Drug intelligence / Profile preview

CTAP101

Development stage
Phase 2
Lead developer
OPKO Health
Modality
Injectable Hydrogels → Hydrogel Systems → Drug Delivery Systems, Implantable Hydrogels → Hydrogel Systems → Drug Delivery Systems, Small Molecules, Implantable Devices → Device-based Delivery → Drug Delivery Systems, Transdermal Patches → Device-based Delivery → Drug Delivery Systems
Administration
Oral
01

Overview

CTAP101 is an extended-release oral formulation of calcifediol (25-hydroxyvitamin D3), developed primarily for the treatment of secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency. Calcifediol is the physiological precursor to the active vitamin D hormone, 1,25-dihydroxyvitamin D3 (calcitriol). The drug works by increasing serum total 25-hydroxyvitamin D levels and reducing elevated plasma intact parathyroid hormone (iPTH), thereby addressing both vitamin D insufficiency and SHPT. Clinical studies have shown that CTAP101 reliably raises serum total vitamin D prohormone concentrations to target levels while lowering iPTH without significant adverse effects on calcium or phosphorus homeostasis. The product is marketed under the brand name Rayaldee[1][4][7][8].

Brand names
Rayaldee
Other names
calcifediol extended-release25-hydroxyvitamin D3 extended-releasecalcidiol extended-release
02

Targets

VDR (Vitamin D receptor)

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