Toei Shinyaku Obtains Patent After Confirming Improvement of Andropause Symptoms (ED, Decreased Libido, etc.) Through Human Clinical Trial of Outdoor-Cultivated Agaricus blazei KA21 Strain

Toei Shinyaku Co., Ltd. (Head Office: Mitaka City, Tokyo; President & CEO: Akitomo Motoi) has confirmed through a human clinical trial that intake of the outdoor-cultivated Agaricus KA21 strain contributes to improvement of symptoms associated with male menopause (Late-Onset Hypogonadism; LOH syndrome), including decreased libido, erectile dysfunction (ED), depressive mood, and reduced muscle strength.

Based on these findings, the Company has obtained a patent covering these effects. This patent is expected to support applications in men’s health supplements, protein products, beverages, and related formulations.

■ Patent Acquisition

Through joint research with the Faculty of Health Sciences, Shigakukan University, Toei Shinyaku confirmed the potential of outdoor-cultivated Agaricus KA21 to improve multiple symptoms associated with male menopause.

Based on these research results, the Company has obtained a patent from the Japan Patent Office titled:

“Composition for Improving Male Menopausal Symptoms Including Decreased Libido, Erectile Dysfunction (ED), Depressive Mood, and Reduced Muscle Strength, and Pharmaceutical and Food/Drink Products for Prevention or Improvement of Male Menopausal Symptoms Containing the Same.”

This patent specifically covers the outdoor-cultivated Agaricus KA21 strain whose efficacy in improving ED and male menopausal symptoms has been confirmed through human clinical trials.

■ Patent Overview

Patent Number: Patent No. 7818243

Patent Application Number: 2024-109541

Filing Date: July 8, 2024

Registration Date: February 12, 2026

Inventors: Takanori Tada, Akitomo Motoi

Applicants: Toei Shinyaku Co., Ltd.; Shigakukan Educational Corporation

Title of the Invention

Composition for Improving Male Menopausal Symptoms Including Decreased Libido, Erectile Dysfunction (ED), Depressive Mood, and Reduced Muscle Strength, and Pharmaceutical and Food/Drink Products for Prevention or Improvement of Male Menopausal Symptoms Containing the Same.

Patent No. 7818243 on the improvement of Andropause symptoms

■ Overview of Human Clinical Trial Data

A total of 24 men aged 50 to under 70 years consumed 900 mg per day of outdoor-cultivated Agaricus KA21 for two months. Indicators related to male menopausal symptoms were compared before and after intake.

The following evaluation indices showed statistically significant improvement:

AMS Score (Aging Male Symptoms scale – comprehensive symptom evaluation) ***

EHS Score (Erection Hardness Score) *

SHIM Score (Sexual Health Inventory for Men) *

Hair Loss Condition *

*P < 0.05, ***P < 0.001

These results were presented at the 25th Annual Meeting of the Japanese Society of Anti-Aging Medicine.

■ About Male Menopause (LOH Syndrome)

Testosterone plays a vital role in maintaining both physical and mental functions in men. However, testosterone levels gradually decline with age and are also affected by lifestyle factors and stress.

Reduced testosterone levels are closely associated with muscle loss and decreased strength (sarcopenia) and may influence the onset or prevention of various diseases, including angina, arteriosclerosis, obesity, metabolic syndrome, and dementia.

This condition is known as Late-Onset Hypogonadism (LOH syndrome). It has been reported that approximately 10% of middle-aged working men experience symptoms of male menopause, with onset often occurring in the late 40s. LOH is gaining attention from both social and economic perspectives.

Common symptoms include:

General fatigue

Decreased libido

Reduced motivation

Erectile dysfunction (ED)

Difficulty concentrating

Insomnia

Irritability

Shoulder stiffness

Urinary issues

Heavy-headed feeling

Reduced morning erections

Testosterone decline is also associated with increased risk of depression, sexual dysfunction, cognitive decline, cardiovascular disease, visceral fat accumulation, insulin resistance, decreased HDL cholesterol, and increased total and LDL cholesterol.

(Source: Japanese Society for Men’s Health)

https://jsmh.jp/loh/

■ About Agaricus

Agaricus is a mushroom widely used in the field of complementary and alternative medicine as a health food ingredient. Its composition and quality vary significantly depending on strain, cultivation conditions, and origin.

■ Outdoor-Cultivated Brazilian Agaricus KA21 (Agaricus KA21)

Outdoor-cultivated Agaricus KA21 is grown in Brazil using the King Agaricus 21 (KA21) strain under natural sunlight conditions.

Compared to conventional indoor (house-cultivated) Agaricus grown in dark environments, outdoor-cultivated Agaricus KA21:

Develops larger fruiting bodies

Contains higher levels of β-glucan (its primary active component)

Contains higher levels of vitamin D (*1)

Outdoor culticated King Agaricus KA21 by Touei Shinyaku Co.Ltd.

Difference in size of agaricus 

Left: Indoor / house-grown, Right:Outdoor cultivated agaricus

Difference in content of β-glucan, the main component

Difference in vitamins and minerals

Additionally, it has been reported that outdoor-cultivated KA21 exhibits more than five times higher antioxidant activity compared to indoor-cultivated products (*2), suggesting that cultivation environment significantly influences functional properties.

Difference in antioxidant activity

*1 Japan Food Research Laboratories*2 International Journal of Medicinal Mushrooms, 2019; 21(3): 31–43

■ About Toei Shinyaku Co., Ltd.

Toei Shinyaku Co., Ltd., as the manufacturer of outdoor-cultivated Agaricus KA21, has conducted over 30 years of research and development on the KA21 strain and has published 34 international academic papers.

The Company has collaborated with:

Azabu University (Faculty of Veterinary Medicine)

Keio University SFC Research Institute

National Center for Geriatrics and Gerontology

Shigakukan University (Faculty of Health Sciences)

Juntendo University (Faculty of Medicine)

The University of Tokyo (Food Safety Research Center)

Tokyo University of Pharmacy and Life Sciences (Department of Immunology)

These collaborations have generated extensive scientific data supporting outdoor-cultivated Agaricus KA21.

■ Company Profile

Company Name: Toei Shinyaku Co., Ltd.

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

Representative: Akitomo Motoi, President & CEO

Capital: JPY 10,000,000