Pharmacological profile and clinical efficacy of anamorelin HCl (ADLUMIZ®Tablets), the first orally available drug for cancer cachexia with ghrelin-like action in Japan

Nakanishi Yasutomo, Higuchi Junya, Honda Naoki, Komura Naoyuki

doi:10.1254/fpj.21046

Bibliographic Information

Other Title

グレリン様作用を有する経口投与可能な日本初のがん悪液質治療薬　アナモレリン塩酸塩（エドルミズ®錠50 mg）の薬理学的特性と臨床効果
グレリン様作用を有する経口投与可能な日本初のがん悪液質治療薬アナモレリン塩酸塩(エドルミズ錠50mg)の薬理学的特性と臨床効果
グレリンヨウサヨウオユウスルケイコウトウヨカノウナニホンハツノガンアクエキシツチリョウヤクアナモレリンエンサンエン(エドルミズジョウ 50mg)ノヤクリガクテキトクセイトリンショウコウカ

Search this article

Description

Anamorelin hydrochloride (hereinafter referred to as anamorelin) is an orally active, small-molecule drug with a similar pharmacological action to ghrelin, an endogenous ligand of growth hormone secretagogue receptor type 1a (GHS-R_1a). It was first approved in Japan for the treatment of cancer cachexia, characterized by weight loss and anorexia. Anamorelin stimulated the secretion of growth hormone (GH) from cultured rat pituitary cells and increased plasma GH levels by oral administration to rats, pigs and humans. When anamorelin was orally administered once daily for 6 days to rats, larger body weight gain associated with increased food consumption compared to the control group was observed from after the first dose. Anamorelin is a selective agonist for GHS-R_1a and enhanced GHS-R_1a-mediated pituitary GH secretion and increased food consumption, resulting in body weight gain. In the two Japanese phase II studies in patients with cancer cachexia associated with non-small cell lung cancer (NSCLC), improvement of lean body mass (LBM) and body weight losses and anorexia were demonstrated. The tumor types of target patients in the Japanese phase III study were colorectal, gastric, and pancreatic cancer. As a result, maintenance and increase of LBM and body weight as well as improvement of anorexia were observed, and the efficacy against cancer cachexia associated with colorectal, gastric, and pancreatic cancer was confirmed. There were no observed events considered to be significant safety risks. In conclusion, anamorelin is expected to provide a new therapeutic option for cancer cachexia for which no effective treatment has been available.

Journal

Folia Pharmacologica Japonica

Folia Pharmacologica Japonica 156 (6), 370-381, 2021

The Japanese Pharmacological Society

Keywords

Details 詳細情報について

Export

Report a problem

Pharmacological profile and clinical efficacy of anamorelin HCl (ADLUMIZ<sup>®</sup>Tablets), the first orally available drug for cancer cachexia with ghrelin-like action in Japan