NDAINTRAVENOUSSOLUTION
Approved
Nov 2014
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
PARICALCITOL (paricalcitol) by Hikma is 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. First approved in 2014.
Drug data last refreshed 5h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Paricalcitol is an intravenous vitamin D2 analog that selectively activates vitamin D receptors to reduce parathyroid hormone (PTH) synthesis and secretion. It is used to treat secondary hyperparathyroidism in patients with chronic kidney disease. The drug binds to the vitamin D receptor (VDR) and modulates PTH levels through vitamin D-responsive pathways.
Peak
Product is in peak commercial phase under Hikma sponsorship with moderate competitive pressure (30), indicating a mature, established franchise with stable team requirements.
Mechanism of Action
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 paricalcitol have been shown to reduce parathyroid hormone levels by inhibiting PTH synthesis and secretion.
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.