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KRN23
KRN23 is a monoclonal antibody that inhibits fibroblast growth factor 23 (FGF23), restoring phosphate reabsorption and vitamin D metabolism in patients with X-linked hypophosphatemia.
KRN23 is a monoclonal antibody that inhibits fibroblast growth factor 23 (FGF23), restoring phosphate reabsorption and vitamin D metabolism in patients with X-linked hypophosphatemia. Used for X-linked hypophosphatemia (XLH) in children and adults.
At a glance
| Generic name | KRN23 |
|---|---|
| Also known as | Burosumab, Crysvita, burosumab, Crysvita® |
| Sponsor | Kyowa Kirin Co., Ltd. |
| Drug class | FGF23 inhibitor (monoclonal antibody) |
| Target | FGF23 (Fibroblast Growth Factor 23) |
| Modality | Small molecule |
| Therapeutic area | Endocrinology / Rare Metabolic Disorders |
| Phase | FDA-approved |
Mechanism of action
KRN23 binds to and neutralizes FGF23, a hormone that suppresses renal phosphate reabsorption and 1,25-dihydroxyvitamin D production. By blocking FGF23 activity, the drug allows the kidneys to retain phosphate and increase active vitamin D synthesis, correcting the biochemical abnormalities underlying X-linked hypophosphatemia and improving bone mineralization and growth.
Approved indications
- X-linked hypophosphatemia (XLH) in children and adults
Common side effects
- Hyperphosphatemia
- Hypercalcemia
- Injection site reactions
- Headache
- Dental abnormalities (in pediatric patients)
Key clinical trials
- X-linked Hypophosphatemia Disease Monitoring Program
- Expanded Access to Burosumab
- Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Burosumab in Patients Less Than 1 Year of Age (PHASE1, PHASE2)
- Efficacy and Safety of Burosumab Versus Oral Phosphate and Active Vitamin D Treatment in Pediatric Patients With XLH (PHASE3)
- Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Adult Chinese Patients With TIO (PHASE4)
- Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Pediatric Chinese Patients With XLH (PHASE4)
- Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Adult Chinese Patients With XLH (PHASE4)
- Open Label Study of KRN23 on Osteomalacia in Adults With X-linked Hypophosphatemia (XLH) (PHASE3)
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 |