Sodium Oligomannate capsule (GV-971, also known as Sodium Oligo-mannurarate , by Shanghai Greenvalley Pharmaceutical Co., Ltd.), the innovative drug for treatment of Alzheimer’s disease was conditionally approved by China NPMA in Nov 02, 2019. The launch of sodium oligomannate capsule fills the gap of Alzheimer’s disease medicine absence for 16 years. International multi centered Phase III clinical trial is started in the United Stated following the most recent report. GV-971 Sodium Oligomannate is now available for sale in China, cost is around 500 USD per month.
Alzheimer’s disease drug is a global difficulty
Long-March-of-Sodium-OligomannateTremendous scientific efforts are dedicated into Alzheimer’s disease innovative drug development. However, A report shows that 146 Alzheimer’s disease drugs worldwide have failed clinically from 1998 – 2017, and only 6 drugs have been successfully marketed in the past 30 years.
- Tacrine approved in 1993
- Donepezil approved in 1996
- Kabbalah approved in 2000
- Galantamine approved in 2001
- Memantine hydrochloride approved in 2003
- Memantine/donepezil compound approved in 2014
Long March of Sodium Oligomannate (GV-971)
Following the milestones from Green Valley official website, it takes more than 20 years before the launch of GV-971 on China market.
Following the public information of Sodium Oligomannate development, it takes more than 20 years before the launch of GV-971 on China market.
Potential drug activity is found by Prof. Geng in 1997. It takes 10 years before clinical trail registration completed in 2006. The phase I clinical trail, phase II clinical trail and phase III clinical trail are completed in China in 2008, 2013 and 2018. Sodium Oligomannate was official approved by China NMPA, official launched China market in 2019. It is 23 years since the founded date.
Sodium Oligomannate is a complex structure isolated from seaweed. Present research shows that gut dysbiosis and inflammation in the brain have close relationship. Brain disorders such as Alzheimer’s disease might caused by that. A large group of microorganisms living in the gut symbiotically with the host, sodium oligomannate works by restoring the normal pattern of gut microbiot. Prof. Meiyu Geng and coworker explains in a recent published paper in Cell Research. [1]Cell Research volume 29, pages787–803(2019),Sodium oligomannate therapeutically remodels gut microbiota and suppresses gut bacterial amino acids-shaped neuroinflammation to inhibit Alzheimer’s … Continue reading
Sodium Oligomannate controversy
From the date of approval, Sodium Oligomannate has also been questioned due to different pharmacological factors and insufficient experimental data.
Prof. Yi Rao published a paper in Cell Research suggesting that there is an omission of citation of 12 previous publications about GV-971 paper.[2]Cell Research volume 30, page819(2020),Omission of previous publications by an author should be corrected And Prof. Meiyu Geng and coworker states disagreement, and claim that the team have committed decade-long efforts to better understand the molecular mechanisms and therapeutic utility of GV-971[3]Cell Research volume 30, page820(2020), Geng et al. reply.
By now, the International multi centered Phase III clinical trial is under process. How the most strict drug evaluation system judges this Alzheimer’s disease medicine? PharmArch will follow the progresses of Sodium Oligomannate.
References
| ↑1 | Cell Research volume 29, pages787–803(2019),Sodium oligomannate therapeutically remodels gut microbiota and suppresses gut bacterial amino acids-shaped neuroinflammation to inhibit Alzheimer’s disease progression |
| ↑2 | Cell Research volume 30, page819(2020),Omission of previous publications by an author should be corrected |
| ↑3 | Cell Research volume 30, page820(2020), Geng et al. reply |
