Toei Shinyaku confirms in human clinical trials that outdoor-grown Agaricus KA21 strain improves male menopausal symptoms (ED, decreased libido, etc.), obtains patent | Toei Shinyaku Co., Ltd.

Toei Shinyaku Co., Ltd. (location: Mitaka City, Tokyo, CEO: Akitomo Motoi) has confirmed in human clinical trials that ingestion of the open-grown Agaricus KA21 strain focuses on improving symptoms related to andropause (LOH syndrome), such as decreased sexual desire, erectile dysfunction (ED), depression, and muscle weakness.

■About patent acquisition

Toei Shinyaku Co., Ltd., through joint research with Shigakukan Shigakukan University, Faculty of Health Sciences, has confirmed that intake of open-field cultivated Agaricus KA21 strain may focus on improving multiple symptoms associated with andropause.

Based on the results of this research, we are pleased to announce that we have been granted a patent by the Japan Patent Office for “compositions for improving male menopausal symptoms such as decreased sexual desire, erectile dysfunction (ED), depression, and muscle weakness, as well as pharmaceuticals, food and beverages containing the compositions for preventing and improving male menopausal symptoms.”

■Summary

Patent No. 7818243

Patent application 2024-109541

July 8, 2024 (Reiwa 6)

February 12, 2026 (Reiwa 8)

Takanori Tada, Akitomo Motoi

Toei Shinyaku Co., Ltd., Shigakukan Educational Corporation

Compositions for improving male menopausal symptoms such as decreased sexual desire, erectile dysfunction (ED), depression, and muscle weakness, and pharmaceuticals and foods containing the same for preventing and improving male menopausal symptoms

This patent is for the open-field cultivated Agaricus KA21 strain, which has been confirmed in human clinical trials to improve ED and andropause symptoms.

Patent certificate of patent No. 7818243 regarding the improvement effect of male menopausal disorder

■Summary of human clinical trial data

We asked 24 men aged 50 to 70 to take 900 mg of open-grown Agaricus KA21 strain per day for 2 months, and compared the indicators associated with male menopausal symptoms by drinking the drugs in order.

As a result, statistically conscious improvements were confirmed for the following evaluation indicators.

The results of this study were presented at the 25th General Meeting of the Japanese Society of Anti-Aging Medicine.

AMS score (comprehensive evaluation index of andropause symptoms)***

EHS score (durability hardness evaluation)*

SHIM score (male sexual health evaluation index)*

Hair loss condition *

*P<0.05, ***P<0.001

■About male menopause

Testosterone, a male hormone, plays an important role in maintaining men’s physical and mental functions. It is closely related to sarcopenia, a condition such as loss of muscle mass and muscle weakness, and there are concerns about the causes and preventive effects of a wide range of diseases, including angina pectoris, arteriosclerosis, obesity, metabolic syndrome, and dementia. This is called onset hypogonadism (LOH syndrome).

Aging male hypogonadism syndrome (LOH) causes a variety of symptoms, including general fatigue, decreased sexual desire, lack of motivation, erectile dysfunction (ED), decreased concentration, insomnia, irritability, stiff shoulders, urinary problems, a heavy head, and decreased awakening in the early morning. Decreased telone levels increase the risk of a variety of health problems, including depression, decreased sexual function, decreased cognitive performance, cardiovascular disease, increased visceral fat, worsened insulin resistance, decreased good cholesterol (HDL), and increased total sterol and bad cholesterol (LDL) levels.

(From the Japan Men’s Health Medicine Association website)

https://jsmh.jp/loh/

■About Agaricus

Agaricus is a type of mushroom that has been used as a health food in complementary and alternative medicine, and it is known that its component characteristics and quality vary greatly depending on the strain, cultivation conditions, and region of production.

■Brazilian outdoor cultivation Agaricus KA21 strain (Agaricus KA21)

The open-field cultivated Agaricus KA21 strain is an agaricus grown outdoors under sunlight using the King Agaricus 21 (KA21) strain in Brazil. Compared to greenhouse-grown Agaricus, which is generally grown in a dark place, Agaricus has been confirmed not only to have larger fruiting bodies, but also to contain more of its main components, β-glucan and vitamin D (*1).

Toei Shinyaku Co., Ltd.’s open-field cultivated Agaricus KA21 (commonly known as King Agaricus)

Differences in Agaricus size Left: General greenhouse cultivation Right: Agaricus grown outdoors

Differences in the content of the main component β-glucan

Difference between vitamins and minerals

In addition, it has been reported that the antioxidant activity of Agaricus KA21 strain grown outdoors is more than 5 times higher than that of the greenhouse-grown product (*2), suggesting that differences in the cultivation environment may have an impact on component characteristics and focused functions.

Differences in antioxidant activity

*1 According to research by Japan Food Research Center

*2 International Medicinal Mushroom Journal, 2019. 21(3):31-43

■About Toei Shinyaku Co., Ltd.

Toei Shinyaku Co., Ltd., as a manufacturer of the open-field cultivated Agaricus KA21 strain, has conducted research and development on the KA21 strain for 30 years and published more than 34 international papers.

We have a track record of joint research with Azabu University School of Veterinary Medicine, Keio University SFC Research Institute, National Center for Geriatrics and Gerontology, Shigakukan University Faculty of Health Sciences, Juntendo University School of Medicine, University of Tokyo Food Safety Research Center, Tokyo Pharmaceutical University Faculty of Pharmaceutical Sciences Department of Immunology, and have published a variety of useful data on the open-field cultivated Agaricus KA21 strain.

■Company overview

Brand name: Toei Shinyaku Co., Ltd.

Head Office: 1-11-23 Shimorenjaku, Mitaka City, Tokyo

Representative Director: Akitomo Motoi

Capital: 10 million yen

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