Hormone · In Clinical Trials
Anamorelin (Adlumiz)
No lawful US pathway
01 · Overview
Anamorelin is an orally active ghrelin receptor agonist that acts at the growth hormone secretagogue receptor (GHS-R1a) to stimulate appetite, food intake, weight gain, and growth hormone secretion (PMID 40037850). It is a small-molecule (non-peptide) ghrelin mimetic developed for cancer anorexia and cachexia (PMID 30400622).
Its oral bioavailability differentiates it from injectable ghrelin.
02 · Research summary & key findings
In the phase 3 ROMANA 1 and ROMANA 2 trials in advanced non-small-cell lung cancer with cachexia, anamorelin increased lean body mass versus placebo over 12 weeks but did not improve handgrip strength (Lancet Oncol, 2016) (PMID 26906526). Regulatory decisions have varied internationally; it was approved in Japan in 2021 for cancer cachexia but is not FDA-approved (PMID 39740881, PMID 40037850). Japanese pharmacovigilance data show a signal for cardiac conduction defects, typically within about three weeks of starting treatment (PMID 39740881).
03 · Regulatory status
Anamorelin (Adlumiz) is currently undergoing clinical trials. It is not yet FDA-approved and is available only through clinical research settings or investigational protocols.
No lawful pathway today
Anamorelin (Adlumiz) is not FDA-approved and does not currently have a lawful prescription or compounding pathway in the United States, so there is nothing for us to sell you here and no consultation to book. That can change: in 2026 FDA began reviewing several peptides for compounding.
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Looking for a lawful, clinician-prescribed option for hormone optimization?
Anamorelin (Adlumiz) is still in clinical trials, is not FDA-approved, and has no lawful US compounding pathway, so we do not offer it and no clinician we work with will prescribe it. Products sold online as “research chemicals” are not made or tested to the standards required of medicines. If you are working on hormone optimization, a licensed clinician can tell you at a free consultation whether an FDA-approved or lawfully compounded treatment fits you, or whether nothing does.
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04 · Administration routes
- Oral
References
- [1]Anamorelin in patients with non-small-cell lung cancer and cachexia (ROMANA 1 and ROMANA 2): results from two randomised, double-blind, phase 3 trials Lancet Oncol, 2016. PMID 26906526
- [2]Efficacy of Anamorelin, a Novel Non-Peptide Ghrelin Analogue, in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) and Cachexia-Review and Expert Opinion Int J Mol Sci, 2018. PMID 30400622
- [3]Anamorelin and Conduction Defects: A Literature Review and Analysis of the Japanese Pharmacovigilance Database In Vivo, 2025. PMID 39740881
- [4]Anamorelin in the Management of Cancer Cachexia: Clinical Efficacy, Challenges, and Future Directions Anticancer Res, 2025. PMID 40037850
Primary literature
- PubMed: "Anamorelin"
Peer-reviewed literature indexed by the National Library of Medicine.
- ClinicalTrials.gov: "Anamorelin"
Registered interventional and observational studies, including status and phase.
- PubChem: "Anamorelin"
Chemical structure, molecular properties, and bioactivity data.
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