Anamorelin

Dosing from the Literature

Published for cancer-related weight and muscle loss: 100 mg by mouth once a day, the dose of Japan’s approval and of every Phase 3 trial (Ono, January 22, 2021; Temel et al., 2016). Not published: a dose shown to add muscle in people without cancer; the one such trial found no significant gain (Dawson-Hughes et al., 2024).

The table records doses as the Japanese approval or each trial gave them. All were taken by mouth; they are trial and label doses, not recommendations.

What It Is

Anamorelin is a small-molecule drug, not a peptide (Garcia & Polvino, 2009). Its chemical name describes 2-methylalanine and D-tryptophan joined to a benzyl-piperidine carbohydrazide (C31H42N6O3, 546.7 Da); the hydrochloride salt in Adlumiz tablets is 583.2 Da (PubChem; PMDA, 2020). It mimics ghrelin, a 28-amino-acid hormone made mainly in the stomach that stirs appetite and growth-hormone release (Pietra et al., 2014; PMDA, 2020). Ghrelin itself has a half-life of about 30 minutes and has to be injected (Pietra et al., 2014); anamorelin works by mouth, with a half-life of 6–7 hours after a single 25 mg dose in a US study of healthy adults (Leese et al., 2015) and 8.2 to 9.2 hours after single doses of 25 to 125 mg in healthy Japanese men, six per dose (PMDA, 2020); Europe’s assessment describes a range of 6.3 to 24.6 hours (EMA, 2017). Its development codes are RC-1291, ONO-7643 and ST-1291 (PubChem).

Novo Nordisk developed it in 1999 and licensed it to Ono and Helsinn for cancer anorexia and cachexia (Graf & Garcia, 2017). Under its licence with Helsinn, Ono holds the rights in Japan, South Korea and Taiwan and Helsinn those in the rest of the world (Ono, January 22, 2021). Helsinn’s Phase 3 trials, ROMANA 1 and 2, enrolled 979 adults with advanced non-small-cell lung cancer and cachexia at 93 sites in 19 countries between 2011 and 2014 (Temel et al., 2016). On that evidence Helsinn Birex Pharmaceuticals applied in the EU; the European Medicines Agency’s committee adopted a negative opinion on May 18, 2017, confirmed it on re-examination on September 14, 2017, and the refusal followed on November 16, 2017 (EMA, 2017).

In Japan, Ono ran its own trials. Japan’s First Committee on New Drugs concluded on December 11, 2020 that the drug may be approved (PMDA, 2020), and on January 22, 2021 Japan approved Adlumiz 50 mg tablets for cancer cachexia in non-small-cell lung, gastric, pancreatic and colorectal cancer, mainly on a Japanese placebo-controlled trial in lung cancer and an open-label trial in digestive cancers (Ono, January 22, 2021). It went on sale on April 21, 2021 (Ono, April 21, 2021), and a 2026 study describes it as approved only in Japan (Morimoto et al., 2026). Between 2019 and 2023 Helsinn ran two more Phase 3 trials in lung cancer, the SCALA programme, with 636 patients (Skipworth et al., 2023; NCT03743051; NCT03743064). Their results are posted on ClinicalTrials.gov and were the subject of a 2023 conference abstract on their efficacy and safety (Currow et al., 2023), but no full journal article has appeared (PubMed and Europe PMC, searched October 4, 2026).

Drugs@FDA holds no application for anamorelin (openFDA, searched October 4, 2026). PubMed returns 185 records for “anamorelin” and 186 when its codes are added (October 4, 2026), most of them about cancer cachexia.

Mechanism of Action

The receptor and animal findings in this section come mostly from one study led by a Helsinn scientist, whose animal experiments are stated to follow Ono’s in-house guidance (Pietra et al., 2014). The hormone and appetite effects were also measured in people (Garcia & Polvino, 2009; Blum et al., 2019); the appetite results in people come from two Phase 1 studies by Rejuvenon, the company now called Helsinn Therapeutics (Blum et al., 2019).

• Ghrelin receptor (GHS-R1a) agonist — In cells engineered to carry the human receptor, anamorelin activated it with an EC50 of 0.74 nM (human HEK293 cells) and bound it with a Ki of 0.70 nM (membranes of receptor-carrying cells), close to ghrelin’s 0.67 nM and 0.58 nM, and showed no blocking activity up to 1,000 nM; it released growth hormone from rat pituitary cells with an EC50 of 1.5 nM (Pietra et al., 2014). Cryo-electron microscopy structures show it occupying a two-part binding pocket of the receptor (Wang et al., 2025).
• Growth hormone, IGF-1 and IGFBP-3 — In 32 healthy volunteers given 25, 50 or 75 mg a day or placebo, growth hormone rose at every dose, and IGF-1 and IGFBP-3 stayed raised after 5–6 days, with negligible effects on other pituitary hormones (Garcia & Polvino, 2009). In pigs, the growth-hormone response to daily dosing was smaller by the seventh dose while IGF-1 rose (Pietra et al., 2014). In 16 patients with cancer cachexia, three days of 50 mg raised IGF-1 by 54.09 ng/mL against a 3.56 ng/mL fall on placebo (Garcia et al., 2013).
• Appetite — In rats, 3, 10 or 30 mg/kg by mouth once a day raised food intake and body weight from the second day (Pietra et al., 2014). In nine healthy young men, single 25 and 50 mg doses raised hunger scores and, at a meal four hours later, calorie intake by 18.4% more than placebo (Blum et al., 2019).
• Sodium channels in the heart (off-target) — At 10 µM, more than 10,000 times its receptor EC50, it bound weakly to sodium channels, L-type calcium channels and the serotonin transporter (Pietra et al., 2014). Japan’s regulator attributes its effects on cardiac conduction to sodium-channel inhibition (PMDA, 2020). In healthy adults, single doses of 300 and 400 mg lengthened the PR and QRS intervals (EMA, 2017; PMDA, 2020), and in Japan’s trials conduction-related adverse drug reactions were also more common on the 100 mg treatment dose than on placebo (PMDA, 2020; see Side Effects & Risks).
• Blood sugar (a proposed effect) — In healthy volunteers, insulin resistance measured by HOMA-IR appeared at 75 mg a day but not at 25 or 50 mg (Garcia & Polvino, 2009). The applicant told Japan’s regulator that, as a ghrelin receptor agonist, it may raise blood glucose (PMDA, 2020).

What the Research Shows

The results below come from laboratory and animal work; the next section covers the human trials.

• Appetite and weight in rats and pigs — In groups of seven rats, 3, 10 or 30 mg/kg by mouth once a day for 6 days raised food intake and weight gain at every dose, more at higher doses; in pigs, a single 3.5 mg/kg dose into the stomach raised growth hormone (Pietra et al., 2014).
• Tumour growth in mice — In female nude mice carrying human A549 lung tumours, 15–21 per group, 3, 10 or 30 mg/kg by mouth daily for 28 days did not change tumour growth against controls, while weight gain was higher at 10 and 30 mg/kg (Northrup et al., 2013). Its first author worked for Helsinn.
• Chemotherapy-induced wasting — In mice given gemcitabine and cisplatin, 20 mg/kg a day by mouth for two weeks lessened the drop in food intake, the weight loss at day 8 and muscle wasting (Miyake et al., 2020). In ferrets given cisplatin, 1–3 mg/kg of anamorelin into the belly cut weight loss in the delayed phase by about 24%, as ipamorelin did, without changing vomiting; 10 µg given into the brain cut early vomiting by 60%; three of the ten authors worked for Helsinn (Lu et al., 2024).
• With muscle-preserving drugs, in mice — With MID-35, a myostatin-blocking peptide, the combination raised food intake and grip strength, and survival was better than with either alone, though not significantly (p = 0.052); the combination group also tended to have larger tumours than untreated mice (p = 0.09), and the authors describe a growth-promoting effect on tumours (Hanada et al., 2022). In mice with lung cancer, anamorelin alone raised food intake, but lean mass, activity and survival improved only when an activin-receptor decoy (ActRIIB-Fc) was added, and only in females (Queiroz et al., 2022).

Human Data

Published: Phase 1 studies in healthy volunteers, placebo-controlled trials in cancer cachexia of 16 to 513 patients, including two Phase 3 trials and their extension, uncontrolled Japanese trials, two smaller randomized trials since approval, post-marketing data from Japan, and one placebo-controlled trial of muscle and bone in adults without cancer. Registered with results posted but no full paper: the two SCALA Phase 3 trials (two 2023 conference abstracts aside), a 10-patient Veterans Affairs trial (NCT01505764) and a 4-patient pancreatic-cancer trial (NCT04844970). Registered with no results posted and no journal article: a 228-patient Phase 2 (NCT00622193) and a 51-patient Phase 2 (NCT00378131) (ClinicalTrials.gov, PubMed and Europe PMC, searched October 4, 2026); Europe’s assessment summarizes both, and in neither did handgrip strength differ from placebo (EMA, 2017).

• Healthy volunteers, Phase 1 — In a dose-escalation study, 50 mg and 75 mg once a day raised weight from baseline by 1.25 and 1.16 kg after 6 days, significantly more than placebo (p = .0022 for each); one volunteer on 50 mg had a moderate, short-lived rise in liver enzymes (Garcia & Polvino, 2007). In 32 volunteers, growth hormone, IGF-1 and IGFBP-3 rose (Garcia & Polvino, 2009). After a single 25 mg dose, blood levels peaked within 30–45 minutes and again at 2–4 hours, the half-life was 6–7 hours, exposure was about 1.8–1.9 times higher in women, and the growth-hormone rise was smaller in older people (Leese et al., 2015); one of that study’s four authors worked for Helsinn.
• Pilot crossover, 16 patients (Garcia et al., 2013) — Patients with different cancers and cachexia took 50 mg a day or placebo for 3 days each. Weight changed by +0.77 kg against −0.33 kg on placebo, and symptom scores on the Anderson Symptom Assessment Scale, which includes appetite, improved (8.1 against 1.0). The paper reports this as significant; a later review co-written by its lead author calls it a numerical improvement that the study was not powered to confirm (Graf & Garcia, 2017). Adverse events possibly or probably related to anamorelin were high blood sugar in two patients, nausea in one and dizziness in one.
• Phase 2, 82 patients, 12 weeks (Garcia et al., 2015) — Two US trials pooled: adults with advanced cancer and 5% or more weight loss took 50 mg or placebo once a day. In the 74 evaluable patients, lean body mass rose by 1.89 kg on anamorelin and fell by 0.20 kg on placebo (difference 2.09 kg; p = 0.0006). Handgrip strength, a secondary endpoint, rose more than on placebo (p = 0.014), but no quality-of-life measure differed at week 12 (EMA, 2017); a review co-written by the trials’ lead author describes quality of life as favoring anamorelin (Graf & Garcia, 2017). Adverse events affected 95% on anamorelin and 87% on placebo; the most common grade 3–4 events on anamorelin were fatigue, weakness, atrial fibrillation and breathlessness, two patients each. Helsinn funded both trials, and four of the seven authors worked for it.
• Japanese Phase 2, 181 patients, 12 weeks (Takayama et al., 2016) — Patients with non-small-cell lung cancer and cachexia took 50 or 100 mg or placebo. In the per-protocol analysis, which the trial’s plan put first, lean body mass rose 1.15 kg on 100 mg against 0.55 kg on placebo over 12 weeks, a difference of borderline significance; in the confirmatory analysis of all eligible patients measured on treatment the gap was 0.89 kg (P = 0.0037); 50 mg did not differ significantly. Weight changed by −0.93 kg on placebo, +0.54 kg on 50 mg and +1.77 kg on 100 mg; handgrip strength did not change in any group. It was Ono’s study ONO-7643-03 (PMDA, 2020), and two of its twelve authors worked for Ono.
• ROMANA 1 and 2, 979 patients, 12 weeks (Temel et al., 2016) — Two randomized, double-blind Phase 3 trials at 93 sites in 19 countries gave 100 mg or placebo (2:1) to adults with inoperable stage III–IV non-small-cell lung cancer and cachexia, defined as 5% or more weight loss in 6 months or a body-mass index under 20. Median lean body mass rose 0.99 kg against −0.47 kg on placebo in ROMANA 1 and 0.65 kg against −0.98 kg in ROMANA 2 (both p < 0.0001). Handgrip strength, the other co-primary endpoint, did not differ (−1.10 against −1.58 kg, p = 0.15; −1.49 against −0.95 kg, p = 0.65); it did better on anamorelin only in subgroups: men in ROMANA 1 (Graf & Garcia, 2017) and, in a later post hoc analysis run by Helsinn, patients with the most systemic inflammation (Laird et al., 2025). Under the trials’ analysis plan, anamorelin could be declared superior only if both co-primary endpoints were met, and Europe’s committee wrote that the handgrip result “renders the studies a failure” (EMA, 2017). Treatment-related grade 3–4 high blood sugar affected 1 of 320 and 4 of 330 patients on anamorelin. Helsinn funded both trials; three of the seven authors worked for it. In Europe’s assessment, anorexia–cachexia symptom scores improved 2.21 and 2.14 points more than on placebo, fatigue scores did not differ, these secondary endpoints were tested without control for multiple comparisons, and 12-month survival was similar (hazard ratio 1.06) (EMA, 2017). In that post hoc pooled analysis, weight rose 2.19 kg more than on placebo (Laird et al., 2025).
• ROMANA 3, 513 patients, 12 more weeks (Currow et al., 2017) — Patients who completed ROMANA 1 or 2 continued their treatment. Adverse-event rates were similar on anamorelin and placebo. Over the full 24 weeks, weight rose 3.1 kg against 0.9 kg; handgrip fell slightly in both groups (−0.8 and −0.6 kg). Deaths were 10.5% on anamorelin and 13.8% on placebo, none judged drug-related; drug-related high blood sugar affected 1.2% against none. Helsinn sponsored the trial (NCT01395914).
• Japan’s pivotal trial, ONO-7643-04, 174 patients, 12 weeks (Katakami et al., 2018) — Japanese adults with stage III–IV non-small-cell lung cancer and cachexia took 100 mg or placebo. Lean body mass changed by +1.38 kg against −0.17 kg (P < .0001), and weight and anorexia symptoms improved at every time point; handgrip strength and the 6-minute walk test did not differ. Adverse drug reactions affected 41.0% against 22.2% on placebo. Serious adverse events affected 19.3% against 8.9% (serious adverse drug reactions 2.4% against none), and 6.0% of patients on anamorelin died during the trial against 12.2% on placebo, most deaths from disease progression (Katakami et al., 2018). Median survival was 8.08 months on anamorelin and 8.21 on placebo. Ono sponsored the trial.
• Single-arm Japanese trials (Hamauchi et al., 2019; Naito et al., 2022) — In 50 patients with colorectal, gastric or pancreatic cancer and cachexia, 63.3% kept or gained lean body mass over 12 weeks, with average gains of 1.89 kg of lean mass and 1.41 kg of weight. In 102 patients with lung or digestive cancer, cachexia and a body-mass index under 20, mean age 71, 25.9% met a combined response at 9 weeks (5% weight gain, a 2-point better appetite score, alive); adverse drug reactions affected 36.6%. Neither trial had a comparison group, and Ono funded both.
• SCALA, 636 patients, results posted (NCT03743051; NCT03743064) — Two identical double-blind Phase 3 trials gave 100 mg or placebo for up to 24 weeks to adults with advanced non-small-cell lung cancer, weight loss and anorexia; a 2023 conference abstract describes their co-primary endpoints as revised from the time spent above set thresholds of weight and appetite gain to the mean changes in weight and appetite score over 12 weeks (Skipworth et al., 2023). The registry lists 318 enrolled in each trial, 636 in all; the abstract counted 632 treated. In the posted results, weight rose more on anamorelin in both trials (by 1.35 and 1.28 kg; p < 0.0001), but the 5-item anorexia symptom score did not differ (by 0.62 points, p = 0.15; by 0.14, p = 0.72), and the registered analysis needed both endpoints met to declare anamorelin superior to placebo. Deaths were 27 of 159 against 26 of 159, and 25 of 154 against 28 of 164 (ClinicalTrials.gov). A second 2023 conference abstract covers their efficacy and safety (Currow et al., 2023); no full journal article had been published by October 4, 2026 (PubMed and Europe PMC).
• Randomized trials since approval (Yamamoto et al., 2025; Odagiri et al., 2025) — In an open-label trial in Japan, 203 patients with advanced gastric cancer and cachexia on chemotherapy were randomized to 100 mg a day for 12 weeks or no anamorelin; at 8 weeks lean body mass had risen 0.99 kg against 0.14 kg, a difference that was not significant (P = 0.063); high blood sugar of grade 1–2 affected 4% and grade 3 1% of the anamorelin group. Ono funded it. In 38 patients with metastatic urothelial cancer on platinum chemotherapy (20 on anamorelin, 18 controls), prealbumin, the main measure, weight and muscle index changed similarly in both groups.
• Japan after approval (Takayama et al., 2024; Morimoto et al., 2026) — In the 6,016 patients of the safety analysis of Ono’s post-marketing survey, treatment-related high blood sugar affected 3.9% and nausea 2.6%, and treatment-related conduction disorders and their associated events 1.1%; in the 4,511 patients with effectiveness data, weight was 1.19 kg above baseline at week 12, with no comparison group. In a prospective observational study of 114 patients with non-small-cell lung cancer and cachexia given anamorelin while starting chemoimmunotherapy, progression-free survival did not clear its preset benchmark; of 118 in the safety analysis, 6 (5.1%) had grade 3 or worse high blood sugar. Ono sponsored the study (Morimoto et al., 2026).
• Pooled trials (Taniguchi et al., 2023) — A meta-analysis of seven randomized trials with 1,944 patients found 1.73 kg more body weight and 1.06 kg more lean body mass than on placebo, a quality-of-life difference of 0.16 standard deviations, and no difference in adverse events, severe adverse events, survival, handgrip strength or appetite.
• Outside cancer: 32 adults aged 50 or older, 1 year (Dawson-Hughes et al., 2024) — A pilot randomized, placebo-controlled trial at Tufts in men and women aged 50 or older with low muscle and bone mass gave 100 mg a day, an hour before breakfast (NCT04021706); 26 of the 32 randomized finished. Muscle mass changed by 0.40 kg on anamorelin and −0.01 kg on placebo, a difference that was not significant (P = .71), and lean body mass did not differ significantly either; the trial was sized to detect a 2.28 kg difference. Knee flexion torque at one test speed rose 20% (P = .013), with a similar change in knee extension that was not statistically significant; the bone-formation marker P1NP rose 75%, and IGF-1 50%. Four of the 17 on anamorelin did not finish: two stopped for mild digestive symptoms and one for muscle aches, and one with type 2 diabetes was withdrawn for a raised fasting glucose; fasting glucose rose 7.6 mg/dL on anamorelin and fell 2.1 mg/dL on placebo (P = .017) (Dawson-Hughes et al., 2024).
• Other registered trials — A Veterans Affairs trial ended for poor recruitment at 10 patients (NCT01505764); a pancreatic-cancer trial ended at 4 patients for low enrolment and insufficient funds (NCT04844970); a 25-patient MD Anderson study of anorexia in lung cancer is active, not recruiting (NCT03637816).

The evidence meter on the Anamorelin card reads “Controlled trials”: it counts published human data on anamorelin itself, for muscle, and randomized, placebo-controlled trials up to Phase 3 measured lean body mass in cancer cachexia (Temel et al., 2016; Katakami et al., 2018). Its approval is Japanese, not FDA, so the meter stops short of “Approved drug”. Controlled is not the same as stronger: pooled across the trials, handgrip strength did not differ from placebo (Taniguchi et al., 2023), and the one muscle trial outside cancer found no significant gain in muscle mass (Dawson-Hughes et al., 2024).

Reconstitution & Storage

There is nothing to reconstitute: Adlumiz is a film-coated tablet holding 50 mg of anamorelin hydrochloride (PMDA, 2020). Every trial in people described on this page gave it by mouth (Temel et al., 2016; Katakami et al., 2018); one Phase 1 study in healthy adults also gave a single 10 mg dose into a vein, beside 100 mg by mouth, to measure how much of an oral dose reaches the bloodstream (EMA, 2017; PMDA, 2020).

• Food — Absolute bioavailability, the share of an oral dose that reaches the bloodstream, is about 37%, and with food the peak level and exposure were 18% lower (EMA, 2017); the label text in PMDA’s review has it taken fasting, with no food for at least an hour afterwards (PMDA, 2020).
• Storage — PMDA’s review records a proposed shelf life of 36 months at room temperature for the tablets in press-through blister packs, and the tablets tested photostable (PMDA, 2020). One reagent supplier’s catalogue lists its powder for storage at −20 °C and states “Products are for research use only. Not for human use” (supplier catalogue, read October 4, 2026).
• Products outside Japan — What is sold outside Japan is powder: laboratory reagent and bulk ingredient listed with FDA (see Legal Status). No study has tested such a product in people, and no independent analysis of one has been published.

→ Peptide Calculator — vial-to-syringe math

Side Effects & Risks

• Heart conduction in studies — In a heart-rhythm (thorough QT) study in healthy adults, a 30-person cohort at 400 mg was stopped after one participant’s QRS widened by 87 ms, about 90%, and the study restarted at 300 mg (EMA, 2017). For the 100 mg treatment dose, Europe’s assessment reports that the upper confidence limit of the QTc change against placebo passed the 10 ms regulatory threshold (EMA, 2017), while Japan’s review gives that limit as 7.73 ms at 100 mg and 10.31 ms at 300 mg (PMDA, 2020). Pooling Japan’s three trials, PMDA counted conduction-related adverse drug reactions in 11.5% of patients on 100 mg who were not taking heart-toxic cancer drugs and 9.1% of those who were, against 1.9% and 2.4% on placebo (PMDA, 2020); first-degree AV block affected 6.0% on anamorelin and none on placebo in ONO-7643-04 (Katakami et al., 2018). In Japan’s adverse-event database, the adjusted reporting odds ratio for conduction defects was 20.00, with a median onset of 13 days (Yabuki et al., 2025).
• High blood sugar — In Japan’s first Phase 2 (Takayama et al., 2016), blood-sugar-related adverse drug reactions affected 23.6% on 100 mg, 10.8% on 50 mg and 1.7% on placebo (PMDA, 2020). In ROMANA 1 and 2, blood-sugar-related adverse events affected 16.2% of patients on anamorelin and 8.1% on placebo (PMDA, 2020), and treatment-related grade 3–4 high blood sugar affected 5 of 650 patients on anamorelin (Temel et al., 2016). In a Japanese claims database, 12.3% had a glucose-related adverse effect, at a median of 17 days, more often with pancreatic cancer or prior diabetes (Ohta et al., 2023); in 23 patients with pancreatic cancer, 26.1% had grade 2 or worse (Matsukane et al., 2026).
• What Europe’s regulator found — In the pivotal safety population, adverse events (78% against 73.6%), serious adverse events (27.4% against 26.7%) and deaths during the 12 weeks (12.7% against 10.4%) were more common on anamorelin. The committee called these differences “not very pronounced” but concluded that “significant toxicity was consistently observed”, especially in the higher number of deaths; it named high blood sugar and diabetes, liver events and “especially cardiotoxicity which could provide an explanation for the imbalance of fatal events”, and noted that the most dangerous rhythm events, three of the torsade de pointes or ventricular tachycardia type among about 900 patients, occurred only on anamorelin (EMA, 2017). Japan’s regulator records that these three were ventricular tachycardia in two patients and a prolonged QT in one, that a causal link to anamorelin was denied in all three, and that treatment continued (PMDA, 2020). Inspections at trial sites could not confirm that serious adverse events had been properly collected and reported, so a full safety assessment was not possible (EMA, 2017). The trial reports judged no death in ROMANA 3 drug-related (Currow et al., 2017).
• Liver — The liver clears anamorelin, and the label text in PMDA’s review rules it out in moderate or severe liver impairment because blood levels may rise (PMDA, 2020). Both patients in a two-case report of wide-QRS tachycardia had liver dysfunction (Okidono et al., 2022), and one healthy volunteer had a short-lived liver-enzyme rise (Garcia & Polvino, 2007).
• Drug interactions — It is broken down mainly by CYP3A4: ketoconazole raised its peak level 3.1-fold and its exposure 3.2-fold, and rifampicin lowered its exposure (EMA, 2017). The label text in PMDA’s review rules out clarithromycin, indinavir, itraconazole, nelfinavir, saquinavir, telaprevir, voriconazole, and ritonavir- or cobicistat-containing products (PMDA, 2020).
• Other effects in trials — In ONO-7643-04, rash affected 6.0% on anamorelin and 1.1% on placebo (Katakami et al., 2018); in the single-arm digestive-cancer trial, treatment-related effects included raised GGT (8.2%), diabetes (6.1%) and a prolonged QRS complex (6.1%) (Hamauchi et al., 2019).
• Tumour growth (a theoretical risk) — Raising growth hormone and IGF-1 in people with cancer raises concerns about stimulating tumour growth (Northrup et al., 2013). In mice with human lung tumours it did not speed growth (Northrup et al., 2013); in mice given it with a myostatin-blocking peptide, tumours tended to be larger than in untreated mice (p = 0.09), and the authors describe that combination as growth-promoting for tumours (Hanada et al., 2022). Median survival was similar to placebo in Japan’s lung-cancer trial (Katakami et al., 2018) and over 12 months in ROMANA (EMA, 2017).
• What has not been tested — The longest published trial ran a year (Dawson-Hughes et al., 2024); no trial has tested it for muscle in young or healthy adults, or tested powder bought outside Japan; PubMed holds no record on pregnancy (searched October 4, 2026).
• WADA — WADA’s 2026 Prohibited List names anamorelin in section S2.2.4, among “growth hormone secretagogues (GHS) and their mimetics [e.g. anamorelin, capromorelin, ibutamoren (MK-677), ipamorelin, lenomorelin (ghrelin), macimorelin and tabimorelin]”, in class S2, prohibited at all times, in and out of competition (World Anti-Doping Agency, 2026). Forensic toxicologists, writing for doping control, describe it as potentially misused in sport and have mapped its breakdown products in human liver cells to help detect it (Gameli et al., 2023).

Bloodwork & Monitoring

No monitoring guidance for anamorelin has been published outside the Japanese label text in PMDA’s review and the trials. That review sets out these checks (PMDA, 2020):

• ECG — Regularly during treatment, with measures up to stopping the drug if abnormalities appear, drawing on the criteria used in Japan’s trials 04 and 05 (PMDA, 2020).
• Electrolytes — Before and during treatment, since low magnesium and other electrolyte problems may add to the conduction risk (PMDA, 2020).
• Blood and urine glucose — Measured during treatment (PMDA, 2020).
• Liver function — Before and during treatment (PMDA, 2020).
• Weight and appetite — Checked around week 3, when the label text has the drug stopped if neither has improved, and reviewed periodically after (PMDA, 2020).
• What the trials measured — Lean body mass by DXA scan, handgrip strength, the 6-minute walk, IGF-1, IGFBP-3 and prealbumin (Katakami et al., 2018), and anorexia–cachexia symptom scores (Temel et al., 2016; EMA, 2017).
• Which tests fit a given person — A question for a licensed healthcare provider. This page can’t answer it.

Commonly Stacked With

In people, anamorelin has been tested on top of cancer care: 80% of the patients in the pooled US Phase 2 trials were on chemotherapy (Graf & Garcia, 2017), Japan’s pivotal trial enrolled patients regardless of past chemotherapy, and the gastric- and urothelial-cancer trials gave it alongside chemotherapy (Katakami et al., 2018; Yamamoto et al., 2025; Odagiri et al., 2025). No study has tested it with another compound on this site (PubMed and Europe PMC, searched October 4, 2026); in mice it has been combined with a myostatin-blocking peptide and an activin-receptor decoy (Hanada et al., 2022; Queiroz et al., 2022).

→ Peptide Calculator — vial-to-syringe math

Legal Status

Related Compounds

People researching anamorelin often also look at these:

Next Steps

References

1. National Library of Medicine. PubChem: Anamorelin, CID 9828911 (C31H42N6O3, 546.7 g/mol; synonyms RC-1291, ONO-7643 and ST-1291; UNII DD5RBA1NKF; CAS 249921-19-5), and anamorelin hydrochloride, CID 16072155 (C31H43ClN6O3, 583.2 g/mol). pubchem.ncbi.nlm.nih.gov. Read October 4, 2026.
2. Pharmaceuticals and Medical Devices Agency (PMDA). Report on the Deliberation Results (December 11, 2020), Review Report (August 20, 2019) and Second Review Report (November 16, 2020), English translation: Adlumiz Tablets 50 mg (anamorelin hydrochloride), Ono Pharmaceutical Co., Ltd. Includes the product’s indication, dosage, contraindications, precautions and the regulator’s safety review. pmda.go.jp/files/000242929.pdf. Read October 4, 2026.
3. Ono Pharmaceutical Co., Ltd. and Helsinn Group. ONO Receives a Manufacturing and Marketing Approval of Adlumiz (Anamorelin), a Ghrelin Receptor Agonist for the Treatment of Cancer Cachexia in Japan. Press release, January 22, 2021. ono-pharma.com/sites/default/files/en/news/press/enews20210122.pdf. Read October 4, 2026.
4. Ono Pharmaceutical Co., Ltd. Launch of Adlumiz (anamorelin), a Ghrelin Receptor Agonist in Japan. Press release, April 21, 2021. ono-pharma.com/sites/default/files/en/news/press/enews20210421.pdf. Read October 4, 2026.
5. European Medicines Agency (EMA). Adlumiz (anamorelin hydrochloride), EMEA/H/C/003847: refused. Questions and answers on refusal of the marketing authorisation, outcome of re-examination, EMA/599030/2017 (September 15, 2017), and refusal public assessment report EMA/647868/2017. ema.europa.eu/en/medicines/human/EPAR/adlumiz. Read October 4, 2026.
6. Graf SA, Garcia JM. Anamorelin hydrochloride in the treatment of cancer anorexia-cachexia syndrome: design, development, and potential place in therapy. Drug Des Devel Ther. 2017;11:2325-2331. PMID: 28848326. DOI: 10.2147/DDDT.S110131.
7. Morimoto K, Uchino J, Hibino M, Takeyasu Y, et al. A Prospective Observational Study of Anamorelin During Chemoimmunotherapy in Non-Small Cell Lung Cancer With Cachexia (SPIRAL-ANA). J Cachexia Sarcopenia Muscle. 2026;17(4):e70340. PMID: 42411631. DOI: 10.1002/jcsm.70340. Correction: J Cachexia Sarcopenia Muscle. 2026;17(4):e70352. PMID: 42552565 (data management and monitoring were funded by Ono Pharmaceutical, not Chugai).
8. Pietra C, Takeda Y, Tazawa-Ogata N, Minami M, et al. Anamorelin HCl (ONO-7643), a novel ghrelin receptor agonist, for the treatment of cancer anorexia-cachexia syndrome: preclinical profile. J Cachexia Sarcopenia Muscle. 2014;5(4):329-337. PMID: 25267366. DOI: 10.1007/s13539-014-0159-5.
9. Wang RL, Sun J, Liu H, Guo SM, et al. Molecular recognition of two approved drugs Macimorelin and Anamorelin by the growth hormone secretagogue receptor. Acta Pharmacol Sin. 2025;46(11):2998-3008. PMID: 40542284. DOI: 10.1038/s41401-025-01606-7.
10. Garcia JM, Polvino WJ. Pharmacodynamic hormonal effects of anamorelin, a novel oral ghrelin mimetic and growth hormone secretagogue in healthy volunteers. Growth Horm IGF Res. 2009;19(3):267-273. PMID: 19196529. DOI: 10.1016/j.ghir.2008.12.003.
11. Garcia JM, Polvino WJ. Effect on body weight and safety of RC-1291, a novel, orally available ghrelin mimetic and growth hormone secretagogue: results of a phase I, randomized, placebo-controlled, multiple-dose study in healthy volunteers. Oncologist. 2007;12(5):594-600. PMID: 17522248. DOI: 10.1634/theoncologist.12-5-594.
12. Leese PT, Trang JM, Blum RA, de Groot E. An open-label clinical trial of the effects of age and gender on the pharmacodynamics, pharmacokinetics and safety of the ghrelin receptor agonist anamorelin. Clin Pharmacol Drug Dev. 2015;4(2):112-120. PMID: 26640742. DOI: 10.1002/cpdd.175.
13. Blum RA, Mair S, Duus EM. Appetite and food intake results from phase I studies of anamorelin. J Cachexia Sarcopenia Muscle. 2019;10(5):1027-1035. PMID: 31074178. DOI: 10.1002/jcsm.12439.
14. Northrup R, Kuroda K, Duus EM, Barnes SR, et al. Effect of ghrelin and anamorelin (ONO-7643), a selective ghrelin receptor agonist, on tumor growth in a lung cancer mouse xenograft model. Support Care Cancer. 2013;21(9):2409-2415. PMID: 23579947. DOI: 10.1007/s00520-013-1800-0.
15. Miyake M, Hori S, Itami Y, Oda Y, et al. Supplementary Oral Anamorelin Mitigates Anorexia and Skeletal Muscle Atrophy Induced by Gemcitabine Plus Cisplatin Systemic Chemotherapy in a Mouse Model. Cancers (Basel). 2020;12(7):1942. PMID: 32709007. DOI: 10.3390/cancers12071942.
16. Lu Z, Ngan MP, Liu JYH, Yang L, et al. The growth hormone secretagogue receptor 1a agonists, anamorelin and ipamorelin, inhibit cisplatin-induced weight loss in ferrets: Anamorelin also exhibits anti-emetic effects via a central mechanism. Physiol Behav. 2024;284:114644. PMID: 39043357. DOI: 10.1016/j.physbeh.2024.114644.
17. Hanada K, Fukasawa K, Hinata H, Imai S, et al. Combination therapy with anamorelin and a myostatin inhibitor is advantageous for cancer cachexia in a mouse model. Cancer Sci. 2022;113(10):3547-3557. PMID: 35849084. DOI: 10.1111/cas.15491.
18. Queiroz AL, Dantas E, Ramsamooj S, Murthy A, et al. Blocking ActRIIB and restoring appetite reverses cachexia and improves survival in mice with lung cancer. Nat Commun. 2022;13(1):4633. PMID: 35941104. DOI: 10.1038/s41467-022-32135-0.
19. Garcia JM, Friend J, Allen S. Therapeutic potential of anamorelin, a novel, oral ghrelin mimetic, in patients with cancer-related cachexia: a multicenter, randomized, double-blind, crossover, pilot study. Support Care Cancer. 2013;21(1):129-137. PMID: 22699302. DOI: 10.1007/s00520-012-1500-1.
20. Garcia JM, Boccia RV, Graham CD, Yan Y, et al. Anamorelin for patients with cancer cachexia: an integrated analysis of two phase 2, randomised, placebo-controlled, double-blind trials. Lancet Oncol. 2015;16(1):108-116. PMID: 25524795. DOI: 10.1016/S1470-2045(14)71154-4.
21. Takayama K, Katakami N, Yokoyama T, Atagi S, et al. Anamorelin (ONO-7643) in Japanese patients with non-small cell lung cancer and cachexia: results of a randomized phase 2 trial. Support Care Cancer. 2016;24(8):3495-3505. PMID: 27005463. DOI: 10.1007/s00520-016-3144-z.
22. Temel JS, Abernethy AP, Currow DC, Friend J, et al. 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. 2016;17(4):519-531. PMID: 26906526. DOI: 10.1016/S1470-2045(15)00558-6.
23. Currow D, Temel JS, Abernethy A, Milanowski J, et al. ROMANA 3: a phase 3 safety extension study of anamorelin in advanced non-small-cell lung cancer (NSCLC) patients with cachexia. Ann Oncol. 2017;28(8):1949-1956. PMID: 28472437. DOI: 10.1093/annonc/mdx192.
24. Laird BJA, Skipworth R, Bonomi PD, Fallon M, et al. Anamorelin Efficacy in Non-Small-Cell Lung Cancer Patients With Cachexia: Insights From ROMANA 1 and ROMANA 2. J Cachexia Sarcopenia Muscle. 2025;16(1):e13732. PMID: 39992021. DOI: 10.1002/jcsm.13732.
25. Katakami N, Uchino J, Yokoyama T, Naito T, et al. 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. 2018;124(3):606-616. PMID: 29205286. DOI: 10.1002/cncr.31128.
26. Hamauchi S, Furuse J, Takano T, Munemoto Y, et al. A multicenter, open-label, single-arm study of anamorelin (ONO-7643) in advanced gastrointestinal cancer patients with cancer cachexia. Cancer. 2019;125(23):4294-4302. PMID: 31415709. DOI: 10.1002/cncr.32406.
27. Naito T, Uchino J, Kojima T, Matano Y, et al. A multicenter, open-label, single-arm study of anamorelin (ONO-7643) in patients with cancer cachexia and low body mass index. Cancer. 2022;128(10):2025-2035. PMID: 35195274. DOI: 10.1002/cncr.34154.
28. Skipworth RJE, Laird BJA, Roeland EJ, Solheim TS, et al. Two phase 3 studies to evaluate the ghrelin receptor agonist anamorelin for malignancy-associated weight loss and anorexia in adults with non-small cell lung cancer (NSCLC): updates to the ongoing SCALA programme. Abstract 2-08, in: Abstracts. J Cachexia Sarcopenia Muscle. 2023;14(5):2359-2438. DOI: 10.1002/jcsm.13299. PMCID: PMC10570116.
29. Currow D, Chessari S, Bonomi P, Giorgino R, Skipworth R. LBA95 Anamorelin and weight gain in patients with advanced non-small cell lung cancer (NSCLC) and cachexia: Efficacy and safety in the multinational phase III SCALA program. Ann Oncol. 2023;34:S1335. DOI: 10.1016/j.annonc.2023.10.098. (Conference abstract; known here from its Crossref record, since the journal’s page could not be opened.)
30. Yamamoto K, Kurokawa Y, Miyazaki Y, Omori T, et al. Efficacy and safety of anamorelin for cancer cachexia in patients with unresectable or recurrent gastric cancer: a multicentre, open-label, randomised controlled trial. EClinicalMedicine. 2025;88:103500. PMID: 41181834. DOI: 10.1016/j.eclinm.2025.103500.
31. Odagiri K, Mimura Y, Naiki T, Tasaki Y, et al. Efficacy and safety of anamorelin in patients with metastatic urothelial carcinoma receiving systemic chemotherapy: a randomized controlled study. Oncologist. 2025;30(7):oyaf167. PMID: 40592718. DOI: 10.1093/oncolo/oyaf167.
32. Taniguchi J, Mikura S, da Silva Lopes K. The efficacy and safety of anamorelin for patients with cancer-related anorexia/cachexia syndrome: a systematic review and meta-analysis. Sci Rep. 2023;13(1):15257. PMID: 37709824. DOI: 10.1038/s41598-023-42446-x.
33. Takayama K, Kojima A, Honda C, Nakayama M, et al. Real-world safety and effectiveness of anamorelin for cancer cachexia: Interim analysis of post-marketing surveillance in Japan. Cancer Med. 2024;13(9):e7170. PMID: 38693813. DOI: 10.1002/cam4.7170.
34. Dawson-Hughes B, Barger K, Reitshamer E, Fielding RA, et al. Effect of Anamorelin, a Ghrelin Receptor Agonist, on Muscle and Bone in Adults With Osteosarcopenia. J Clin Endocrinol Metab. 2024;109(3):e945-e955. PMID: 38057159. DOI: 10.1210/clinem/dgad702.
35. Yennurajalingam S, Basen-Engquist K, Reuben JM, Fellman BM, et al. Anamorelin combined with physical activity, and nutritional counseling for cancer-related fatigue: a preliminary study. Support Care Cancer. 2022;30(1):497-509. PMID: 34331589. DOI: 10.1007/s00520-021-06463-8.
36. Kojima K, Furukawa S, Ishikawa T, Inoue S. First case report of anamorelin-induced fatal arrhythmia complicated by sinus arrest and refractory ventricular tachycardia. HeartRhythm Case Rep. 2023;9(3):185-189. PMID: 36970378. DOI: 10.1016/j.hrcr.2022.12.011. (The patient survived the arrhythmia; she died about six months later of a cancer-related bowel obstruction, with no further cardiac event.)
37. Okidono Y, Osada J, Otsu K, Kowase S, et al. Two cases of wide QRS complex tachycardia caused by anamorelin. J Cardiol Cases. 2022;26(3):212-216. PMID: 36091615. DOI: 10.1016/j.jccase.2022.04.015.
38. Yabuki N, Sako KI, Maeda T, Ide N. Anamorelin and Conduction Defects: A Literature Review and Analysis of the Japanese Pharmacovigilance Database. In Vivo. 2025;39(1):404-410. PMID: 39740881. DOI: 10.21873/invivo.13842.
39. Ohta H, Horii T, Yasu T. Adverse Metabolic Effects on Glucose in Patients Receiving Anamorelin Using a Japanese Claims Database. Oncology. 2023;101(12):782-785. PMID: 37579746. DOI: 10.1159/000533539.
40. Matsukane R, Minami H, Fujimori N, Ueda K, et al. Prospective study of anamorelin in pancreatic cancer cachexia: Clinical and translational insights into response heterogeneity. Clin Nutr. 2026;58:106581. PMID: 41619712. DOI: 10.1016/j.clnu.2026.106581.
41. Gameli PS, Taoussi O, Basile G, Carlier J, Busardò FP. Metabolism Study of Anamorelin, a GHSR1a Receptor Agonist Potentially Misused in Sport, with Human Hepatocytes and LC-HRMS/MS. Metabolites. 2023;13(8):949. PMID: 37623892. DOI: 10.3390/metabo13080949.
42. Yamashita K, Nishio K, Mizutani S, Nishimura Y, et al. A randomized controlled trial evaluating the effects of anamorelin in postoperative patients with upper gastrointestinal cancer: protocol for the CLEAR-UP study. Jpn J Clin Oncol. 2026;56(4):496-499. PMID: 41543044. DOI: 10.1093/jjco/hyaf223.
43. ClinicalTrials.gov. Registrations of anamorelin (RC-1291, ONO-7643): NCT00219817 and NCT00267358 (Phase 2, pooled in Garcia et al., 2015), NCT00378131 (Phase 2, 51 enrolled, completed 2007), NCT00622193 (Phase 2, 228, completed 2009), NCT01387269 (ROMANA 1, 484), NCT01387282 (ROMANA 2, 495), NCT01395914 (ROMANA 3, 513), NCT01505764 (Phase 2, 10, terminated, “poor recruitment”), NCT03035409 (Phase 2, 129, active, not recruiting), NCT03637816 (Phase 2/3, 25, active, not recruiting, estimated primary completion December 31, 2026), NCT03743051 (Phase 3, 318, completed February 11, 2023), NCT03743064 (Phase 3, 318, completed December 27, 2022), NCT04021706 (osteosarcopenia, 32, completed 2023) and NCT04844970 (Phase 2, 4, terminated). NCT00219817, NCT00267358, NCT00378131, NCT00622193 and NCT03637816 post no results; the three ROMANA trials (results first posted July 11, 2017), the two SCALA trials, NCT03035409, NCT04021706, NCT01505764 and NCT04844970 do. clinicaltrials.gov, API v2. Read October 4 and 5, 2026.
44. FDA. National Drug Code Directory: four bulk-ingredient listings of anamorelin hydrochloride powder (marketing start dates January 1, 2014; September 19, 2024; March 18, 2026; August 21, 2026) (openFDA drug/ndc, data of October 2, 2026); and “About the NDC directory,” fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory. Read October 4, 2026.
45. FDA. Drugs@FDA through openFDA (api.fda.gov/drug/drugsfda.json): searches for anamorelin, anamorelin hydrochloride and Adlumiz; DailyMed search for anamorelin; FDA warning-letter search for anamorelin (fda.gov). All October 4, 2026; no records.
46. Code of Federal Regulations. 21 CFR 216.23, Bulk drug substances that can be used to compound drug products in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act. ecfr.gov. Read October 4, 2026.
47. FDA. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act (categories 1–3). Updated May 14, 2026. fda.gov/media/94155/download.
48. FDA. Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act (categories 1–3). Updated March 21, 2025. fda.gov/media/94164/download.
49. World Anti-Doping Agency. Prohibited List 2026 (in effect January 1, 2026). S2.2.4, Growth hormone releasing factors: growth hormone secretagogues (GHS) and their mimetics. wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf. Read October 4, 2026.
50. Searches of October 4, 2026: PubMed, “anamorelin” (185 records) and “anamorelin OR RC-1291 OR RC1291 OR ONO-7643 OR ONO7643 OR ST-1291” (186); PubMed and Europe PMC, anamorelin with ibutamoren or MK-677, ipamorelin, tesamorelin, sermorelin, GHRP, hexarelin, CJC-1295 or macimorelin (no study of a combination; one ferret study tested anamorelin and ipamorelin separately), with testosterone, oxandrolone, enobosarm, megestrol, olanzapine, mirtazapine or dronabinol (no combination trial), and with pregnancy or lactation (no record); PubMed and Europe PMC, the SCALA trial numbers (no full results paper); ClinicalTrials.gov, “anamorelin” (11 records), “ONO-7643” and “RC-1291” (3 more); laboratory reagent supplier catalogues listing anamorelin for research use only (suppliers not named). October 5, 2026: Crossref, the SCALA conference abstract; PubMed, “NCT01505764 OR NCT04844970” (0 records); a web search for anamorelin products (laboratory reagent catalogues only; suppliers not named).

Related Research

• MacimorelinOral ghrelin-receptor agonist · US diagnostic test for GH deficiency
• MK-677Oral GH secretagogue (ibutamoren)
• IpamorelinSelective ghrelin-receptor peptide
• BimagrumabActivin type II receptor antibody