Drug

Paricalcitol

As of the edition of 20 October 2026, Paricalcitol is a small molecule: marketed, first approved in 1998 (US); acts on VDR; no US protection is listed.

Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.

The drug

Status
Marketed; latest approval 2014
Kind
Small molecule
Brand name
Zemplar
First approved
17 April 1998 (US)
Approvals on record
19 in 4 regions
Holder of the most recent approval
Accord Healthcare; 4 holders in all
Registered trials
76, 17 stopped early
Disease areas
Urinary and reproductive; Pregnancy and women's health; Hormones; Cancer; Nutrition and metabolism; Digestive system

US protection

No US protection is listed.

The FDA registers list no drug-substance patent or exclusivity that counts for this drug.

This is the US only.

Companies that need a new molecule because of this drug

1 company on route B because of this drug.

Companies on route B for this drug

In the product

1 company is on route B because of Paricalcitol.

Target

GeneProteinUniProt
VDRVitamin D3 receptorP11473

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated9513
Phase 113625
Phase 2161501
Phase 3171303
Phase 4211405
All trials76

Who has held its approvals

CompanyRoleYears
AbbottOriginator, Later holder and Lead sponsor of trials1998 to now
AbbVieAcquired holder and Lead sponsor of trials2008 to now
PfizerLater holder2014 to now
Hikma PharmaceuticalsLater holder2014 to now
Accord HealthcareLater holder2016 to now