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Drug

Laronidase

Approved · EMA
Late-stage development

Also known as Aldurazyme, Laronidasa, Human Recombinant alpha-L-iduronidase.

RxNorm392509UNIIWP58SVM6R4
1
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

PEARL (PrEnAtal Enzyme Replacement Therapy for Lysosomal Storage Disorders)

Clinical trial2026-03-17Results expected Q3 2031 · ClinicalTrials.gov

Approval: Aldurazyme (EMA)

Regulatory2003-06-09EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Laronidase
Aliases & brands
AldurazymeLaronidasaHuman Recombinant alpha-L-iduronidase
RxNorm CUI
392509
UNII
WP58SVM6R4
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2003-06-09
Latest approval
2003-06-09
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2003-06-09Approval
Approval: Aldurazyme (EMA)
Indication: Aldurazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of mucopolysaccharidosis I (MPS I; alpha-L-iduronidase deficiency) to treatShow full indication

Aldurazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of mucopolysaccharidosis I (MPS I; alpha-L-iduronidase deficiency) to treat the nonneurological manifestations of the disease.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

14 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
14
registered trials across all phases
LATEST COMPLETION 2023
1
Active studies
1
Recruiting
8
Late-stage (III+)
10
Completed
3
Discontinued
PHASE DISTRIBUTIONn = 14
Phase 14Phase 1 / 21Phase 21Phase 33Phase 44Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.