Imiglucerase clinical trials
Imiglucerase is named as an intervention in 2 current clinical trials in our UK, USA, Germany, Japan, China, France, Italy, Turkey, Canada and Taiwan registers. None are recruiting at the moment. The most common phase is Phase 2. The sponsor with the most trials is Genzyme, a Sanofi Company (1). The most-studied condition is Gaucher Disease Type 1. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Where Imiglucerase is approved
All regulators →Of the three regulators tracked here, the first to approve Imiglucerase was the US, on 23 May 1994. It is approved in 3 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
What health systems spend on Imiglucerase
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Imiglucerase works
All drug targets →- Gaucher disease type IPhase 3
- Gaucher disease type IIIPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1201632, CC BY-SA 3.0. The Guide to Pharmacology has no record of this medicine, so its targets rest on ChEMBL alone. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Imiglucerase
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 3 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: CerezymeEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Imiglucerase
- ATC code
- A16AB02
- ChEMBL
- CHEMBL1201632
- DrugBank
- DB00053
- CAS number
- 154248-97-2
- FDA UNII
- Q6U6J48BWY
- Wikidata
- Q2620206
- Wikipedia
- Imiglucerase
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Imiglucerase
2 trials| Study | Phase | Status | Lead sponsor | Registers |
|---|---|---|---|---|
|
Study to Evaluate the Efficacy and Safety of Venglustat in Adult and Pediatric Patients With Gaucher Disease Type 3
NCT05222906 · Gaucher's Disease Type III
|
Phase 3 | Active, closed | Sanofi | UK, USA, China, Germany, France, Italy, Turkey, Canada, Japan, Taiwan |
|
Venglustat in Combination With Cerezyme in Adult Patients With Gaucher Disease Type 3 With Venglustat Monotherapy Extension
NCT02843035 · Gaucher Disease Type 1, Gaucher Disease Type 3
|
Phase 2 | Active, closed | Genzyme, a Sanofi Company | UK, USA, Germany, Japan |
Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Imiglucerase in the EU trials register (CTIS)
1 trialAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Imiglucerase. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
EFC18362 - A Phase 3, multicenter, multinational, randomized, open-label, active-comparator study to evaluate the efficacy and safety of venglustat compared with Cerezyme in pediatric participants 2 to 11 years of age with Gaucher disease type 3 who have reached therapeutic goals with enzyme replacement therapy
2026-525374-19-00 · Immune System Diseases
|
Phase 3 | Authorised | Sanofi-Aventis Recherche & Developpement | Hungary, Italy, France + 3 more |
Imiglucerase across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
3 single-substance products containing Imiglucerase on the HPRA medicines list.
- Cerezyme 400 Units Powder for concentrate for solution for infusionSanofi B.V. · EU/1/97/053/003
- Cerezyme 400 Units Powder for concentrate for solution for infusionSanofi B.V. · EU/1/97/053/004
- Cerezyme 400 Units Powder for concentrate for solution for infusionSanofi B.V. · EU/1/97/053/005
Supply shortages
- CerezymeEU (EMA) · Shortage resolved · first published 4 Nov 2013
Conditions studied with Imiglucerase
3 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Genzyme, a Sanofi Company | 1 |
| Sanofi | 1 |
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Imiglucerase trials
How many clinical trials are testing Imiglucerase?
2 current trials in our UK, USA, Germany, Japan, China, France, Italy, Turkey, Canada and Taiwan registers name Imiglucerase as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Imiglucerase trials recruiting patients?
Not at the moment. None of the 2 trials in our registers is recruiting; they are active but closed to enrolment, not yet open, or enrolling by invitation. Only the study team can confirm whether a patient is eligible.
Who sponsors Imiglucerase clinical trials?
Genzyme, a Sanofi Company (1) and Sanofi (1). The number in brackets is how many trials each organisation leads.
Is Imiglucerase licensed in Ireland?
Yes. The HPRA medicines list includes 3 single-substance products containing Imiglucerase, for example Cerezyme 400 Units Powder for concentrate for solution for infusion (Sanofi B.V.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Imiglucerase shortage?
The registers we track list 1 entry for Imiglucerase: Cerezyme (EU: shortage resolved). Shortages are product- and country-specific; check with a pharmacist.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Imiglucerase works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Imiglucerase works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Imiglucerase (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.