Overview
Anamorelin, also known as ONO-7643, is a ghrelin receptor agonist developed by Helsinn and studied for cancer-associated cachexia and anorexia. Strictly speaking, it is not a peptide: it is a small-molecule peptidomimetic designed to reproduce ghrelin's receptor activity in a more stable, drug-like form. It is included in peptide research catalogues because its pharmacology is defined entirely by the ghrelin system, a peptide hormone pathway.
Anamorelin is approved in Japan, marketed as Adlumiz, for cancer cachexia associated with certain tumour types. It is not approved in the US, and the EMA refused marketing authorisation in 2017. Two large phase 3 trials in non-small cell lung cancer cachexia, known as ROMANA 1 and ROMANA 2, reported changes in lean body mass and appetite measures, but differences in handgrip strength, a co-primary functional endpoint, were not demonstrated. This mixture of findings made anamorelin a widely discussed case in cachexia research about how to define meaningful endpoints. WADA lists it as a prohibited growth hormone secretagogue.
Mechanism studied
- Anamorelin
- GHS-R1a
- Appetite & GH ↑
- Lean body mass
Anamorelin binds and activates the growth hormone secretagogue receptor type 1a, GHS-R1a, the receptor for the stomach-derived hormone ghrelin. In the hypothalamus, receptor activation stimulates orexigenic neurons expressing neuropeptide Y and agouti-related peptide, increasing appetite signalling. At the pituitary, it stimulates growth hormone release, which in turn raises circulating insulin-like growth factor-1, a mediator of anabolic effects on skeletal muscle. In cachexia research, these combined central and endocrine actions are proposed to counter the anorexia and muscle wasting that accompany advanced cancer. Effects on body composition have been measured with imaging such as DEXA.
Research highlights
- 01Developed by Helsinn as a stable non-peptide mimetic of ghrelin, discovered in 1999.
- 02The ROMANA 1 and ROMANA 2 phase 3 trials examined lean body mass, appetite and handgrip strength in lung cancer cachexia.
- 03Approved in Japan but refused by the EMA in 2017 and not approved by the FDA.
- 04Its mixed results fuelled methodological debate over functional versus body-composition endpoints in cachexia research.
- 05Open questions include its effects on muscle function and its role in combination approaches to cachexia.
Latest published research
176 papers on PubMed →Predictors of anamorelin discontinuation in patients with cancer-associated cachexia undergoing chemotherapy: A retrospective observational study
Fukui A et al. · International journal of clinical pharmacology and therapeutics · 2026 Nov · PMID 42596744
Predictors of early discontinuation and therapeutic response to anamorelin in patients with cancer cachexia: A retrospective study
Takahashi K et al. · International journal of clinical pharmacology and therapeutics · 2026 Oct · PMID 42544527
Three-Week Monitoring After Anamorelin Initiation in Unresectable or Recurrent Pancreatic Cancer: Dietary Intake Category, Observed Body Weight, and Prognostic Nutritional Index
Ogino B et al. · Journal of palliative medicine · 2026 Sep · PMID 42237597
Exploring Inhibitory Impacts of Anamorelin on Colorectal Cancer Proliferation via Regulation of Transketolase
Fu Z et al. · Current medicinal chemistry · 2026 Aug 22 · PMID 42693844
Correction to 'A Prospective Observational Study of Anamorelin During Chemoimmunotherapy in Non-Small Cell Lung Cancer With Cachexia (SPIRAL-ANA)'
Journal of cachexia, sarcopenia and muscle · 2026 Aug · PMID 42552565
A Prospective Observational Study of Anamorelin During Chemoimmunotherapy in Non-Small Cell Lung Cancer With Cachexia (SPIRAL-ANA)
Morimoto K et al. · Journal of cachexia, sarcopenia and muscle · 2026 Aug · PMID 42411631
Gamma-glutamyl Transferase and Triglycerides Associated with an Early Food Intake Response to Anamorelin in Gastrointestinal Cancer Cachexia
Kurahashi T et al. · Internal medicine (Tokyo, Japan) · 2026 Jul 25 · PMID 42528246
Trends in the Use of Anamorelin Hydrochloride for Cancer Cachexia: Examining the Timing of Anamorelin Initiation
Okamoto M et al. · Annals of nutrition & metabolism · 2026 Jun 26 · PMID 42360910
Live feed from PubMed (NCBI) for “Anamorelin”, updated 2026-10-30. Listing a paper is not an endorsement of its findings.
Registered studies
11 on ClinicalTrials.gov →- CompletedPhase 3
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) - 2
NCT03743064 · Helsinn Healthcare SA · 2019-05-06
- Active not recruitingPhase 2Phase 3
Anamorelin Hydrochloride in Reducing Anorexia in Patients With Advanced Non-small Cell Lung Cancer
NCT03637816 · M.D. Anderson Cancer Center · 2018-11-27
- CompletedPhase 3
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) - 1
NCT03743051 · Helsinn Healthcare SA · 2019-03-05
- Active not recruitingPhase 2
Anamorelin Hydrochloride, Physical Activity, and Nutritional Counseling in Decreasing Cancer-Related Fatigue in Patients With Incurable Metastatic or Recurrent Solid Tumors
NCT03035409 · M.D. Anderson Cancer Center · 2017-02-08
- TerminatedPhase 2
Anamorelin Study for Advanced Pancreatic Cancer
NCT04844970 · Lahey Clinic · 2023-04-01
- CompletedPhase 1
Effect of a Ghrelin Receptor Agonist on Muscle and Bone
NCT04021706 · Tufts University · 2019-12-05
- TerminatedPhase 2
The Role of Ghrelin in Cancer Cachexia
NCT01505764 · VA Office of Research and Development · 2012-06
- CompletedPhase 3
Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 2)
NCT01387282 · Helsinn Therapeutics (U.S.), Inc · 2011-07
From the public ClinicalTrials.gov registry for “Anamorelin”, updated 2026-10-30. Shown for research context only; Purity Peptides products are not for human use.
Key references
- [1]Manufacturer's prescribing information — FDA / EMA / ANVISA
- [2]Temel et al., 2016 — Lancet Oncol 17:519–531
- [3]WADA — Prohibited List of Substances and Methods
FAQ
No. Anamorelin is a small-molecule peptidomimetic that mimics the activity of the peptide hormone ghrelin at its receptor. It is grouped with peptide research compounds because it acts entirely through the ghrelin pathway.
The EMA refused authorisation in 2017, concluding that the evidence, which showed changes in lean body mass but no demonstrated effect on handgrip strength, did not sufficiently establish a meaningful functional effect.
Anamorelin is approved in Japan for cancer cachexia associated with certain tumour types. It is not approved in the US or EU, and WADA lists it as a prohibited substance. Research material is for laboratory use only.
FOR RESEARCH USE ONLY.Not for human or veterinary use. Not intended to diagnose, treat, cure, or prevent any disease.



