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

Exploring Inhibitory Impacts of Anamorelin on Colorectal Cancer Proliferation via Regulation of Transketolase. (PubMed, Curr Med Chem) - "By integrating bioinformatics analysis with in vitro cellular experiments, we systematically validated the molecular mechanism whereby anamorelin inhibited tumor cell proliferation and migration via the targeted suppression of TKT. These findings provide a theoretical foundation for the development of novel metabolism-based therapeutic strategies for CRC, ultimately contributing to improved clinical outcomes."

Journal • Cachexia • Colorectal Cancer • Oncology • Solid Tumor

Predictors of anamorelin discontinuation in patients with cancer-associated cachexia undergoing chemotherapy: A retrospective observational study. (PubMed, Int J Clin Pharmacol Ther) - "In patients with cancer-associated cachexia, baseline PS and PNI were associated with anamorelin discontinuation. Furthermore, competing risk analysis demonstrated PS was the primary determinant of anamorelin discontinuation, whereas PNI may be more closely associated with mortality risk. Therefore, early diagnosis of cancer-associated cachexia and timely initiation of anamorelin before declines in PS and PNI may enable long-term administration."

Journal • Observational data • Retrospective data • Cachexia • Oncology

Predictors of 12-Week Anamorelin Treatment Continuation in Gastrointestinal Cancer Cachexia: A Single-Center, Retrospective Study. (PubMed, Nutr Cancer) - "Impaired ECOG PS and elevated NLR were associated with failure to complete 12-week anamorelin treatment. Earlier initiation of anamorelin before performance status declines and systemic inflammation progresses may support treatment completion."

Journal • Retrospective data • Anorexia • Cachexia • Gastrointestinal Cancer • Oncology • Solid Tumor

Predictors of early discontinuation and therapeutic response to anamorelin in patients with cancer cachexia: A retrospective study. (PubMed, Int J Clin Pharmacol Ther) - "Baseline nutritional and inflammatory statuses strongly influence both treatment continuation and response to anamorelin. The PNI is a practical predictor for identifying patients who are likely to benefit from therapy. Early intervention before severe nutritional deterioration may optimize the outcomes of patients with cancer cachexia."

Journal • Retrospective data • Cachexia • Oncology • Solid Tumor

Gamma-glutamyl Transferase and Triglycerides Associated with an Early Food Intake Response to Anamorelin in Gastrointestinal Cancer Cachexia. (PubMed, Intern Med) - "Conclusion An increase in documented early food intake within 14 days was observed in approximately 70% of the evaluable patients. The associations of low pre-treatment GGT and TG levels with an early increase in food intake should be interpreted as hypothesis-generating and warrant external validation."

Journal • Cachexia • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

A Prospective Observational Study of Anamorelin During Chemoimmunotherapy in Non-Small Cell Lung Cancer With Cachexia (SPIRAL-ANA). (PubMed, J Cachexia Sarcopenia Muscle) - "Anamorelin combined with chemoimmunotherapy did not prolong PFS in advanced NSCLC with cancer cachexia, but achieved a high rate of cachexia reversal. Transition to a non-cachectic state was associated with improved OS, suggesting that cachexia reversal may serve as a surrogate for survival benefit."

Journal • Observational data • Cachexia • Diabetes • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Trends in the Use of Anamorelin Hydrochloride for Cancer Cachexia: Examining the Timing of Anamorelin Initiation. (PubMed, Ann Nutr Metab) - "Prescribing patterns of anamorelin did not substantially change after the proposal of the AWGC criteria. Conversely, longer treatment continuation was observed in patients at an earlier stage of cachexia and in those with preserved baseline PS. Thus, in addition to updated diagnostic criteria, earlier intervention and initiation at a stage with better general condition may be important when optimizing the timing of anamorelin treatment."

Journal • Cachexia • Oncology

Anamorelin Hydrochloride, Physical Activity, and Nutritional Counseling in Decreasing Cancer-Related Fatigue in Patients With Incurable Metastatic or Recurrent Solid Tumors (clinicaltrials.gov) - P2 | N=129 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Feb 2026 ➔ Feb 2028

Trial completion date • Fatigue • Oncology • Solid Tumor

Association between anamorelin therapy and renal function in patients with cancer cachexia: a propensity score-matched retrospective study. (PubMed, Eur J Clin Pharmacol) - "ANAM treatment was associated with improvements in renal function markers and a lower risk of renal function deterioration in patients with cancer cachexia. These findings suggest that ANAM may potentially confer renoprotective effects in addition to its established therapeutic benefits for cachexia."

Journal • Observational data • Retrospective data • Cachexia • Oncology

A RANDOMIZED CONTROLLED TRIAL EVALUATING THE EFFICACY OF ANAMORELIN HYDROCHLORIDE IN PATIENTS WITH GASTRIC CANCER CACHEXIA (MASCC-ISOO 2026) - "These results support anamorelin as a promising supportive-care option for advanced gastric cancer. Funded by Ono Pharmaceutical Co., Ltd."

Clinical • Anorexia • Cachexia • Diabetes • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Pharmacist-Led CDTM Screening Enables Early Multidisciplinary Intervention for Cancer Cachexia and Improves Physical Function in Digestive Cancers (MASCC-ISOO 2026) - "Introduction Anamorelin, a ghrelin receptor agonist approved exclusively in Japan since April 2021, provides a unique opportunity to evaluate real-world supportive care for cancer cachexia...The marked discrepancy between Japanese regulatory criteria and the 2023 Asian Working Group for Cachexia (AWGC) standards suggests that current indications may delay timely supportive care. Pharmacist-driven, patient-centered screening represents a scalable model to enable earlier and more effective cachexia management in Asian oncology practice."

Anorexia • Cachexia • Colorectal Cancer • Oncology • Solid Tumor

Prospective study of Anamorelin in pancreatic cancer cachexia: clinical and translational insights into treatment response heterogeneity (MASCC-ISOO 2026) - "Baseline BMI and insulin secretion may help optimize patient selection and risk stratification. Future studies should further characterize determinants of response and evaluate generalizability, so that insights from anamorelin can inform therapeutic strategies for cancer cachexia."

Clinical • Heterogeneity • Cachexia • Diabetes • Oncology • Pancreatic Cancer • Solid Tumor • CRP • IGF1 • IL1B • IL6 • TNFA

Cost-Effectiveness Analysis of Anamorelin and Olanzapine for Cancer Cachexia in Non-Small Cell Lung Cancer Patients in Japan. (PubMed, Value Health Reg Issues) - "Both anamorelin and olanzapine exceeded conventional cost-effectiveness thresholds in Japan. Given the limitations of pharmacotherapy in improving physical function, multimodal cachexia management incorporating nutritional counselling, exercise therapy, and rehabilitation warrants consideration."

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

Three-Week Monitoring After Anamorelin Initiation in Unresectable or Recurrent Pancreatic Cancer: Dietary Intake Category, Observed Body Weight, and Prognostic Nutritional Index. (PubMed, J Palliat Med) - "These descriptive findings require cautious multidimensional interpretation; causal treatment effects cannot be inferred."

Journal • Cachexia • Oncology • Pancreatic Cancer • Solid Tumor

A randomized controlled trial evaluating anamorelin hydrochloride in patients with gastric cancer cachexia (TEAM-GUSTO). (ASCO 2026) - "In gastric cancer cachexia, anamorelin did not achieve a statistically significant increase in LBM at 8 weeks but significantly improved body weight and appetite-related QOL with a favorable safety profile. Anamorelin represents a feasible supportive option during chemotherapy in multimodal gastric cancer care."

Clinical • Cachexia • Gastric Cancer • Lung Cancer • Oncology • Solid Tumor

Efficacy and safety of anamorelin in patients with non–small cell lung cancer and cancer cachexia undergoing chemoimmunotherapy: A real-world prospective cohort study (SPIRAL-ANA). (ASCO 2026) - "In this prospective real-world cohort of patients with NSCLC and cancer cachexia receiving first-line chemoimmunotherapy, anamorelin was associated with a manageable safety profile but did not achieve the primary endpoint of PFS prolongation. Cachexia improvement at week 12 was observed in a substantial proportion of patients and was associated with longer OS. These findings suggest that the clinical value of anamorelin in this setting may lie in facilitating cachexia improvement."

Clinical • Real-world • Real-world evidence • Anorexia • Cachexia • Diabetes • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CRP

Economic Burden of Cachexia in Japanese Lung Cancer Patients: A Retrospective Claims Database Analysis. (PubMed, Biol Pharm Bull) - "Anamorelin use increased from 2.4 to 29.8% post-diagnosis, although 70.2% of patients did not receive this therapy...The extremely short survival after diagnosis and the shift toward supportive care highlight the need for earlier recognition and intervention. These findings provide essential data for the economic evaluation of cachexia therapies."

HEOR • Journal • Retrospective data • Cachexia • Lung Cancer • Oncology • Solid Tumor

Targeting Cancer Cachexia: A Mechanistic Evaluation of Anti-GDF-15 Antibody-Based Combination Therapies. (PubMed, J Cachexia Sarcopenia Muscle) - P3 | "These data provide proof-of-principle that mechanistically distinct approaches targeting muscle anabolism and appetite may act additively with GDF-15 neutralization, particularly in cancer cachexia settings with lower GDF-15 dependence."

Journal • Cachexia • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • GDF15

Timing and Risk Factors for Hyperglycemia Associated With Anamorelin Administration. (PubMed, Anticancer Res) - "Anamorelin-induced hyperglycemia occurred in nearly one-third of patients, predominantly within the first month of therapy. Diabetes mellitus and elevated ALT level were independent predictors, highlighting the need for close glucose monitoring in at-risk patients."

Journal • Retrospective data • Cachexia • Colorectal Cancer • Diabetes • Lung Cancer • Metabolic Disorders • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Systemic proteomic and organ aging signatures associated with plasma Aβ oligomerization in a Korean cohort: a cross-sectional study. (PubMed, Front Aging Neurosci) - "Furthermore, several potential pharmacological modulators of OAβT, including Minocycline and Anamorelin, were identified. Our findings demonstrated OAβT as a reflection of systemic changes linked to early AD pathology. Moreover, the influence of medications and systemic aging on OAβT values pointed to the potential avenues for intervention and emphasized the importance of considering systemic factors in AD pathogenesis and treatment."

Journal • Observational data • Alzheimer's Disease • CNS Disorders • Dementia

KARIs, Ghrelin Receptor Agonists With Excellent Brain Permeability, Increase Food Intake and Attenuate the Muscle Loss in Mice. (PubMed, J Cachexia Sarcopenia Muscle) - "KARIs are potent, brain-penetrant GHSR-1a agonists with favourable pharmacokinetics compared to anamorelin. They enhance appetite, preserve skeletal muscle mass and improve physical performance in models of aging and cancer cachexia, supporting their potential as next-generation therapies for anorexia and muscle wasting."

Journal • Preclinical • Anorexia • Cachexia • CNS Disorders • Oncology • Sarcopenia

Predictors of long-term anamorelin hydrochloride use in patients with cancer cachexia: a single-center real-world retrospective study. (PubMed, Future Oncol) - "Lower mGPS, and better ECOG PS were associated with longer continuation of anamorelin, whereas patients with gastric cancer showed a tendency toward shorter duration. These findings provide guidance for patient selection and tailored supportive care in clinical practice."

Journal • Real-world evidence • Retrospective data • Cachexia • Colorectal Cancer • Gastric Cancer • Oncology • Pancreatic Cancer • Solid Tumor

GABA Enhances Growth Hormone Expression by Modulating Somatotroph Pit-1 Transcription via Activation of Calmodulin-Dependent Kinases. (PubMed, Nutrients) - "Ghrelin receptor activation by anamorelin (ANA) increased Pit-1 (ctrl: 0.83 ± 0.8; ANA: 1.59 ± 0.28; p = 0.0425) and GH (ctrl: 0.27 ± 0.03; ANA: 0.66 ± 0.16; p = 0.0497) through a CaMKK2-independent pathway but required basal GABAAR activity for maximal effect. These findings identify GABA as a modulator of somatotroph hormone expression through a CaMKK2/CaMKIV-dependent cascade and reveal a previously unrecognized interplay whereby the basal GABAergic tone promotes Pit-1 expression, thereby positively regulating ghrelin receptor signaling. This study provides new insights on the cellular mechanisms behind GABA-induced GH synthesis, which may reveal new strategies for modulating the somatotropic axis and help contextualize the variety of reported physiological and cognitive effects of GABA supplementation."

Journal

Optimizing Nutritional Support in Advanced Non-Small Cell Lung Cancer: Evidence and Controversies in Oral, Enteral, and Parenteral Approaches. (PubMed, Nutr Cancer) - "Multimodal care, encompassing nutrition, exercise, and pharmacotherapy (e.g., appetite stimulants, investigational agents such as anamorelin), is crucial...Barriers such as inconsistent screening and limited resources persist. Future research should focus on lung cancer-specific trials of EN, standardized cachexia definitions, and equitable access to nutritional support, especially in underserved populations."

Journal • Review • Anorexia • Cachexia • Gastrointestinal Disorder • Infectious Disease • Lung Cancer • Metabolic Disorders • Non Small Cell Lung Cancer • Oncology • Solid Tumor • IL6 • TNFA

Predictors of the early discontinuation of anamorelin hydrochloride in gastrointestinal cancer-related cachexia: a multicenter retrospective cohort study (HGCSG2201). (PubMed, Support Care Cancer) - "Initiating ANAM while patients can still receive concurrent chemotherapy may help prevent Ed and achieve better therapeutic benefit. Trial registration The registration number in the UMIN Clinical Trial Registry is UMIN000051550. The date of registration is July 7, 2023."

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