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Burosumab · 1 trial · 3 indications
| Arm | Type | Description |
|---|---|---|
| Primary; open label | EXPERIMENTAL | Injection of Burosumab every two to three weeks based on Serum Phosphorus level of subject. Initial dose to be 0.3 mg/kg. Subsequent dosing will be titrated up or down depending on Serum Phosphorus level for that time period. |
| Name | Type | Description |
|---|---|---|
| Burosumab | BIOLOGICAL | recombinant human IgG1 monoclonal antibody to fibroblast growth factor 23) |
Inclusion Criteria: 1. Patient has confirmed ENS by physician diagnosis 2. Patient has confirmed FGF23 elevations in the context of low serum phosphorous \< 4.1 mg/dL 3. Patient able to tolerate KRN23 treatment 4. Have a corrected serum calcium level \< 10.8mg/dL 5. Have an eGFR \>60 ml/min 6. Must...
Burosumab is used to treat hypophosphatemia, including hypophosphatemic rickets. It is a monoclonal antibody developed by Ultragenyx Pharmaceutical Inc. (ticker: RARE) and has been studied in a Phase 3 trial for patients with these conditions. The trial also assessed chronic pain in a patient with hypophosphatemic rickets.
Burosumab targets FGF23, a hormone that regulates phosphate metabolism. By inhibiting FGF23, burosumab works to increase phosphate levels in patients with hypophosphatemia. This mechanism addresses the underlying cause of hypophosphatemic rickets and related disorders.
Burosumab is being developed by Ultragenyx Pharmaceutical Inc., a biopharmaceutical company traded under the ticker RARE. Ultragenyx focuses on rare and ultra-rare diseases, and burosumab is part of its pipeline for endocrine disorders such as hypophosphatemia.
Burosumab is in Phase 3 clinical development. It has completed a Phase 3 trial (NCT03581591) that assessed its safety and efficacy in a patient with hypophosphatemic rickets and chronic pain. The drug is investigational and has not been approved by the FDA for the studied indication.
Burosumab has been studied in a completed Phase 3 clinical trial, NCT03581591. This open-label trial evaluated the safety and efficacy of burosumab (also known as KRN23) in a single female patient with hypophosphatemic rickets and chronic pain in the United States. No active trials are currently listed.
Yes, Burosumab is also known as KRN23. KRN23 was the original designation used during early development, and the drug is now referred to as burosumab. Both names refer to the same monoclonal antibody targeting FGF23, developed by Ultragenyx Pharmaceutical Inc.