Phuturdex › Drugs › Imiglucerase
Drugs in development · updated 10 November 2026
Imiglucerase: clinical trials and development status
Other names and codes: Cerezyme
As of 10 November 2026 Imiglucerase is in 3 active clinical trials (recruiting or ongoing, phases I–III) for 1 diseases. The most advanced phase is III.
Summary updated every week · data as of 10 November 2026. In Phuturdex you can follow Imiglucerase and get an email at every change or safety alert.
Sign in free →What it is and what it is used for
Cerezyme is used for the long-term treatment of patients with Gaucher disease. Gaucher disease is a rare inherited disorder, in which people do not have enough of an enzyme called acid beta-glucosidase, which normally breaks down a fatty waste product called glucosylceramide. Without the enzyme, glucosylceramide builds up in the body, typically in the liver, spleen and bone marrow, which produces the symptoms of the disease: anaemia (low red blood cell counts), tiredness, easy bruising and a tendency to bleed, an enlarged spleen and liver, and bone pain and breaks. Cerezyme is used in patients who have type 1 Gaucher disease, which does not affect the nerve cells, or type 3 Gaucher disease, which progresses slowly and affects the nerve cells. The patients must have symptoms that are not affecting the nervous system, including one or more of the following conditions:
- anaemia;
- thrombocytopenia (low blood platelet counts);
- bone disease;
- an enlarged liver or spleen.
The medicine can only be obtained with a prescription.
How it works
Gaucher disease has previously been treated using an enzyme called alglucerase, which was prepared from human placentas. Imiglucerase, the active substance in Cerezyme, is a copy of this enzyme, which is produced by a method known as ‘recombinant DNA technology’: the enzyme is made by a cell that has received a gene (DNA), which enables it to produce the enzyme. Imiglucerase replaces the missing enzyme in Gaucher disease, helping to break down glucosylceramide and stopping it building up in the body.
Approved uses in the United States (FDA)
CEREZYME is indicated for the treatment of non-central nervous system (CNS) manifestations of Type 1 or Type 3 Gaucher disease in adults and pediatric patients. […]
Source: FDA label of Cerezyme, section «Indications and Usage» (openFDA), version of 27 August 2026
Official documents
- Cerezyme: summary of product characteristics and package leaflet (EMA) · EMA update of 1 December 2025
- Cerezyme: package leaflet (AIFA, in Italian) · AIFA data of 10 November 2026
- Cerezyme: summary of product characteristics (AIFA, in Italian) · AIFA data of 10 November 2026
- Cerezyme: FDA label (DailyMed) · FDA version of 27 August 2026
Use, doses, side effects and interactions: only these official documents are authoritative.
Diseases studied
For each disease: the drug’s most advanced phase and active trials, with the reference trial on ClinicalTrials.gov.
| Disease | Most advanced phase | Active trials | Reference trial |
|---|---|---|---|
| Gaucher's disease | III | 3 | NCT07927140 |
Sites in Europe
10 sites of the active trials in 5 European countries, 0 recruiting.
- United Kingdom3
- France2
- Germany2
- Italy2
- Hungary1
Sites declared by the sponsors on ClinicalTrials.gov; region worked out by Phuturdex from the geographic point. The list of sites with city and recruitment status is in the app. See the sites →
Everything on Imiglucerase
In Phuturdex you get every trial with sponsors, countries and dates, development events, FDA and EMA approvals, patents and exclusivities, orphan designations and safety alerts, with PDF and Excel export. Free until 31 March 2027.
Open in Phuturdex →Source: Phuturdex analysis of ClinicalTrials.gov (U.S. National Library of Medicine), FDA and EMA data, updated 10 November 2026. Active trials = recruiting or ongoing, phases I–III. Diseases are those named by each trial (NLM MeSH terms). The estimated launch, when shown, is a Phuturdex calculation described on the Method page, not official data.