Lotuzol is a new herbal drug composing water extract powder of Nelumbinis Semen to treat depression without sexual dysfunction, a major adverse effect in commonly used anti-depressants.

Rapid anti-depression effect through recovery of 5-HT1A binding activity. Increase of 5-HT, serotonin's release in hippocampus of rats under normal condition and CMS condition. Increase of protein le

Lotuzol is a new herbal drug composing water extract powder of Nelumbinis Semen to treat depression without sexual dysfunction, a major adverse effect in commonly used anti-depressants. Recent brief clinical trial shows that Lotuzol has an effective anti-depression effect in mild depressed patients without distinct adverse effects. Lotuzol has obtained IND approval for Phase IIb clinical trials in Korea. Lotuzol is currently in Phase IIb clinical trials in Korea for the treatment of mild and moderate depressions and listed as a complementary medicine in Australia. Lotuzol is formulated as a film-coated, oval and white color tablet for oral administration. Lotuzol is indicated for major depression in Phase II clinical trial of Korea and it is listed for indication as “The Chinese medicine has been traditionally used to help relieve nervous tension, stress and mild anxiety” in TGA, Australia. Lotuzol has fast and reliable anti-depression effects and minimized adverse effects: No sexual dysfunction, No insomnia, No weight loss. Lotuzol has other therapeutic effect such as reduction of cardiovascular disorder. In double-blind, randomized, placebo-controlled clinical trial of Lotuzol in 46 mild depressed patients for two weeks in Catholic University Medical Center in Seoul, Korea, there were significant reductions of Beck’s Depression Inventory (BDI) scores, its subscale scores of BDI A, a score for negative attitudes towards self and C, a score for somatic disturbances, and Stress Response Inventory (SRI) scores, its subscale score of SRI E, a score for depression, compared to placebo group. Also, occurrence rates of adverse effects are very low and grades of the adverse effects are very minimal in that clinical trial. In FST, immobility time in rats was significant reduced with treatment of Lotuzol and faster anti-depression effect, compared to fluoxetin and St. John’s Wort. In open field test, various damaged behaviors of animals under CMS were recovered, reduced sucrose intake recovered and sexual dysfunction recovered. While heart dysfunction induced by ischemia was recovered. In its mechanism, Lotuzol showed rapid anti-depression effect through recovery of 5-HT1A binding activity, recovery of decreased 5-HT1A binding in hippocampus, hypothalamus and frontal cortex of rats under CMS, increase of 5-HT, serotonin’s release in hippocampus of rats and increase of protein level involved in anti-depression effects under normal condition and CMS condition. In pharmacokinetics, there was not much effects on CYP450 enzymes, which indicates safety of Lotuzol. In toxicology, Minimal Lethal Dose (MLD) was found as 10 g/kg and NOAEL as 4 g/kg. In stability of Lotuzol, there wereno significant change in finished products through tests of description, weight variation, identification, content, heavy metal limit, disintegration and microbe limit at room temperature 25±2℃ and relative humidity 60±5% for 6 monthsandin finished products through same tests as long-term store test at temperature 40±2℃ and relative humidity 75±5% for 6 months.

Phase II

Issued patents for Lotuzol in the present in Korea

 

 

 

Applied patents for Lotuzol in the present

 

 

 

Issued patents for Lotuzol in the present in Australia

 

Title: EXTRACT OF NELUMBINIS SEMEN FOR THE TREATMENT OF DEPRESSION, MEDICINAL COMPOSITE AND HEALTH FOODS INCLUDING THE EXTRACT OF NELUMBINIS SEMEN

Patent number: 2005260339

Issued date: 01/17/2008

 

Issued patents for Lotuzol in the present in Korea as anti-ischemic heart disease agent

 

Title: NELUMBINIS SEMEN EXTRACT FOR PREVENTING AND TREATING ISCHEMIC HEART DISEASE AND PHARMACEUTICAL COMPOSITION AND HEALTH FOOD CONTAINING THE SAME

Patent number: 672951

Issued date: 01/16/2007

 

Applied patents for Lotuzol in the present in other countries as anti-ischemic heart disease agent

 

Title: NELUMBINIS SEMEN EXTRACT FOR PREVENTING AND TREATING ISCHEMIC HEART DISEASE AND PHARMACEUTICAL COMPOSITION AND HEALTH FOOD CONTAINING THE SAME

Applied countries: PCT, USA, Japan, Australia, Europe

Applied patent number: PCT/KR05/001739, 11/570,331, 2007-527009, 2005251640, 05765041.8

Applied date: 06/09/2005, 12/08/2006, 12/08/2006, 01/02/2007, 01/09/2007

 

 

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