Product Description
Imiglucerase is a hydrolytic lysosomal glucocerebrosidase-specific enzyme. It is an analogue of the human enzyme b-glucocerebrosidase (b-D-glucosyl-N-acylsphingosine glucohydrolase, E.C. 3.2.1.45), produced by recombinant DNA technology using mammalian cell culture (Chinese hamster ovary). (Sourced from: https://products.sanofi.us/cerezyme/cerezyme.html)
Mechanisms of Action: Glucocerebroside Hydrolyzer
Novel Mechanism: No
Modality: Coagulation Factor
Route of Administration: Intravenous
FDA Designation: None *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Belgium | Bosnia | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Indonesia | Ireland | Israel | Italy | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Netherlands | New Zealand | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela
Approved Indications: None
Known Adverse Events: None
Company: Sanofi
Company Location: PARIS I0 75008
Company CEO: Paul Hudson
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Canada, China, France, Germany, Italy, Japan, Russia, Spain, Sweden, Turkey, United Kingdom, United States
Active Clinical Trial Count: 6
Highest Development Phases
Phase 3: Gaucher Disease
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| EFC13738 | P3 |
Unknown Status |
Gaucher Disease |
2025-11-20 |
|
| ELIKIDS | P3 |
Active, not recruiting |
Gaucher Disease |
2025-11-20 |
95% |
| ELIKIDS | P3 |
Active, not recruiting |
Gaucher Disease |
2025-11-20 |
95% |
| ELIKIDS | P3 |
Active, not recruiting |
Gaucher Disease |
2025-10-09 |
|
| PDY13949 | P2 |
Unknown Status |
Gaucher Disease |
2025-09-30 |