taliglucerase alfa
Trade name: elelyso
Approved
May 1, 2012
Taliglucerase alfa, sold under the brand name Elelyso among others, is a biopharmaceutical medication developed by Protalix and Pfizer. The drug, a recombinant glucocerebrosidase used to treat Gaucher's disease, is the first plant-made pharmaceutical to win approval by the U.S. Food and Drug Administration (FDA). Each vial has 200 units of taliglucerase alfa. — Wikipedia
Clinical trial activity
11 trials · 5 clinical orgs · 2 marketing orgs
Earliest trial started Nov 1, 1999 (NCT00004293)
Timeline
1990s
- Jan 1, 1999
Earliest Phase 2 Sponsor(trial)
2000s
- Jan 1, 2007
Earliest Phase 3 Sponsor(trial)
- Sep 3, 2009
Orphan Drug Designation
2010s
- May 1, 2012
Target Health Inc. — Earliest FDA Approval
- May 1, 2012
Pfizer — NDA Secondary Org
- May 1, 2012
Target Health Inc. — NDA Organization
Indications
Approved 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
- approvedFast trackMay 1, 2012
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaTaliglucerase alfa ↗
- NCATS0R4NLX88O4 ↗
- ChEMBLCHEMBL1964120 ↗
Also known as
- elelyso
- elelyso
- elelyso
- elelyso
- prgcd
- prgcd
- taliglucerase alfa
- taliglucerase alfa
- taliglucerase alfa
- taliglucerase alfa
- taliglucerase alfa
- taliglucerase alfa
- taliglucerase alfa
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT04002830 | Phase 4 | Aug 1, 2019 | Hebrew University, Pfizer |
| NCT03021941 | Phase 4 | Jun 1, 2017 | Pfizer |
| NCT04353466 | N/A | Jan 1, 2017 | Hebrew University, Pfizer |
| NCT01411228 | Phase 3 | Sep 1, 2011 | Hebrew University, Protalix |
| NCT01422187 | Phase 3 | Aug 1, 2011 | Protalix |
| NCT01132690 | Phase 4 | Aug 1, 2010 | Hebrew University, Protalix |
| NCT00962260 | N/A | Aug 18, 2009 | Protalix |
| NCT00712348 | Phase 3 | Dec 1, 2008 | Hebrew University, Protalix |
| NCT00705939 | Phase 3 | Jun 1, 2008 | Hebrew University, Protalix |
| NCT00376168 | Phase 3 | Aug 1, 2007 | Hebrew University, Protalix |
| NCT00004293 | Phase 2 | Nov 1, 1999 | National Center for Research Resources (NCRR), University of Pittsburgh |
Organizations
Research & Development (5)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Hebrew University | Academic/Hospital | 7 | 2 | 3 | 2007 |
| Protalix | For profit | 7 | 7 | 3 | 2007 |
| Pfizer | For profit | 3 | 1 | 2 | 2017 |
| National Center for Research Resources (NCRR) | Government | 1 | 1 | 1 | 1999 |
| University of Pittsburgh | Academic/Hospital | 1 | 0 | 1 | 1999 |
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Pfizer | For profit | NDA2 | May 1, 2012 |
| Target Health Inc. | For profit | NDA | May 1, 2012 |