Anamorelin

Not a peptide. Anamorelin is an orally active small molecule (a piperidine-based "peptidomimetic" designed to imitate a peptide's shape). It is included because it is a ghrelin receptor agonist discussed constantly alongside GHRPs and ipamorelin, and people search for it here. The same evidence standards apply.

Adlumiz (brand, Japan), ONO-7643, RC-1291, ST-1291, anamorelin hydrochloride

Growth hormone axis

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Note on this profile. Anamorelin is an approved prescription medicine in Japan (since 2021) for cancer cachexia, and was refused marketing authorisation in the EU. This page explains the published science. Use outside a prescription is unapproved.

Summary

Class: Non-peptide small-molecule ghrelin receptor (GHS-R1a) agonist; oral
Mechanism: Mimics ghrelin to stimulate appetite and release growth hormone and IGF-1, aiming to increase lean body mass in people losing weight from cancer
Routes studied: Oral, once daily
Dose range reported: Approved (Japan): 100 mg orally once daily before breakfast. Phase 3 trials (ROMANA 1 and 2): 100 mg once daily for 12 weeks; Phase 2 trials also used 50 mg. No community dose convention; the compound is seldom used outside oncology
Half-life: ~7 hours; IGF-1 rises over days and plateaus within 1–2 weeks
Storage: Approved tablets: room temperature, as labelled
Regulatory status: Approved in Japan; refused by the EMA (2017); not approved in the US, UK, Australia or South Africa

Doses are as reported in studies or by the community — never recommendations.

1What it is

Anamorelin was developed by Helsinn (and in Japan by Ono Pharmaceutical) specifically for cancer cachexia — the wasting syndrome of weight loss, muscle loss and appetite loss that affects a large share of people with advanced cancer and for which there had been no approved treatment. It is a small molecule, not a peptide, engineered to bind the ghrelin receptor and survive oral dosing. The idea is simple: ghrelin is the hunger hormone and also a GH releaser, so a once-daily ghrelin mimic might restore appetite and rebuild lean tissue.

It went through the largest clinical programme of any ghrelin receptor . The results — consistent gains in lean body mass and appetite but no improvement in handgrip strength or function — split regulators. Japan approved it in 2021 for cachexia in non-small-cell lung, gastric, pancreatic and colorectal cancer; the EMA's committee concluded the benefit was too small and uncertain.

2How it's thought to work

Anamorelin activates in the hypothalamus (appetite) and pituitary (GH release). The appetite effect comes through the same NPY/AgRP neurons ghrelin uses; the anabolic effect comes partly from the GH–IGF-1 axis and partly from ghrelin receptor effects on muscle and inflammation. Because cachexia is driven by tumour-related inflammation and catabolism rather than simple under-eating, the lean mass gained in trials appears to have been genuine tissue plus some water, but did not translate into measurable strength.

An orally active ghrelin receptor agonist developed for cancer cachexia. It raises appetite, lean mass and growth hormone, though trials did not show a gain in strength.Schematic — not to scale

3What the research shows

Lean body mass in cancer cachexia

ROMANA 1 (n=484) and ROMANA 2 (n=495), double-blind placebo-controlled Phase 3 trials in advanced non-small-cell lung cancer with cachexia, 100 mg daily for 12 weeks: lean body mass increased by about 1 kg versus a loss of 0.5–1 kg on placebo in both trials (Temel 2016, Lancet Oncol). Appetite and body weight also improved, as did anorexia/cachexia symptom scores. [1]

Graded A (negative)

Handgrip strength and function

Neither ROMANA trial showed any difference in handgrip strength, the co-primary endpoint; this was the basis of the EMA's negative opinion. The 12-week extension (ROMANA 3) found the effects were maintained with no new safety signal (Currow 2017, Ann Oncol). [2]

Graded A/B

Japanese trials

ONO-7643 Phase 2 studies in Japanese NSCLC patients (Katakami 2018, Cancer) and in gastrointestinal cancers (Hamauchi 2019, Cancer — single-arm) reported similar lean mass and appetite gains at 100 mg, forming the basis of the Japanese approval. [4][5]

Earlier Phase 2

Two pooled randomised trials (n=82) in mixed cancers showed dose-dependent increases in weight, lean mass, IGF-1 and appetite over 12 weeks (Garcia 2015, Lancet Oncol). [3]

Non-cancer uses, body composition in healthy people

No studies. Community interest is limited; the compound is usually mentioned as a comparator for GHRPs.

4Reported side effects and interactions

Literature-reported

Literature. generally well tolerated in trials. Most common: hyperglycaemia and worsening of diabetes, nausea, increased appetite beyond intended, dizziness, fatigue. Small increases in fasting glucose and HbA1c consistent with GH/IGF-1 release.

Serious / label warnings (Japan). cardiac conduction effects — PR interval prolongation was observed, and the Japanese label contraindicates use in people with congestive heart failure, conduction disorders or ischaemic heart disease, and requires ECG monitoring; hyperglycaemia requiring treatment; hepatic impairment increases exposure. Rare reports of QT prolongation have been examined.

Community-reported

almost none; the drug is rarely available outside Japanese oncology.

Theoretical. the GH/IGF-1 class concerns — insulin resistance, fluid retention — and the question, inherent to any anabolic agent in cancer, of whether stimulating growth pathways affects tumour progression; the ROMANA trials found no difference in survival or progression at 12–24 weeks.

Interactions. anamorelin is metabolised by CYP3A4; strong CYP3A4 inhibitors (e.g. clarithromycin, ketoconazole, ritonavir) increase exposure and are contraindicated or cautioned in the Japanese label; it is also a P-glycoprotein substrate. Glucose-lowering medicines may need adjustment.

Markers researchers commonly monitor

Following the Japanese label and trial protocols:

Marker	Why it's watched
Fasting glucose and HbA1c	hyperglycaemia is the most common clinically significant adverse effect; the label calls for regular glucose checks.
ECG (PR interval, QTc)	before starting and periodically; conduction effects are the reason for the cardiac contraindications.
IGF-1	confirms the pharmacological effect; rises within a week.
Body weight and lean body mass (DEXA or bioimpedance)	the outcomes the drug exists to change.
Appetite score (e.g. FAACT A/CS)	used in the trials; a simple daily appetite rating serves the same purpose.
Liver function	exposure rises with hepatic impairment.
Handgrip strength	honest tracking of what the trials failed to show.

Free for everyone. Safety information is never behind a paywall.

5Formulation and handling

Approved 50 mg tablets (two taken once daily, before breakfast, on an empty stomach — food reduces absorption). Store at room temperature as labelled. No . Non-pharmaceutical "research" powders of anamorelin exist; dosing them accurately requires a milligram balance, and no calculator link is offered.

6Commonly studied alongside

Standard chemotherapy (in the trials); nutritional counselling; compared conceptually with megestrol acetate and corticosteroids (older appetite stimulants with worse side-effect profiles). Among research compounds, ipamorelin, GHRP-2, GHRP-6 and MK-677 / ibutamoren as fellow ghrelin receptor agonists; capromorelin and macimorelin as fellow small-molecule agonists.

Informational cross-links. Not stack recommendations.

7Regulatory status by region

Region	Status (checked —)
United States	Not FDA-approved; no NDA filed as of review date †. Not a compounding-list substance
European Union	Marketing authorisation refused by the CHMP (2017) on the basis that lean mass gain was small and handgrip strength did not improve
United Kingdom	Not licensed
Australia	Not approved
South Africa	Not registered
Sport	Prohibited by WADA (S2 — anamorelin is named as an example of a ghrelin mimetic)

8Open questions

Whether lean mass gained with anamorelin ever translates into function or survival in a longer or differently designed trial.
Whether earlier treatment (pre-cachexia) would do better; a trial in that setting was planned.
Any role outside cancer (e.g. heart failure cachexia, COPD, anorexia of ageing) — untested.

9References

1Temel JS et al. (2016). 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. PubMed · DOI
2Currow D et al. (2017). ROMANA 3: a phase 3 safety extension study of anamorelin in advanced non-small-cell lung cancer (NSCLC) patients with cachexia. Ann Oncol. PubMed · DOI
3Garcia JM et al. (2015). Anamorelin for patients with cancer cachexia: an integrated analysis of two phase 2, randomised, placebo-controlled, double-blind trials. Lancet Oncol. PubMed · DOI
4Katakami N et al. (2018). 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). Cancer. PubMed · DOI
5Hamauchi S et al. (2019). A multicenter, open-label, single-arm study of anamorelin (ONO-7643) in advanced gastrointestinal cancer patients with cancer cachexia. Cancer. PubMed
6European Medicines Agency (2017). Adlumiz: refusal of the marketing authorisation — CHMP assessment report. PubMed
7Ono Pharmaceutical. Adlumiz (anamorelin hydrochloride) tablets — Japanese package insert (current). PubMed

References are being resolved to PubMed/DOI identifiers; links search PubMed for the citation until then.

† Being confirmed by our reviewers against current sources.

10Community

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Self-reported side effects Phase 2

Not enough data yet. 0 of the 50 members needed have logged this compound for 4+ weeks. We don't show anything below 50, so no one can be identified.

11Page history

26 Oct 2026Profile published — awaiting medical review

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