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

Advancements of investigational agents for cancer cachexia: what clinical progress have we seen in the last 5 years? (PubMed, Expert Opin Investig Drugs) - "This review covers key investigational therapies developed over the past five years, with a focus on agents targeting Growth Differentiation Factor 15 (GDF-15), including ponsegromab, AV-380, and NGM120. Additional agents include ghrelin receptor agonists (e.g. anamorelin), anabolic/catabolic modulators (ACM-001), and cannabinoids (ART27.13). The evolving role of low-dose olanzapine is also discussed in the 2023 ASCO guideline update...The lack of standardized endpoints, heterogeneity of the syndrome, and absence of FDA-approved treatments remain major barriers to treatment implementation. Multimodal strategies combining pharmacological treatment with nutritional and rehabilitative support are likely to define future therapeutic success."

Journal • Cachexia • Oncology • GDF15

Anamorelin Study for Advanced Pancreatic Cancer (clinicaltrials.gov) - P2 | N=4 | Terminated | Sponsor: Lahey Clinic | N=100 ➔ 4 | Recruiting ➔ Terminated; The study closure was initiated by the financial sponsor and agreed upon by the site PI. The study is closing because of low enrollment and insufficient funds.

Enrollment change • Trial termination • Anorexia • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Nutrition in cachexia: support by pharmacological options? (DGHO 2025) - "According to initial clinical studies there is a group of particularly promising agents, including: the selective androgen enobosarm, S-pindolol, which has a mixed effect on beta receptors, the central appetite stimulant anamorelin, which has been approved in Japan, the cytokine-blocking substances bermekimab (anti-IL1alpha), tocilizumab (anti-IL6) and ruxolitinib (Jak1/2 inhibitor), the atypical neuroleptic olanzapine and newer GDF-15 antibodies such as ponsegromab. For approval, effects on the spectrum of symptoms, performance and body composition will probably be required."

Anorexia • Cachexia • Fatigue • GDF15 • IL1A

Reversible ST-T Segment Changes Induced by Anamorelin: A Case Report. (PubMed, Respirol Case Rep) - "The manufacturer reports that anamorelin is shown to weakly but competitively bind to calcium channel L-type receptors, which could inhibit repolarization. Even if patients do not complain of chest discomfort, an early ECG should be considered."

Journal • Cachexia • Cardiovascular • CNS Disorders • Depression • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pain • Psychiatry • Solid Tumor

Sarcopenia in gastrointestinal cancers. (PubMed, Int J Clin Oncol) - "Pharmacologic therapy, such as anamorelin, may be considered for refractory cachexia accompanied by significant anorexia...This review summarizes the current understanding of sarcopenia in GI cancers, highlights its clinical impact across different treatment settings, and discusses strategies for assessment and integrated management. Addressing sarcopenia is an essential component of personalized cancer care in GI oncology."

Journal • Review • Anorexia • Cachexia • Gastrointestinal Cancer • Oncology • Sarcopenia • Solid Tumor

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

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

Efficacy and safety of anamorelin for cancer cachexia in patients with unresectable or recurrent gastric cancer: a multicentre, open-label, randomised controlled trial. (PubMed, EClinicalMedicine) - "These results support further evaluation of anamorelin to improve physical condition in this population with limited treatment options. Ono Pharmaceutical Co., Ltd."

Journal • Cachexia • Diabetes • Gastric Cancer • Lung Cancer • Oncology • Solid Tumor

Impact of the Timing of Initial Anamorelin Administration in Advanced Gastrointestinal Cancer With Cancer Cachexia. (PubMed, In Vivo) - "Anamorelin improved body weight, food intake, and nutritional status in patients with advanced gastrointestinal cancer cachexia. However, the modest degree of recovery suggests that earlier administration, before substantial weight and muscle loss, may maximize therapeutic benefits, support treatment continuity, and potentially improve survival outcomes. Therefore, early intervention should be considered in the clinical management of cancer cachexia."

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

Anamorelin in Cancer Cachexia: Gut Microbiota Effects and CONUT Score as a Predictor of Response. (PubMed, In Vivo) - "In this pilot study, anamorelin significantly increased body weight and suggested an improvement in appetite in patients with cancer and cachexia. No significant changes in overall QOL or gut microbiota diversity were detected at 6 weeks. The finding that a high baseline CONUT score may predict a lack of short-term weight gain warrants further investigation."

Journal • Observational data • Anorexia • Cachexia • Colorectal Cancer • Gastric Cancer • Lung Cancer • Non Small Cell Lung Cancer • 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

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

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