ALDURAZYME

(laronidase)

Phase 1Protein / enzyme

GGenzyme, a Sanofi Company

ALDURAZYME is one of 26 small molecule programs targeting Mucopolysaccharidosis. It is currently in Phase 1.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

MucopolysaccharidosisActive, not recruiting

MucopolysaccharidosisPhase 1

Active, not recruiting

Competition

Competitive Landscape

34 competitors in Mucopolysaccharidosis

#DrugCompanyPhaseTrials

Trexall

Alnylam Pharmaceuticals

Approved

1 2

Rituxan

Roche

Approved

1 3

Neoral

Novartis

Approved

—4

Imuran

LLegacy Health System

Immunoglobulin

1 6

BMN 333

BioMarin Pharmaceutical

Phase 3

5 7

ELAPRASE

Takeda

Approved

2 8

ELAPRASE

Takeda

Phase 3

2 9

Humira

CCelltrion

Phase 2

1 10

Genotropin

EMD Serono

Phase 2

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Mucopolysaccharidosis2 trials

Intrathecal Enzyme Replacement Therapy for Spinal Cord Compression in Mucopolysaccharidosis (MPS) I

Terminated·PPatricia I. Dickson, M.D.·Phase 1·NCT00215527·4 enrolled

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

Terminated· Sanofi logo

Sanofi·Phase 4·NCT00418821·2 enrolled

Bone Marrow Transplant1 trial

Administration of IV Laronidase Post Bone Marrow Transplant in Hurler

Completed·MMasonic Cancer Center, University of Minnesota·Phase 1·NCT01173016·11 enrolled

Antibody1 trial

A Study Investigating the Relationship Between the Development of Laronidase Antibody and Urinary GAG (Glycosaminoglycan) Levels in Aldurazyme® Treated Patients

Completed· Sanofi logo

Sanofi·Phase 4·NCT00144768·25 enrolled

Immune Tolerance1 trial

Immune Tolerance Study With Aldurazyme® (Laronidase)

Completed· Sanofi logo

Sanofi·Phase 1/2·NCT00741338·7 enrolled

Hematopoietic Stem Cell Transplant1 trial

Laronidase (Aldurazyme TM) Enzyme Replacement Therapy With Hematopoietic Stem Cell Transplant for Hurler Syndrome

Terminated·MMasonic Cancer Center, University of Minnesota··NCT01572636·20 enrolled

4 more indications

Cognitive Decline1 trial

A Study of Intrathecal Enzyme Therapy for Cognitive Decline in MPS I

Completed·PPatricia I. Dickson, M.D.·N/A·NCT00852358·9 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of YW17 (Laronidase-CinnaGen) Compared to Aldurazyme® in MPS I Patients

Completed·CCinnagen·Phase 3·NCT06406153·12 enrolled

MPS I1 trial

Extension Study of Intrathecal Enzyme Replacement Therapy for MPS I

Terminated·PPatricia I. Dickson, M.D.·Phase 1·NCT00786968·3 enrolled

ALD1 trial

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

Completed· Sanofi logo

Sanofi·Phase 4·NCT05134571·12 enrolled

Regulatory

FDA Approval Timeline[4]

Apr 30, 2003

ALDURAZYME

BLA BLA125058

Sources

References

[1]
ClinicalTrials.gov — 10 trial records for laronidase. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — laronidase compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for laronidase. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA125058). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Genzyme, a Sanofi Company company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Protein / enzyme[2]
Highest Phase: Phase 1[1]
Company: GGenzyme, a Sanofi Company

ALDURAZYME

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Mucopolysaccharidosis2 trials

Bone Marrow Transplant1 trial

Antibody1 trial

Immune Tolerance1 trial

Hematopoietic Stem Cell Transplant1 trial

Cognitive Decline1 trial

Efficacy and Safety1 trial

MPS I1 trial

ALD1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Related News