Friday, July 10, 2026

Drug profile · INN

imiglucerase

imiglucerase (CEREZYME) is a glucocerebroside hydrolytic enzyme. Route of administration: injection. Current US regulatory status: approved.

FDA: approved EMA: approved Alimentary tract and metabolism (A16) A16AB02
US status approved
Patents linked 0
Pipeline programs 3
News articles 1
Drug details — imiglucerase
US status
approved
Class
Alimentary tract and metabolism (A16)
Route
INJECTION
Patents
0
Programs
3
Data quality
0.84

Quick answer

imiglucerase (CEREZYME) is a glucocerebroside hydrolytic enzyme. Route of administration: injection. Current US regulatory status: approved.

Key facts

INN imiglucerase
Brand CEREZYME
Mechanism Glucocerebroside hydrolytic enzyme
Target Glucocerebroside
Therapeutic class Alimentary tract and metabolism (A16)
Route INJECTION
Formulation INJECTABLE
ATC code A16AB02

Mechanism of action

Glucocerebroside hydrolytic enzyme

Primary target: Glucocerebroside

Approval history

Authority Status Date
FDA approved
EMA approved

Recent coverage

Pipeline programs

  1. EFC13738 Phase 3 · Genzyme Europe · Gaucher's disease type I; Gaucher's disease type III
  2. EFC17215 - LEAP2MONO Phase 3 · Sanofi-Aventis U.S · Gaucher's disease type III
  3. PDY13949 Phase 2 · Genzyme Europe · Gaucher disease type 3, Gaucher disease type 1

Related & competitor drugs

  1. agalsidase alfa Alimentary tract and metabolism (A16)
  2. alogliptin Alimentary tract and metabolism (A10)
  3. alogliptin benzoate Alimentary tract and metabolism (A10)
  4. aprepitant Alimentary tract and metabolism (A04)
  5. budesonide Alimentary tract and metabolism (A07)
  6. canagliflozin Alimentary tract and metabolism (A10)

Frequently asked questions

What is imiglucerase?

imiglucerase (CEREZYME) is a glucocerebroside hydrolytic enzyme. Route of administration: injection. Current US regulatory status: approved.

What is the brand name for imiglucerase?

CEREZYME is a marketed brand name for imiglucerase. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of imiglucerase?

imiglucerase has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.