| Product: | FC818 (ferric citrate), tablets |
| Indication: | Treatment for hyperphosphatemia in ESRD patients (Rx) |
| Status: | Phase III |
FC818 is a non-calcium phosphate binder for the control of serum phosphorus in patients with end-stage renal disease (ESRD).
Hyperphosphatemia in ESRD Patients
Hyperphosphatemia in patients with end-stage renal disease (ESRD) can lead to secondary hyperparathyroidism, renal osteodystrophy, soft tissue mineralization and the progression of renal failure – all of which significantly increase patient mortality and morbidity.
As such, phosphorus control is critical to the quality of care for dialysis patients.
Treatment with Phosphate Binders
The treatment of hyperphosphatemia usually involves dialysis in conjunction with dietary phosphate restrictions and intake of phosphate binders. Phosphate binders are generally classified as calcium-based and non-calcium-based drugs.
Clinical Demand for Non-Calcium Phosphate Binders
Calcium-based phosphate binders, such as Phosmin and CM139 are proven and effective agents for controlling serum phosphorous levels. However, these drugs can potentially promote a positive net calcium balance. Therefore, for hypercalcemic dialysis patients with severe vascular and/or other soft tissue calcifications, there is a clinical need for a non-calcium-based phosphate binder.
There are currently no non-calcium-based phosphate binders available for treating ESRD patients with hyperphosphatemia in China.FC818
FC818 is a novel non-calcium-based phosphate binder.
One Phase I and two pivotal Phase II clinical trials showed FC818 to be an effective and safe treatment for lowering and/or maintaining serum phosphorus levels <5.5 mg/dL in ESRD patients with hyperphosphatemia. Based on these results, PUMC Pharmaceutical plans to initiate a pivotal Phase III clinical trial.
