Drugs / Taliglucerase alfa
Taliglucerase alfa
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | ELELYSO | — | 2014-08-27 – 2016-12-20 | fda.gov ↗ |
| Refused (EMA) | EU (EMA) | Elelyso | — | 2012-10-25 | europa.eu ↗ |
| Approved | US (FDA) | ELELYSO | — | 2012-05-01 | fda.gov ↗ |
Trials 12 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01747980 | Mar 2013 → Jan 2014 | Gaucher disease | Protalix | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT02107846 | Apr 2014 → Dec 2015 | Gaucher disease | Protalix | Completed | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT01411228 | Sep 2011 → Jul 2014 | Gaucher disease | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT01422187 | Aug 2011 → May 2014 | Gaucher disease | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00712348 | Dec 2008 → Apr 2013 | Gaucher disease | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00705939 | Jun 2008 → May 2012 | Gaucher disease | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00376168 | Aug 2007 → Sep 2009 | Gaucher disease | Pfizer | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT04002830 | Nov 2020 → Jul 2023 | Gaucher disease type III | Ari Zimran | Completed | No outcome recorded |
| Phase 4 | NCT03021941 | Jul 2019 → Jun 2020 | Gaucher disease type I | Pfizer | Withdrawn | No outcome recorded |
| Phase 4 | NCT01132690 | Aug 2010 → May 2012 | Gaucher disease | Pfizer | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT04353466 | Jan 2017 → Jul 2021 | Gaucher disease type I | Shaare Zedek Medical Center | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT00962260 | — | Gaucher disease | Pfizer | No longer available | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2/3 | NCT05815004 Comparator | Oct 2023 → Dec 2027 | Gaucher disease type III | AVROBIO | Withdrawn | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2015-02-12 | Pfizer | Safety and Efficacy of ELELYSO® (taliglucerase alfa) for Injection in Pediatric Patients with Type 1 Gaucher Disease in Long-term Outcome Study Presented at the WORLDSymposium 2015 pfizer.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | taliglucerase alfa | “Taliglucerase alfa is a beta-glucocerebrosidase enzyme replacement therapy approved in the United States, Israel, and other countries for treatment of Type 1 Gaucher disease in...” PMID 26053270 ↗ Jun 20158“This is a multicenter study to assess the safety and efficacy of taliglucerase alfa (60 units/kg) in previously untreated subjects of any age with Type 3 GD.” NCT04002830 ↗ “Elelyso (taliglucerase alfa)” NCT03021941 ↗ “taliglucerase alfa” NCT05815004 ↗ |
| Known as | Elelyso | “Intravenous infusion of Taligluucerase alfa (Elelyso) in treatment-naive patients with type 3 Gaucher disease” NCT04002830 ↗ |
| Known as | Plant cell expressed recombinant glucocerebrosidase | “Plant cell expressed recombinant glucocerebrosidase (prGCD)” NCT00962260 ↗ |
| Known as | plant recombinant human glucocerebrosidase | “Administration of PRX-112, a plant recombinant human glucocerebrosidase (prGCD) using plant cells as carrier vehicle” NCT01747980 ↗ |
| Known as | prGCD | “Administration of PRX-112, a plant recombinant human glucocerebrosidase (prGCD) using plant cells as carrier vehicle” NCT01747980 ↗ |
| Known as | PRX-112 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02107846 ↗ |
| Known as | velaglucerase | “velaglucerase” NCT05815004 ↗ |
| Action | Restore | “a novel enzyme replacement therapy for Gaucher disease” PMID 21900191 ↗ Sep 2011 |
| Modality | Protein / enzyme biologic | “Taliglucerase alfa is a beta-glucocerebrosidase enzyme replacement therapy approved in the United States, Israel, and other countries for treatment of Type 1 Gaucher disease in...” PMID 26053270 ↗ Jun 2015 |
| Route | Intravenous | “receive intravenous (IV) infusions of taliglucerase alfa every two weeks” NCT00712348 ↗ |