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CRYSVITA (BUROSUMAB-TWZA)
CRYSVITA (generic name: BUROSUMAB-TWZA) is a drug developed by KYOWA KIRIN. It is currently FDA-approved for Familial x-linked hypophosphatemic vitamin D refractory rickets, Osteomalacia.
Burosumab is a monoclonal antibody that inhibits fibroblast growth factor 23, a protein involved in bone mineralization. It is being studied as a potential treatment for conditions such as X-linked Hypophosphatemia (XLH), Tumor-Induced Osteomalacia, and Craniosynostoses.
At a glance
| Generic name | BUROSUMAB-TWZA |
|---|---|
| Sponsor | KYOWA KIRIN |
| Target | Fibroblast growth factor 23 |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
- Familial x-linked hypophosphatemic vitamin D refractory rickets
- Osteomalacia
Common side effects
- Injection site reactions
- Rash
- Injection site rash
- Injection site urticaria
- Urticaria
Key clinical trials
- A Phase 2 Study of Burosumab for Fibroblast Growth Factor-23 Mediated Hypophosphatemia in Fibrous Dysplasia (Phase 2)
- NCT03775187 (N/A)
- 12-months of Treatment With Burosumab in Children and Adolescents With X-linked Hypophosphatemia: a Prospective Longitudinal Cohort Study (Phase 4)
- A Retrospective Observational Study of the Effect of Dosing Regimen of Burosumab on Biochemical Control of Serum Phosphate Levels in Patients With X-linked Hypophosphataemia (XLH) (N/A)
- A Phase 3b Open-label Study of the Anti-FGF23 Antibody, Burosumab (KRN23) in Adult Patients With X-linked Hypophosphatemia (XLH) (Phase 3)
- 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) (Phase 3)
- An Open-label, Multi-center, Single-cohort, Post-marketing Phase 4 Study to Evaluate the Efficacy, Pharmacodynamics, and Safety of the Anti-FGF23 Antibody, KRN23, in Adult Chinese Patients With X-link (Phase 4)
- An Open Label Trial to Assess the Safety and Efficacy of Burosumab in a Single Patient With Cutaneous Skeletal Hypophosphatemia Syndrome (CSHS) (EARLY/Phase 1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- CRYSVITA CI brief — competitive landscape report
- CRYSVITA updates RSS · CI watch RSS
- KYOWA KIRIN portfolio CI
Frequently asked questions about CRYSVITA
What is CRYSVITA?
What is CRYSVITA used for?
Who makes CRYSVITA?
What is the generic name of CRYSVITA?
What development phase is CRYSVITA in?
What are the side effects of CRYSVITA?
What does CRYSVITA target?
Related
- Target: All drugs targeting Fibroblast growth factor 23
- Manufacturer: KYOWA KIRIN — full pipeline
- Therapeutic area: All drugs in Other
- Indication: Drugs for Familial x-linked hypophosphatemic vitamin D refractory rickets
- Indication: Drugs for Osteomalacia
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing