BLAINJECTIONINJECTABLEPriority Review
Approved
May 1994
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
10
Data completeness
5/8 — Partial
Priority Review
CEREZYME (imiglucerase) by Sanofi is β-glucocerebrosidase activity, which results in accumulation of glucocerebroside in various tissues including liver, spleen, and bone marrow. First approved in 1994.
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CEREZYME (imiglucerase) is a recombinant human glucocerebrosidase enzyme replacement therapy approved in 1994 for Gaucher disease, a rare lysosomal storage disorder. It works by catalyzing the hydrolysis of glucocerebroside to glucose and ceramide, reducing pathogenic accumulation in liver, spleen, and bone marrow. The enzyme is administered intravenously and utilizes mannose-mediated uptake by macrophages.
$0.015BPart D
LOE ApproachingStable
The product is approaching loss of exclusivity with modest spending ($15M in 2023 Part D claims), indicating a mature, specialized rare disease franchise with limited growth trajectory for commercial teams.
Mechanism of Action
β-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…
Pharmacologic Class:
Hydrolytic Lysosomal Glucocerebroside-specific Enzyme
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (10)
Study to Evaluate Efficacy and Safety of Imiglucerase Treatment in Chinese Patients With Gaucher Disease Type Ⅲ
Started Mar 2021
12 enrolled
Gaucher's Disease
Blood-Brain-Barrier Disruption With Cerezyme in Patient's With Parkinson's Disease
Started Jul 2020
4 enrolled
Parkinson Disease
A Phase I Study to Compare Abcertin and EU-sourced Cerezyme® in Healthy Volunteers
Started Jan 2020
42 enrolled
Gaucher Disease
Safety and Efficacy of Eliglustat With or Without Imiglucerase in Pediatric Patients With Gaucher Disease (GD) Type 1 and Type 3
Started Apr 2018
57 enrolled
Gaucher's Disease Type IGaucher's Disease Type III
Venglustat in Combination With Cerezyme in Adult Patients With Gaucher Disease Type 3 With Venglustat Monotherapy Extension
Started Jan 2017
12 enrolled
Gaucher Disease Type 1Gaucher Disease Type 3
Worked on CEREZYME at Sanofi? Share your interview experience or compensation data (+7 days Pro)
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.