Laronidase
Trade name: Aldurazyme
Recombinant proteinapprovedOrphan Drug FDA
Approved
Apr 30, 2003
Iduronidase, sold as Aldurazyme, is an enzyme with the systematic name glycosaminoglycan α-L-iduronohydrolase. It catalyses the hydrolysis of unsulfated α-L-iduronosidic linkages in dermatan sulfate. — Wikipedia
Clinical trial activity
20 trials · 18 clinical orgs · 1 marketing orgs
Phase 1
8
Phase 2
9
Phase 3
4
Phase 4
4
Earliest trial started Dec 1, 2000 (NCT00912925)
Timeline
Indications
Mechanism of action
- Heparan sulfateHYDROLYTIC ENZYME
Heparan sulfate hydrolytic enzyme
Replacement of alpha-L-iduronidase enzyme
- Dermatan sulfateHYDROLYTIC ENZYME
Dermatan sulfate hydrolytic enzyme
Replacement of alpha-L-iduronidase enzyme
- Alpha-L-iduronidaseSupplementation
IDUA supplementation
Approval history
- approvedApr 30, 2003
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Black box warning
Sources
- WikipediaIduronidase ↗
- NCATSWP58SVM6R4 ↗
- ChEMBLCHEMBL2108607 ↗
- ChEMBLCHEMBL1201636 ↗
- ChEMBLCHEMBL1201595 ↗
Also known as
- aldurazyme
- aldurazyme
- aldurazyme
- aldurazyme
- a-l-iduronidase
- alpha-l-iduronidase
- alpha-l-iduronidase precursor
- human alpha iduronidase
- laronidase
- laronidase
- laronidase
- laronidase
- laronidase
- laronidase
- laronidase
- laronidase
- laronidase
- laronidase (genetical recombination)
- ovine hyaluronidase
- sperm adhesion molecule 1
- sperm surface protein ph-20
- vitrase
- wydase
- wydase
- wydase
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06406153 | Phase 3 | Sep 10, 2022 | Cinnagen |
| NCT05134571 | Phase 4 | Oct 28, 2021 | Genzyme, Sanofi |
| NCT04453085 | Phase 1/Phase 2 (Phase 2) | May 1, 2021 | JCR Pharmaceuticals Co., Ltd. |
| NCT04532047 | Phase 1 | Dec 1, 2020 | Duke University, University of California, San Francisco |
| NCT04227600 | Phase 1/Phase 2 (Phase 2) | Sep 1, 2020 | JCR Pharmaceuticals Co., Ltd. |
| NCT02232477 | N/A | May 1, 2014 | Los Angeles Biomedical Research Institute, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), The Ryan Foundation, UCLA Medical Center, University of California, Los Angeles, University of California, San Francisco, University of Minnesota |
| NCT01173016 | Phase 1 | May 1, 2012 | University of Minnesota |
| NCT00418821 | Phase 4 | Oct 1, 2010 | Genzyme |
| NCT00852358 | N/A | Jun 1, 2009 | Biomarin, National Center for Advancing Translational Science (NCATS), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), The Ryan Foundation, University of California, Los Angeles, University of Minnesota, Washington University in St. Louis |
| NCT00741338 | Phase 1/Phase 2 (Phase 2) | Sep 1, 2008 | Genzyme |
| NCT00638547 | Phase 1 | Jan 2, 2008 | University of Minnesota |
| NCT00786968 | Phase 1 | Jan 1, 2008 | The Ryan Foundation, University of California, Los Angeles, Washington University in St. Louis |
| NCT00258011 | Phase 3 | Dec 1, 2005 | Genzyme |
| NCT00215527 | Phase 1 | Nov 1, 2005 | Food and Drug Administration, The Ryan Foundation, University of California, Los Angeles, Washington University in St. Louis |
| NCT00144781 | Phase 4 | Dec 1, 2004 | Genzyme |
| NCT00144768 | Phase 4 | Jul 1, 2004 | Genzyme |
| NCT00176891 | Phase 2 | Mar 1, 2004 | University of Minnesota |
| NCT00146757 | Phase 2 | Oct 1, 2002 | Genzyme |
| NCT00146770 | Phase 3 | May 1, 2001 | Genzyme |
| NCT00912925 | Phase 3 | Dec 1, 2000 | Genzyme |
Showing 20 of 20 trials
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Organizations
Research & Development (18)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Genzyme | For profit | 9 | 9 | 3 | 2000 |
| University of Minnesota | Academic/Hospital | 5 | 3 | 3 | 2004 |
| The Ryan Foundation | Academic/Hospital | 4 | 0 | 2 | 2005 |
| University of California, Los Angeles | Academic/Hospital | 4 | 0 | 2 | 2005 |
| Washington University in St. Louis | Academic/Hospital | 3 | 3 | 2 | 2005 |
| JCR Pharmaceuticals Co., Ltd. | For profit | 2 | 2 | 1 | 2020 |
| National Institute of Neurological Disorders and Stroke (NINDS) | Government | 2 | 0 | 1 | 2009 |
| National Institutes of Health (NIH) | Government | 2 | 0 | 1 | 2009 |
| University of California, San Francisco | Academic/Hospital | 2 | 1 | 2 | 2014 |
| Biomarin | For profit | 1 | 0 | 1 | 2009 |
| Cinnagen | For profit | 1 | 1 | 1 | 2022 |
| Duke University | Academic/Hospital | 1 | 0 | 1 | 2020 |
| Food and Drug Administration | Government | 1 | 0 | 1 | 2005 |
| Los Angeles Biomedical Research Institute | Academic/Hospital | 1 | 0 | 1 | 2014 |
| National Center for Advancing Translational Science (NCATS) | Government | 1 | 0 | 1 | 2009 |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Government | 1 | 0 | 1 | 2009 |
| Sanofi | For profit | 1 | 0 | 1 | 2021 |
| UCLA Medical Center | Academic/Hospital | 1 | 1 | 1 | 2014 |
18 organizations
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