What is Anamorelin (non-peptide)?

An oral ghrelin-receptor agonist approved in Japan (Adlumiz) for cancer cachexia; it raises GH and IGF-1 and increases appetite and lean mass.

Anamorelin (non-peptide) in the library · Metabolic & Weight Peptides · Human Trials · What are peptides?

11 registered trials · 13 indexed papers · 9 human / 1 animal studies

From the PeptideWhiz library entry. "As described" sections summarize claims made in the sources; they are not PeptideWhiz endorsements.

What it is

Anamorelin is described as a small-molecule oral ghrelin mimetic, in the same receptor class as ipamorelin and MK-677.

Mechanism (as described)

  • It activates the ghrelin receptor (GHS-R1a), raising growth hormone and IGF-1 and stimulating appetite.

Evidence (as described)

  • The phase 3 ROMANA 1 and 2 trials in lung-cancer cachexia reported increases in lean body mass but no improvement in handgrip strength (Temel et al., 2016). Japanese use is reviewed by Wakabayashi et al., 2023.

Status

Approved in Japan (2021) for cancer cachexia. Not FDA- or EMA-approved (EMA refused it in 2017).

Registered human trials (11)

TrialPhaseStatusYearEnrolled
Anamorelin Study for Advanced Pancreatic CancerPhase 2terminated20234
A Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) - 1Phase 3completed2019318
A Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) - 2Phase 3completed2019318
Effect of a Ghrelin Receptor Agonist on Muscle and BonePhase 1completed201932
Anamorelin Hydrochloride in Reducing Anorexia in Patients With Advanced Non-small Cell Lung CancerPhase 2/Phase 3active not recruiting201825
Anamorelin Hydrochloride, Physical Activity, and Nutritional Counseling in Decreasing Cancer-Related Fatigue in Patients With Incurable Metastatic or Recurrent Solid TumorsPhase 2active not recruiting2017129
The Role of Ghrelin in Cancer CachexiaPhase 2terminated201210
Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 1)Phase 3completed2011484
Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 2)Phase 3completed2011495
Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study (ROMANA 3)Phase 3completed2011513
Dose Range Study of Anamorelin in Patients With Non-small Cell Lung CancerPhase 2completed2008228

Peer-reviewed studies (13)

PaperAuthorsJournalYearType
Targeting Cancer Cachexia: A Mechanistic Evaluation of Anti-GDF-15 Antibody-Based Combination TherapiesBreen DM et al.Journal of cachexia, sarcopenia and muscle2026Clinical Trial, Phase III
Efficacy and safety of anamorelin in patients with metastatic urothelial carcinoma receiving systemic chemotherapy: a randomized controlled studyOdagiri K et al.The oncologist2025Randomized Controlled Trial
Anamorelin Efficacy in Non-Small-Cell Lung Cancer Patients With Cachexia: Insights From ROMANA 1 and ROMANA 2Laird BJA et al.Journal of cachexia, sarcopenia and muscle2025Randomized Controlled Trial
Efficacy and safety of anamorelin in patients with cancer cachexia: Post-hoc subgroup analyses of a placebo-controlled studyTakayama K et al.Cancer medicine2023Randomized Controlled Trial
A multicenter, open-label, single-arm study of anamorelin (ONO-7643) in patients with cancer cachexia and low body mass indexNaito T et al.Cancer2022Clinical Trial
Appetite and food intake results from phase I studies of anamorelinBlum RA et al.Journal of cachexia, sarcopenia and muscle2019Randomized Controlled Trial
Anamorelin (ONO-7643) for the treatment of patients with non-small cell lung cancer and cachexia: Results from a randomized, double-blind, placebo-controlled, multicenter study of Japanese patients (ONO-7643-04)Katakami N et al.Cancer2018Randomized Controlled Trial
ROMANA 3: a phase 3 safety extension study of anamorelin in advanced non-small-cell lung cancer (NSCLC) patients with cachexiaCurrow D et al.Annals of oncology : official journal of the European Society for Medical Oncology2017Clinical Trial, Phase III
Anamorelin (ONO-7643) in Japanese patients with non-small cell lung cancer and cachexia: results of a randomized phase 2 trialTakayama K et al.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2016Randomized Controlled Trial
Anamorelin in patients with non-small-cell lung cancer and cachexia (ROMANA 1 and ROMANA 2): results from two randomised, double-blind, phase 3 trialsTemel JS et al.The Lancet. Oncology2016Randomized Controlled Trial
Brief versions of the FACIT-fatigue and FAACT subscales for patients with non-small cell lung cancer cachexiaSalsman JM et al.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2015Randomized Controlled Trial
Therapeutic potential of anamorelin, a novel, oral ghrelin mimetic, in patients with cancer-related cachexia: a multicenter, randomized, double-blind, crossover, pilot studyGarcia JM et al.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2013Randomized Controlled Trial
Pharmacodynamic hormonal effects of anamorelin, a novel oral ghrelin mimetic and growth hormone secretagogue in healthy volunteersGarcia JM et al.Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society2009Randomized Controlled Trial

More cited research

Conditions researched

Related compounds

FAQ

What is Anamorelin (non-peptide)?

An oral ghrelin-receptor agonist approved in Japan (Adlumiz) for cancer cachexia; it raises GH and IGF-1 and increases appetite and lean mass.

How many registered human trials study Anamorelin (non-peptide)?

The PeptideWhiz trial index lists 11 registered trials for Anamorelin (non-peptide), the most recent from 2023.

How much published research exists on Anamorelin (non-peptide)?

The PeptideWhiz paper index links 13 PubMed papers to Anamorelin (non-peptide); by study type, 9 human and 1 animal studies.

Which conditions is Anamorelin (non-peptide) researched for?

Fat loss, obesity & body recomposition, Fatigue & low energy (incl. midlife), Muscle gain, sarcopenia & building muscle after 40, Osteoporosis and bone density.

Research and education only. Not medical advice. No dosing guidance. Data: ClinicalTrials.gov registry and PubMed via the PeptideWhiz index (204,289 studies).

Reported dosing ranges from research