Adlumiz (anamorelin) / Helsinn, Ono Pharma, Specialised Therap - LARVOL DELTA

Real-world effectiveness of anamorelin in patients with unresectable and relapse pancreatic cancer: a prospective observational study. (PubMed, J Gastrointest Oncol) - "In inoperable and relapsed PC, anamorelin may be more effective in patients with a better overall condition and is associated with longer survival. To improve patient outcomes, appetite and BW must be monitored regularly and anamorelin treatment should begin early."

Journal • Observational data • Real-world evidence • Cachexia • Oncology • Pancreatic Cancer • Solid Tumor

Z&A Therapy: Pain Alleviation and Appetite Stimulation in Pancreatic Cancer Patients Using ZICTHORU® Tapes and Anamorelin (ASA 2025) - "Based on these observations, we tentatively refer to this combined approach as Z&A Therapy, a strategy that warrants further investigation for its potential role in enhancing patient outcomes. Notably, despite the use of NSAIDs, eGFR improved in both cases, suggesting that pain alleviation and subsequent increases in physical activity may have contributed to better renal function."

Clinical • Oncology • Pain • Pancreatic Cancer • Solid Tumor

Effect of anamorelin on body weight in patients with gastric cancer-associated cachexia: an observational study. (PubMed, Gastric Cancer) - "In patients with gastric cancer-related cachexia, anamorelin was associated with significant increases in body weight and improvements in appetite. Lower BMI and lower systemic inflammation (NLR < 4.0) were predictive of better response."

Journal • Observational data • Cachexia • Gastric Cancer • Oncology • Solid Tumor

Efficacy and safety of anamorelin in patients with metastatic urothelial carcinoma receiving systemic chemotherapy: a randomized controlled study. (PubMed, Oncologist) - "Anamorelin was well tolerated in patients with mUC. A higher serum IGF-1 level might be associated with anamorelin efficacy; however, a larger study is needed to confirm this."

Journal • Cachexia • Oncology • Solid Tumor • Urothelial Cancer • IGF1 • IL6

Molecular recognition of two approved drugs Macimorelin and Anamorelin by the growth hormone secretagogue receptor. (PubMed, Acta Pharmacol Sin) - "In addition, structural comparison of GHSR in complex with different G protein subtypes elucidated the mechanisms driving G protein selectivity. Our results provide crucial insights into GHSR-drug interactions and offer valuable guidance for designing more selective and potent GHSR agonists."

Journal • Cachexia • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Adult) • Oncology

Sarcopenia in Ageing and Chronic Illness: Trial Endpoints and Regulatory Issues. (PubMed, J Cachexia Sarcopenia Muscle) - "Furthermore, novel therapeutic approaches were explored, including 20-hydroxyecdysone, enobosarm, anamorelin, ponsegromab, and nutritional supplementation, alongside broader strategies targeting myostatin-activin signalling inhibition and Akt pathway activation. Given that the population that may be addressed in aging associated sarcopenia is vast, the safety requirement standards applied for studies may be equivalent to those of studies in type 2 diabetes mellitus. Some argued at the meeting that this would make study programs so large that from an economic standpoint only therapies that significantly impact on morbidity/mortality outcomes have a chance to be considered commercially feasible for development."

Journal • Cachexia • Diabetes • Metabolic Disorders • Sarcopenia • Type 2 Diabetes Mellitus

Effect of anamorelin treatment duration on survival of patients with cancer cachexia: A retrospective study. (PubMed, Mol Clin Oncol) - "The corresponding median survival durations after anamorelin treatment termination in the STT and LTT groups were 38 and 34 days (P=0.554), respectively. Anamorelin treatment duration influenced patient survival, with post-discontinuation survival being ~1 month, regardless of treatment length."

Journal • Retrospective data • Cachexia • Colorectal Cancer • Gastric Cancer • Lung Cancer • Oncology • Solid Tumor

Wide-range and high-throughput quantification of anamorelin in human plasma using ultra-high-performance liquid chromatography coupled to tandem mass spectrometry. (PubMed, Clin Biochem) - "We established and validated a method to measure plasma anamorelin concentrations using UHPLC/MS-MS combined with SPE, and successfully applied the novel method to measure plasma anamorelin concentrations in patients with cancer cachexia. By measuring plasma anamorelin concentrations in large scale studies, the established quantitative method is expected to contribute to the pharmacokinetic study of anamorelin."

Journal • Cachexia • Oncology

A Model-Based Cost-Effectiveness Analysis of Anamorelin and Olanzapine in NSCLC Cachexia Treatment in Japan (ISPOR 2025) - "Both anamorelin and olanzapine show efficacy in NSCLC patients with cachexia, but further evaluation is needed from a cost-effectiveness perspective. Future studies should consider long-term effects and costs. Given the limitations of drug therapy alone, a comprehensive approach to cachexia, including nutritional and exercise therapy, may be necessary to enhance efficiency."

Cost effectiveness • HEOR • Cachexia • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

NCI-2018-01593: Anamorelin Hydrochloride in Reducing Anorexia in Patients With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=25 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Phase classification: P2/3 ➔ P1

Phase classification • Anorexia • Cachexia • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CXCL8 • IGF1 • IL6R

The Optimal Timing for Initiating Anamorelin in the Treatment of Cancer Cachexia. (PubMed, Cureus) - "Comparing CRP ≤0.5 mg/dL vs. CRP >0.5 mg/dL, survival was significantly longer for CRP ≤0.5 mg/dL (p < 0.01). Conclusions Initiating anamorelin treatment with close attention to CRP and ensuring that prescribing criteria are met may be helpful in treating cachexia."

Journal • Anorexia • Cachexia • Colon Cancer • Colorectal Cancer • Gastric Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CRP

Association between the Pretreatment Body Mass Index and Anamorelin's Efficacy in Patients with Cancer Cachexia: A Retrospective Cohort Study. (PubMed, Acta Med Okayama) - "Together these results indicate that it is beneficial to initiate ANAM treatment before a patient's BMI drops below 19.5 kg/m2. Our findings will help advance cancer cachexia treatment and serve as a reference for clinicians to predict ANAM's efficacy."

Journal • Retrospective data • Anorexia • Cachexia • Oncology

Does anamorelin have beneficial effects in advanced cancer patients with systemic inflammation in the real world? (PubMed, Invest New Drugs) - No abstract available

Journal • Real-world evidence • Oncology

Ghrelin-LEAP2 interactions along the stomach-liver axis. (PubMed, Endocr J) - "Anamorelin, a low-molecular-weight ghrelin agonist, has been launched in Japan for the treatment of cancer cachexia, and its therapeutic potential has attracted attention due to the various biological activities of ghrelin...Serum LEAP2 elevated and ghrelin reduced in obesity. Ghrelin and LEAP2 regulate body weight, food intake, and GH and blood glucose concentrations, and other physiological phenomena through their interactions with the same receptor, GHSR."

Journal • Review • Cachexia • Gastrointestinal Disorder • Genetic Disorders • Obesity • Oncology

Anamorelin in the Management of Cancer Cachexia: Clinical Efficacy, Challenges, and Future Directions. (PubMed, Anticancer Res) - "Based on several retrospective datasets, the initiation of anamorelin at earlier stages of cancer cachexia, combined with nutritional and exercise therapy, should be considered. However, current evidence is insufficient, and results of future studies are awaited."

Clinical • Journal • Review • Cachexia • Oncology

Anamorelin Induced Hyperglycemia in a Patient with Type 1 Diabetes by Stimulating Growth Hormone Secretion: A Case Report. (PubMed, Intern Med) - "These results suggest that anamorelin stimulates GH secretion and induces hyperglycemia. Our findings suggest the need to take special care of hyperglycemia when anamorelin is prescribed to patients with type 1 diabetes."

Journal • Cachexia • Diabetes • Metabolic Disorders • Oncology • Respiratory Diseases • Type 1 Diabetes Mellitus

Anamorelin Efficacy in Non-Small-Cell Lung Cancer Patients With Cachexia: Insights From ROMANA 1 and ROMANA 2. (PubMed, J Cachexia Sarcopenia Muscle) - P3 | "Anamorelin improved body composition parameters in all patients, as well as physical function and symptom burden, particularly in patients with systemic inflammation, BMI < 20 kg/m2 and weight loss ≥ 10%. These results highlight that the anabolic mechanisms of anamorelin are more effective in high-risk groups."

Clinical • Journal • Anorexia • Cachexia • Immunology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Systemic Inflammatory Response Syndrome

Significance of Neutrophil-to-Lymphocyte Ratio in Predicting the Efficacy of Anamorelin for Cancer Cachexia. (PubMed, Cureus) - "ROC analysis identified a baseline NLR < 4.4 as predictive of achieving a posttreatment NLR < 5 (AUC, 0.78; sensitivity, 80%; specificity, 75%), with significantly higher one-year OS observed in the baseline NLR < 4.4 group (68%, n = 29/42) compared to the NLR ≥ 4.4 group (34%, n = 8/24). Conclusions These findings highlight the potential of NLR as a prognostic marker and suggest that initiating anamorelin treatment with a baseline NLR < 4.4 is likely to improve outcomes, emphasizing the importance of NLR-based therapeutic interventions."

Journal • Cachexia • Colorectal Cancer • Gastric Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Anamorelin as a Therapeutic Option for Cancer Cachexia in Advanced Pancreatic Cancer: A Case Report Demonstrating Significant Weight Gain and Quality of Life Improvement. (PubMed, Intern Med) - "Cachexia's complex metabolic changes make treatment difficult; however, anamorelin's appetite and weight gain effects highlight its possible role in managing cachexia in pancreatic cancer. Therefore, further research is required in this regard."

HEOR • Journal • Cachexia • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

Plain language summary of a clinical study: anamorelin for treatment of Japanese people with gastrointestinal cancer and cachexia. (PubMed, Future Oncol) - No abstract available

Journal • Cachexia • Gastrointestinal Cancer • Gastrointestinal Disorder • Oncology • Solid Tumor

Plain language summary of a clinical study: anamorelin for treatment of Japanese people with non-small cell lung cancer and cachexia. (PubMed, Future Oncol) - No abstract available

Journal • Cachexia • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

The structure and function of the ghrelin receptor coding for drug actions. (PubMed, Nat Struct Mol Biol) - "To tackle this common issue across a broad drug target, this study aims to understand how anamorelin, the only approved drug targeting the ghrelin receptor, operates compared to other synthetic drugs...Moreover, our study showcased the utility of structural information in effectively identifying natural genetic variations altering drug action and causing severe functional deficiencies, offering a basis for selecting the right medication on the basis of the individual's genomic sequence. Thus, by building on structural analysis, this study enhances the foundational framework for selecting therapeutic agents targeting the ghrelin receptor, by effectively leveraging signaling bias and genetic variations."

Journal • Anorexia • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity

Investigation of the association between therapeutic effectiveness of anamorelin and Glasgow prognostic score in patients with cancer cachexia: a competing risk analysis. (PubMed, Invest New Drugs) - "Additionally, TTF was shorter in patients with a GPS of 2 with a GPS of 0 or 1 (adjusted subdistribution hazard ratio 2.22 [95% CI 1.22-4.03], P = 0.009). Anamorelin could be more effective in improving appetite and prolonging the duration of treatment effect in patients with a GPS of 0 or 1 than those with a GPS of 2."

Journal • Cachexia • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Mechanisms and pharmacotherapy of cancer cachexia-associated anorexia. (PubMed, Pharmacol Res Perspect) - "Nevertheless, several agents have recently emerged, including anamorelin, a ghrelin receptor agonist, growth differentiation factor 15 neutralization therapy, and melanocortin receptor antagonist, as candidates for ameliorating anorexia associated with cancer cachexia. Therefore, in this review, we outline cancer cachexia-associated anorexia and its pharmacotherapy, including corticosteroids, progesterone analogs, cannabinoids, anti-psychotics, and thalidomide which have been previously explored for their efficacy, in addition to the aforementioned novel agents, along with their mechanisms."

Journal • Review • Anorexia • Cachexia • Cardiovascular • CNS Disorders • Congestive Heart Failure • Heart Failure • Metabolic Disorders • Oncology • Renal Disease • Targeted Protein Degradation • GDF15

Early administration of anamorelin improves cancer cachexia in gastrointestinal cancer patients: an observational study. (PubMed, Sci Rep) - "In the univariate analysis, anamorelin treatment before second-line chemotherapy correlated with weight gain at 12 weeks and with improved overall survival in patients with weight gain at 12 weeks. Early anamorelin treatment contributes to appetite improvement and BW gain in colorectal and gastric cancers with cachexia."

Journal • Observational data • Retrospective data • Cachexia • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Oncology • Solid Tumor