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GV-971 Sodium Oligomannate Capsules

NMPA Class I new drug

A new drug for Alzheimer's disease developed over 22 years, the world's first treatment for Alzheimer's disease with mechanism for brain-gut axis, filling the blank of the 17-year absence of new drugs in the AD field globally

Oligosaccharide compounds of marine origin

New mechanism of action targeting the brain-gut axis

GV-971 is an orally administered mixture of acidic linear oligosaccharides derived from marine brown algae that systematically treats the complex pathogenesis of Alzheimer’s disease with gut-brain axis

About GV-971

GV-971 (Sodium Oligomannate) is a first-in-class new drug for the treatment of Alzheimer's disease (AD) successfully developed by the research team led by Professor Meiyu-Geng, Deputy Director of the Shanghai Institute of Materia Medica (SIMM), Chinese Academy of Sciences(CAS), following persistent hard work over 22 years with the efforts successively made by Ocean University of China, the SIMM, and Shanghai Green Valley Pharmaceutical Co. Ltd. It is the world's first new drug for the treatment of Alzheimer's disease targeting the brain-gut axis. On November 2, 2019, GV-971 was approved by the NMPA through the priority review and approval process "for mild to moderate Alzheimer's disease and improving cognitive function in patients".

Filling the blank of the 17-year absence of new drugs in the AD field globally

Global Multi-Center Clinical Trial Accelerates Benefits to Patients Worldwide

In April 2020, the U.S. Food and Drug Administration (FDA) approved the IND for the global multi-center Phase III clinical trial of GV-971 (Sodium Oligomannate). The "Green Memory" global clinical trial of GV-971 will be conducted in approximately 200 study sites in 14 countries and regions, including a 52-week double-blind period and a 26-week open-label extension, and will include blood, microbiota and other biomarkers to further validate the unique mechanism of action of GV-971, and to determine the disease-modifying potential of the drug and its efficacy over a long term.

GV-971 R&D expedition

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2022

The study team discovered the active substance of GV-971 from marine brown algae
IND approval obtained from the NMPA
Phase I clinical study completed
Global development license obtained by Green Valley
Phase II clinical study completed
Phase III clinical study initiated
On June 22, the last patient out (LPO)
On July 17, Phase III clinical study unblinded
On October 18, the NDA submitted
On November 14, the NDA accepted by CDE
In Sep. mechanism of action published
On November 2, the NDA approved
On December 29, marketing of the new drug in China
On April 2, the IND of global phase III clinical trial approved in the U.S. by FDA
On February 4, the first patient dosed globally for GP3
On August 2, the first patient dosed in Greater China for GP3
On December 16, FDA approved IND application for GV-971 global multi-center phase-II clinical trial in the treatment of Parkinson's disease
On January 13, 2022, the US Food and Drug Administration issued a formal decision letter to approve the Investigational New Drug (IND) application for the international multi-center phase-II clinical study of GV-971 in Parkinson’s disease– the IND effective date is December 16, 2021.

GV-971 R&D Grants

Received funding from “863 Program”, National Natural Science Foundation of China, “973 Program”, National Science and Technology Major Project of China for “Significant New Drugs Development”, Strategic Priority Research Program of Chinese Academy of Sciences (Class A) and the Shanghai Science and Technology Program, etc.

The "Green Memory" global multi-center phase III clinical study of GV-971 is an in-depth research on the etiological mechanism of action to explore the potential for long-term disease modification

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