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Cerezyme® / Imiglucerase
Cerezyme® / Imiglucerase is a Enzyme replacement therapy Small molecule drug developed by Sanofi. It is currently FDA-approved for Gaucher disease type 1, Gaucher disease type 3.
Imiglucerase is a recombinant glucocerebrosidase enzyme that breaks down glucocerebroside, a lipid that accumulates in Gaucher disease.
Cerezyme (Imiglucerase) is a medication used to treat Gaucher Disease, Type 1, and other related conditions such as Glucocerebrosidase Deficiency Disease and Glucosylceramide Beta-Glucosidase Deficiency Disease. It works by replacing the deficient enzyme glucocerebrosidase in patients with these conditions.
At a glance
| Generic name | Cerezyme® / Imiglucerase |
|---|---|
| Sponsor | Sanofi |
| Drug class | Enzyme replacement therapy |
| Target | Glucocerebrosidase (β-glucosidase) |
| Modality | Small molecule |
| Therapeutic area | Rare genetic disease / Lysosomal storage disorder |
| Phase | FDA-approved |
Mechanism of action
Gaucher disease is a lysosomal storage disorder caused by deficiency of the enzyme glucocerebrosidase (also called β-glucosidase), leading to accumulation of glucocerebroside in macrophages and other cells. Imiglucerase is a recombinant human glucocerebrosidase produced in mammalian cell culture that replaces the deficient enzyme, allowing degradation of accumulated substrate and reduction of pathological lipid burden in affected tissues.
Approved indications
- Gaucher disease type 1
- Gaucher disease type 3
Common side effects
- Infusion-related reactions
- Fatigue
- Headache
- Nausea
- Dizziness
- Antibody formation
Key clinical trials
- Blood-Brain-Barrier Disruption With Cerezyme in Patient's With Parkinson's Disease (NA)
- Study to Evaluate the Efficacy and Safety of Venglustat in Adult and Pediatric Patients With Gaucher Disease Type 3 (PHASE3)
- Study to Evaluate Efficacy and Safety of Imiglucerase Treatment in Chinese Patients With Gaucher Disease Type Ⅲ (PHASE4)
- Eliglustat on Gaucher Disease Type IIIB (NA)
- Study of the Effect of Velaglucerase Alfa (VPRIV®) on Bone-related Pathology in Treatment-naïve Participants With Type 1 Gaucher Disease (PHASE4)
- A Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) Enzyme Replacement Therapy in Gaucher Disease (PHASE3)
- Open-Label Extension Study Evaluating Long Term Safety in Patients With Type 1 Gaucher Disease Receiving DRX008A (ERT) (PHASE1, PHASE2)
- An Open-Label Extension Study of GA-GCB ERT in Patients With Type 1 Gaucher Disease (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Cerezyme® / Imiglucerase CI brief — competitive landscape report
- Cerezyme® / Imiglucerase updates RSS · CI watch RSS
- Sanofi portfolio CI
Frequently asked questions about Cerezyme® / Imiglucerase
What is Cerezyme® / Imiglucerase?
How does Cerezyme® / Imiglucerase work?
What is Cerezyme® / Imiglucerase used for?
Who makes Cerezyme® / Imiglucerase?
What drug class is Cerezyme® / Imiglucerase in?
What development phase is Cerezyme® / Imiglucerase in?
What are the side effects of Cerezyme® / Imiglucerase?
What does Cerezyme® / Imiglucerase target?
Related
- Drug class: All Enzyme replacement therapy drugs
- Target: All drugs targeting Glucocerebrosidase (β-glucosidase)
- Manufacturer: Sanofi — full pipeline
- Therapeutic area: All drugs in Rare genetic disease / Lysosomal storage disorder
- Indication: Drugs for Gaucher disease type 1
- Indication: Drugs for Gaucher disease type 3
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing