Last reviewed 2026-04-20 · How we verify

Elaprase

At a glance

Approved indications

• Mucopolysaccharidosis, MPS-II

Common side effects

• Hypersensitivity reactions
• Rash
• Urticaria
• Pruritus
• Headache
• Flushing
• Pyrexia
• Fatigue
• Musculoskeletal pain
• Diarrhea
• Cough
• Vomiting

Serious adverse events

• Hypoxic episodes
• Cardiac arrhythmia
• Pulmonary embolism
• Cyanosis
• Respiratory failure
• Infection
• Arthralgia

Key clinical trials

• PEARL (PrEnAtal Enzyme Replacement Therapy for Lysosomal Storage Disorders) (PHASE1)
• A Phase III Study of JR-141 in Patients With Mucopolysaccharidosis II (STARLIGHT) (PHASE3)
• An Extension Study to Assess the Long-term Safety and Efficacy of Hunterase (Idursulfase Beta) (PHASE3)
• A Study of ELAPRASE in Treatment-naïve Participants With Hunter Syndrome (Mucopolysaccharidosis [MPS] II) (PHASE4)
• Extension Study of Idursulfase-IT Along With Elaprase in Children and Adults With Hunter Syndrome and Cognitive Impairment (PHASE2, PHASE3)
• Long-term Evaluation on Height and Weight in Patients With MPS II Who Started Treatment at < 6 Years of Age (PHASE4)
• An Extension Study of HGT-HIT-045 Evaluating Long-Term Safety and Clinical Outcomes of Idursulfase-IT in Conjunction With Elaprase in Pediatric Participants With Hunter Syndrome and Cognitive Impairment (PHASE1, PHASE2)
• 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) (PHASE2, PHASE3)

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Elaprase CI brief — competitive landscape report
• Elaprase updates RSS · CI watch RSS
• Shire portfolio CI