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Zemplar (PARICALCITOL)
Zemplar works by activating the Vitamin D3 receptor, mimicking the natural effects of Vitamin D to regulate calcium levels and bone health.
Zemplar (Paricalcitol) is a Vitamin D Analog developed by Abbvie, targeting the Vitamin D3 receptor. It is a small molecule modality, FDA-approved in 1998 for treating Secondary Hyperparathyroidism due to Chronic Renal Failure. As an off-patent medication, it is available from multiple generic manufacturers. Key considerations include its 5.3-hour half-life and 72% bioavailability. Zemplar's commercial status allows for generic competition.
At a glance
| Generic name | PARICALCITOL |
|---|---|
| Sponsor | AbbVie |
| Drug class | Vitamin D2 Analog [EPC] |
| Target | Vitamin D3 receptor |
| Modality | Small molecule |
| Therapeutic area | Nephrology |
| Phase | FDA-approved |
| First approval | 1998 |
Mechanism of action
Preclinical and in vitro studies have demonstrated that paricalcitols biological actions are mediated through binding of the vitamin receptor (VDR), which results in the selective activation of vitamin responsive pathways. Vitamin and paricalcitol have been shown to reduce parathyroid hormone levels by inhibiting PTH synthesis and secretion.
Approved indications
- Hyperparathyroidism Secondary to Chronic Renal Failure
Common side effects
- Nausea
- Vomiting
- Edema
- Palpitations
- Gastrointestinal Hemorrhage
- Dry Mouth
- Chills
- Pyrexia
- Malaise
- Pneumonia
- Sepsis
- Influenza
Key clinical trials
- Paricalcitol and Hydroxychloroquine in Combination With Gemcitabine and Nab-Paclitaxel for Advanced Pancreatic Cancer (PHASE2)
- A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD) (PHASE3)
- Paricalcitol Addition to Chemotherapy in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (PHASE2)
- A PiLot ClinicaL TrIal of ParicAlcitol for ChroNiC PancrEatitis (EARLY_PHASE1)
- Combination Therapy for Patients With Untreated Metastatic Pancreatic Ductal Adenocarcinoma (PHASE2)
- A Study of Neoadjuvant Paricalcitol to Target the Microenvironment in Resectable Pancreatic Cancer (PHASE1)
- Pre-operative Treatment for Patients With Untreated Pancreatic Cancer (PHASE2)
- PHL Treatment in Pancreatic Cancer (EARLY_PHASE1)
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 |