Treats Hurler and Hurler-Scheie forms of Mucopolysaccharidosis I (MPS I). Sold as Aldurazyme. Every FDA application for this active ingredient.
As of Nov 14, 2026, FDA lists 1 application for Laronidase (sold as Aldurazyme), first approved Apr 30, 2003, with 2 new uses approved and 0 published complete response letters.
| Aldurazyme | Part D | $7.6M | +3% | 0 |
| Aldurazyme | Part B | $1.3M | +62% | 0 |
| Evaluation of Intravenous Laronidase Pharmacokinetics Before and After Hematopoietic Cell Transplantation in Patients With Mucopolysaccharidosis Type IH.Hematopoietic Cell Transplantation, Mucopolysaccharidosis Type I · Masonic Cancer Center, University of Minnesota | — | Active, not recruiting | Dec 2, 2022 |
| PEARL (PrEnAtal Enzyme Replacement Therapy for Lysosomal Storage Disorders)MPS I, MPS II · University of California, San Francisco | Phase 1 | Recruiting | Aug 31, 2020 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Apr 30, 2003 | AldurazymeBLA 125058 · New molecular entity | Biomarin | 9 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
