Alglucosidase alfa
- Generic Name
- Alglucosidase alfa
- Brand Names
- Lumizyme, Myozyme
- Drug Type
- Biotech
- CAS Number
- 420784-05-0
- Unique Ingredient Identifier
- DTI67O9503
- Background
Aglucosidase alfa consists of the human enzyme acid alpha-glucosidase (GAA) which is essential for the degradation of glygogen to glucose in lysosomes. It is encoded by the most predominant of nine observed haplotypes of this gene. Aglucosidase alfa is produced by recombinant DNA technology in a Chinese hamster ovary cell line. Alglucosidase alfa degrades glycogen by catalyzing the hydrolysis of a-1,4- and a-1,6- glycosidic linkages of lysosomal glycogen. Structurally, Alglucosidase alfa is a glycoprotein with a calculated mass of 98,008 daltons for the 883 residue mature polypeptide chain, and a total mass of approximately 109,000 daltons, including carbohydrates. It is used for the treatment of Pompe disease (GAA deficiency) in infants and pediatric patients.
- Indication
For the treatment of Pompe disease (GAA deficiency) in infants and pediatric patients.
- Associated Conditions
- Glycogen Storage Disease Type II
A Study to Evaluate the Efficacy and Safety of Alglucosidase Alfa Produced at the 4000 L Scale for Pompe Disease
- First Posted Date
- 2012-02-06
- Last Posted Date
- 2015-12-08
- Lead Sponsor
- Genzyme, a Sanofi Company
- Target Recruit Count
- 113
- Registration Number
- NCT01526785
Proteus Sustained Behavior Change Study
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Device: Proteus Sustained Behavior Change system
- First Posted Date
- 2012-01-02
- Last Posted Date
- 2013-03-05
- Lead Sponsor
- Proteus Digital Health, Inc.
- Registration Number
- NCT01503008
- Locations
- 🇺🇸
Northwestern University, Chicago, Illinois, United States
🇺🇸Center for Connected Health, Partners Healthcare, Boston, Massachusetts, United States
A Study of LY2189265 in Japanese Participants With Type 2 Diabetes Mellitus
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Drug: GlinidesDrug: Biguanides (BG)Drug: Sulfonylureas (SU)
- First Posted Date
- 2011-11-09
- Last Posted Date
- 2015-01-29
- Lead Sponsor
- Eli Lilly and Company
- Target Recruit Count
- 394
- Registration Number
- NCT01468181
- Locations
- 🇯🇵
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Wakayama, Japan
Drug-drug Interaction Study
- First Posted Date
- 2011-06-27
- Last Posted Date
- 2024-07-31
- Lead Sponsor
- Amicus Therapeutics
- Target Recruit Count
- 25
- Registration Number
- NCT01380743
Long-term Safety Study of MP-513 in Patients With Type 2 Diabetes
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- First Posted Date
- 2011-02-23
- Last Posted Date
- 2015-11-18
- Lead Sponsor
- Mitsubishi Tanabe Pharma Corporation
- Target Recruit Count
- 462
- Registration Number
- NCT01301833
A Study of the Safety and Pharmacokinetics of rhGAA in Siblings With Glycogen Storage Disease Type II
- Conditions
- Glycogen Storage Disease Type IIPompe DiseaseAcid Maltase Deficiency DiseaseGlycogenosis 2
- Interventions
- First Posted Date
- 2003-01-22
- Last Posted Date
- 2014-02-05
- Lead Sponsor
- Genzyme, a Sanofi Company
- Target Recruit Count
- 2
- Registration Number
- NCT00051935
- Locations
- 🇺🇸
Saint Peter's University Hospital, New Brunswick, New Jersey, United States
Safety and Efficacy of Recombinant Human Acid Alpha-Glucosidase in the Treatment of Classical Infantile Pompe Disease
- Conditions
- Glycogenosis 2Pompe DiseaseGlycogen Storage Disease Type IIAcid Maltase Deficiency Disease
- First Posted Date
- 2001-11-01
- Last Posted Date
- 2014-11-13
- Lead Sponsor
- Genzyme, a Sanofi Company
- Target Recruit Count
- 8
- Registration Number
- NCT00025896
- Locations
- 🇺🇸
Duke University Medical Center, Durham, North Carolina, United States
Drug Development Updates
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