Burosumab
- Generic Name
- Burosumab
- Brand Names
- Crysvita
- Drug Type
- Biotech
- 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
Examining the Effect of Burosumab on Muscle Function
- Conditions
- X-linked Hypophosphatemia
- Interventions
- First Posted Date
- 2019-10-31
- Last Posted Date
- 2023-08-24
- Lead Sponsor
- Yale University
- Target Recruit Count
- 10
- Registration Number
- NCT04146935
- Locations
- 🇺🇸
Yale University School of Medicine, New Haven, Connecticut, United States
Burosumab for CSHS
- Conditions
- Epidermal Nevus SyndromeCutaneous Skeletal Hypophosphatemia Syndrome (CSHS)
- 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
- Conditions
- X-linked HypophosphatemiaTumor-Induced Osteomalacia
- First Posted Date
- 2018-12-13
- Last Posted Date
- 2025-03-05
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- Registration Number
- NCT03775187
A Study of KRN23 in Pediatric Patients With X-linked Hypophosphatemic Rickets/Osteomalacia
- First Posted Date
- 2017-07-28
- Last Posted Date
- 2022-09-06
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- Target Recruit Count
- 16
- Registration Number
- NCT03233126
- Locations
- 🇯🇵
Kanagawa Prefectural Hospital Organization Kanagawa Children's Medical Center, Yokohama, Kanagwa, Japan
🇯🇵Osaka Hospital, Japan Community Healthcare Organization (JCHO), Ōsaka, Osaka, Japan
🇯🇵Okayama Saiseikai General Hospital Outpatient Center, Okayama, Japan
A Study of KRN23 in Subjects With Tumor-Induced Osteomalacia or Epidermal Nevus Syndrome
- Conditions
- Tumor-Induced Osteomalacia or Epidermal Nevus Syndrome
- Interventions
- First Posted Date
- 2016-03-30
- Last Posted Date
- 2022-09-06
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- Target Recruit Count
- 14
- Registration Number
- NCT02722798
A Study of KRN23 in Subjects With X-linked Hypophosphatemic Rickets/Osteomalacia
- First Posted Date
- 2014-07-04
- Last Posted Date
- 2017-03-03
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- Target Recruit Count
- 15
- Registration Number
- NCT02181764
An Extension Study of KRN23 in Adults With X-Linked Hypophosphatemia
- First Posted Date
- 2012-04-05
- Last Posted Date
- 2024-06-18
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- Target Recruit Count
- 23
- Registration Number
- NCT01571596
- Locations
- 🇺🇸
University of Texas Health Science Center at Houston, Houston, Texas, United States
🇺🇸Duke Clinical Research Unit, Durham, North Carolina, United States
🇺🇸University of California San Francisco, San Francisco, California, United States
A Repeated Study of KRN23 in Adults With X-Linked Hypophosphatemia
- First Posted Date
- 2011-04-22
- Last Posted Date
- 2024-06-18
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- Target Recruit Count
- 29
- Registration Number
- NCT01340482
- Locations
- 🇺🇸
University of California, San Francisco Medical Center, San Francisco, California, United States
🇺🇸Clinical Research Center, Indiana University School of Medicine, Indianapolis, Indiana, United States
🇺🇸Yale University School of Medicine, New Haven, Connecticut, United States
A Study of KRN23 in X-linked Hypophosphatemia
- First Posted Date
- 2009-01-28
- Last Posted Date
- 2024-06-17
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- Target Recruit Count
- 42
- Registration Number
- NCT00830674
- Locations
- 🇺🇸
Yale University School of Medicine, New Haven, Connecticut, United States
🇺🇸Duke Clinical Research Unit, Durham, North Carolina, United States
🇺🇸General Clinical Research Center, Indiana University School of Medicine, Indianapolis, Indiana, United States
Drug Development Updates
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