Friday, July 10, 2026

Drug profile · INN

alglucosidase alfa

alglucosidase alfa (MYOZYME) is a starch hydrolytic enzyme. Route of administration: iv (infusion). Current US regulatory status: approved.

FDA: approved EMA: approved PMDA: approved Alimentary tract and metabolism (A16) A16AB07
US status approved
Patents linked 0
Pipeline programs 5
News articles 1
Drug details — alglucosidase alfa
US status
approved
Class
Alimentary tract and metabolism (A16)
Route
IV (INFUSION)
Patents
0
Programs
5
Data quality
0.84

Quick answer

alglucosidase alfa (MYOZYME) is a starch hydrolytic enzyme. Route of administration: iv (infusion). Current US regulatory status: approved.

Key facts

INN alglucosidase alfa
Brand MYOZYME
Mechanism Starch hydrolytic enzyme
Target Starch
Therapeutic class Alimentary tract and metabolism (A16)
Route IV (INFUSION)
Formulation POWDER
ATC code A16AB07

Mechanism of action

Starch hydrolytic enzyme

Primary target: Starch

Approval history

Authority Status Date
FDA approved
EMA approved
PMDA approved

Recent coverage

Pipeline programs

  1. EFC14462 Phase 3 · Sanofi-Aventis U.S · Glycogen storage disease type II
  2. Myozyme 50 mg powder for concentrate for solution for infusion Approved · Disc Medicine · Pompe disease / glycogenosis type II / acid maltase deficien
  3. Myozyme powder for concentrate for solution f... for Pompe disease Approved · Disc Medicine · Pompe disease
  4. alglucosidase alfa Approved · Sanofi Pasteur MSD · Pompe Disease (Infantile-Onset)
  5. alglucosidase alfa Approved · Sanofi Pasteur MSD · Pompe Disease

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 alglucosidase alfa?

alglucosidase alfa (MYOZYME) is a starch hydrolytic enzyme. Route of administration: iv (infusion). Current US regulatory status: approved.

What is the brand name for alglucosidase alfa?

MYOZYME is a marketed brand name for alglucosidase alfa. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of alglucosidase alfa?

alglucosidase alfa 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.