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Crysvita (BUROSUMAB)

Ultragenyx Pharm Inc · FDA-approved approved Monoclonal antibody Quality 62/100

Burosumab-twza binds to and inhibits FGF23, restoring renal phosphate reabsorption and increasing 1,25 dihydroxy vitamin D levels.

Crysvita (Burosumab) is a small molecule modality developed by Ultragenyx Pharmaceuticals for the treatment of Familial X-linked Hypophosphatemic Vitamin D Refractory Rickets and Osteomalacia. It targets fibroblast growth factor 23, a protein involved in phosphate regulation. Crysvita was FDA-approved in 2018 and remains a patented product. Key safety considerations include monitoring of serum phosphate levels and potential effects on kidney function. It is a relatively new treatment option for these rare conditions.

At a glance

Generic nameBUROSUMAB
SponsorUltragenyx Pharm Inc
TargetFGF23
ModalityMonoclonal antibody
Therapeutic areaRare Disease
PhaseFDA-approved
First approval2018
Annual revenue700

Mechanism of action

X-linked hypophosphatemia results from excessive FGF23, which reduces phosphate reabsorption in the kidneys and decreases 1,25 dihydroxy vitamin D production. Burosumab-twza targets and neutralizes FGF23, thereby improving phosphate reabsorption and boosting 1,25 dihydroxy vitamin D levels.

Approved indications

Common side effects

Key clinical trials

Primary sources

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SourceUsed for
FDA labelMechanism, indications, dosing, boxed warnings, drug interactions
ClinicalTrials.govTrial enrolment, design, endpoints, results
SEC EDGARRevenue + earnings