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 13h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZEMPLAR (paricalcitol) is a synthetic vitamin D2 analog that binds to the vitamin D receptor to selectively activate vitamin D responsive pathways, primarily reducing parathyroid hormone (PTH) levels by inhibiting PTH synthesis and secretion. It is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease. The drug is administered orally in capsule form.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30), suggesting contraction of brand team and shift toward generic transition planning.
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.