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HormoneFDA Approved

Anamorelin (Adlumiz)

Overview

Anamorelin is an orally active selective ghrelin receptor agonist designed to stimulate appetite and promote anabolic processes by mimicking endogenous ghrelin at the growth hormone secretagogue receptor (GHS-R1a). The small-molecule peptidomimetic increases growth hormone and IGF-1 secretion while enhancing food intake and lean body mass, targeting the muscle wasting and cachexia associated with chronic illness. Its oral bioavailability and receptor selectivity differentiate it from earlier injectable ghrelin analogues.

Key Research Findings

Phase 3 trials (ROMANA 1 and 2) in patients with cancer cachexia, published in Journal of Clinical Oncology (2016), demonstrated significant increases in lean body mass but did not meet co-primary endpoints for handgrip strength, leading to a complete response letter from the FDA in 2017. Anamorelin received conditional approval in Japan in 2021 under the trade name Adlumiz for cancer cachexia, representing the first ghrelin receptor agonist approved for human use in any jurisdiction.

Route of Administration

Oral

Regulatory Status

FDA Approved

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