ALDURAZYME

LOE Approaching

laronidase

BLAINTRAVENOUSVIALPriority Review
Approved
Apr 2003
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
10

Mechanism of Action

(GAG). Mucopolysaccharidosis I (MPS I) is characterized by the deficiency of α-L-iduronidase, a lysosomal hydrolase which catalyzes the hydrolysis of terminal α-L-iduronic acid residues of dermatan sulfate and heparan sulfate. Reduced or absent α-L-iduronidase activity results in the accumulation…

Pharmacologic Class:

Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme

Clinical Trials (5)

NCT05134571Phase 4Completed

China Post-marketing Surveillance (PMS) Study of Aldurazyme®

Started Oct 2021
12 enrolled
Mucopolysaccharidosis I
NCT05073783N/ACompleted

A Study to Assess the Safety of Myozyme® and of Aldurazyme® in Male and Female Participants of Any Age Group With Pompe Disease or With Mucopolysaccharidosis Type I (MPS I) in a Home-care Setting

Started Oct 2021
57 enrolled
Pompe DiseaseMucopolysaccharidosis Type I (MPS I)
NCT00418821Phase 4Terminated

A Study of the Effect of Aldurazyme® (Laronidase) Treatment on Lactation in Female Patients With Mucopolysaccharidosis I (MPS I) and Their Breastfed Infants

Started Oct 2010
2 enrolled
Mucopolysaccharidosis IHurler's SyndromeHurler-Scheie Syndrome+1 more
NCT00741338Phase 1/2Completed

Immune Tolerance Study With Aldurazyme® (Laronidase)

Started Sep 2008
7 enrolled
Mucopolysaccharidosis I
NCT00258011Phase 3Completed

Study of Aldurazyme® Replacement Therapy in Patients With Mucopolysaccharidosis I (MPS I) Disease

Started Dec 2005
3 enrolled
Mucopolysaccharidosis IHurler SyndromeHurler-Scheie Syndrome+1 more