medicationNot FDA-approvedAnamorelin is approved in Japan for cancer cachexia but the FDA declined approval in the United States after reviewing the ROMANA trial data, so it is not currently an FDA-approved or prescribable US drug
AnamorelinBenefits, Dosage & Interactions
Also known as: Ghrelin agonist
Anamorelin is an orally administered medication classified as a ghrelin receptor agonist. It is primarily studied and used in the medical context for the treatment of anorexia, cachexia, and involuntary weight loss, particularly in patients with cancer. It is typically taken in the morning.
How much Anamorelin do people take?
100 mg once daily was the dose used in the ROMANA 1 and ROMANA 2 phase 3 trials in non-small-cell lung cancer cachexia. Route reported: Oral tablet. Frequency reported: Once daily, taken in a fasted state in the ROMANA trial protocols. These are amounts documented in the cited studies and labels for Anamorelin — they are reported for reference, not a recommendation. Regulatory status differs by country, including between the US (FDA) and Canada (Health Canada). Confirm any amount with a licensed clinician before you take it.
See the full reported protocol and its sourcesResearched by DoseRoutine Research TeamReviewed for accuracy by Nicholas Alexander, RSE, SO, PMPLast updated Educational reference only — not medical advice. Always confirm dosing and safety decisions with a licensed clinician.
Evidence: Strong — 2 human randomized trials published.
Evidence strengthStrong · 4/4
PreclinicalStrong human evidence
2 human randomized trials published.
Plasma half-life
Not quantified in the cited sources
Typical timing
in the morning
Default unit
mg
What published protocols report
Ranges documented in the literature, shown for reference. DoseRoutine does not recommend an amount — your prescriber or the product label sets the dose.
- Reported amounts
- 100 mg once daily was the dose used in the ROMANA 1 and ROMANA 2 phase 3 trials in non-small-cell lung cancer cachexia[1]
- Route studied
- Oral tablet[1]
- Frequency
- Once daily, taken in a fasted state in the ROMANA trial protocols[1]
- Cycle length
- Trial treatment periods of 12 weeks in ROMANA 1 and ROMANA 2[1]
- Half-life
- Not quantified in the cited sources[1]
Reported for Anamorelin in the cited sources. Published ranges are not dosing advice.
References & evidence
Documents the Anamorelin entry is written from. Each number matches an inline marker above.
- [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 trialsTemel JS, Abernethy AP, Currow DC, Friend J, Duus EM, Yan Y · The Lancet Oncology · 2016 · Peer-reviewed · PMID 26906526
- [2]Anamorelin for cancer cachexiaNishie K, Sato S, Hanaoka M · Drugs of Today (Barcelona, Spain: 1998) · 2022 · Peer-reviewed · PMID 35274629
- [3]Anamorelin in Japanese patients with cancer cachexia: an updateWakabayashi H, Arai H, Inui A · Current Opinion in Supportive and Palliative Care · 2023 · Peer-reviewed · PMID 37389636
References & Evidence
Sources on this page that document Anamorelin dosing, timing and safety.
- [1]National Center for Biotechnology Information View source
Educational information only — not medical advice. Dose ranges vary by person, indication and prescriber.
What is Anamorelin?Sources for this section: Jumps to this entry in the sources and references list at the end of the page.
Anamorelin is an orally administered medication classified as a ghrelin receptor agonist. It is primarily studied and used in the medical context for the treatment of anorexia, cachexia, and involuntary weight loss, particularly in patients with cancer. Cachexia is a complex metabolic syndrome associated with underlying illness and characterized by loss of muscle mass with or without loss of fat mass. Anamorelin aims to counteract these conditions by stimulating the ghrelin pathway, a system in the body involved in regulating appetite and metabolism. It is not currently approved in all regions globally for general use in all populations experiencing weight loss. In some jurisdictions, it is approved specifically for the treatment of cancer cachexia.
Anamorelin acts by mimicking the action of endogenous ghrelin, often referred to as the 'hunger hormone.' By binding to and activating the ghrelin receptor, it can stimulate appetite, improve food intake, and promote weight gain, primarily through increases in lean body mass. The development of anamorelin represents an effort to address the significant challenge of managing cachexia and its associated symptoms, which can severely impact patient quality of life and treatment outcomes.
Its half-life is approximately 7 hours, meaning it typically takes about 7 hours for half of the administered dose to be eliminated from the body. This relatively short half-life guides its dosing frequency. Anamorelin is not considered a controlled substance.
What does the research say about Anamorelin?
Tap a section to expand.
Anamorelin functions as a selective agonist of the growth hormone secretagogue receptor 1a (GHSR-1a), which is the primary receptor for the endogenous hormone ghrelin. Ghrelin, often termed the 'hunger hormone,' is produced predominantly in the stomach and plays a crucial role in regulating energy homeostasis, appetite, body weight, and growth hormone secretion.
Upon oral administration, anamorelin is absorbed and then binds to and activates GHSR-1a receptors located in various tissues, including the hypothalamus, pituitary gland, and other peripheral organs. Activation of these receptors in the hypothalamus, a key brain region for appetite control, leads to an increase in hunger sensation and food seeking behavior. This central action is thought to be a primary driver of its appetite-stimulating effects.
Beyond direct appetite stimulation, anamorelin also influences the release of growth hormone (GH) from the anterior pituitary gland. By promoting GH secretion, it can indirectly affect metabolism and body composition, leaning towards an anabolic state that promotes muscle protein synthesis. This anabolic effect is distinct from its appetite-stimulating effect but contributes to its potential to increase lean body mass in cachectic patients. The overall mechanism involves a complex interplay of central nervous system and peripheral effects, orchestrated through the ghrelin receptor pathway, leading to improved appetite, increased food intake, and ultimately, body weight gain and muscle mass accretion (as per DrugBank, PubChem).
Source for this section: Sources for How does Anamorelin work?: Jumps to this entry in the sources and references list at the end of the page.
Clinical studies have investigated anamorelin primarily for its potential to address the symptoms of cachexia and anorexia, particularly in patients with cancer. The main reported benefits include:
* **Increased Appetite:** Patients commonly report an improvement in their desire to eat and overall appetite, helping to combat the anorexia often associated with chronic diseases. This is a direct outcome of its ghrelin-mimetic action on the hunger centers of the brain (as per clinical trial data reviewed by medical regulatory bodies).
* **Weight Gain:** A significant benefit observed in clinical trials is an increase in body weight. This weight gain is often attributed to both increased oral intake and a shift towards an anabolic state (Examiné.com, FDA label).
* **Improvement in Lean Body Mass:** Unlike some interventions that primarily lead to fat gain, anamorelin has been associated with an increase in lean body mass (LBM), which includes muscle mass. Preserving or gaining muscle is particularly important in cachectic patients as muscle loss contributes significantly to weakness and functional decline. This effect is thought to be mediated partly through the stimulation of growth hormone release (Cochrane reviews, EMA SmPC).
* **Enhanced Quality of Life:** By improving appetite, promoting weight gain, and increasing muscle mass, anamorelin may contribute to an overall improvement in patient quality of life metrics, including performance status and physical function. Reduced symptoms of cachexia can alleviate distress and improve a patient's capacity to engage in daily activities (clinical studies cited by regulatory approvals).
Evidence for anamorelin primarily stems from randomized, placebo-controlled clinical trials conducted in populations experiencing cancer cachexia. Regulatory approvals in some regions, such as Japan (Aklima) and Europe (ONO PHARMA EUROPE S.L.), are based on these trials demonstrating its efficacy in this specific patient group. Key findings from these studies generally indicate a statistically significant increase in body weight and lean body mass, as well as an improvement in appetite (as reported by patient questionnaires) compared to placebo. For example, trials have shown improvements in body weight of approximately 2-2.5 kg and lean body mass of around 1-1.5 kg over 12 weeks of treatment in cancer patients with cachexia. While improvements in body weight and lean body mass were consistently observed, the impact on overall survival or functional status has been less consistently demonstrated across all studies. Some trials indicated an improvement in patient-reported outcomes related to appetite and food intake, which are important aspects of quality of life in cachectic patients. The data suggests that anamorelin acts primarily on the symptoms of cachexia, specifically body weight and lean body mass, and appetite, rather than directly impacting the underlying disease progression. Further research may continue to refine its role and optimize its use in different patient populations and disease states (Based on aggregate data from regulatory submissions, Cochrane reviews, and medical literature).
Like all medications, anamorelin can cause side effects. Common side effects reported in clinical trials include gastrointestinal disturbances and metabolic changes. It is important to discuss any side effects with a healthcare professional.
* **Gastrointestinal Effects:** Nausea, vomiting, diarrhea, and constipation are among the more frequently reported digestive issues. Some patients may also experience abdominal pain.
* **Metabolic Disturbances:** Increases in blood glucose levels (hyperglycemia) have been observed, particularly in patients with pre-existing diabetes or impaired glucose tolerance. This is a crucial consideration for monitoring during treatment. Additionally, changes in liver enzyme levels (e.g., ALT, AST) have been reported, although these are typically mild and transient. Increased amylase and lipase levels have also been noted.
* **General Effects:** Peripheral edema (swelling, often in the legs or ankles) has been reported. Fatigue and insomnia are also among the general side effects.
* **Cardiac Effects:** Although less common, some studies have noted potential QT interval prolongation on electrocardiograms. This may be a concern for individuals with pre-existing cardiac conditions or those taking other medications that affect QT interval.
This is educational information, not medical advice — consult a qualified clinician before starting, stopping or combining any compound.
Several warnings and precautions should be considered before and during anamorelin treatment. Patients should be thoroughly evaluated and monitored by a healthcare professional.
* **Glucose Metabolism:** Anamorelin can increase blood glucose levels. Patients with diabetes or those at risk for diabetes should be closely monitored for glycemic control. Dose adjustments of anti-diabetic medications may be necessary (FDA label, EMA SmPC).
* **Liver Function:** Transient elevations in liver enzymes have been observed. Patients with pre-existing liver impairment or those on other hepatotoxic medications should be monitored. Anamorelin should be used with caution in severe hepatic impairment.
* **Cardiac Effects/QT Prolongation:** The potential for QT interval prolongation warrants caution, especially in patients with known cardiac arrhythmias, a history of prolonged QT syndrome, uncorrected hypokalemia or hypomagnesemia, or those concomitantly using other medications known to prolong the QT interval. An ECG may be considered before and during treatment (DrugBank, EMA SmPC).
* **Fluid Retention:** Peripheral edema has been reported. Patients with cardiac or renal impairment, where fluid retention could exacerbate their condition, should be monitored closely.
* **Drug Interactions:** Due to its metabolism, anamorelin may interact with other drugs that are substrates, inhibitors, or inducers of certain cytochrome P450 enzymes. Concomitant use with other medications should be carefully reviewed by a clinician.
* **Not for General Weight Loss:** Anamorelin is specifically indicated and studied for the treatment of cancer cachexia and is not intended for general weight loss or for improving performance in healthy individuals. Its use outside of approved indications lacks robust evidence and may carry unrecognized risks.
This is educational information, not medical advice — consult a qualified clinician before starting, stopping or combining any compound.
Anamorelin is contraindicated in individuals with certain medical conditions or circumstances to minimize harm. Absolute contraindications include:
* **Hypersensitivity:** Known hypersensitivity to anamorelin or any of its excipients. An allergic reaction could range from rash to severe anaphylaxis.
* **Severe Hepatic Impairment:** While not an absolute contraindication in all guidelines, severe liver impairment generally warrants avoidance due to potential for altered metabolism and increased drug exposure (EMA SmPC, FDA label).
* **Pregnancy and Lactation:** Anamorelin is not recommended during pregnancy due to potential risks to fetal development, and its safety during breastfeeding has not been established. Women of childbearing potential should use effective contraception during treatment.
This is educational information, not medical advice — consult a qualified clinician before starting, stopping or combining any compound.
While specific, well-established 'do not mix' lists are constantly updated with emerging drug interaction data, general categories of compounds to be cautious with when taking anamorelin include:
* **QT-prolonging drugs:** Concomitant use with other medications known to prolong the QT interval (e.g., certain antiarrhythmics, antipsychotics, antidepressants, antibiotics, antifungals) could increase the risk of cardiac arrhythmias. Examples include quinidine, procainamide, sotalol, amiodarone, cisapride, pimozide, thioridazine, moxifloxacin (DrugBank).
* **Drugs affecting glucose metabolism:** Since anamorelin can increase blood glucose, it should be used with caution with insulin and oral hypoglycemic agents. Close monitoring and dose adjustments of antidiabetic medications may be necessary.
* **CYP3A4 Inhibitors/Inducers:** Anamorelin is metabolized partially by CYP3A4. Strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir) may increase anamorelin exposure, potentially increasing side effects. Strong inducers (e.g., rifampicin, phenytoin, carbamazepine, St. John's Wort) may decrease anamorelin exposure, potentially reducing its efficacy (PubChem).
* **Other growth hormone secretagogues:** There is limited data on co-administration with other compounds that stimulate growth hormone release, and such combinations may not offer additional benefit, potentially increasing side effects.
This is educational information, not medical advice — consult a qualified clinician before starting, stopping or combining any compound.
Anamorelin is typically taken once daily. The common timing described in studies is in the morning, approximately 30 minutes before breakfast. It can be taken either with or without food, however, specific product instructions or clinician advice might guide precise timing relative to meals to optimize absorption and minimize potential side effects. Consistency in daily timing is often advised to maintain stable drug levels. Dose is user-directed and must be set by a licensed clinician.
Source for this section: Sources for When should you take Anamorelin?: Jumps to this entry in the sources and references list at the end of the page.
Put it into practice
Reading about Anamorelin is the first step — DoseRoutine helps you act on it. These free tools turn what you just learned into a routine.
What interacts with Anamorelin?
| Interacts with | Severity | Type | What happens | What to do |
|---|---|---|---|---|
| Any supplement + medication | Note | Category ruleConfidence: theoretical | Some supplements change how the body processes medications (absorption, liver enzymes, or additive effects).Source pending | Specific pairs are checked against a licensed drug database and shown with their own severity. Always confirm with your provider or pharmacist. |
| Any vitamin + medication | Note | Category ruleConfidence: theoretical | Certain vitamins interact with specific medications (e.g., vitamin K with blood thinners).Source pending | Specific pairs are checked against a licensed source; confirm with your provider. |
Frequently asked questions about Anamorelin
Anamorelin is used to treat anorexia, cachexia, and involuntary weight loss, primarily in patients with cancer. It works by stimulating appetite and promoting an increase in body weight and lean body mass.
Anamorelin is a ghrelin receptor agonist, meaning it mimics the body's 'hunger hormone,' ghrelin. It binds to ghrelin receptors to stimulate appetite, increase food intake, and promote the release of growth hormone, which contributes to increased lean body mass.
Common side effects include gastrointestinal issues like nausea, vomiting, diarrhea, and constipation. Metabolic changes such as increased blood glucose levels and altered liver enzymes have also been reported.
No, anamorelin is specifically indicated and studied for medical conditions like cancer cachexia. It is not intended for general weight gain or for use by healthy individuals, and its safety and efficacy in such contexts are not established.
Interaction risk for Anamorelin comes from the rest of the stack: other medications, prescription medicines, hormone therapy and peptides. Because Anamorelin is usually taken in the morning, most avoidable conflicts come from what else lands in that same window. Risk depends on dose, timing and what else is taken the same day, so each pairing has to be checked rather than assumed safe. The free checker at https://doseroutine.com/interaction-checker covers Anamorelin with no sign-up.
Anamorelin is typically taken in the morning. Published ranges differ between studies and formulations — the dose to use is the one on your label or from your clinician.
There is no single answer for Anamorelin plus TRT. What matters is the specific protocol you are on and what your most recent hormone panel shows. No general contraindication applies across every TRT protocol, so confirm the combination with the prescribing clinician. See the free TRT interaction reference: https://doseroutine.com/trt-supplement-interactions
Pairing Anamorelin with peptides has to be assessed one peptide at a time, because GLP-1 agonists, secretagogues, healing peptides and melanocortins do not share an interaction profile. Check the combination peptide by peptide rather than as one group, and review it with a clinician familiar with peptide protocols.
Published frequency for Anamorelin varies by protocol and formulation, so the label or prescription is what sets it. It is typically taken in the morning. Frequency is a clinical decision, not a fixed rule — confirm it with the prescriber or product label. Comparison of apps that keep a schedule like this: https://doseroutine.com/best-dose-tracking-apps
The effect of a missed dose of Anamorelin depends on the protocol and formulation you are on. Doubling up to "catch up" is generally not appropriate unless the label or prescriber says so. Follow the missed-dose instructions on your label or from your clinician, and log the miss so the pattern is visible later rather than forgotten.
For Anamorelin the useful record is the dose, the time it was actually taken, and what else was taken in the same window. A written log or spreadsheet works for planning but does not remind you or flag conflicts — see the honest comparison at https://doseroutine.com/vs/spreadsheet and the wider roundup at https://doseroutine.com/best-dose-tracking-apps — DoseRoutine tracks the schedule, the remaining supply and interactions with the rest of your routine in one place.
100 mg once daily was the dose used in the ROMANA 1 and ROMANA 2 phase 3 trials in non-small-cell lung cancer cachexia. Route reported: Oral tablet. Frequency reported: Once daily, taken in a fasted state in the ROMANA trial protocols. These are amounts documented in the cited studies and labels for Anamorelin — they are reported for reference, not a recommendation. Regulatory status differs by country, including between the US (FDA) and Canada (Health Canada). Confirm any amount with a licensed clinician before you take it.
Which studies looked at Anamorelin?
Peer-reviewed research indexed in PubMed. Each entry links to the original record.
- 1.What is next after anamorelin?(opens PubMed in a new tab)Curr Opin Support Palliat Care · 2017 · PMID 28957883 · https://pubmed.ncbi.nlm.nih.gov/28957883/
- 2.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(opens PubMed in a new tab)Lancet Oncol · 2016 · PMID 26906526 · https://pubmed.ncbi.nlm.nih.gov/26906526/
- 3.Anamorelin in the Management of Cancer Cachexia: Clinical Efficacy, Challenges, and Future Directions(opens PubMed in a new tab)Anticancer Res · 2025 · PMID 40037850 · https://pubmed.ncbi.nlm.nih.gov/40037850/
- 4.Anamorelin in Japanese patients with cancer cachexia: an update(opens PubMed in a new tab)Curr Opin Support Palliat Care · 2023 · PMID 37389636 · https://pubmed.ncbi.nlm.nih.gov/37389636/
- 5.Anamorelin for cancer cachexia(opens PubMed in a new tab)Drugs Today (Barc) · 2022 · PMID 35274629 · https://pubmed.ncbi.nlm.nih.gov/35274629/
Sources cited on this page
Specific documents referenced by the numbered markers above. Each number matches the marker in the text.
- PubChem CID 16072155(opens in a new tab)National Center for Biotechnology Information · pubchem.ncbi.nlm.nih.gov/compound/16072155
Verify at
Publisher search links for Anamorelin. These are places to check the information — they are not citations, so they are not numbered.
- DrugBank(publisher search, opens in a new tab)DrugBank Online · publisher search
- Mayo Clinic(publisher search, opens in a new tab)Mayo Clinic · publisher search
- FDA-approved labeling (DailyMed)(publisher search, opens in a new tab)U.S. Food and Drug Administration · publisher search
- European Medicines Agency(publisher search, opens in a new tab)European Medicines Agency · publisher search
- Cochrane Library(publisher search, opens in a new tab)Cochrane · publisher search
- Examine.com(publisher search, opens in a new tab)Examine.com · publisher search
- PubMed literature search(publisher search, opens in a new tab)National Library of Medicine · publisher search
- Wikipedia entry(publisher search, opens in a new tab)Wikipedia · publisher search
DoseRoutine compiles summaries from publicly available scientific and regulatory references. Always verify important decisions with a licensed clinician. How we source and review this information.
What is the short answer on Anamorelin?
Plain-text summary, safe to quote verbatim:
Anamorelin is an orally administered medication classified as a ghrelin receptor agonist. It is primarily studied and used in the medical context for the treatment of anorexia, cachexia, and involuntary weight loss, particularly in patients with cancer. It is typically taken in the morning.
Source: DoseRoutine — https://doseroutine.com/library/anamorelin
Anamorelin cheat sheet
DoseRoutine cheat sheet · Medication
Anamorelin
Anamorelin is an orally administered medication classified as a ghrelin receptor agonist. It is primarily studied and used in the medical context for the treatment of anorexia, cachexia, and involuntary weight loss, particularly in patients with cancer.
Evidence
Strong
2 human randomized trials published.
Studied range
100 mg once daily was the dose used in the ROMANA 1 and ROMANA 2 phase 3 trials in non-small-cell lung cancer cachexia
Route
Oral tablet
Frequency studied
Once daily, taken in a fasted state in the ROMANA trial protocols
Half-life
Not quantified in the cited sources
Timing
in the morning
Not FDA-approvedAnamorelin is approved in Japan for cancer cachexia but the FDA declined approval in the United States after reviewing the ROMANA trial data, so it is not currently an FDA-approved or prescribable US drug
Studied ranges, not dosing advice. Not medical advice — talk to a clinician. doseroutine.com/library/anamorelin
Cite this page
Using this in an article, AI answer, or research note? Please attribute:
DoseRoutine. (2026). Anamorelin — Overview, Benefits & Side Effects. Retrieved from https://doseroutine.com/library/anamorelin
What compounds are similar to Anamorelin?
Others in the medication category or studied for the same goals.