{"id":"anamorelin","rwe":[],"tags":[{"label":"Small Molecule","category":"modality"},{"label":"Growth hormone secretagogue receptor type 1","category":"target"},{"label":"GHSR","category":"gene"},{"label":"Active","category":"status"},{"label":"Cancer cachexia","category":"indication"},{"label":"ONO PHARMACEUTICAL Co., Ltd","category":"company"}],"phase":"marketed","safety":{"safetySignals":[{"llr":96.044,"date":"","count":29,"signal":"Malignant neoplasm progression","source":"DrugCentral FAERS","actionTaken":"Reported 29 times (LLR=96)"}],"commonSideEffects":[]},"trials":[],"aliases":[],"company":"ONO PHARMACEUTICAL Co., Ltd","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=ANAMORELIN","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:33:12.479346+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:33:18.958778+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ANAMORELIN","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:33:20.793099+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2110579/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:33:21.273559+00:00"}},"allNames":"adlumiz","offLabel":[],"synonyms":["anamorelin","anamorelin hydrochloride","adlumiz","ONO-7643","ST-1291","RC-1291"],"timeline":[{"date":"2021-01-22","type":"positive","source":"DrugCentral","milestone":"PMDA approval (ONO PHARMACEUTICAL Co., Ltd)"}],"aiSummary":"Adlumiz (Anamorelin) is a small molecule growth hormone secretagogue receptor type 1 agonist developed by ONO PHARMACEUTICAL Co., Ltd. It works by binding to the growth hormone secretagogue receptor type 1, stimulating the release of growth hormone, which helps to increase appetite and muscle mass. Adlumiz is approved to treat cancer cachexia, a condition characterized by weight loss and muscle wasting in patients with cancer. The commercial status of Adlumiz is patented, and it is currently owned by ONO PHARMACEUTICAL Co., Ltd. Key safety considerations include potential gastrointestinal side effects and interactions with other medications.","brandName":"Adlumiz","ecosystem":[{"indication":"Cancer cachexia","otherDrugs":[],"globalPrevalence":null}],"mechanism":{"target":"Growth hormone secretagogue receptor type 1","targets":[{"gene":"GHSR","source":"DrugCentral","target":"Growth hormone secretagogue receptor type 1","protein":"Growth hormone secretagogue receptor type 1"}],"modality":"Small Molecule","explanation":"","oneSentence":"","technicalDetail":"Adlumiz acts as a selective agonist of the growth hormone secretagogue receptor type 1 (GHSR1a), a G protein-coupled receptor that plays a key role in regulating growth hormone release."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5487","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=ANAMORELIN","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ANAMORELIN","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T08:43:42.579616","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:33:23.149521+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"capromorelin","drugSlug":"capromorelin","fdaApproval":"","relationship":"same-target"},{"drugName":"macimorelin","drugSlug":"macimorelin","fdaApproval":"2017-12-20","patentExpiry":"Oct 12, 2027","patentStatus":"Patent protected","relationship":"same-target"}],"genericName":"anamorelin","indications":{"approved":[{"name":"Cancer cachexia","source":"DrugCentral","snomedId":788876001,"regulator":"FDA"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"capromorelin","brandName":"capromorelin","genericName":"capromorelin","approvalYear":"","relationship":"same-target"},{"drugId":"macimorelin","brandName":"macimorelin","genericName":"macimorelin","approvalYear":"2017","relationship":"same-target"}],"trialDetails":[{"nctId":"NCT04844970","phase":"PHASE2","title":"Anamorelin Study for Advanced Pancreatic Cancer","status":"TERMINATED","sponsor":"Lahey Clinic","startDate":"2023-04-01","conditions":["Metastatic Pancreatic Cancer"],"enrollment":4,"completionDate":"2023-11-07"},{"nctId":"NCT03035409","phase":"PHASE2","title":"Anamorelin Hydrochloride, Physical Activity, and Nutritional Counseling in Decreasing Cancer-Related Fatigue in Patients With Incurable Metastatic or Recurrent Solid Tumors","status":"ACTIVE_NOT_RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2017-02-08","conditions":["Advanced Malignant Solid Neoplasm","C-Reactive Protein Measurement","Cancer Fatigue","Metastatic Malignant Solid Neoplasm","Recurrent Malignant Solid Neoplasm","Weight Loss"],"enrollment":129,"completionDate":"2026-02-28"},{"nctId":"NCT03637816","phase":"PHASE2,PHASE3","title":"Anamorelin Hydrochloride in Reducing Anorexia in Patients With Advanced Non-small Cell Lung Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2018-11-27","conditions":["Anorexia","Lung Non-Small Cell Carcinoma","Stage III Lung Cancer AJCC v8","Stage IIIA Lung Cancer AJCC v8","Stage IIIB Lung Cancer AJCC v8","Stage IIIC Lung Cancer AJCC v8","Stage IV Lung Cancer AJCC v8","Stage IVA Lung Cancer AJCC v8","Stage IVB Lung Cancer AJCC v8"],"enrollment":25,"completionDate":"2026-12-31"},{"nctId":"NCT03743051","phase":"PHASE3","title":"A 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)","status":"COMPLETED","sponsor":"Helsinn Healthcare SA","startDate":"2019-03-05","conditions":["Cachexia; Cancer","Non Small Cell Lung Cancer"],"enrollment":318,"completionDate":"2023-02-11"},{"nctId":"NCT03743064","phase":"PHASE3","title":"A 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)","status":"COMPLETED","sponsor":"Helsinn Healthcare SA","startDate":"2019-05-06","conditions":["Cachexia; Cancer","Non Small Cell Lung Cancer"],"enrollment":318,"completionDate":"2022-12-27"},{"nctId":"NCT04021706","phase":"PHASE1","title":"Effect of a Ghrelin Receptor Agonist on Muscle and Bone","status":"COMPLETED","sponsor":"Tufts University","startDate":"2019-12-05","conditions":["Sarcopenia","Osteopenia"],"enrollment":32,"completionDate":"2023-01-26"},{"nctId":"NCT01505764","phase":"PHASE2","title":"The Role of Ghrelin in Cancer Cachexia","status":"TERMINATED","sponsor":"VA Office of Research and Development","startDate":"2012-06","conditions":["Cancer Cachexia"],"enrollment":10,"completionDate":"2016-03"},{"nctId":"NCT01387269","phase":"PHASE3","title":"Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 1)","status":"COMPLETED","sponsor":"Helsinn Therapeutics (U.S.), Inc","startDate":"2011-07","conditions":["Cachexia","Non-Small Cell Lung Cancer"],"enrollment":484,"completionDate":"2015-02"},{"nctId":"NCT01387282","phase":"PHASE3","title":"Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 2)","status":"COMPLETED","sponsor":"Helsinn Therapeutics (U.S.), Inc","startDate":"2011-07","conditions":["Cachexia","Non-Small Cell Lung Cancer"],"enrollment":495,"completionDate":"2015-02"},{"nctId":"NCT01395914","phase":"PHASE3","title":"Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study (ROMANA 3)","status":"COMPLETED","sponsor":"Helsinn Therapeutics (U.S.), Inc","startDate":"2011-07","conditions":["Cachexia","Non-Small Cell Lung Cancer"],"enrollment":513,"completionDate":"2015-02"},{"nctId":"NCT00622193","phase":"PHASE2","title":"Dose Range Study of Anamorelin in Patients With Non-small Cell Lung Cancer","status":"COMPLETED","sponsor":"Helsinn Therapeutics (U.S.), Inc","startDate":"2008-03","conditions":["Carcinoma, Non-Small-Cell Lung"],"enrollment":228,"completionDate":"2009-12"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"crossReferences":{"UNII":"DD5RBA1NKF","INN_ID":"8846","UMLSCUI":"C2698934","chemblId":"CHEMBL2110579","ChEMBL_ID":"CHEMBL2110579","KEGG_DRUG":"D08856","DRUGBANK_ID":"DB06645","PUBCHEM_CID":"9828911","SECONDARY_CAS_RN":"249921-19-5","MESH_SUPPLEMENTAL_RECORD_UI":"C000593861"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"present","companyName":"ONO PHARMACEUTICAL Co., Ltd","relationship":"Current Owner"}],"publicationCount":162,"therapeuticAreas":["Oncology"],"biosimilarFilings":[],"recentPublications":[],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","companyName":"ONO PHARMACEUTICAL Co., Ltd","companyId":"ono-pharmaceutical-co-ltd","modality":"Small molecule","firstApprovalDate":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"EU","regulator":"EMA","status":"refused","approval_date":null,"mah":null,"brand_name_local":"Adlumiz","application_number":"EMEA/H/C/003847"},{"country_code":"GB","regulator":"MHRA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Adlumiz","application_number":null},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":3,"withResults":2},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:33:23.149521+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}