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Hectorol (DOXERCALCIFEROL)

Sanofi · FDA-approved approved Small molecule Verified Quality 70/100

Hectorol works by activating the Vitamin D receptor, which helps regulate calcium levels in the body.

Hectorol (Doxercalciferol) is a Vitamin D2 analog that targets the Vitamin D3 receptor. It is a small molecule modality that was originally developed by Genzyme Corp and is now owned by Sanofi. Hectorol is FDA-approved for the treatment of secondary hyperparathyroidism in patients with chronic renal failure undergoing dialysis. The drug is off-patent and has multiple generic manufacturers. As an off-patent medication, Hectorol's commercial status is primarily driven by generic competition.

At a glance

Generic nameDOXERCALCIFEROL
SponsorSanofi
Drug classVitamin D2 Analog [EPC]
TargetVitamin D3 receptor
ModalitySmall molecule
Therapeutic areaMetabolic
PhaseFDA-approved
First approval1999

Mechanism of action

Mechanism of Action. Calcitriol (1,25-(OH)2D3) and 1,25-(OH)2D2 regulate blood calcium at levels required for essential body functions. Specifically, the biologically active vitamin metabolites control the intestinal absorption of dietary calcium, the tubular reabsorption of calcium by the kidney and, in conjunction with parathyroid hormone (PTH), the mobilization of calcium from the skeleton. They act directly on bone cells (osteoblasts) to stimulate skeletal growth, and on the parathyroid glands to suppress PTH synthesis and secretion. These functions are mediated by the interaction of these biologically active metabolites with specific receptor proteins in the various target tissues. In uremic patients, deficient production of biologically active vitamin metabolites (due to lack of or insufficient 25-hydroxyvitamin D-1-alpha-hydroxylase activity) leads to secondary hyperparathyroidism, which contributes to the development of metabolic bone disease in patients with renal failure.

Approved indications

Common side effects

Key clinical trials

Primary sources

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SourceUsed for
FDA labelMechanism, indications, dosing, boxed warnings, drug interactions
ClinicalTrials.govTrial enrolment, design, endpoints, results

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