Burosumab
- Generic Name
- Burosumab
- Brand Names
- Crysvita
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 1610833-03-8
- Unique Ingredient Identifier
- G9WJT6RD29
- Background
Burosumab (KRN23) is an entirely human monoclonal IgG1 antibody that binds excess fibroblast growth factor 23 (FGF23) and has been successfully tested in clinical trials in children with X-linked hypophosphatemic rickets .
The U.S. Food and Drug Administration approved Crysvita (burosumab) in April 2018. This is the first drug approved to treat adults and children ages 1 year and older with X-linked hypophosphatemia (XLH), which is a rare, inherited form of rickets. X-linked hypophosphatemia causes low circulating levels of phosphorus in the blood. It causes impaired bone growth and development in children and adolescents and issues with bone mineralization throughout a patient’s life .
XLH is a serious disease which affects about 3,000 children and 12,000 adults in the United States. Most children with XLH suffer from bowed or bent legs, short stature, bone pain and severe dental pain. Some adults with this condition suffer from persistent, unrelenting discomfort and complications, such as joint pain, impaired mobility, tooth abscesses and hearing loss .
- Indication
This drug is indicated for the treatment of X-linked hypophosphatemia with radiological evidence of bone disease in children of 1 year of age and older and adolescents with growing skeletons .
- Associated Conditions
- Hypophosphatemia, X-Linked Hypophosphatemia
- Associated Therapies
- -
Burosumab for Fibroblast Growth Factor-23 Mediated Hypophosphatemia in Fibrous Dysplasia
- First Posted Date
- 2022-08-22
- Last Posted Date
- 2024-08-06
- Target Recruit Count
- 12
- Registration Number
- NCT05509595
- Locations
- 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States
A Study to Describe the Lived Experience of XLH for Adolescents at End of Skeletal Growth
- Conditions
- First Posted Date
- 2022-01-06
- Last Posted Date
- 2024-06-20
- Lead Sponsor
- Kyowa Kirin Pharmaceutical Development Ltd
- Target Recruit Count
- 25
- Registration Number
- NCT05181839
- Locations
- 🇫🇷
APHP Paris - Assistance Publique Hopitaux de Paris, Paris, France
🇪🇸Hospital General Universitario Santa Lucía, Cartagena, Murcia, Spain
🇪🇸Hospital Universitario Virgen a de las Nieves, Granada, Spain
Anti-FGF23 (Burosumab) in Adult Patients With XLH
- First Posted Date
- 2021-01-05
- Last Posted Date
- 2023-05-03
- Lead Sponsor
- Wuerzburg University Hospital
- Target Recruit Count
- 36
- Registration Number
- NCT04695860
- Locations
- 🇩🇪
Clinical Trial Unit, Orthopedic Department, Wuerzburg University, Würzburg, Germany
Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Burosumab in Patients Less Than 1 Year of Age
- First Posted Date
- 2019-12-06
- Last Posted Date
- 2024-11-07
- Lead Sponsor
- Kyowa Kirin Pharmaceutical Development Ltd
- Target Recruit Count
- 16
- Registration Number
- NCT04188964
- Locations
- 🇦🇹
Kepler Universitaetsklinikum GmbH, Linz, Austria
🇮🇹Ospedale Pediatrico Bambino Gesù, Rome, Italy
🇫🇷Centre de reference des maladies renales rares-Hospices Civils de Lyon-Hopital Femme Mere Enfant, Lyon, France
Burosumab for CSHS
- Conditions
- Interventions
- First Posted Date
- 2019-06-21
- Last Posted Date
- 2022-03-07
- Lead Sponsor
- Laura Tosi
- Target Recruit Count
- 1
- Registration Number
- NCT03993821
- Locations
- 🇺🇸
Children's National Hospital, Washington, District of Columbia, United States
Study of the Anti-FGF23 Antibody, Burosumab, in Adults With XLH
- First Posted Date
- 2019-04-18
- Last Posted Date
- 2022-05-20
- Lead Sponsor
- Kyowa Kirin Pharmaceutical Development Ltd
- Target Recruit Count
- 35
- Registration Number
- NCT03920072
- Locations
- 🇮🇹
Azienda ospedaliera universitaria Careggi, Florence, Italy
🇮🇪St. Vincent's University Hospital, Dublin, Ireland
🇫🇷Hopital Lariboisiere, Paris, France
Expanded Access to Burosumab
- First Posted Date
- 2018-12-13
- Last Posted Date
- 2024-09-05
- Lead Sponsor
- Ultragenyx Pharmaceutical Inc
- Registration Number
- NCT03775187
Drug Development Updates
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