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
Burosumab for Fibroblast Growth Factor-23 Mediated Hypophosphatemia in Fibrous Dysplasia
- First Posted Date
- 2022-08-22
- Last Posted Date
- 2025-01-22
- Lead Sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
- Target Recruit Count
- 12
- Registration Number
- NCT05509595
- Locations
- 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States
Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Adult Chinese Patients With TIO
- First Posted Date
- 2022-05-03
- Last Posted Date
- 2024-07-09
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- Target Recruit Count
- 9
- Registration Number
- NCT05357573
- Locations
- 🇨🇳
Peking Union Medical College Hospital, Beijing, China
🇨🇳West China Hospital, Sichuan University, Chengdu, China
🇨🇳Shanghai Jiaotong University Affiliated Sixth People's Hospital, Shanghai, China
A Study to Describe the Lived Experience of XLH for Adolescents at End of Skeletal Growth
- Conditions
- X-Linked Hypophosphatemia
- 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
Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Adult Chinese Patients With XLH
- First Posted Date
- 2021-04-12
- Last Posted Date
- 2024-07-09
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- Target Recruit Count
- 18
- Registration Number
- NCT04842019
- Locations
- 🇨🇳
Peking Union Medical College Hospital, Beijing, China
🇨🇳Nanfang Hospital, Guangzhou, China
🇨🇳The First Medical Center of Chinese People's Liberation Army General Hospital, Beijing, China
Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Pediatric Chinese Patients With XLH
- First Posted Date
- 2021-04-12
- Last Posted Date
- 2024-07-09
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- Target Recruit Count
- 28
- Registration Number
- NCT04842032
- Locations
- 🇨🇳
Shanghai 6th Hospital, Shanghai, China
🇨🇳Guangzhou Women and Children Medical Center, Guangzhou, China
🇨🇳Peking Union Medical College Hospital, Beijing, China
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
Burosumab in Children and Adolescents With X-linked Hypophosphatemia
- First Posted Date
- 2020-06-05
- Last Posted Date
- 2020-06-05
- Lead Sponsor
- Bicetre Hospital
- Target Recruit Count
- 57
- Registration Number
- NCT04419363
- Locations
- 🇫🇷
Hospital Bicetre, Le Kremlin-Bicêtre, France
A Trial to Assess the Safety and Efficacy of KRN23 in Epidermal Nevus Syndrome (ENS)
- Conditions
- Epidermal Nevus Syndrome
- Interventions
- First Posted Date
- 2020-03-25
- Last Posted Date
- 2022-10-07
- Lead Sponsor
- University of Alabama at Birmingham
- Target Recruit Count
- 1
- Registration Number
- NCT04320316
- Locations
- 🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States
A Study of KRN23 in Adult and Pediatric Patients With X-linked Hypophosphatemic Rickets/Osteomalacia
- First Posted Date
- 2020-03-13
- Last Posted Date
- 2022-09-06
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- Target Recruit Count
- 27
- Registration Number
- NCT04308096
- Locations
- 🇯🇵
National University Corporation Osaka University, Suita, Osaka, Japan
🇯🇵The University of Tokyo Hospital, Bunkyō-Ku, Tokyo, Japan
🇯🇵Hokkaido University Hospital, Sapporo, Hokkaido, Japan
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
Drug Development Updates
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