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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 a monoclonal antibody used for hypophosphatemia, a condition of low blood phosphate. It is being developed for hypophosphatemic rickets and chronic pain associated with this condition. The drug is currently in Phase 3 clinical development and is considered investigational.
Burosumab is a monoclonal antibody that targets fibroblast growth factor 23 (FGF23), a key regulator of phosphate homeostasis. By binding to FGF23, it aims to increase phosphate reabsorption in the kidney, addressing the underlying cause of hypophosphatemia.
Burosumab is developed by Ultragenyx Pharmaceutical Inc., a biopharmaceutical company traded on NASDAQ under the ticker RARE. The company is advancing the drug through clinical trials for hypophosphatemia and related conditions.
Burosumab is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed, and the drug is not currently in active trials.
Burosumab has one completed Phase 3 clinical trial, identified as NCT03581591. This open-label, uncontrolled study assessed the safety and efficacy of Burosumab in a single female patient with hypophosphatemic rickets and chronic pain. The trial was conducted in the United States.
Yes, Burosumab is also known as KRN23. In clinical trial NCT03581591, the drug is referred to as Burosumab (KRN23), confirming that these names refer to the same investigational monoclonal antibody for hypophosphatemia.