Asfotase alfa
- Generic Name
- Asfotase alfa
- Brand Names
- Strensiq
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 1174277-80-5
- Unique Ingredient Identifier
- Z633861EIM
- Background
Asfotase alfa is a first-in-class bone-targeted enzyme replacement therapy designed to address the underlying cause of hypophosphatasia (HPP)—deficient alkaline phosphatase (ALP). Hypophosphatasia is almost always fatal when severe skeletal disease is obvious at birth. By replacing deficient ALP, treatment with Asfotase Alfa aims to improve the elevated enzy...
- Indication
Indicated for the treatment of patients with perinatal/infantile and juvenile onset hypophosphatasia (HPP).
- Associated Conditions
- Infantile-onset Hypophosphatasia, Juvenile-onset Hypophosphatasia, Perinatal-onset Hypophosphatasia
- Associated Therapies
- -
Phase 3 Study of ALXN1850 in Pediatric Participants With HPP Previously Treated With Asfotase Alfa
- First Posted Date
- 2023-10-12
- Last Posted Date
- 2024-12-10
- Lead Sponsor
- Alexion Pharmaceuticals, Inc.
- Target Recruit Count
- 40
- Registration Number
- NCT06079372
- Locations
- 🇬🇧
Research Site, Sheffield, United Kingdom
Patient Reported Outcomes in Adults With Pediatric-onset Hypophosphatasia Treated With Strensiq® (Asfotase Alfa)
- First Posted Date
- 2019-12-12
- Last Posted Date
- 2024-07-10
- Lead Sponsor
- Alexion Pharmaceuticals, Inc.
- Target Recruit Count
- 50
- Registration Number
- NCT04195763
- Locations
- 🇺🇸
Xcenda, LLC, Palm Harbor, Florida, United States
Relieving Burden of Hypophosphatasia in Adults With Functional Impairment Due to Chronic Disease
- First Posted Date
- 2019-12-06
- Last Posted Date
- 2020-06-04
- Lead Sponsor
- Alexion Pharmaceuticals, Inc.
- Registration Number
- NCT04189315
Pharmacokinetic and Dose Response Study of Asfotase Alfa in Adult Patients With Pediatric-Onset Hypophosphatasia (HPP)
- First Posted Date
- 2016-06-14
- Last Posted Date
- 2019-09-17
- Lead Sponsor
- Alexion Pharmaceuticals, Inc.
- Target Recruit Count
- 27
- Registration Number
- NCT02797821
- Locations
- 🇩🇪
University of Würzburg, Würzburg, Germany
🇺🇸Duke University Medical Center, Durham, North Carolina, United States
🇺🇸Vanderbilt Medical Center Endocrinology, Nashville, Tennessee, United States
Open-Label Study of Asfotase Alfa in Infants and Children ≤ 5 Years of Age With Hypophosphatasia (HPP)
- First Posted Date
- 2010-08-05
- Last Posted Date
- 2019-03-13
- Lead Sponsor
- Alexion Pharmaceuticals, Inc.
- Target Recruit Count
- 69
- Registration Number
- NCT01176266
- Locations
- 🇫🇷
Chu de Toulouse, Toulouse, France
🇷🇺Federal State Budgetary Institution, Moscow, Russian Federation
🇩🇪Universitätskinderklinikum Würzburg, Würzburg, Germany
Safety and Efficacy Study of Asfotase Alfa in Adolescents and Adults With Hypophosphatasia (HPP)
- First Posted Date
- 2010-07-15
- Last Posted Date
- 2019-03-13
- Lead Sponsor
- Alexion Pharmaceuticals, Inc.
- Target Recruit Count
- 19
- Registration Number
- NCT01163149
- Locations
- 🇨🇦
Health Sciences Centre Winnipeg, University of Manitoba, Winnipeg, Manitoba, Canada
🇺🇸Shriner's Hospital for Children, Saint Louis, Missouri, United States
🇺🇸Duke University Medical Center, Durham, North Carolina, United States
Drug Development Updates
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