CEREZYME

(Imiglucerase)

Phase 3Protein / enzyme

GGenzyme, a Sanofi Company

CEREZYME is one of 25 small molecule programs targeting Gaucher disease type 1. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Gaucher Disease Type 1Active, not recruiting

Gaucher DiseaseActive, not recruiting

Gaucher's Disease Type IIIActive, not recruiting

Gaucher Disease Type 1Phase 2

Active, not recruiting

Gaucher DiseasePhase 3

Active, not recruiting

Gaucher's Disease Type IIIPhase 3

Active, not recruiting

Competition

Competitive Landscape

36 competitors in Gaucher Disease

#DrugCompanyPhaseTrials

Busulfex

Akero Therapeutics

Approved

—2

Cytoxan

BBaxter Healthcare Corporation

Opfolda

2 4

Aquasol E

NNational Eye Institute (NEI)

Phase 3

1 5

ELELYSO

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

3 6

Cerdelga

GGenzyme, a Sanofi Company

Phase 3

4 7

Cerezyme

Sanofi

Approved

4 8

CEREZYME

GGenzyme, a Sanofi Company

Phase 3

3 9

Gene Therapy

CCapsida Biotherapeutics, Inc.

Phase 3

1 10

Elelyso

SShaare Zedek Medical Center

Approved

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Gaucher's Disease Type III

NCT05222906

Phase 2Active, not recruiting

Gaucher Disease Type 1

NCT02843035

Clinical

Trials by Indication[1]

Gaucher Disease3 trials

Validating a New Severity Score System for Adults With Type 1 Gaucher Disease (GD1)

Completed·UUniversity Research Foundation for Lysosomal Storage Diseases, Inc.··NCT01136304·173 enrolled

Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) ERT Compared With Imiglucerase in Type I Gaucher Disease

Completed· Takeda logo

Takeda·Phase 3·NCT00553631·34 enrolled

A Study of Eliglustat Tartrate (Genz-112638) in Patients With Gaucher Disease Who Have Reached Therapeutic Goals With Enzyme Replacement Therapy (ENCORE)

Completed· Sanofi logo

Sanofi·Phase 3·NCT00943111·160 enrolled

Gaucher's Disease Type III1 trial

A Phase 3, Multicenter, Multinational, Randomized, Double-blind, Double-dummy, Active-comparator Study to Evaluate the Efficacy and Safety of Venglustat in Adult and Pediatric Patients With Gaucher Disease Type 3 (GD3) Who Have Reached Therapeutic Goals With Enzyme Replacement Therapy (ERT)

Active, not recruiting· Sanofi logo

Sanofi·Phase 3·NCT05222906·43 enrolled

Gaucher disease type 11 trial

A 4-part, Open-label, Multicenter, Multinational Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamic, and Exploratory Efficacy of Venglustat in Combination With Cerezyme in Adult Patients With Gaucher Disease Type 3 With Venglustat Monotherapy Extension

Active, not recruiting· Sanofi logo

Sanofi·Phase 2·NCT02843035·12 enrolled

Regulatory

FDA Approval Timeline[4]

May 23, 1994

CEREZYME

BLA BLA020367

Sources

References

[1]
ClinicalTrials.gov — 5 trial records for Imiglucerase. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Imiglucerase compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Imiglucerase. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA020367). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Genzyme, a Sanofi Company company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Protein / enzyme[2]
Highest Phase: Phase 3[1]
Company: GGenzyme, a Sanofi Company

CEREZYME

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Gaucher Disease3 trials

Gaucher's Disease Type III1 trial

Gaucher disease type 11 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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