laronidase
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | ALDURAZYME | — | 2009-05-20 | fda.gov ↗ |
| Approved | EU (EMA) | Aldurazyme | — | 2003-06-09 | europa.eu ↗ |
| Approved | US (FDA) | ALDURAZYME | — | 2003-04-30 | fda.gov ↗ |
Trials 15 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 3 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 32 trials | ||||||
| Phase 3 | NCT00146770 Comparator | May 2001 → Mar 2005 | Hurler syndrome, Hurler-Scheie syndrome, Scheie syndrome | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 3 | NCT00912925 Comparator | Dec 2000 → Sep 2001 | Hurler syndrome, Hurler-Scheie syndrome | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT00144781 Comparator | Dec 2004 → Jan 2006 | Hurler syndrome, Hurler-Scheie syndrome, Scheie syndrome | Genzyme, a Sanofi Company | Completed | No outcome recorded |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 21 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | laronidase | “Our goal was to evaluate the long-term safety and efficacy of recombinant human alpha-l-iduronidase (laronidase) in patients with mucopolysaccharidosis I.” PMID 19117887 ↗ Jan 200916“evaluate the safety of laronidase administered by intravenous drip infusion in Japanese patients with MPS I disease” NCT00258011 ↗ “A Dose-optimization Study of Aldurazyme® (Laronidase) in Patients With Mucopolysaccharidosis I (MPS I) Disease” NCT00144781 ↗ “laronidase 1.74 mg IT q 3 months” NCT02232477 ↗ “Aldurazyme® (laronidase)” NCT00146757 ↗ “Aldurazyme (laronidase)” NCT04532047 ↗ |
| Known as | A-l-iduronidase | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201595 ↗ |
| Known as | Aldurazyme | “Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 Units/kg (approximately 0.58 mg/kg = labeled dose) administered intravenously over...” NCT00912925 ↗8“Laronidase (Aldurazyme®) stands as the sole FDA-approved enzyme replacement therapy (ERT) for MPS I to date.” PMID 41163043 ↗ Oct 2025 “Laronidase as Aldurazyme® (the first 12 weeks) or YW17 (the second 12 weeks) is administered.” NCT06406153 ↗ “Aldurazyme (Recombinant Human Alpha-L-Iduronidase)” NCT00258011 ↗ “Recombinant Human Alpha-L-Iduronidase, Aldurazyme®” NCT00144768 ↗ |
| Known as | Alronidase | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201595 ↗ |
| Known as | Ec 3.2.1.76 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201595 ↗ |
| Known as | Laronidasa | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201595 ↗ |
| Known as | Recombinant Human Alpha-L-Iduronidase | “Patients received Aldurazyme (recombinant human alpha-L-iduronidase (rhIDU)) once per week” NCT00146757 ↗1“Recombinant Human Alpha-L-Iduronidase, Aldurazyme®” NCT00144768 ↗ |
| Known as | rhIDU | “Patients received Aldurazyme (recombinant human alpha-L-iduronidase (rhIDU)) once per week” NCT00146757 ↗ |
| Known as | YW17 | “Laronidase as Aldurazyme® (the first 12 weeks) or YW17 (the second 12 weeks) is administered.” NCT06406153 ↗ |
| Action | Restore | “Laronidase replaces the missing enzyme alpha-L-iduronidase and restores sufficient enzyme activity to break down GAG buildup.” NCT00638547 ↗ |
| Modality | Protein / enzyme biologic | “Recombinant Human Alpha-L-Iduronidase, Aldurazyme®” NCT00144768 ↗ |
| Route | Intravenous | “dose of 0.58mg/kg body weight IV every week” NCT00144768 ↗ |