{"id":"macimorelin","rwe":[{"pmid":"41793495","year":"2026","title":"Real-world diagnostic performance of the macimorelin stimulation test in the diagnosis of adult growth hormone deficiency.","finding":"","journal":"Pituitary","studyType":"Clinical Study"},{"pmid":"41604371","year":"2026","title":"Computational repurposing of approved drugs targeting KRAS G12D and EGFR for colorectal cancer therapy.","finding":"","journal":"PloS one","studyType":"Clinical Study"},{"pmid":"40542284","year":"2025","title":"Molecular recognition of two approved drugs Macimorelin and Anamorelin by the growth hormone secretagogue receptor.","finding":"","journal":"Acta pharmacologica Sinica","studyType":"Clinical Study"},{"pmid":"40335774","year":"2025","title":"Consensus and controversies about diagnosing GH deficiency: a Delphi survey by the GH research society.","finding":"","journal":"Pituitary","studyType":"Clinical Study"},{"pmid":"38927114","year":"2024","title":"Insights into the Effects of Ligand Binding on Leucyl-tRNA Synthetase Inhibitors for Tuberculosis: In Silico Analysis and Isothermal Titration Calorimetry Validation.","finding":"","journal":"Biomolecules","studyType":"Clinical Study"}],"tags":[{"label":"Growth Hormone Secretagogue Receptor Agonist","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Growth hormone secretagogue receptor type 1","category":"target"},{"label":"GHSR","category":"gene"},{"label":"V04CD06","category":"atc"},{"label":"Oral","category":"route"},{"label":"Granule","category":"form"},{"label":"LOE Approaching","category":"status"},{"label":"Aeterna Zentaris","category":"company"},{"label":"Approved 2010s","category":"decade"}],"phase":"marketed","safety":{"commonSideEffects":[{"effect":"Dysgeusia","drugRate":"74.5%","severity":"serious"},{"effect":"Dizziness","drugRate":"63.9%","severity":"serious"},{"effect":"Headache","drugRate":"63.9%","severity":"serious"},{"effect":"Fatigue","drugRate":"63.9%","severity":"serious"},{"effect":"Nausea","drugRate":"53.2%","severity":"serious"},{"effect":"Hunger","drugRate":"53.2%","severity":"serious"},{"effect":"Diarrhea","drugRate":"31.9%","severity":"serious"},{"effect":"Upper respiratory tract infection","drugRate":"31.9%","severity":"serious"},{"effect":"Feeling hot","drugRate":"21.3%","severity":"common"},{"effect":"Hyperhidrosis","drugRate":"21.3%","severity":"common"},{"effect":"Nasopharyngitis","drugRate":"21.3%","severity":"common"},{"effect":"Sinus bradycardia","drugRate":"6.1%","severity":"common"}],"specialPopulations":{"Pregnancy":"There are no available data with MACRILEN use in pregnant women to inform drug associated risk for adverse developmental outcomes. MACRILEN is indicated as single dose which limits the risk of adverse developmental outcomes from exposure to MACRILEN. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown.","Geriatric use":"Growth hormone secretion normally decreases with age. Therefore, elderly subjects might require lower cut-off point for diagnosis of adult growth hormone deficiency. Clinical studies of MACRILEN did not include sufficient number of subjects aged 65 and over to determine whether elderly patients respond differently from younger subjects.","Paediatric use":"The safety and efficacy of MACRILEN in pediatric patients have not been established."}},"trials":[],"aliases":[],"company":"Aeterna Zentaris","patents":[{"applNo":"N205598","source":"FDA Orange Book","status":"Active","expires":"Oct 12, 2027","useCode":"U-2220","territory":"US","drugProduct":false,"patentNumber":"8192719","drugSubstance":false}],"pricing":[],"allNames":"macrilen","offLabel":[],"synonyms":["macimorelin","macimorelin acetate","D-87575","EP1572","ARD 07"],"timeline":[{"date":"2017-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from AETERNA ZENTARIS GMBH to Aeterna Zentaris"},{"date":"2017-12-20","type":"positive","source":"DrugCentral","milestone":"FDA approval (Aeterna Zentaris Gmbh)"},{"date":"2019-01-11","type":"positive","source":"DrugCentral","milestone":"EMA approval (Aeterna Zentaris Gmbh)"}],"approvals":[{"date":"2017-12-20","orphan":true,"company":"AETERNA ZENTARIS GMBH","regulator":"FDA"},{"date":"2019-01-11","orphan":false,"company":"AETERNA ZENTARIS GMBH","regulator":"EMA"}],"brandName":"Macrilen","ecosystem":[],"mechanism":{"target":"Growth hormone secretagogue receptor type 1","novelty":"Follow-on","targets":[{"gene":"GHSR","source":"DrugCentral","target":"Growth hormone secretagogue receptor type 1","protein":"Growth hormone secretagogue receptor type 1"}],"moaClass":"Growth Hormone Secretagogue Receptor Agonists","modality":"Small Molecule","drugClass":"Growth Hormone Secretagogue Receptor Agonist","explanation":"Macimorelin stimulates GH release by activating growth hormone secretagogue receptors present in the pituitary and hypothalamus.","oneSentence":"Macrilen works by binding to the growth hormone secretagogue receptor type 1, triggering a response that stimulates the release of growth hormone.","technicalDetail":"Macrilen 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 from the anterior pituitary gland."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Macimorelin","title":"Macimorelin","extract":"Macimorelin (INN) – or Macrilen – is a drug that was developed by Aeterna Zentaris for use in the diagnosis of adult growth hormone deficiency. Macimorelin acetate, the salt formulation, is a synthetic growth hormone secretagogue receptor agonist. It is a growth hormone secretagogue receptor agonist, causing release of growth hormone from the pituitary gland. Macimorelin acetate is described chemically as D-Tryptophanamide, 2-methylalanyl-N-[(1R)-1-(formylamino)-2-(1H-indol-3-yl)ethyl]-acetate."},"commercial":{"launchDate":"2017","_launchSource":"DrugCentral (FDA 2017-12-20, AETERNA ZENTARIS GMBH)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5271","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=MACIMORELIN","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=MACIMORELIN","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Macimorelin","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange 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It targets the growth hormone secretagogue receptor type 1 to stimulate the release of growth hormone. Macrilen is FDA-approved for diagnostic use in adults with a high risk of having a growth hormone deficiency. The drug has a half-life of 4.1 hours but its bioavailability is unknown. 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