Wednesday, July 8, 2026

Drug profile · INN

laronidase

laronidase (ALDURAZYME) is a dermatan sulfate hydrolytic enzyme. Associated with BioMarin Pharmaceutical Australia Pty Ltd. Current US regulatory status: approved.

FDA: approved EMA: approved Alimentary tract and metabolism (A16) A16AB05
US status approved
Patents linked 0
Pipeline programs 5
News articles 0
Drug details — laronidase
US status
approved
Class
Alimentary tract and metabolism (A16)
Route
Patents
0
Programs
5
Data quality
0.84

Quick answer

laronidase (ALDURAZYME) is a dermatan sulfate hydrolytic enzyme. Associated with BioMarin Pharmaceutical Australia Pty Ltd. Current US regulatory status: approved.

Key facts

INN laronidase
Brand ALDURAZYME
Mechanism Dermatan sulfate hydrolytic enzyme
Target Dermatan sulfate
Therapeutic class Alimentary tract and metabolism (A16)
Formulation VIAL
ATC code A16AB05

Mechanism of action

Dermatan sulfate hydrolytic enzyme

Primary target: Dermatan sulfate

Approval history

Authority Status Date
FDA approved
EMA approved

Pipeline programs

  1. Aldurazyme Phase 3 · BioMarin Pharmaceutical Australia · Mucopolysaccharidosis I
  2. OTL-203-02 Phase 3 · ORCHARD THERAPEUTICS · Mucopolysaccharidosis type I, Hurler Syndrome
  3. Aldurazyme (Recombinant Human Alpha-L-Iduronidase) Approved · BioMarin Pharmaceutical Australia · Mucopolysaccharidosis I
  4. laronidase Approved · BioMarin Pharmaceutical Australia · Mucopolysaccharidosis I
  5. laronidase Unknown · BioMarin Pharmaceutical Australia · Cognitive Decline

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 laronidase?

laronidase (ALDURAZYME) is a dermatan sulfate hydrolytic enzyme. Associated with BioMarin Pharmaceutical Australia Pty Ltd. Current US regulatory status: approved.

What is the brand name for laronidase?

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

What is the US approval status of laronidase?

laronidase 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.