Anamorelin is an oral, non-peptide drug that activates the ghrelin receptor, the same receptor that ghrelin (the stomach’s “hunger hormone”) uses to raise appetite and growth hormone (GH) release. It was developed by Helsinn (code RC-1291) and, in Japan, by Ono Pharmaceutical (code ONO-7643) as a treatment for cancer cachexia: the loss of weight, muscle and appetite that often comes with advanced cancer.

The most important fact is that its regulatory record is split. Japan approved it on January 22, 2021, as Adlumiz 50 mg tablets for cancer cachexia in four cancer types. Europe refused it in 2017, judging the effect on lean body mass “marginal” with no proven gain in strength or quality of life. It is not approved by the US FDA. Across trials it typically added about 1–2 kg of lean mass or body weight over 12 weeks compared with placebo, but it never improved handgrip strength.

This page summarizes what the Japanese approval documents, the European assessment report and the clinical trials report. It is for education only and is not medical advice.

Property	Detail
Drug class	Non-peptide ghrelin receptor (GHS-R1a) agonist; growth hormone secretagogue
Other names	ONO-7643, RC-1291; anamorelin hydrochloride; brand Adlumiz (Japanese spelling romanized as Edlumiz)
Route	Oral tablet, taken on an empty stomach
Approved dose (Japan)	100 mg once daily (two 50 mg tablets), no food for 1 hour after
Half-life	Mean terminal ≈6–7 h in healthy volunteers; EMA describes a two-phase decline over 6.3–24.6 h
Japan	Approved January 22, 2021, for cancer cachexia in non-small cell lung, gastric, pancreatic and colorectal cancer
European Union	Marketing authorisation refused (CHMP negative opinion 2017, confirmed on re-examination)
United States	Not FDA-approved; Drugs@FDA lists no anamorelin product
WADA status	Prohibited at all times (S2.2.4, growth hormone secretagogues; named on the list)

What it is

Anamorelin is a small synthetic molecule built from an indole (tryptophan-like) group and a benzyl-piperidine core. The free base has the formula C₃₁H₄₂N₆O₃ and a molecular weight of 546.7 g/mol (PubChem CID 9828911). The drug is supplied as the hydrochloride salt.

Ghrelin itself is a peptide with a short half-life that must be injected. Anamorelin was designed as an oral, longer-acting mimic (Garcia & Polvino, Growth Horm IGF Res 2009). In cell assays it activates the ghrelin receptor at very low concentrations (EC50 1.5 nM) (EMA assessment report, 2017).

Activating this receptor has two effects that matter for cachexia:

More growth hormone and IGF-1. The pituitary releases more GH, and the liver then makes more insulin-like growth factor 1 (IGF-1), which supports muscle protein.
More appetite. Ghrelin receptors in the brain drive hunger and food intake.

In 32 healthy volunteers given 25, 50 or 75 mg/day, anamorelin raised GH at all doses and kept IGF-1 and IGFBP-3 elevated over 5–6 days. It had negligible effects on other pituitary hormones (prolactin, ACTH, LH, FSH, TSH) or fasting glucose. Some insulin resistance appeared at 75 mg but not at the lower doses (Garcia & Polvino, Growth Horm IGF Res 2009).

How it compares with ibutamoren

Anamorelin works on the same receptor as ibutamoren (MK-677), another oral, non-peptide ghrelin mimetic. The difference is the development path. Ibutamoren was tested for frailty and other conditions but never approved anywhere. Anamorelin was taken through phase 3 trials specifically for cancer cachexia and is an approved prescription drug in Japan.

Pharmacokinetics

From the European assessment report (EMA, 2017) and a healthy-volunteer study (Leese et al., Clin Pharmacol Drug Dev 2015):

Parameter	Value
Oral bioavailability	≈37%
Time to peak (100 mg tablet)	≈0.7–1 h
Effect of food	AUC and peak level 18% lower when taken fed; hence dosing on an empty stomach
Protein binding	97–98%, mainly to alpha-1 acid glycoprotein
Elimination half-life	Two-phase decline, 6.3–24.6 h (EMA); mean terminal 6–7 h after a 25 mg dose (Leese)
Metabolism	Liver, mainly CYP3A4; also a P-glycoprotein substrate
Excretion	92–93% of a radiolabeled dose recovered in feces, mostly unchanged; 1–7% unchanged in urine
Accumulation	Minimal with repeated daily dosing

Two practical points follow from these numbers:

Strong CYP3A4 inhibitors raise exposure about threefold. With ketoconazole, anamorelin’s peak level rose about 3.1-fold and total exposure about 3.2-fold.
Women had higher exposure in early studies. With the early 25 mg capsule, women had about 1.8–1.9-fold higher exposure than men, but the GH response was virtually identical in both sexes, and the GH response was weaker in older adults.

Regulatory status

Japan: approved in 2021

Ono received Japanese approval on January 22, 2021, for “cancer cachexia” in non-small cell lung cancer (NSCLC), gastric cancer, pancreatic cancer and colorectal cancer. The labeled adult dose is 100 mg once daily in the fasting state (Ono press release, 2021). An expert committee had first postponed its decision in August 2019 because of doubts about efficacy and safety, then recommended approval in December 2020 (Wakabayashi et al., J Cachexia Sarcopenia Muscle 2021). Approval rested mainly on two small Japanese trials, not on the larger international ROMANA trials.

Ono’s proper-use document, issued with the approval, restricts use to patients who meet all of the following (Ono proper-use guidance, 2021):

unresectable, advanced or recurrent cancer of one of the four approved types;
cachexia not improved enough by nutrition therapy;
5% or more weight loss within 6 months plus loss of appetite, and at least two of: fatigue or malaise, general muscle weakness, or abnormal blood markers (CRP over 0.5 mg/dL, hemoglobin under 12 g/dL or albumin under 3.2 g/dL).

The same document says to stop treatment if neither weight nor appetite has improved after about 3 weeks, and notes that the Japanese trials had no experience beyond 12 weeks.

Europe: refused in 2017

Helsinn applied to the European Medicines Agency (EMA) for Adlumiz in NSCLC-related anorexia and cachexia, based on the ROMANA 1 and 2 trials. The CHMP (EMA’s human medicines committee) adopted a negative opinion on May 18, 2017, and confirmed it on re-examination on September 14, 2017. The European Commission formally refused authorisation on November 16, 2017 (EMA: Adlumiz). The CHMP gave two main reasons:

Marginal benefit. The trials showed a marginal effect on lean body mass and no proven effect on handgrip strength or quality of life.
Unreliable safety data. Inspections of trial sites found serious problems with how serious adverse events were recorded and reported, so the safety database could not be fully assessed.

United States: not approved

Anamorelin has no FDA approval, and Drugs@FDA lists no anamorelin application or product (Drugs@FDA). After the European refusal, Helsinn ran two further phase 3 trials in advanced NSCLC from 2019 to 2023. Each met its body-weight endpoint but missed its anorexia-symptom endpoint (see below) (ClinicalTrials.gov NCT03743051; NCT03743064).

The ASCO cachexia guideline (2020) concluded that no specific drug can be recommended as standard of care for cancer cachexia (Roeland et al., J Clin Oncol 2020).

What the research shows

ROMANA 1 and 2: international phase 3 trials

Two identical double-blind trials randomized patients with inoperable stage III–IV NSCLC and cachexia (5% or more weight loss in 6 months, or BMI under 20) 2:1 to anamorelin 100 mg or placebo once daily for 12 weeks. The co-primary endpoints were lean body mass (measured by DXA, a low-dose X-ray body scan) and handgrip strength (Temel et al., Lancet Oncol 2016):

Trial	n	Lean body mass, anamorelin	Lean body mass, placebo	Handgrip, anamorelin	Handgrip, placebo
ROMANA 1	484	+0.99 kg	−0.47 kg	−1.10 kg	−1.58 kg (p = 0.15)
ROMANA 2	495	+0.65 kg	−0.98 kg	−1.49 kg	−0.95 kg (p = 0.65)

Values are medians over 12 weeks. Both lean-mass differences were significant (p under 0.0001). Grip strength fell in both groups, and anamorelin did not slow that decline.

In ROMANA 3, 513 patients who completed either trial continued on their assigned treatment for another 12 weeks. Anamorelin kept body weight higher than placebo at every time point and improved anorexia-cachexia symptom scores through week 16. Handgrip strength still did not improve (Currow et al., Ann Oncol 2017).

Over 12 months of follow-up in ROMANA 1 and 2, 60.2% of patients on anamorelin and 58.0% on placebo died. Median survival was 8.9 vs 9.2 months, a difference that was not significant (hazard ratio 1.06, 95% CI 0.89–1.26) (EMA assessment report, 2017).

Japanese trials behind the approval

Trial	Design and n	Result over 12 weeks
ONO-7643-03 (Takayama et al., Support Care Cancer 2016)	Phase 2, NSCLC, 50 mg vs 100 mg vs placebo; n = 181	Lean mass +1.15 kg (100 mg) vs +0.55 kg (placebo); body weight +1.77 kg (100 mg), +0.54 kg (50 mg), −0.93 kg (placebo); no handgrip effect
ONO-7643-04 (Katakami et al., Cancer 2018)	Randomized, double-blind, NSCLC, 100 mg vs placebo; n = 174	Lean mass +1.38 kg vs −0.17 kg (p under 0.0001); better appetite and body weight; no change in handgrip strength or 6-minute walk distance
ONO-7643-05 (Hamauchi et al., Cancer 2019)	Single-arm, no placebo, colorectal, gastric or pancreatic cancer; n = 50	63.3% kept or gained lean mass; lean mass +1.89 kg, body weight +1.41 kg

The gastrointestinal-cancer study had no control group, so its results cannot separate the drug’s effect from other changes over the 12 weeks.

Helsinn’s later phase 3 trials (2019–2023)

Two more double-blind trials randomized 318 patients each with advanced NSCLC and weight loss to anamorelin 100 mg or placebo once daily, with 24 weeks of planned treatment. The co-primary endpoints over 12 weeks were body weight and a 5-item anorexia symptom score (ClinicalTrials.gov NCT03743051; NCT03743064):

Trial	Body weight, anamorelin vs placebo	Difference (95% CI)	Anorexia symptom score difference (95% CI)
NCT03743051	+1.94 vs +0.59 kg	+1.35 kg (0.72–1.97)	+0.62 points (−0.23 to 1.47), p = 0.15
NCT03743064	+1.82 vs +0.54 kg	+1.28 kg (0.72–1.85)	+0.14 points (−0.64 to 0.92), p = 0.72

Weight gain was again significant, but neither trial showed that patients felt less loss of appetite than on placebo, the second goal each trial had to meet.

Pooled evidence

A 2023 meta-analysis of 7 randomized trials (1,944 patients) found that, compared with placebo, anamorelin (Taniguchi et al., Sci Rep 2023):

increased total body weight by 1.73 kg (95% CI 1.34–2.13);
increased lean body mass by 1.06 kg (95% CI 0.30–1.81);
slightly improved quality of life (standardized mean difference 0.16, 95% CI 0.04–0.27);
did not significantly change adverse events, overall survival, handgrip strength or appetite.

Real-world use in Japan

Japan’s all-case post-marketing surveillance analyzed 6,016 patients who started anamorelin in 2021. Mean weight gain was 0.64 kg at week 3, 1.19 kg at week 12 and 1.42 kg at week 52. Median treatment lasted only 29 days (Takayama et al., Cancer Med 2024).

Lean mass is not strength. Anamorelin’s added lean mass, about 1–2 kg in 12 weeks, did not improve grip strength in any controlled trial, or walking distance in the one trial that measured it. This was the central reason EMA judged the benefit marginal. We found no published trials testing it for muscle building or performance in healthy people.

Side effects and risks

Heart conduction

Anamorelin has sodium channel-blocking activity, which can slow electrical conduction in the heart. The Japanese labeling lists ECG abnormalities (marked PR or QRS prolongation, QT prolongation), atrioventricular block, fast or slow heart rate, palpitations and low blood pressure. It calls for regular checks of ECG, pulse, blood pressure and electrolytes, especially early in treatment (Ono proper-use guidance, 2021).

The evidence behind this warning:

Dose-finding. In the thorough QT study, a 400 mg dose caused a QRS widening of up to 87 ms (about 90% above baseline) in one subject, so the first cohort was stopped and the study restarted with 300 mg as the highest dose. At 100 mg, the upper bound of the QTc change exceeded the 10 ms regulatory threshold (EMA assessment report, 2017).
Japanese trials. Pooled across the three Japanese trials, cardiovascular events and ECG abnormalities occurred in 10.7% of anamorelin patients vs 2.0% on placebo (Ono risk management plan, 2026).
After approval. In the post-marketing surveillance, treatment-related conduction disorders occurred in 1.1% of patients (Takayama et al., Cancer Med 2024). An analysis of Japan’s adverse event database found conduction defects reported far more often with anamorelin than with other drugs (adjusted reporting odds ratio 20.0, 95% CI 14.9–26.9), with a median onset of 13 days (Yabuki et al., In Vivo 2025).

Blood sugar

Raised blood glucose is the most common drug-related problem.

Trials. Glucose-related side effects occurred in 15.0% of anamorelin patients vs 1.4% on placebo in the pooled Japanese trials, and 7.8% vs 3.7% in ROMANA 1 and 2 (Ono risk management plan, 2026).
Post-marketing surveillance. Hyperglycemia was the most common treatment-related adverse event (3.9%) (Takayama et al., Cancer Med 2024).
Ketoacidosis. By December 2025, 21 cases of diabetic ketoacidosis or related events (including ketosis and hyperosmolar states) had been reported after approval in Japan. These prompted a 2026 update to the risk management plan.

The labeling advises checking blood glucose before and during treatment (Ono proper-use guidance, 2021).

Liver

Liver enzyme increases are an identified risk. Animal studies showed raised liver enzymes, and dogs had inflammatory liver changes. In ROMANA 1 and 2, hepatic adverse events occurred in 6.4% of anamorelin patients vs 3.6% on placebo (EMA assessment report, 2017). In post-marketing surveillance, treatment-related liver problems occurred in 1.2% (Takayama et al., Cancer Med 2024).

Tumor growth

Raised IGF-1 could in theory feed tumor growth. Japan’s risk management plan lists tumor progression as a potential risk. It notes that trials showed no difference in progression rates or survival, but also that long-term epidemiological data are lacking (Ono risk management plan, 2026).

Who should not take it (Japanese labeling)

The Japanese contraindications are (Ono proper-use guidance, 2021):

congestive heart failure;
myocardial infarction or angina;
severe conduction disorders such as complete heart block;
moderate or severe liver impairment (Child-Pugh B or C);
current use of strong CYP3A4 inhibitors (for example clarithromycin, itraconazole, voriconazole, ritonavir- or cobicistat-containing products);
inability to eat because of gastrointestinal obstruction;
previous hypersensitivity to the drug.

The labeling advises caution in people with diabetes, other heart disease, QT prolongation, electrolyte disturbances, prior anthracycline chemotherapy or mild liver impairment.

Interactions

The labeling flags these interactions (Ono proper-use guidance, 2021):

Interacting drug or food	Concern
Antiarrhythmics, beta-blockers, anthracyclines	Added suppression of heart conduction or function
Drugs that prolong the QT interval	Higher risk of QT prolongation and ventricular arrhythmia
Moderate CYP3A4 inhibitors (e.g. erythromycin, diltiazem), grapefruit juice	Higher anamorelin levels
CYP3A4 inducers (e.g. rifampicin, carbamazepine, phenytoin, St. John’s wort)	Lower anamorelin levels and reduced effect

Legal status and use outside medicine

WADA names anamorelin as an example of a growth hormone secretagogue under S2.2.4. It is prohibited for athletes at all times, in and out of competition (WADA 2026 Prohibited List). Its only approved use is cancer cachexia in Japan. We found no trials in healthy or athletic people, so its benefit-risk balance outside that setting is unknown. The cardiac conduction and blood sugar risks were seen in patients under ECG and laboratory monitoring.

Key takeaways

An oral ghrelin mimic. Anamorelin activates the ghrelin receptor to raise appetite, GH and IGF-1, like ibutamoren, but was developed specifically for cancer cachexia.
Approved only in a narrow setting. Japan approved it in January 2021 for cachexia in four cancer types; EMA refused it in 2017, and it is not FDA-approved.
Small, consistent weight and lean-mass gains. Trials showed about 1–2 kg more lean mass or body weight than placebo over 12 weeks (pooled weight gain 1.73 kg).
No strength or function benefit. Handgrip strength did not improve in any controlled trial, and two 2019–2023 phase 3 trials missed their appetite-symptom endpoint.
Heart conduction and glucose are the key risks. It can slow cardiac conduction (contraindicated in heart failure and severe heart block) and raise blood sugar, with ketoacidosis cases reported in Japan.
Banned in sport. WADA prohibits it at all times under S2.2.4.

Sources

Ono Pharmaceutical Co., Ltd., 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.
Ono Pharmaceutical Co., Ltd., Anamorelin Proper Use Committee. Request for the proper use of Edlumiz tablets 50 mg (in Japanese). January 22, 2021. JRS.
Ono Pharmaceutical Co., Ltd. Edlumiz tablets 50 mg risk management plan (in Japanese), submitted April 28, 2026. PMDA.
European Medicines Agency. Adlumiz (anamorelin): refusal of the marketing authorisation; and Adlumiz EPAR, refusal public assessment report, EMA/647868/2017. EMA; EPAR PDF.
Wakabayashi H, Arai H, Inui A. The regulatory approval of anamorelin for treatment of cachexia in patients with non-small cell lung cancer, gastric cancer, pancreatic cancer, and colorectal cancer in Japan: facts and numbers. J Cachexia Sarcopenia Muscle. 2021;12(1):14–16. PubMed.
Temel JS, Abernethy AP, Currow DC, 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. PubMed.
Currow D, Temel JS, Abernethy A, 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. PubMed.
Helsinn Healthcare SA. A phase 3 randomized, double-blind, placebo-controlled, multicenter 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). ClinicalTrials.gov results, NCT03743051 and NCT03743064. NCT03743051; NCT03743064.
Takayama K, Katakami N, Yokoyama T, 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. PubMed.
Katakami N, Uchino J, Yokoyama 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. PubMed.
Hamauchi S, Furuse J, Takano T, 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. PubMed.
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. PubMed.
Takayama K, Kojima A, Honda C, 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. PubMed.
Yabuki N, Sako KI, Maeda T, et al. Anamorelin and conduction defects: a literature review and analysis of the Japanese pharmacovigilance database. In Vivo. 2025;39(1):404–410. PubMed.
Leese PT, Trang JM, Blum RA, et al. 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. PubMed.
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. PubMed.
Roeland EJ, Bohlke K, Baracos VE, et al. Management of cancer cachexia: ASCO guideline. J Clin Oncol. 2020;38(21):2438–2453. PubMed.
National Center for Biotechnology Information. PubChem compound summary: anamorelin (CID 9828911). PubChem.
U.S. Food and Drug Administration. Drugs@FDA: FDA-approved drugs (searched for anamorelin, October 2026). FDA.
World Anti-Doping Agency. World Anti-Doping Code International Standard: Prohibited List 2026. WADA 2026 Prohibited List.

Anamorelin