Last reviewed 2026-04-20 · How we verify

Cerezyme (IMIGLUCERASE)

Cerezyme replaces the deficient enzyme in patients with Gaucher disease, allowing for the breakdown of glucocerebroside.

Cerezyme (Imiglucerase) is a hydrolytic lysosomal glucocerebroside-specific enzyme developed by Genzyme, currently owned by the same company. It is a small molecule modality approved by the FDA in 1994 for the treatment of glucosylceramide beta-glucosidase deficiency. Cerezyme works by replacing the deficient enzyme in patients with Gaucher disease, allowing for the breakdown of glucocerebroside. The commercial status of Cerezyme is patented, and it is not yet available as a generic. Key safety considerations include monitoring for infusion reactions and hypersensitivity.

At a glance

Mechanism of action

Gaucher disease is characterized by deficiency of -glucocerebrosidase activity, which results in accumulation of glucocerebroside in various tissues including liver, spleen, and bone marrow. The mannose sugars on imiglucerase mediate binding to and internalization by cells including macrophages. Cerezyme catalyzes the hydrolysis of glucocerebroside to glucose and ceramide.

Approved indications

• Glucosylceramide beta-glucosidase deficiency

Boxed warnings

• WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS Patients treated with enzyme replacement therapies have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. Initiate CEREZYME in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue CEREZYME and immediately initiate appropriate medical treatment, including use of epinephrine. Inform patients of the symptoms of life-threatening hypersensitivity reactions, including anaphylaxis and to seek immediate medical care should symptoms occur [see Warnings and Precautions (5.1) ] . WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS See full prescribing information for complete boxed warning . Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. ( 5.1 ) Initiate CEREZYME in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment. ( 5.1 ) If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue CEREZYME and immediately initiate appropriate medical treatment, including use of epinephrine. ( 5.1 )

Common side effects

• Hypersensitivity
• Increased elimination half-life

Key clinical trials

• Genetic Studies of Lysosomal Storage Disorders
• Blood-Brain-Barrier Disruption With Cerezyme in Patient's With Parkinson's Disease (NA)
• Phase 1/2a Clinical Trial of PR001 (LY3884961) in Patients With Parkinson's Disease With at Least One GBA1 Mutation (PROPEL) (PHASE1,PHASE2)
• Positron Emission Tomography (PET) Imaging in People With Gaucher Mutations
• MR-guided Focused Ultrasound Plus GCase (NA)
• Safety and Efficacy of Eliglustat With or Without Imiglucerase in Pediatric Patients With Gaucher Disease (GD) Type 1 and Type 3 (PHASE3)
• International Collaborative Gaucher Group (ICGG) Gaucher Disease Registry & Pregnancy Sub-registry
• Genotypic Influences on Network Progression in Parkinson's Disease

Patents

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Cerezyme CI brief — competitive landscape report
• Cerezyme updates RSS · CI watch RSS
• Sanofi portfolio CI