Drugs / velaglucerase alfa
velaglucerase alfa
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | VPRIV | — | 2013-11-21 | fda.gov ↗ |
| Approved | EU (EMA) | Vpriv | — | 2010-08-26 | europa.eu ↗ |
| Approved | US (FDA) | VPRIV | — | 2010-02-26 | fda.gov ↗ |
Trials 14
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT01685216 | Sep 2012 → Mar 2015 | Gaucher disease type III | Shire | Completed | No outcome recorded |
| Phase 1/2 | NCT00391625 | Sep 2004 → Jan 2008 | Gaucher disease | Shire | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00478647 | Jul 2007 → Jun 2009 | Gaucher disease | Shire | Completed | No outcome recorded |
| Phase 36 trials · 1 met primary | ||||||
| Phase 3 | NCT05529992 | Jan 2023 → Aug 2024 | Gaucher disease | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT01842841 | Mar 2013 → Oct 2014 | Gaucher disease | Shire | Completed | No outcome recorded |
| Phase 3 | NCT01614574 | Mar 2012 → May 2013 | Gaucher disease | Shire | Completed | No outcome recorded |
| Phase 3 | NCT00635427 | Mar 2008 → Dec 2012 | Gaucher disease type I | Shire | Completed | No outcome recorded |
| Phase 3 | NCT00553631 | Jan 2008 → May 2009 | Gaucher disease type I | Shire | Completed | No outcome recorded |
| Phase 3 | NCT00430625 | Feb 2007 → Apr 2009 | Gaucher disease type I | Shire | Completed | Met primary |
| Phase 44 trials | ||||||
| Phase 4 | NCT03702361 | Sep 2018 → Sep 2019 | — | Shaare Zedek Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT02574286 | Jun 2016 → Nov 2020 | Gaucher disease | Shire | Completed | No outcome recorded |
| Phase 4 | NCT04120506 | Jan 2016 → Jan 2017 | Gaucher disease type I | Shaare Zedek Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT02528617 | Jul 2015 → Oct 2017 | Gaucher disease type I, Gaucher disease type III | Baylor Research Institute | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase not stated1 trial | ||||||
| — | NCT00954460 | — | Gaucher disease type I | Shire | Approved for marketing | No outcome recorded |
Press releases naming this drug 3 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | velaglucerase alfa | “The efficacy of ERT with velaglucerase alfa was assessed based on the achievement of published therapeutic goals and the normalization of disease parameters” PMID 27839979 ↗ Oct 2016 |
| Known as | EC 3.2.1.45 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201865 ↗ |
| Known as | GA-GCB | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00391625 ↗ |
| Known as | Velaglucerasa alfa | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201865 ↗ |
| Known as | VPRIV | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00635427 ↗ |
| Action | Restore | “has been developed as an enzyme replacement therapy for Gaucher disease” NCT01614574 ↗ |
| Modality | Protein / enzyme biologic | “Velaglucerase alfa is a glucocerebrosidase produced by gene activation technology in a human fibroblast cell line (HT-1080)” PMID 23339116 ↗ Jan 2013 |
| Route | Intravenous | “15-60 U/kg every other week via intravenous infusion” NCT00391625 ↗ |