NDAORALCAPSULE
Approved
May 2005
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
ZEMPLAR (paricalcitol) by AbbVie is synthetic, biologically active vitamin d 2 analog. First approved in 2005.
Drug data last refreshed 18h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZEMPLAR (paricalcitol) is a synthetic vitamin D2 analog that selectively activates vitamin D receptors to reduce parathyroid hormone (PTH) synthesis and secretion. It is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease. The drug works through VDR-mediated pathways to suppress abnormal PTH levels.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100); brand teams are likely focused on lifecycle extension or managed decline strategies.
Mechanism of Action
synthetic, biologically active vitamin D 2 analog. Preclinical and in vitro studies have demonstrated that paricalcitol's biological actions are mediated through binding of the vitamin D receptor (VDR), which results in the selective activation of vitamin D responsive pathways. Vitamin D and…
Pharmacologic Class:
Vitamin D2 Analog
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
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)
Started Sep 2020
2 enrolled
Chronic Kidney Disease (CKD)Secondary Hyperparathyroidism (SHPT)
Liposomal Irinotecan Plus 5-FU / LV Combined With Paricalcitol in Patients With Advanced Pancreatic Cancer Progressed on Gemcitabine-based Therapy
Started Jul 2019
20 enrolled
Pancreatic CancerPancreas CancerCancer of the Pancreas
Repeated-dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of CTAP101, Immediate-release Calcifediol, High-dose Cholecalciferol, and Paricalcitol Plus Low-dose Cholecalciferol in Patients With Secondary Hyperparathyroidism, Chronic Kidney Disease 3-4 and Vitamin D Insufficiency
Started Jun 2018
69 enrolled
Secondary Hyperparathyroidism Due to Renal CausesVitamin D InsufficiencyCKD Stage 3+1 more
Paclitaxel Protein Bound Plus Cisplatin Plus Gemcitabine and Paricalcitol for Pancreatic Adenocarcinoma (NABPLAGEMD)
Started Jan 2018
34 enrolled
Pancreatic CancerPancreatic Ductal AdenocarcinomaPancreatic Adenocarcinoma+2 more
Efficacy and Safety of Paricalcitol in the Reduction of Secondary Hyperparathyroidism After Kidney Transplantation.
Started Jan 2014
148 enrolled
Secondary Hyperparathyroidism Due to Renal Causes
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.