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approvedMuscle & Performance

Anamorelin

Also known as: Adlumiz, ONO-7643, RC-1291

Anamorelin is an oral, non-peptide ghrelin receptor agonist approved in Japan (2021) as Adlumiz for cancer-related cachexia and anorexia. It stimulates appetite and growth hormone release through the GHS-R1a receptor, addressing the devastating muscle wasting and appetite loss that affects 50–80% of advanced cancer patients. The ROMANA clinical trials demonstrated significant lean body mass preservation and appetite improvement, though regulatory agencies outside Japan have not yet approved it.

4 cited references·5 researched benefits

Quick Answer

Anamorelin (Adlumiz) is an oral ghrelin receptor agonist approved in Japan for cancer cachexia — the severe muscle wasting and appetite loss affecting most advanced cancer patients. By mimicking ghrelin's orexigenic and anabolic effects, it increases appetite, preserves lean body mass, and stimulates growth hormone release. The ROMANA phase 3 trials showed significant improvements in lean body mass and appetite scores versus placebo in non-small cell lung cancer patients.

Key Facts

Mechanism
Anamorelin is an orally bioavailable peptidomimetic that selectively agonizes the growth hormone secretagogue receptor 1a (GHS-R1a), the endogenous receptor for ghrelin. Activation triggers two primary pathways: (1) hypothalamic appetite stimulation via neuropeptide Y and agouti-related peptide (AgRP) neurons, increasing food intake and reducing satiety; and (2) anterior pituitary GH release via Gq/phospholipase C signaling, promoting anabolic processes through the GH/IGF-1 axis. In cancer cachexia, where inflammatory cytokines (TNF-α, IL-6) suppress appetite and promote muscle proteolysis, anamorelin counteracts these catabolic signals by restoring orexigenic drive and anabolic hormone levels.
Research Status
approved
Half-Life
~7 hours
Primary Use
Muscle & Performance
Table of Contents

Benefits

  • Lean body mass preservation — ROMANA trials showed +0.6 to +1.5 kg lean mass gain versus placebo over 12 weeks in cancer cachexia patientsstrong
  • Appetite stimulation — significant improvements in appetite scores and food intake in patients with cancer-related anorexiastrong
  • Growth hormone elevation — increases GH and IGF-1 levels, restoring anabolic hormone balance disrupted by cancerstrong
  • Oral convenience — once-daily oral dosing is practical for cancer patients who may have difficulty with injectionsstrong
  • Quality of life improvement — patients report improved energy, mood, and functional capacitymoderate

Dosage Protocols

RouteDosage RangeFrequencyNotes
Oral tablet100 mgOnce dailyTake on an empty stomach at least 1 hour before first meal of the day. Approved in Japan for cancer cachexia in patients with inoperable advanced or recurrent non-small cell lung cancer, gastric cancer, pancreatic cancer, or colorectal cancer.

Medical disclaimer

Dosage information is provided for educational reference only. Always follow your prescriber's instructions and consult a qualified healthcare provider before starting any peptide protocol.

Side Effects

  • Hyperglycemia — elevated blood glucose reported in 5–10% due to GH-mediated insulin resistancecommon
  • Peripheral edema — fluid retention reported in 3–5%, related to GH/IGF-1 effectscommon
  • QTc prolongation — dose-dependent QTc increase; ECG monitoring recommended for patients with cardiac risk factorsrare
  • Nausea — paradoxically reported in some patients despite appetite-stimulating mechanismcommon
  • Liver enzyme elevation — mild transaminase increases observed in clinical trialsrare

Frequently Asked Questions

Why is anamorelin only approved in Japan?
The FDA declined to approve anamorelin based on the ROMANA trials because, while it improved lean body mass and appetite, it did not demonstrate improvement in handgrip strength — the co-primary endpoint. The FDA considered functional improvement (strength) more clinically meaningful than body composition alone. Japan's PMDA accepted lean body mass and appetite as sufficient endpoints. European regulators also declined approval, though re-evaluation with additional data is possible.
What is cancer cachexia and why is it hard to treat?
Cancer cachexia is a multifactorial syndrome of involuntary weight loss (primarily skeletal muscle) affecting 50–80% of advanced cancer patients. It is driven by tumor-derived factors and host inflammatory responses (TNF-α, IL-6, IL-1β) that promote muscle proteolysis, suppress appetite, increase basal metabolic rate, and resist nutritional intervention. Unlike simple starvation, nutritional support alone cannot reverse cachexia. It contributes to 20–30% of cancer deaths and significantly reduces treatment tolerance and quality of life.
How does anamorelin differ from MK-677 (ibutamoren)?
Both are oral ghrelin receptor agonists, but anamorelin is a peptidomimetic with selective GHS-R1a activity, while MK-677 is a non-peptide spiropiperidine with broader receptor engagement. Anamorelin has completed rigorous phase 3 clinical trials and achieved regulatory approval in Japan with established safety data. MK-677 was studied in phase 2 trials for various indications but never received regulatory approval. Anamorelin's clinical development focused specifically on cancer cachexia, providing indication-specific efficacy data.
Does anamorelin improve survival in cancer patients?
The ROMANA trials were not powered to detect survival differences, and no statistically significant survival benefit was demonstrated. However, preserving lean body mass and improving nutritional status in cancer patients is associated with better treatment tolerance, reduced chemotherapy dose reductions, and improved quality of life — all factors that may indirectly influence outcomes. Dedicated survival trials with anamorelin have not been conducted.
Can anamorelin be used for non-cancer wasting conditions?
Anamorelin is approved only for cancer-related cachexia in Japan. However, ghrelin pathway activation could theoretically benefit other wasting conditions including COPD-related cachexia, cardiac cachexia, sarcopenia of aging, and HIV-associated wasting. Small studies have explored ghrelin agonists in some of these conditions. Anamorelin has not been specifically studied or approved for non-cancer wasting, though the mechanism is relevant.

References

  1. 1
    Anamorelin for patients with cancer cachexia: ROMANA 1 and ROMANA 2 phase 3 trials(2015)PubMed ↗
  2. 2
    Anamorelin for the treatment of cancer anorexia-cachexia: ROMANA 3 extension trial(2017)PubMed ↗
  3. 3
    Ghrelin receptor agonists for cancer cachexia: a systematic review and meta-analysis(2021)PubMed ↗
  4. 4
    Mechanisms of cancer cachexia and the role of ghrelin pathway as a therapeutic target(2020)PubMed ↗

Latest Research

Last updated: 2026-02-19