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Calcitriol (Rocaltrol®)
Calcitriol is the active form of vitamin D that binds to vitamin D receptors to regulate calcium and phosphate homeostasis and promote bone mineralization.
Calcitriol is the active form of vitamin D that binds to vitamin D receptors to regulate calcium and phosphate homeostasis and promote bone mineralization. Used for Hypocalcemia in patients with chronic kidney disease, Hypoparathyroidism, Vitamin D-dependent rickets.
At a glance
| Generic name | Calcitriol (Rocaltrol®) |
|---|---|
| Also known as | Calcijex®, Rocaltrol® |
| Sponsor | Joslin Diabetes Center |
| Drug class | Vitamin D analog |
| Target | Vitamin D receptor (VDR) |
| Modality | Small molecule |
| Therapeutic area | Endocrinology |
| Phase | FDA-approved |
Mechanism of action
Calcitriol (1,25-dihydroxyvitamin D3) is the hormonally active metabolite of vitamin D that acts as a ligand for the vitamin D receptor (VDR), a nuclear receptor that regulates gene transcription. It increases intestinal absorption of calcium and phosphate, promotes bone mineralization, and modulates parathyroid hormone secretion to maintain serum calcium and phosphate levels within normal ranges.
Approved indications
- Hypocalcemia in patients with chronic kidney disease
- Hypoparathyroidism
- Vitamin D-dependent rickets
- Hypophosphatemia
Common side effects
- Hypercalcemia
- Hyperphosphatemia
- Hypercalciuria
- Nausea
- Headache
- Weakness
Key clinical trials
- Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis (PHASE3)
- Effectiveness of Calcium and Vitamin D, With and Without Collagen Peptide, in Enhancing Bone Mineral Density on Postmenopausal Women With Osteopenia (NA)
- Management of Mineral and Bone Disease in Hemodialysis-Calcitriol vs. Paricalcitol (PHASE4)
- Safety & Effectiveness of Clobex Spray, Followed by Calcitriol Ointment in Management of Plaque Psoriasis (PHASE3)
- Evaluate Safety/Efficacy of Two Treatment Regimens for Vectical™ Ointment & Clobex® Spray for Moderate Plaque Psoriasis (PHASE4)
- The Pharmacokinetics of Rocaltrol When Administered Alone or in Combination With Fosrenol or Renvela in Healthy Volunteers (PHASE1)
- Oral Calcitriol With Ketoconazole in CRPC (PHASE2)
- Bone Markers and Bone Density Changes in Hyperperparathyroid Dialysis Patients Under Cinacalcet Treatment (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Calcitriol (Rocaltrol®) CI brief — competitive landscape report
- Calcitriol (Rocaltrol®) updates RSS · CI watch RSS
- Joslin Diabetes Center portfolio CI