BLAIV (INFUSION)INJECTABLEPriority Review
Approved
Jul 2006
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
18
Data completeness
5/8 — Partial
Priority Review
ELAPRASE (idursulfase) by Takeda. Approved for hydrolytic lysosomal glycosaminoglycan-specific enzyme [epc]. First approved in 2006.
Drug data last refreshed 12h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ELAPRASE (idursulfase) is a recombinant lysosomal enzyme replacement therapy designed to treat Hunter syndrome (mucopolysaccharidosis II), a rare genetic disorder caused by deficiency of the iduronate-2-sulfatase enzyme. It works by replacing the missing enzyme to break down glycosaminoglycans that accumulate in cells and tissues. The drug is administered intravenously as a chronic infusion therapy.
$6MPart D
LOE ApproachingProduct is in late-stage lifecycle with modest Part D spending (~$6M), suggesting a stable but niche market with limited commercial expansion opportunities and potential team rationalization ahead.
Mechanism of Action
Pharmacologic Class:
Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (18)
Extension Study of Idursulfase-IT Along With Elaprase in Children and Adults With Hunter Syndrome and Cognitive Impairment
Started Mar 2024
6 enrolled
Hunter Syndrome
A Study of ELAPRASE in Treatment-naïve Participants With Hunter Syndrome (Mucopolysaccharidosis [MPS] II)
Started Feb 2023
0Mucopolysaccharidosis (MPS)Hunter Syndrome
A Study to Determine the Efficacy and Safety of Tividenofusp Alfa (DNL310) vs Idursulfase in Pediatric and Young Adult Participants With Neuronopathic (nMPS II) or Non-Neuronopathic Mucopolysaccharidosis Type II (nnMPS II)
Started Jul 2022
63 enrolled
Mucopolysaccharidosis II
A Study of Elaprase in Children and Adults With Hunter Syndrome (Mucopolysaccharidosis II) in India
Started Apr 2022
5 enrolled
Hunter Syndrome
An Extension Study to Assess the Long-term Safety and Efficacy of Hunterase (Idursulfase Beta)
Started May 2018
30 enrolled
MPS IIHunter Syndrome (MPS II)Hunter Syndrome+2 more
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.