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Label indication ZEMPLAR is indicated for the prevention and treatment of secondary hyperparathyroidism in patients 5 years of age and older with chronic kidney disease (CKD) on dialysis. ZEMPLAR is a vitamin D analog indicated for the prevention and treatment of secondary hyperparathyroidism in patients 5 years of age and older with chronic kidney disease on dialysis ( 1 ). FDA label
paricalcitol · 4 trials · 6 indications
The percentage of subjects with hypercalcemia, defined as at least 2 consecutive post-baseline corrected calcium values \> 10.2 mg/dL (2.55 mmol/L).
The target iPTH range was 60-180 pg/mL, based on the average of the last 3 weeks of treatment, and with no hypercalcemia during the treatment phase. Hypercalcemia was defined as at least 1 corrected calcium value \> 11.0 mg/dL or at least 2 corrected calcium values ≥ 10.5 mg/dL. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory.
The primary efficacy endpoint was the percentage of participants who achieved two consecutive ≥ 30% reductions from baseline in intact parathyroid hormone (iPTH) levels during the 12 week double-blind portion of the study regardless of CKD stage.
The Central Cardiac MRI Core Laboratory (CCL) interpreted and analyzed all cardiac MRI data. Left Ventricular Mass (LVM) was normalized to the participant's height by the following equation to obtain LVMI: LVM (grams) divided by height (meters)\^2.7.
| Arm | Type | Description |
|---|---|---|
| Paricalcitol | EXPERIMENTAL | Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks. |
| Maxacalcitol | ACTIVE_COMPARATOR | Participants received maxacalcitol at an initial dose of 5 µg (iPTH \< 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg. |
| Part 1: Paricalcitol | EXPERIMENTAL | Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1. |
| Part 2: Placebo | PLACEBO_COMPARATOR | Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels. |
| Part 2: Paricalcitol | EXPERIMENTAL | Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels. |
| Placebo | PLACEBO_COMPARATOR | Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period. |
| Name | Type | Description |
|---|---|---|
| paricalcitol | DRUG | Paricalcitol soft capsule. Starting dose of paricalcitol was determined by the intact parathyroid hormone (iPTH) value (iPTH/120) from prior to Day 1, rounded down to the nearest whole number, not to exceed 16 µg 3 times weekly, no more frequently than every other day. Decisions to hold, maintain, increase, or decrease a dose were based on the iPTH, phosphorus, and calcium results generated from the most recent visit and within target Kidney Dialysis Outcomes Quality Initiatives (KDOQI) levels. |
| maxacalcitol | DRUG | - |
| paricalcitol placebo | DRUG | - |
| maxacalcitol placebo | DRUG | - |
| Placebo | DRUG | Placebo capsules taken with water |
Inclusion Criteria: * Subject must be receiving peritoneal dialysis or hemodialysis for at least 3 months prior to Screening * Subject is currently being diagnosed and/or treated for secondary hyperparathyroidism * For entry into the Dosing Period (for subjects that are naïve to Vitamin D Receptor ...
Top 15 of 23 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 11 | PHASE3 | Savolitinib, Baxdrostat, Zibotentan/Dapagliflozin, Dapagliflozin, AZD4248 |
| Eli Lilly and Company | LLY | 4 | PHASE3 | Retatrutide, Orforglipron, LY3841136, SGLT2 inhibitor |
| Novartis AG Sponsored ADR | NVS | 4 | PHASE3 | Zigakibart, OJR520 |
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 3 | PHASE3 | DCR-PHXC, NNC0519-0130, Semaglutide |
| Amgen Inc. | AMGN | 1 | PHASE3 | Etelcalcetide |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 2 | PHASE3 | Mezagitamab |
| ProKidney Corp. Class A | PROK | 3 | PHASE3 | Rilparencel |
| Humacyte, Inc. | HUMA | 1 | PHASE3 | Symvess |
| Fresenius Medical Care AG Sponsored ADR | FMS | 6 | PHASE2 | Difelikefalin |
| GSK plc Sponsored ADR | GSK | 1 | PHASE1 | GSK4771261 |
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE1 | Vonsetamig |
| United Therapeutics Corporation | UTHR | 2 | PHASE1 | 10 GE Xenokidney, GGTA1 KO Thymokidney |
| Pfizer Inc. | PFE | 1 | PHASE1 | PF-07328948 |
| OPKO Health, Inc. | OPK | 1 | PHASE2 | CTAP101 |
| Incyte Corporation | INCY | 1 | PHASE1 | INCB123667 |
Paricalcitol is used to treat secondary hyperparathyroidism in people with chronic kidney disease, including stage 3 and 4 CKD, end-stage renal disease, and patients receiving dialysis. It is a small molecule developed by AbbVie Inc. (ticker ABBV) and has been studied in both adult and pediatric kidney disease populations.
Paricalcitol targets the vitamin D receptor (VDR) and acts as an agonist. By activating VDR, it helps lower elevated parathyroid hormone levels associated with secondary hyperparathyroidism in chronic kidney disease. This mechanism is distinct from calcium-based therapies and is central to its use in managing mineral and bone disorders in kidney disease.
Paricalcitol is developed by AbbVie Inc., which trades under the ticker ABBV. AbbVie is the company associated with the drug's clinical development across multiple Phase 3 trials in chronic kidney disease and secondary hyperparathyroidism.
Paricalcitol has been studied in Phase 3 clinical trials. The trials listed are completed, and no active trials are currently reported in this dataset. It is an investigational therapy in the contexts studied, and its development has focused on chronic kidney disease and secondary hyperparathyroidism.
Paricalcitol has been evaluated in several completed Phase 3 trials, including NCT01382212 in pediatric patients with stage 5 CKD on dialysis, NCT01341782 comparing paricalcitol injection with maxacalcitol in Japanese adults on hemodialysis, NCT01020487 in children with CKD stages 3 and 4, and NCT00497146 (the PRIMO study) in adults with CKD stage 3/4 and left ventricular hypertrophy.
No, paricalcitol and maxacalcitol are different drugs. A Phase 3 trial, NCT01341782, directly compared paricalcitol injection with maxacalcitol injection in adult Japanese chronic kidney disease subjects receiving hemodialysis with secondary hyperparathyroidism. Paricalcitol is a vitamin D receptor agonist developed by AbbVie, while maxacalcitol is a separate vitamin D analog.