{"id":"idursulfase-beta","rwe":[{"pmid":"41078579","year":"2025","title":"Case report of neuronopathic mucopolysaccharidosis type II: Early intracerebroventricular enzyme replacement therapy and hematopoietic cell transplantation with developmental outcomes up to 5 years of age.","finding":"","journal":"Molecular genetics and metabolism reports","studyType":"Clinical Study"},{"pmid":"40782865","year":"2025","title":"Site-specific characterization of mannose-6-phosphate-containing N-glycans on recombinant idursulfase beta for lysosomal targeting in Hunter syndrome therapy.","finding":"","journal":"International journal of biological macromolecules","studyType":"Clinical Study"},{"pmid":"40411345","year":"2025","title":"Efficacy and safety of idursulfase beta in the treatment of mucopolysaccharidosis II: A phase-3, 2-part study compared with a historical placebo cohort.","finding":"","journal":"Genetics in medicine : official journal of the American College of Medical Genetics","studyType":"Clinical Study"},{"pmid":"37922836","year":"2023","title":"Intracerebroventricular enzyme replacement therapy in patients with neuronopathic mucopolysaccharidosis type II: Final report of 5-year results from a Japanese open-label phase 1/2 study.","finding":"","journal":"Molecular genetics and metabolism","studyType":"Clinical Study"},{"pmid":"37670899","year":"2023","title":"Long-term experience with idursulfase beta (Hunterase) in two adolescent patients with MPS II: A case series.","finding":"","journal":"Molecular genetics and metabolism reports","studyType":"Clinical Study"}],"tags":[{"label":"Biologic","category":"modality"},{"label":"A16AB16","category":"atc"},{"label":"Active","category":"status"},{"label":"Mucopolysaccharidosis type II","category":"indication"},{"label":"Clinigen K.K.","category":"company"}],"phase":"marketed","safety":{},"trials":[],"aliases":[],"company":"Clinigen K.K.","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=IDURSULFASE BETA","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:14:48.233385+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:14:54.120704+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=IDURSULFASE BETA","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:14:54.327621+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Dermatan sulfate hydrolytic enzyme","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:14:55.715719+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL4297988/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:14:55.380984+00:00"}},"allNames":"hunterase","offLabel":[],"synonyms":["idursulfase beta","idursulfase beta (genetical recombination)","hunterase"],"timeline":[{"date":"2021-01-22","type":"positive","source":"DrugCentral","milestone":"PMDA approval (Clinigen K.K.)"}],"aiSummary":"Hunterase (IDURSULFASE BETA) is a small molecule drug developed by Clinigen K.K. for the treatment of Mucopolysaccharidosis type II. It is a replacement enzyme therapy that works by breaking down and removing excess mucopolysaccharides in the body. Hunterase is currently owned by Clinigen K.K. and is used to manage the symptoms of this rare genetic disorder. 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