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Calcijex (CALCITRIOL)
Calcijex (Calcitriol) is a Vitamin D3 analog developed by Validus Pharms and currently owned by Esjay Pharma. It targets the Vitamin D3 receptor and is used to treat various conditions including hyperparathyroidism, hypocalcemia, and plaque psoriasis. Calcijex is a small molecule with a half-life of 11 hours and bioavailability of 61%. It is off-patent with 18 generic manufacturers. Key safety considerations include monitoring of calcium and phosphorus levels.
At a glance
| Generic name | CALCITRIOL |
|---|---|
| Sponsor | Esjay Pharma |
| Drug class | Vitamin D3 Analog [EPC] |
| Target | Vitamin D3 receptor |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 1978 |
Approved indications
- Hyperparathyroidism Secondary to Chronic Renal Failure
- Hypocalcemia
- Hypocalcemia from End-Stage Renal Disease with Dialysis
- Hypoparathyroidism
- Hypophosphatemia
- Plaque psoriasis
- Renal osteodystrophy
Common side effects
- Hypercalcemia
- Hypercalciuria
- Elevated serum creatinine levels
- Polyuria
- Polydipsia
- Anorexia
- Weight loss
- Nocturia
- Pancreatitis
- Photophobia
- Rhinorrhea
- Pruritus
Key clinical trials
- Effect of Local Use of Vitamin D on the Rate of Canine Distillization: a Split Mouth Randomized Control Trial (PHASE1)
- Effects of Vitamin D in Patients Undergoing Fixed Orthodontic Mechanotherapy (NA)
- Vitamin D in OUD: Exploration of Alterations on the Dopamine D2/D3 Receptor System (PHASE1)
- Efficacy and Safety of Encaleret Compared to Standard of Care in Participants With ADH1 (PHASE3)
- Calcitriol Monotherapy for X-Linked Hypophosphatemia (EARLY_PHASE1)
- Clinical Evaluation of Local Calcitriol Delivery on Maxillary Canine Retraction (NA)
- Activated Vitamin D for the Prevention and Treatment of Acute Kidney Injury (PHASE2)
- FGF23 Reduction : Efficacy of a New Phosphate Binder in CHronic Kidney Disease (PHASE3)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Calcijex CI brief — competitive landscape report
- Calcijex updates RSS · CI watch RSS
- Esjay Pharma portfolio CI