Burosumab

BIOLOGICAL14 trials

Sponsors

Kyowa Kirin, Inc., Redwood Dermatology Sciences, Kyowa Kirin Co., Ltd., Kyowa Kirin Pharmaceutical Development Ltd, Laura Tosi

Conditions

Cutaneous Skeletal Hypophosphatemia Syndrome (CSHS)Epidermal Nevus SyndromeEpidermal Nevus Syndrome (ENS)Fibrous Dysplasia Of BoneHypophosphatemiaHypophosphatemic RicketsPain, ChronicTumor Induced Osteomalacia (TIO)

Early Phase 1

Burosumab for CSHS

CompletedNCT03993821

Laura TosiCutaneous Skeletal Hypophosphatemia Syndrome (CSHS), Epidermal Nevus Syndrome

Start: 2019-07-01End: 2026-03-03Updated: 2026-07-30

Phase 1

Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Burosumab in Patients Less Than 1 Year of Age

CompletedNCT04188964

Kyowa Kirin Pharmaceutical Development LtdX-linked Hypophosphatemia (XLH)

Start: 2020-02-26End: 2024-03-06Updated: 2024-11-07

Phase 2

Study of KRN23 (Burosumab), a Recombinant Fully Human Monoclonal Antibody Against Fibroblast Growth Factor 23 (FGF23), in Pediatric Subjects With X-linked Hypophosphatemia (XLH)

CompletedNCT02163577

Kyowa Kirin, Inc.X-linked Hypophosphatemia

Start: 2014-07-02End: 2018-10-30Updated: 2024-05-06

Study of Burosumab (KRN23) in Adults With Tumor-Induced Osteomalacia (TIO) or Epidermal Nevus Syndrome (ENS)

CompletedNCT02304367

Kyowa Kirin, Inc.Epidermal Nevus Syndrome (ENS), Tumor Induced Osteomalacia (TIO)

Start: 2015-03-24End: 2021-01-21Updated: 2024-05-06

Study of the Safety, Pharmacodynamics (PD) and Efficacy of KRN23 in Children From 1 to 4 Years Old With X-linked Hypophosphatemia (XLH)

CompletedNCT02750618

Kyowa Kirin, Inc.X-Linked Hypophosphatemia

Start: 2016-05-05End: 2019-09-10Updated: 2024-05-06

Burosumab for Fibroblast Growth Factor-23 Mediated Hypophosphatemia in Fibrous Dysplasia

CompletedNCT05509595

National Institute of Dental and Craniofacial Research (NIDCR)Fibrous Dysplasia Of Bone

Start: 2022-12-07End: 2024-11-18Updated: 2026-02-02

Phase 3

Study of KRN23 in Adults With X-linked Hypophosphatemia (XLH)

CompletedNCT02526160

Kyowa Kirin, Inc.X-linked Hypophosphatemia

Start: 2015-10-22End: 2018-12-06Updated: 2024-06-18

Open Label Study of KRN23 on Osteomalacia in Adults With X-linked Hypophosphatemia (XLH)

CompletedNCT02537431

Kyowa Kirin, Inc.X-linked Hypophosphatemia

Start: 2015-12-23End: 2018-12-13Updated: 2024-06-18

Efficacy and Safety of Burosumab Versus Oral Phosphate and Active Vitamin D Treatment in Pediatric Patients With XLH

CompletedNCT02915705

Kyowa Kirin, Inc.X-Linked Hypophosphatemia

Start: 2016-09-08End: 2019-07-15Updated: 2024-08-29

Open Label Trial Assessing Safety and Efficacy of Burosumab (KRN23), in a Patient With ENS and Hypophosphatemic Rickets

CompletedNCT03581591

Redwood Dermatology SciencesHypophosphatemia, Hypophosphatemic Rickets, Pain, Chronic

Start: 2018-01-31End: 2019-12-06Updated: 2020-01-18

Study of the Anti-FGF23 Antibody, Burosumab, in Adults With XLH

CompletedNCT03920072

Kyowa Kirin Pharmaceutical Development LtdX-linked Hypophosphatemia

Start: 2019-03-07End: 2022-04-07Updated: 2022-05-20

Anti-FGF23 (Burosumab) in Adult Patients With XLH

CompletedNCT04695860

Wuerzburg University HospitalX-linked Hypophosphatemia

Start: 2021-01-07End: 2023-03-17Updated: 2023-05-03

Unknown Phase

Expanded Access to Burosumab

Kyowa Kirin Co., Ltd.Tumor-Induced Osteomalacia, X-linked Hypophosphatemia

Updated: 2025-03-05

A Study to Describe the Lived Experience of XLH for Adolescents at End of Skeletal Growth

CompletedNCT05181839

Kyowa Kirin Pharmaceutical Development LtdX-Linked Hypophosphatemia

Start: 2021-11-24End: 2024-05-22Updated: 2026-07-13

Related Papers

The lived experience of adolescents with X-linked hypophosphataemia treated with burosumab at end of skeletal growth: a mixed-methods analysis.

2026-03-20

Population Pharmacokinetics and Pharmacokinetic/Pharmacodynamic Analysis of Burosumab in Patients with X-Linked Hypophosphatemia Aged < 12 Months

2025-02-18

Nephrocalcinosis and kidney function in children and adults with X-linked hypophosphatemia: baseline results from a large longitudinal study

Journal of Bone and Mineral Research2024-08-1615 citations

Burosumab Improves Patient-Reported Outcomes in Adults With Tumor-Induced Osteomalacia: Mixed-Methods Analysis

Journal of Bone and Mineral Research2023-08-1415 citations

Benefit of burosumab in adults with X-linked hypophosphataemia (XLH) is maintained with long-term treatment

RMD Open2023-02-0133 citations

Self-Administration of Burosumab in Children and Adults with X-Linked Hypophosphataemia in Two Open-Label, Single-Arm Clinical Studies.

2023-01-316 citations

OR13-1 Long-Term Burosumab Therapy Provides Sustained Benefit in Patients with Tumor-Induced Osteomalacia: End of Study Findings From the Pivotal Phase 2 Study

Journal of the Endocrine Society2022-11-01

Efficacy of Burosumab in Adults with X-linked Hypophosphatemia (XLH): A Post Hoc Subgroup Analysis of a Randomized Double-Blind Placebo-Controlled Phase 3 Study.

2022-08-0415 citations

Sustained Efficacy and Safety of Burosumab, a Monoclonal Antibody to FGF23, in Children With X-Linked Hypophosphatemia

The Journal of Clinical Endocrinology & Metabolism2021-10-1280 citations

Burosumab treatment in a child with cutaneous skeletal hypophosphatemia syndrome: A case report.

2021-10-0114 citations

Burosumab treatment in adults with X-linked hypophosphataemia: 96-week patient-reported outcomes and ambulatory function from a randomised phase 3 trial and open-label extension

RMD Open2021-09-0166 citations

Burosumab Provides Sustained Improvement in Phosphorus Homeostasis and Heals Rickets in Children Aged 1 to 4 Years With X-Linked Hypophosphatemia (XLH)

Journal of the Endocrine Society2021-05-01

Patient-Reported Outcomes from a Randomized, Active-Controlled, Open-Label, Phase 3 Trial of Burosumab Versus Conventional Therapy in Children with X-Linked Hypophosphatemia.

2021-01-2335 citations

OR29-06 Burosumab Improves Biochemical, Skeletal, and Clinical Features of Tumor-Induced Osteomalacia Syndrome

Journal of the Endocrine Society2020-04-013 citations

SUN-356 Burosumab Resulted in Greater Clinical Improvements Compared with Higher-dose Conventional Therapy in Children with X-linked Hypophosphatemia (XLH)

Journal of the Endocrine Society2020-04-01

OR29-01 Long-Term Safety in Adults with X-Linked Hypophosphatemia (XLH) Treated with Burosumab, a Fully Human Monoclonal Antibody Against FGF23: Final Results of a Phase 3 Trial

Journal of the Endocrine Society2020-04-01

Burosumab versus conventional therapy in children with X-linked hypophosphataemia: a randomised, active-controlled, open-label, phase 3 trial.

2019-05-16235 citations

OR13-1 Burosumab Improves the Biochemical, Skeletal, and Clinical Symptoms of Tumor-Induced Osteomalacia Syndrome

Journal of the Endocrine Society2019-04-0111 citations

OR13-2 Burosumab Resulted in Greater Improvement in Rickets Than Conventional Therapy in Children with X-Linked Hypophosphatemia (XLH)

Journal of the Endocrine Society2019-04-01

Efficacy and safety of burosumab in children aged 1-4 years with X-linked hypophosphataemia: a multicentre, open-label, phase 2 trial.

2019-01-09122 citations

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