Drug

Burosumab

Approved · EMA

Emerging researchLate-stage development

Also known as Crysvita.

RxNorm2043855UNIIG9WJT6RD29

Research papers

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 2 Study of Burosumab for Fibroblast Growth Factor-23 Mediated Hypophosphatemia in Fibrous Dysplasia

Clinical trial2026-02-02Results posted · ClinicalTrials.gov

A Randomized, Open-Label, Phase 3 Study to Assess the Efficacy and Safety of KRN23 Versus Oral Phosphate and Active Vitamin D Treatment in Pediatric Patients With X Linked Hypophosphatemia (XLH)

Clinical trial2024-08-29Results posted · ClinicalTrials.gov

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study With Open-Label Extension to Assess the Efficacy and Safety of KRN23 in Adults With X-linked Hypophosphatemia (XLH)

Clinical trial2024-06-18Results posted · ClinicalTrials.gov

An Open-Label, Single-Arm, Phase 3 Study to Evaluate the Effects of KRN23 on Osteomalacia in Adults With X-linked Hypophosphatemia (XLH)

Clinical trial2024-06-18Results posted · ClinicalTrials.gov

A Phase 2 Open-Label Trial to Assess the Efficacy and Safety of KRN23, an Antibody to FGF23, in Subjects With Tumor-Induced Osteomalacia (TIO) or Epidermal Nevus Syndrome (ENS)-Associated Osteomalacia

Clinical trial2024-05-06Results posted · ClinicalTrials.gov

A Randomized, Open-Label, Dose Finding, Phase 2 Study to Assess the Pharmacodynamics and Safety of the Anti-FGF23 Antibody, KRN23, in Pediatric Patients With X-linked Hypophosphatemia (XLH)

Clinical trial2024-05-06Results posted · ClinicalTrials.gov

An Open-Label, Phase 2 Study to Assess the Safety, Pharmacodynamics, and Efficacy of KRN23 in Children From 1 to 4 Years Old With X-linked Hypophosphatemia (XLH)

Clinical trial2024-05-06Results posted · ClinicalTrials.gov

A Phase 1/2, Open-label, Multicenter, Non-randomized Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Burosumab in Pediatric Patients From Birth to Less Than 1 Year of Age With X-linked Hypophosphatemia (XLH)

Clinical trial2024-03-06Completed · ClinicalTrials.gov

Examining the Effect of Burosumab on Muscle Function Using MR Spectroscopy

Clinical trial2023-08-24Results posted · ClinicalTrials.gov

Continued Beneficial Effects of Burosumab in Adults with X-Linked Hypophosphatemia: Results from a 24-Week Treatment Continuation Period After a 24-Week Double-Blind Placebo-Controlled Period.

Research2019-06-04Calcified tissue international

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial Evaluating the Efficacy of Burosumab, an Anti-FGF23 Antibody, in Adults With X-Linked Hypophosphatemia: Week 24 Primary Analysis.

Research2018-06-26Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research

Approval: Crysvita (EMA)

Regulatory2018-02-19EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Burosumab

Aliases & brands

Crysvita

RxNorm CUI

2043855

UNII

G9WJT6RD29

Regulatory jurisdictions

ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2018-02-19

Latest approval

2018-02-19

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2018-02-19Approval

Approval: Crysvita (EMA)

Indication: Crysvita is indicated for the treatment of X-linked hypophosphataemia, in children and adolescents aged 1 to 17 years with radiographic evidence of bone disease, and in adults.… Show full indication

Crysvita is indicated for the treatment of X-linked hypophosphataemia, in children and adolescents aged 1 to 17 years with radiographic evidence of bone disease, and in adults. Crysvita is indicated for the treatment of FGF23-related hypophosphataemia in tumour-induced osteomalacia associated with phosphaturic mesenchymal tumours that cannot be curatively resected or localised in children and adolescents aged 1 to 17 years and in adults.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.