imiglucerase
Trade name: cerezyme
Recombinant proteinapprovedOrphan Drug FDA
Approved
May 23, 1994
Imiglucerase is a medication used in the treatment of Gaucher's disease. — Wikipedia
Clinical trial activity
26 trials · 31 clinical orgs · 3 marketing orgs
Phase 1
4
Phase 2
14
Phase 3
12
Phase 4
8
Earliest trial started Dec 1, 1997 (NCT00365131)
Timeline
1990s
2000s
Indications
Approved for
Studied for
Mechanism of action
- GlucocerebrosideHYDROLYTIC ENZYME
Glucocerebroside hydrolytic enzyme
Given in cases of gaucher disease to overcome a deficiency of beta-glucocerebrosidase activity. Imiglucerase catalyses the hydrolysis of glucocerebroside to glucose and ceramide
- Beta-glucocerebrosidaseSupplementation
GBA supplementation
Approval history
- approvedMay 23, 1994
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
- ChEMBLCHEMBL1201632 ↗
- WikipediaImiglucerase ↗
- NCATSQ6U6J48BWY ↗
- ChEMBLCHEMBL1201865 ↗
- NCATS23HYE36B0I ↗
Also known as
- cerezyme
- d-glucosyl-n-acylsphingosine glucohydrolase
- ec 3.2.1.45
- ec 3.2.1.45
- ga-gcb
- glucosylceramidase
- isu302
- velaglucerase alfa
- velaglucerase alfa
- velaglucerase alfa
- velaglucerase alfa
- velaglucerase alfa
- velaglucerase alfa
- velaglucerase alfa
- velaglucerase alfa
- velaglucerase-alfa
- vpriv
- vpriv
- vpriv
- vpriv
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05529992 | Phase 3 | Dec 12, 2022 | Takeda |
| NCT05222906 | Phase 3 | Apr 18, 2022 | Genzyme, Sanofi |
| NCT04718779 | Phase 4 | Apr 22, 2021 | Takeda |
| NCT04656600 | Phase 4 | Dec 31, 2020 | Sanofi |
| NCT04787887 | Phase 1 | Jan 29, 2020 | ISU Abxis Co., Ltd., Scientia Clinical Research Limited Sydney |
| NCT03702361 | Phase 4 | Sep 4, 2018 | Hebrew University |
| NCT03485677 | Phase 3 | Apr 11, 2018 | Sanofi |
| NCT02574286 | Phase 4 | May 1, 2016 | Shire |
| NCT04120506 | Phase 4 | Jan 10, 2016 | Hebrew University, Shire |
| NCT02528617 | Phase 4 | Jul 1, 2015 | Baylor University, Texas Scottish Rite Hospital for Children |
| NCT01842841 | Phase 3 | Mar 1, 2013 | IQVIA, Shire |
| NCT01951989 | Phase 2 | Nov 1, 2012 | University Clermont Auvergne |
| NCT01685216 | Phase 1/Phase 2 (Phase 2) | Sep 1, 2012 | Shire |
| NCT01614574 | Phase 3 | Mar 1, 2012 | Shire |
| NCT02770625 | Phase 3 | Sep 1, 2011 | Cairo University, ISU Abxis Co., Ltd. |
| NCT01161914 | Phase 3 | Jan 1, 2011 | ISU Abxis Co., Ltd. |
| NCT01881633 | Phase 1 | Oct 1, 2010 | ISU Abxis Co., Ltd. |
| NCT00943111 | Phase 3 | Sep 1, 2009 | Genzyme |
| NCT00954460 | N/A | Aug 5, 2009 | Shire |
| NCT00635427 | Phase 3 | May 1, 2008 | Shire |
Showing 20 of 26 trials
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Organizations
Research & Development (31)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Shire | For profit | 11 | 10 | 4 | 2005 |
| Hebrew University | Academic/Hospital | 6 | 2 | 3 | 2005 |
| Genzyme | For profit | 4 | 4 | 2 | 1997 |
| ISU Abxis Co., Ltd. | For profit | 4 | 4 | 2 | 2010 |
| Sanofi | For profit | 3 | 2 | 2 | 2018 |
| Baylor University | Academic/Hospital | 2 | 1 | 2 | 2007 |
| La Rabta Hospital | Academic/Hospital | 2 | 0 | 1 | 2007 |
| Sociedad Espanola de Socorros Mutuos | Academic/Hospital | 2 | 0 | 1 | 2007 |
| Takeda | For profit | 2 | 2 | 2 | 2021 |
| University of London | Academic/Hospital | 2 | 0 | 1 | 2007 |
| University of Zaragoza | Academic/Hospital | 2 | 0 | 1 | 2007 |
| All India Institute of Medical Sciences | Academic/Hospital | 1 | 0 | 1 | 2008 |
| Cairo University | Academic/Hospital | 1 | 0 | 1 | 2011 |
| Children's Memorial Health Institute, Poland | Academic/Hospital | 1 | 0 | 1 | 2007 |
| Duke University | Academic/Hospital | 1 | 0 | 1 | 2008 |
| Emory University | Academic/Hospital | 1 | 0 | 1 | 2007 |
| IQVIA | For profit | 1 | 0 | 1 | 2013 |
| Malabar Institute of Medical Sciences | Academic/Hospital | 1 | 0 | 1 | 2008 |
| Maria Sklodowska Curie Children's Hospital | Academic/Hospital | 1 | 0 | 1 | 2005 |
| Mother and Child Health Care Institute of Serbia | Academic/Hospital | 1 | 0 | 1 | 2005 |
31 organizations
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