BLAINJECTIONINJECTABLEPriority Review
Approved
Apr 2018
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CRYSVITA (burosumab) is a monoclonal antibody (MAB) administered via injection approved in April 2018 for rare hypophosphatemic disorders including X-linked hypophosphatemia, tumor-induced osteomalacia, epidermal nevus syndrome, and hypophosphatemic rickets. The drug works by inhibiting FGF23, a phosphate-regulating hormone, to restore normal phosphate homeostasis and mineralization. It represents the first and currently a key biologic therapy for these orphan conditions previously managed with oral phosphate supplementation and active vitamin D analogs.
$0.0BPart D
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (7)
Effective Dosing of Burosumab in XLH
Started Sep 2025
120 enrolled
X-linked Hypophosphatemia (XLH)
Anti-FGF23 (Burosumab) in Adult Patients With XLH
Started Jan 2021
36 enrolled
X-linked Hypophosphatemia
Burosumab for CSHS
Started Jul 2019
1 enrolled
Cutaneous Skeletal Hypophosphatemia Syndrome (CSHS)Epidermal Nevus Syndrome
Open Label Trial Assessing Safety and Efficacy of Burosumab (KRN23), in a Patient With ENS and Hypophosphatemic Rickets
Started Jan 2018
1 enrolled
HypophosphatemiaHypophosphatemic RicketsPain, Chronic
Efficacy and Safety of Burosumab Versus Oral Phosphate and Active Vitamin D Treatment in Pediatric Patients With XLH
Started Sep 2016
61 enrolled
X-Linked Hypophosphatemia
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.