CTAP101 Capsules

CTAP101 Capsules is a first-in-class treatment designed to treat vitamin D insufficiency in patients with Stage 3 or 4 CKD by gradually restoring serum total vitamin D pro-hormone concentrations to levels of 30 ng/mL or higher. The product is intended for daily oral administration.

Vitamin D insufficiency frequently causes or exacerbates the development of SHPT in CKD patients.  Emerging data suggest that prolonged vitamin D insufficiency contributes substantially to increased morbidity and mortality rates in later stages of CKD, and accelerates the progression to dialysis.

Recent studies have shown that currently available therapies for vitamin D insufficiency in CKD patients are ineffective for restoring serum total 25-hydroxyvitamin D to adequate levels, and are also ineffective for preventing or treating secondary hyperparathyroidism. CTAP101 Capsules is expected to effectively restore serum total 25-hydroxyvitamin D to adequate levels, thereby preventing the development of secondary hyperparathyroidism. In addition, CTAP101 is intended to lower the risk of vitamin D-related side effects by allowing for a gradual, rather than sudden, elevation of serum total 25-hydroxvitamin D.

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