Wednesday, July 8, 2026

Drug profile · INN

idursulfase

idursulfase (ELAPRASE) is a heparan sulfate hydrolytic enzyme. Associated with Takeda. Route of administration: iv (infusion). Current US regulatory status: approved.

FDA: approved EMA: approved Alimentary tract and metabolism (A16) A16AB09
US status approved
Patents linked 0
Pipeline programs 10
News articles 0
Drug details — idursulfase
US status
approved
Class
Alimentary tract and metabolism (A16)
Route
IV (INFUSION)
Patents
0
Programs
10
Data quality
0.89

Quick answer

idursulfase (ELAPRASE) is a heparan sulfate hydrolytic enzyme. Associated with Takeda. Route of administration: iv (infusion). Current US regulatory status: approved.

Key facts

INN idursulfase
Brand ELAPRASE
Mechanism Heparan sulfate hydrolytic enzyme
Target Heparan sulfate
Therapeutic class Alimentary tract and metabolism (A16)
Route IV (INFUSION)
Formulation INJECTABLE
ATC code A16AB09
Originator Takeda

Mechanism of action

Heparan sulfate hydrolytic enzyme

Primary target: Heparan sulfate

Approval history

Authority Status Date
FDA approved
EMA approved

Pipeline programs

  1. Elaprase 2 mg/ml concentrate for solution for infusion Phase 3 · Denali Therapeutics · Mucopolysaccharidosis Type II [MPS II]
  2. Idursulfase (idursulfase-IT [HGT-2310]) Phase 3 · Takeda · Hunter Syndrome and Cognitive Impairment
  3. JR-141-GS31 Phase 3 · Anaxis Pharma · Mucopolysaccharidosis type II, Hunter Syndrome
  4. idursulfase-IT Phase 3 · Takeda · Hunter Syndrome
  5. Idursulfase IT (1 mg) Phase 2 · Takeda · Hunter Syndrome
  6. ELAPRASE Approved · Takeda · Mucopolysaccharidosis (MPS)
  7. Elaprase Approved · Takeda · Hunter Syndrome
  8. Elaprase for intravenous (IV) infusion Approved · Takeda · Hunter Syndrome

Related & competitor drugs

  1. agalsidase alfa Alimentary tract and metabolism (A16)
  2. alogliptin Alimentary tract and metabolism (A10)
  3. alogliptin benzoate Alimentary tract and metabolism (A10)
  4. aprepitant Alimentary tract and metabolism (A04)
  5. budesonide Alimentary tract and metabolism (A07)
  6. canagliflozin Alimentary tract and metabolism (A10)

Frequently asked questions

What is idursulfase?

idursulfase (ELAPRASE) is a heparan sulfate hydrolytic enzyme. Associated with Takeda. Route of administration: iv (infusion). Current US regulatory status: approved.

What is the brand name for idursulfase?

ELAPRASE is a marketed brand name for idursulfase. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of idursulfase?

idursulfase has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.