HormoneFDA Approved

Anamorelin (Adlumiz)

Oral

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.

Mechanism of Action

Its oral bioavailability and receptor selectivity differentiate it from earlier injectable ghrelin analogues..

Research Summary & Key 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.

Clinical Status

FDA Approved

Anamorelin (Adlumiz) has received FDA approval and is available for clinical use under appropriate medical supervision. Consult a qualified healthcare provider for prescribing information.

Administration Routes

Oral

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Disclaimer: This information is provided for educational and research purposes only. It is not intended as medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider before starting any peptide therapy. The Peptide Association does not endorse or recommend any specific treatment protocol.