BLAINTRAVENOUSVIALPriority Review
Approved
Apr 2003
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
11
Data completeness
5/8 — Partial
Priority Review
ALDURAZYME (laronidase) by BioMarin Pharmaceutical. Approved for hydrolytic lysosomal glycosaminoglycan-specific enzyme [epc]. First approved in 2003.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ALDURAZYME (laronidase) is an intravenous enzyme replacement therapy approved in April 2003 for mucopolysaccharidosis I (MPS I), a rare lysosomal storage disorder. The drug is a recombinant hydrolytic enzyme that catalyzes the breakdown of glycosaminoglycans, correcting the enzymatic deficiency underlying MPS I pathology. Administered as an IV infusion, laronidase addresses the progressive multi-organ manifestations of this devastating genetic disorder. It represents a foundational therapy in the orphan enzyme replacement space and remains a standard-of-care option for MPS I patients.
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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 (11)
Efficacy and Safety of YW17 (Laronidase-CinnaGen) Compared to Aldurazyme® in MPS I Patients
Started Sep 2022
12 enrolled
Mucopolysaccharidosis Type 1
China Post-marketing Surveillance (PMS) Study of Aldurazyme®
Started Oct 2021
12 enrolled
Mucopolysaccharidosis I
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)
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
Immune Tolerance Study With Aldurazyme® (Laronidase)
Started Sep 2008
7 enrolled
Mucopolysaccharidosis I
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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.