanemab, donanemab, gosuranemab, semorinemab, tilavonemab, zagotenemab, masupirdine, or sodium oligomannate in AD. Tau-targeted antibodies (semorinemab, tilavonemab) display modest but non-significant promise, whereas aducanumab's apparent benefit is likely confounded by publication bias. Further large, rigorous randomized controlled trials and improved preclinical models are essential."

Journal • Retrospective data • Review • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

SEX-SPECIFIC MODULATION OF AD-LIKE PHENOTYPES BY THE GUT MICROBIOME IN MOUSE MODELS (ADPD 2026) - "Our studies reveal that ABX- and GV-971-mediated attenuation of Ab and deposition and alterations in microglial biology occurs in a sex-specific manner and that in females, ovarian hormones play a central role in counteracting the beneficial effects of ABX- or GV-971 on neuropathology that are observed in males. Acknowledgments: This work was supported by Cure Alzheimer's Fund (CAF), Open Philanthropy Fund, Bright Focus Foundation, Alzheimer's Association, Good Ventures Foundation, Creative Minds Care Foundation and Luminescence Foundation. SSS is a paid consultant of Amylogenyx Inc."

Preclinical • Alzheimer's Disease • Amyloidosis • CNS Disorders • Inflammation

Comparative assessment of donepezil memantine and sodium oligomannate on cognitive decline and neuroinflammation in early Alzheimer's disease. (PubMed, Pak J Pharm Sci) - "Memantine and sodium oligomannate outperform donepezil in improving cognitive function and neuroinflammation, with sodium oligomannate suggesting the best effect on neuroinflammation. This study provides a scientific basis for optimizing early AD medication."

Journal • Alzheimer's Disease • CNS Disorders • Inflammation • Oncology • Aβ42 • CXCL8 • IL6 • TNFA

Treatment of animal models of Alzheimer's disease with extracellular vesicles or exosomes and involvement of microRNAs. (PubMed, Neural Regen Res) - "Conventional treatments focus on symptom management through acetylcholinesterase inhibitors, such as donepezil, galantamine, and rivastigmine, and the N-methyl-D-aspartate receptor antagonist memantine. However, the past few years have seen the approval of newer agents such as sodium oligomannate, aducanumab, and lecanemab, which show some promise in slowing disease progression...Loading extracellular vesicles and exosomes with microRNA mimics (e.g., miR-22, -29b, -124, -132, -138-5p, -342-5p, -711, and -7670-3p) or antagomirs (e.g., miR-206-antagomir) improved outcomes in animal models of Alzheimer's disease. Supporting results were found in the in vitro cell studies reviewed."

Journal • Preclinical • Alzheimer's Disease • CNS Disorders • Dementia • Inflammation • Vascular Neurology • MIR206 • MIR22

Basic Science and Pathogenesis. (PubMed, Alzheimers Dement) - "These findings highlight the mechanism of sodium oligomannate on Alzheimer's disease."

Journal • Alzheimer's Disease • CNS Disorders • Inflammation • Aβ42 • STING

Sodium oligomannate modulates the gut-brain axis to alleviate post-stroke cognitive impairment by restoring butyrate metabolism. (PubMed, Microbiome) - "Intestinal butyrate levels are significantly associated with PSCI. GV-971 mitigates post-stroke cognitive decline by modulating the gut microbiota to increase butyrate production, highlighting its potential as a therapeutic agent for PSCI."

Journal • Alzheimer's Disease • Cardiovascular • Cognitive Disorders • Inflammation • Transplantation • HDAC3

Efficacy of mannate sodium (GV-971) in the treatment of behavioral and psychological symptoms of in patients with mild to moderate Alzheimer's disease (ChiCTR) - P=N/A | N=120 | Not yet recruiting | Sponsor: The Fourth People's Hospital of Chengdu; The Fourth People's Hospital of Chengdu

New trial • Alzheimer's Disease • CNS Disorders

The Role of Lipoprotein and Gut Microbiome in Alzheimer's Disease: A Review of Novel Findings and Potential Applications. (PubMed, Curr Alzheimer Res) - "Novel therapies targeting lipoproteins, such as ALZ-801 and IDOL inhibitors, show promise in preclinical and clinical trials...Interventions, like probiotics, GV-971, and polyphenols, demonstrate efficacy in restoring microbial balance and mitigating cognitive decline...Integrating insights into lipoprotein biology and gut microbiota dynamics may offer transformative potential for AD treatment, emphasizing combinatorial approaches to modulate these interconnected pathways. Further research is warranted to elucidate mechanistic links and translate preclinical findings into clinical applications."

Journal • Alzheimer's Disease • CNS Disorders • Inflammation • Metabolic Disorders • APOE

Study on the improvement of cognitive deficits in APP/PS1 mice by danggui shaoyao san and its disassembled prescriptions through modulation of the gut microbiota. (PubMed, Front Microbiol) - "Forty APP/PS1 and eight C57BL/6 mice were divided into six groups: DSS (6.4 g/kg/d), QDW (4.6 g/kg/d), DW (1.8 g/kg/d), GV971 (positive control, 40 mg/kg/d), model (saline), and control (saline)...Danggui Shaoyao San and its disassembled prescriptions ameliorate AD-related cognitive impairment and gut dysbiosis, enhance microbial diversity, and modulate metabolic pathways, supporting their therapeutic potential via gut-brain axis regulation. This study elucidates the multi-target mechanisms of DSS in AD treatment, advancing TCM rationalization for neurodegenerative disorders."

Journal • Preclinical • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Mood Disorders • Psychiatry

Chinese authorities did not renew a conditional approval of Green Valley Pharmaceuticals’ controversial Alzheimer’s disease drug sodium oligomannate, also known as GV-971... (Fierce Pharma) - "As part of its routine disclosure of regulatory activities on Aug. 12, China’s National Medical Products Administration (NMPA) put its responses to Green Valley’s applications to turn GV-971’s conditional nod into a full approval in a group marked 'notification delivery' but not the 'approval document delivery' list. This move suggests that the drug did not get approval....The exact reason for the rejection is unclear."

China approval • Alzheimer's Disease

Efficacy and Safety of Sodium Oligomannate in the Prevention of PSCI (clinicaltrials.gov) - P=N/A | N=116 | Recruiting | Sponsor: Nanfang Hospital, Southern Medical University | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2023 ➔ Dec 2025 | Trial primary completion date: Dec 2023 ➔ Dec 2025

Enrollment open • Trial completion date • Trial primary completion date • Cardiovascular • Cognitive Disorders • Ischemic stroke

Chinese Firm Halts Production of Controversial Alzheimer’s Drug (Bloomberg) - "A Chinese company that developed the country’s first indigenous therapy for Alzheimer’s disease has suspended production and sales of the drug, casting doubts on the treatment’s future. The drug’s license has expired and its renewal is now in the final stages of a regulatory review, during which it must stop commercial production and sales, Green Valley Pharmaceutical Co. said in an emailed statement to Bloomberg News on Tuesday....Green Valley’s drug - a seaweed-derived compound known as sodium oligomannate, or GV-971 - was hailed as a major advance when China’s drug regulator gave it conditional approval in 2019....Local and international medical experts have since questioned how effective it really is in slowing or reversing the cognitive declines of Alzheimer’s patients given the relatively short duration of - and the inconsistent results shown in - its late-stage clinical trial in China."

Commercial • Alzheimer's Disease

Screening and Intervention Study of Preclinical Alzheimer's Disease Cohort (ChiCTR) - P=N/A | N=2300 | Recruiting | Sponsor: The Affiliated GuangdongSecond Provincial GeneralHospital of Jinan University; The Affiliated GuangdongSecond Provincial GeneralHospital of Jinan Univ

New trial • Alzheimer's Disease • CNS Disorders

Sodium oligomannate disrupts the adherence of Ribhigh bacteria to gut epithelia to block SAA-triggered Th1 inflammation in 5XFAD Alzheimer's disease mouse (IMMUNOLOGY 2025) - "to gut epithelia via directly binding to Rib, which corrected the excess lactate, reduced SAA, and alleviated Th1-skewed inflammation. Together, we gained further insights between gut bacteria and AD progression and the mechanism of sodium oligomannate in treating AD.Keywords: Animals Rodent; Cells Th1/Th2 Cells; Infections Bacterial; Molecules Acute Phase Reactants; Tissues Mucosa"

Adherence • Preclinical • Alzheimer's Disease • CNS Disorders • Gastrointestinal Disorder • Infectious Disease • Inflammation

One evaluated mannute sodium capsule (GV-971) long-term Clinical studies of safety (ChiCTR) - P=N/A | N=2500 | Completed | Sponsor: Huashan Hospital, Fudan University; Huashan Hospital, Fudan University

New trial • Cognitive Disorders

SEX-SPECIFIC MODULATION OF AD-TYPE PATHOLOGY BY PERTURBATIONS OF THE GUT MICROBIOME (ADPD 2025) - "Our studies reveal that ABX- and GV-971-mediated attenuation of Aß and deposition and alterations in microglial biology occurs in a sex-specific manner and that in females, ovarian hormones play a central role in counteracting the beneficial effects of ABX- or GV-971 on neuropathology that are observed in males."

Amyloidosis • Inflammation

Polymers for the treatment of Alzheimer's disease. (PubMed, Front Pharmacol) - "Moreover, many polymers with inherent therapeutic properties have been developed, including the already marketed GV-971 as well as experimental polymers such as PLGA and CS oligosaccharide. This review summarizes the applications of polymers in AD treatment over the past few years and highlights their current limitations to help researchers better understand current advancements in polymer development and identify future research directions."

Journal • Review • Alzheimer's Disease • CNS Disorders • Oncology • Psychiatry

Multi-Targeting Phytochemicals for Alzheimer's Disease. (PubMed, Phytother Res) - "Food and Drug Administration in the United States has authorized various drugs for the effective treatment of AD, which include galantamine, rivastigmine, donepezil, memantine, sodium oligomannate, lecanemab, and aducanumab. It could be concluded that phytochemicals light serve as an effective therapy for AD. However, more mechanistic investigations are needed to determine the clinical implications of phytochemicals in AD treatment."

Journal • Review • Alzheimer's Disease • CNS Disorders • Inflammation