Drugs / Imiglucerase
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | CEREZYME | — | 2026-01-12 | fda.gov ↗ |
| Approved | EU (EMA) | Cerezyme | — | 1997-11-17 | europa.eu ↗ |
| Approved | US (FDA) | CEREZYME | — | 1994-05-23 | fda.gov ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT01951989 | Nov 2012 → Feb 2016 | Gaucher disease | University Hospital, Clermont-Ferrand | Unknown | No outcome recorded |
| Phase 43 trials · 1 missed | ||||||
| Phase 4 | NCT04656600 | Mar 2021 → Oct 2023 | Gaucher disease type III | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT00364858 | Dec 2001 → Feb 2007 | Gaucher disease type I | Genzyme, a Sanofi Company | Completed | Missed primary |
| Phase 4 | NCT00365131 | Dec 1997 → Jul 2004 | Gaucher disease type I | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Comparator or background therapy7 trials | ||||||
| Phase 1 | NCT04787887 Comparator | Jan → Sep 2020 | Gaucher disease | ISU Abxis Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT02843035 Background | Jan 2017 → Oct 2026 expected | Gaucher disease type I, Gaucher disease type III | Genzyme, a Sanofi Company | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT05815004 Comparator | Oct 2023 → Dec 2027 | Gaucher disease type III | AVROBIO | Withdrawn | No outcome recorded |
| Phase 3 | NCT05222906 Comparator | Apr 2022 → Oct 2025 overdue | Gaucher disease type III | Sanofi | Active not recruiting | Met primary |
| Phase 3 | NCT01161914 Comparator | Jan → Aug 2011 | Gaucher disease type I | ISU Abxis Co., Ltd. | Withdrawn | No outcome recorded |
| Phase 3 | NCT00943111 Comparator | Sep 2009 → Nov 2012 | Gaucher disease type I | Genzyme, a Sanofi Company | Completed | Met primary |
| Phase 3 | NCT00553631 Comparator | Jan 2008 → May 2009 | Gaucher disease type I | Shire | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2021-02-02 | Sanofi | Results Media Update: Data presented at WORLDSymposiumTM reinforces robust rare disease pipeline and highlights additional clinical data for investigational avalglucosidase alfa in Pompe disease sanofi.com ↗
Venglustat Combined with imiglucerase positively affects neurological features and brain connectivity in adult with Gaucher disease type 3 (Encore) |
| 2012-07-02 | Protalix | Results Protalix BioTherapeutics Announces New Clinical Data on taliglucerase alfa Presented at the 10th Annual European Working Group on Gaucher Disease Meeting protalix.com ↗
Both analyses concluded that therapeutic responses are comparable between all three enzyme replacement options. |
All press releases naming this drug 2 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Imiglucerase | “Imiglucerase has been used to treat Gaucher disease since 1997” NCT01951989 ↗ |
| Known as | Cerezyme | “Cerezyme (imiglucerase for injection)” NCT00365131 ↗ |
| Modality | Protein / enzyme biologic | “eliglustat was noninferior to imiglucerase enzyme therapy in maintaining stable platelet counts, hemoglobin concentrations, and spleen and liver volumes.” PMID 28167660 ↗ Feb 2017 |
| Route | Intravenous | “IV infusion, 60 U/kg every other week for 9 months” NCT00553631 ↗ |