Pegunigalsidase alfa
- Generic Name
- Pegunigalsidase alfa
- Brand Names
- Elfabrio
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 1644392-61-9
- Unique Ingredient Identifier
- 8M7V7Q6537
- Background
Pegunigalsidase alfa (PRX-102) is a recombinant form of human α-galactosidase-A indicated for long-term enzyme replacement therapy in patients with Fabry disease, a rare genetic disorder characterized by the deficiency of alpha-galactosidase A. Unlike other forms of recombinant alpha-galactosidase A, such as agalsidase alfa and agalsidase beta, pegunigalsida...
- Indication
Pegunigalsidase alfa is indicated for long-term enzyme replacement therapy in adult patients with a confirmed diagnosis of Fabry disease (deficiency of alpha-galactosidase).
- Associated Conditions
- Fabry's Disease
- Associated Therapies
- -
Open-Label Expanded Access Treatment With Pegunigalsidase Alfa for Fabry Disease Patients
- Conditions
- First Posted Date
- 2020-09-17
- Last Posted Date
- 2024-07-31
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- Registration Number
- NCT04552691
- Locations
- 🇺🇸
University of Alabama-Birmingham, Birmingham, Alabama, United States
🇺🇸University of California Irvine, Orange, California, United States
🇺🇸Central Coas Nephrology, Salinas, California, United States
Open Label Extension of 2 mg/kg Pegunigalsidase Alfa (PRX-102) Every 4 Weeks in Adult Fabry Disease Patients
- First Posted Date
- 2018-08-03
- Last Posted Date
- 2024-10-08
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- Target Recruit Count
- 29
- Registration Number
- NCT03614234
- Locations
- 🇺🇸
Renal Disease Research Institute, LLC, Dallas, Texas, United States
🇩🇰Medical Endocrinology PE 2132, Rigshospitalet, Copenhagen, Denmark
🇺🇸UAB Medicine, Birmingham, Alabama, United States
Open Label Extension Study of 1 mg/kg Pegunigalsidase Alfa Every 2 Weeks in Patients With Fabry Disease
- First Posted Date
- 2018-06-21
- Last Posted Date
- 2024-12-19
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- Target Recruit Count
- 97
- Registration Number
- NCT03566017
- Locations
- 🇺🇸
Emory University School of Medicine, Atlanta, Georgia, United States
🇺🇸Renal Disease Research Institute, LLC - Dallas, Dallas, Texas, United States
🇺🇸O+O Alpan LLC, Fairfax, Virginia, United States
Drug Development Updates
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