TheraRadar
Data updated: May 26, 2026

PARICALCITOL

Renal Approved 2011-07-27

Paricalcitol is a vitamin D analog used to manage secondary hyperparathyroidism in adults with chronic kidney disease. It helps patients across various stages of the disease, including those in stages 3 and 4 as well as stage 5 patients undergoing hemodialysis or peritoneal dialysis. This medication is prescribed to both prevent and treat the hormonal imbalances that occur when the parathyroid glands become overactive due to declining kidney function.

Source: FDA Label • Hikma • Vitamin D2 Analog
Jump to: Indications Approvals Trials Competitors Safety Patents

How PARICALCITOL Works

This drug works by binding to vitamin D receptors, which triggers the activation of specific vitamin D responsive pathways. This process helps lower parathyroid hormone levels by inhibiting the synthesis and secretion of the hormone.

Source: FDA Label
16
Indications
--
Phase 3 Trials
14
Years on Market

Details

Status
Discontinued
First Approved
2011-07-27
Routes
INTRAVENOUS, ORAL, INJECTION
Dosage Forms
SOLUTION, CAPSULE, INJECTABLE

Companies

Hikma AMNEAL PHARMS CO MARKSANS PHARMA EPIC PHARMA LLC CHARTWELL RX Pfizer RISING AMNEAL PHARMS Teva ACCORD HLTHCARE BIONPHARMA Aurobindo Pharma EUGIA PHARMA LOTUS PHARM CO LTD Novartis CAPLIN
Active Ingredient: PARICALCITOL

PARICALCITOL Approval History

2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
94 FDA actions from 2011 to 2025
Aug 2025 SUPPL
Label · Labeling
Mar 2024 SUPPL
Label · Labeling
Dec 2019 SUPPL
Label · Labeling
FDA Letter Label

What PARICALCITOL Treats

2 indications

PARICALCITOL is approved for 2 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Secondary hyperparathyroidism associated with Chronic Kidney Disease Stages 3 and 4
  • Secondary hyperparathyroidism associated with Chronic Kidney Disease Stage 5 in patients on hemodialysis or peritoneal dialysis
Source: FDA Label

PARICALCITOL Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Direct competitors

1

Same target(s) AND same indication — head-to-head.

DOXERCALCIFEROL
Lupin
2011 2 indic.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

IRON SUCROSE
INTL MEDICATION
2025 2 indic.
ARBLI
SCIENTURE
2025 3 indic.
Unlock 8 more competitors across all three rings.
Upgrade to Pro

Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

📋

Clinical Trial Registry

47 trials
Trial Sponsor ID Phase Status Title
NCT04524702 results posted STUDY00000996 NCI-2020-05417, Winship5079-20 Ph 2 completed Paricalcitol and Hydroxychloroquine in Combination With Gemcitabine and Nab-Paclitaxel for Advanced Pancreatic Cancer
NCT04064827 M11-617 Ph 3 terminated 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)
NCT04054362 PINBALL 012255 Ph 2 completed Paricalcitol Addition to Chemotherapy in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma
NCT02754726 results posted NAPPCG-EB 2015-001 Ph 2 completed Combination Therapy for Patients With Untreated Metastatic Pancreatic Ductal Adenocarcinoma
NCT02030860 UPCC 23213 Ph 1 completed A Study of Neoadjuvant Paricalcitol to Target the Microenvironment in Resectable Pancreatic Cancer
NCT03520790 18-021 Ph 1 terminated Paricalcitol Plus Gemcitabine and Nab-paclitaxel in Metastatic Pancreatic Cancer
NCT02876211 PIERAID PIERAID-2013 Ph 4 terminated Paricalcitol Improves Anemia of Inflammation
NCT04617067 CTRIAL-IE 19-33 2020-000073-24, CTRIAL-IE 19-33 Ph 2 completed Paricalcitol Trial: Phase II, Open Label Clinical Trial of Paricalcitol in Combination With Gemcitabine/ Nab-Paclitaxel Therapy in Advanced Pancreatic Cancer
NCT01725113 ECRIP results posted 12027 Ph 4 terminated Management of Mineral and Bone Disease in Hemodialysis-Calcitriol vs. Paricalcitol
NCT02930902 2016-0378 NCI-2016-01937, 2016-0378 Ph 1 completed Pembrolizumab and Paricalcitol With or Without Chemotherapy in Patients With Pancreatic Cancer That Can Be Removed by Surgery
NCT03331562 results posted TGen 17-001 MISP# 56240 Ph 2 completed A SU2C Catalyst® Trial of a PD1 Inhibitor With or Without a Vitamin D Analog for the Maintenance of Pancreatic Cancer
NCT03883919 201905201 Ph 1 completed Liposomal Irinotecan Plus 5-FU / LV Combined With Paricalcitol in Patients With Advanced Pancreatic Cancer Progressed on Gemcitabine-based Therapy
NCT03300921 UPCC 26217 Ph 1 terminated A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer
NCT01506947 results posted W12-645 Ph 4 completed A Pilot Clinical Study Evaluating the Effect of Parathyroid Hormone (PTH) Lowering On Erythropoietin Consumption in Calcitriol-Resistant Patients
NCT01939977 PARIDOINAL results posted ACA-SPAI-11-24 2013-001326-25 Ph 4 completed Efficacy and Safety of Paricalcitol in the Reduction of Secondary Hyperparathyroidism After Kidney Transplantation.
NCT02686827 BM4SIT BM4SIT Ph 2 completed DBPC-Dose-finding-trial of Vitamin D3 for SCIT in Birch Pollen Allergic Patients.
NCT01820767 SENPARIC SENPARIC-2011-01 Ph 3 completed Paricalcitol Over Inflammatory Parameters on Chronical Kidney Disease Patients
NCT00634582 results posted IRB00004564 P30CA012197, CCCWFU-85107 Ph 2 terminated Paricalcitol in Treating Patients With Advanced Prostate Cancer and Bone Metastases
NCT01197664 IRB00013006 NCI-2011-02409, CCCWFU 54110 Ph 1 terminated Paricalcitol, Fluorouracil, and Radiation Therapy in Treating Patients With Rectal Cancer That Can Be Removed in Surgery
NCT01020487 results posted M10-149 2010-019439-37 Ph 3 completed Safety and Efficacy of Paricalcitol Capsules in Decreasing Serum Parathyroid Hormone Levels in Children Aged 10-16 With Chronic Kidney Disease (CKD)
NCT01382212 results posted M11-612 2013-002610-13 Ph 3 completed A Study to Evaluate the Safety of Paricalcitol Capsules in Pediatric Subjects Ages 10 to 16 With Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis
NCT01436747 31-06-2011 Ph 3 completed Efficacy and Safety of Paricalcitol for Reduction of Proteinuria in Kidney Transplant Recipients
NCT00752102 VCOR results posted Abbott #20128 Ph 4 completed Vitamin D and Coronary Calcification Study
NCT00637897 CDR0000583652 P30CA012197, CCCWFU-74307 Ph 1 completed Paricalcitol and Chemotherapy in Treating Women With Metastatic Breast Cancer
NCT01138475 ExtenD results posted 2009-234 Ph 3 completed Trial Of Paricalcitol and Cholecalciferol(Vitamin D3) in the Treatment Of Secondary Hyperparathyroidism in Patients After ROUX-EN-Y Gastric Bypass Surgery
NCT01393808 PROCEED PROCEED 2011-001713-14 Ph 2 completed Salt Intake and Antiproteinuric Effect of Paricalcitol in Type 2 Diabetes
NCT02282813 results posted CTAP101-CL-3003 Ph 3 completed Extension Study of CTAP101-CL-3001 or CTAP101-CL-3002
NCT01694160 2012/107 D 2012-000429-32 Ph 3 completed Oral Paricalcitol in Renal Transplant Recipients for Reducing Albuminuria
NCT00599963 CRE-2007.409-T CRE-2007.409-T Ph 3 withdrawn Paricalcitol for the Treatment of Immunoglobulin A Nephropathy
NCT01265615 results posted VDCRS03 Ph 4 completed Paricalcitol Versus Calcitriol for the Management of Renocardiac Syndrome in Renal Transplant Patients
NCT02372695 MICROBUB MICROBUB-2011-01 2011-002554-30 Ph 4 terminated Effect of Paricalcitol Over Vessel Wall
NCT00823303 PACE results posted 22095 Ph 4 completed Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3/4 Chronic Kidney Disease (CKD) With Secondary Hyperparathyroidism (SHPT)
NCT01768351 PCX1234 paranemia Ph 4 completed Paricalcitol Effect on Anemia in CKD
NCT01012414 VINCA-CKD results posted 09C.110 Ph 3 terminated Effect of Vitamin D Supplement on Inflammation Markers in High-Risk Cardiovascular Patients With Chronic Kidney Disease
NCT01003275 results posted 35501-D Ph 2 completed Metabolic Effects of Paricalcitol
NCT01341782 results posted M11-517 Ph 3 completed Comparison of Efficacy and Safety of Paricalcitol Injection With Maxacalcitol Injection in Adult Japanese Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism
NCT01163162 Paricalcitol results posted 1003-15 Ph 4 completed The Effect of Paricalcitol on Creatinine Filtration, Secretion and Glomerular Filtration Rate
NCT00497146 PRIMO results posted M10-030 2007-001689-34 Ph 3 completed The PRIMO Study: Paricalcitol Capsules Benefits Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease Stage 3/4
NCT01220050 APPLE APPLE 2008-006380-36 Ph 2 completed Paricalcitol in Reducing Parathyroid Hormone Levels and Ameliorating Markers of Bone Remodelling in Renal Transplant Recipients With Secondary Hyperparathyroidism
NCT00977080 IMPACT SHPT results posted M10-967 2009-011378-14 Ph 4 completed Evaluation of the Effectiveness of Paricalcitol Versus Cinacalcet With Low-Dose Vitamin D
NCT01331317 2009-011255-44 Ph 4 completed Effect of a Vitamin D Analogue vs Placebo on p-NT-proBNP in Patients With Type 1 DM and Diabetic Nephropathy
NCT01071070 results posted M06-823 Ph 3 completed Evaluate Safety and Efficacy of Paricalcitol in Reducing Serum Intact Parathyroid Hormone in Chronic Kidney Disease
NCT00664430 results posted W10-131 Ph 4 terminated Efficacy and Safety of Paricalcitol on the Treatment of Secondary Hyperparathyroidism in Calcitriol Resistant Dialysis Subjects
NCT00667576 results posted M10-309 Ph 2 completed Dose-response Study of Paricalcitol Injection in Chronic Kidney Disease Patients Receiving Hemodialysis
NCT00990704 results posted M11-609 Ph 2 completed Paricalcitol Compared to Maxacalcitol in Chronic Kidney Disease Patients With Secondary Hyperparathyroidism
NCT00701805 results posted M10-312 Ph 2 completed Long-term Safety Study of Paricalcitol Injection in Chronic Kidney Disease Patients With Hemodialysis (HD)
NCT00958451 CK0023 Ph 4 completed Vitamin D Deficiency in Chronic Kidney Disease (CKD) Patients
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

PARICALCITOL FDA Label Details

Indications & Usage

FDA Label (PDF)

PARICALCITOL is indicated for the treatment of Secondary hyperparathyroidism associated with Chronic Kidney Disease Stages 3 and 4; Secondary hyperparathyroidism associated with Chronic Kidney Disease Stage 5 in patients on hemodialysis or peritoneal dialysis.

Looking for the branded version?

ZEMPLAR

Full clinical data, patents, trials, and competitive landscape for paricalcitol.

See ZEMPLAR

Data Sources

FDA Approval: NDA205917 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.