Cinacalcet
Other / unclassified targets CASR via activation
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | SENSIPAR | — | 2011-02-25 – 2017-05-23 | fda.gov ↗ |
| Approved | EU (EMA) | Mimpara | — | 2004-10-22 | europa.eu ↗ |
| Approved | US (FDA) | SENSIPAR | — | 2004-03-08 | fda.gov ↗ |
Trials 54 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 20 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00952094 Comparator | Nov 2008 → Jan 2009 | — | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT06288451 Background | Mar 2024 → Feb 2027 expected | chronic renal failure syndrome, renal osteodystrophy | University of Washington | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05663411 Comparator | Feb → Oct 2023 | secondary hyperparathyroidism of renal origin | Shanghai Hengrui Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT02216656 Comparator | Jul 2014 → Feb 2015 | secondary hyperparathyroidism of renal origin | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02133404 Comparator | Mar → Nov 2014 | secondary hyperparathyroidism | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT02525796 Background | Jan 2016 → Oct 2021 | primary hyperparathyroidism | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 2/3 | NCT02549391 Comparator | Sep 2015 → Nov 2016 | secondary hyperparathyroidism | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT07122401 Comparator | Sep 2025 → Nov 2026 expected | secondary hyperparathyroidism of renal origin | Shaanxi Micot Pharmaceutical Technology Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT06434961 Comparator | Jun 2024 → Sep 2025 | secondary hyperparathyroidism of renal origin | Shanghai Hengrui Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT03822507 Comparator | Apr 2019 → Sep 2021 | secondary hyperparathyroidism of renal origin | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03299244 Comparator | May 2018 → Apr 2020 | chronic kidney disease, secondary hyperparathyroidism | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT01896232 Comparator | Aug 2013 → Nov 2014 | chronic kidney disease, secondary hyperparathyroidism of renal origin | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT01011699 Comparator | Jan 2010 → Jun 2013 | chronic renal failure syndrome | Centre Hospitalier Universitaire, Amiens | Terminated | No outcome recorded |
| Phase 3 | NCT00117052 Comparator | Sep 2004 → Nov 2005 | end stage renal failure, secondary hyperparathyroidism of renal origin | Amgen | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT01250405 Comparator | May 2012 → Apr 2014 | chronic kidney disease | Laval University | Completed | No outcome recorded |
| Phase 4 | NCT00977080 Comparator | Nov 2009 → May 2011 | chronic kidney disease, secondary hyperparathyroidism of renal origin | Abbott | Completed | No outcome recorded |
| Phase 4 | NCT00379899 Comparator | Sep 2006 → May 2009 | calcinosis, chronic renal failure syndrome, coronary artery disorder, end stage renal failure +1 | Amgen | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT02273570 Background | Mar 2015 → Dec 2016 | secondary hyperparathyroidism of renal origin | Azienda Ospedaliera Sant'Anna | Unknown | No outcome recorded |
| — | NCT01519037 Comparator | Jan → Jun 2012 | — | Centre Hospitalier Universitaire Vaudois | Completed | No outcome recorded |
| — | NCT01011114 Comparator | Nov 2009 → Oct 2015 | hypophosphatemia | Montefiore Medical Center | Terminated | No outcome recorded |
Press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2017-08-31 | Amgen | European Commission Approves Expanded Use Of Mimpara® (Cinacalcet) For The Treatment Of Secondary Hyperparathyroidism In Children With End-Stage Renal Disease On Dialysis amgen.com ↗ |
| 2017-06-23 | Amgen | Amgen Receives Positive CHMP Opinion To Expand Use Of Mimpara® (cinacalcet) For The Treatment Of Secondary Hyperparathyroidism In Certain Children With End-Stage Renal Disease On Dialysis amgen.com ↗ |
| 2015-11-07 | Amgen | Amgen Presents Detailed Data Comparing Etelcalcetide With Cinacalcet In Patients With Secondary Hyperparathyroidism Receiving Hemodialysis amgen.com ↗ |
| 2015-02-25 | Amgen | Amgen Announces Positive Results From Head-To-Head Study Comparing The Efficacy And Safety Of AMG 416 With Cinacalcet In Patients With Secondary Hyperparathyroidism Receiving Hemodialysis amgen.com ↗ |
| 2010-05-14 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Tentative Approval of Generic Sensipar® tevapharm.com ↗ |
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 81 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | cinacalcet | “Cinacalcet HCl, an oral calcimimetic agent for the treatment of secondary hyperparathyroidism in hemodialysis and peritoneal dialysis: a randomized, double-blind, multicenter study.” PMID 15689407 ↗ Feb 200564“In phase 1, 30 adult HD patients were randomized to cinacalcet or control groups for 12 weeks to explore the achievement of >30% reduction of iPTH.” PMID 31014177 ↗ Nov 2019 “Cinacalcet, as add-on therapy in addition to eplerenone/amiloride/placebo, titrated up to a maximum of 30mg BID” NCT02525796 ↗ “a flexible dose of cinacalcet("Mimpara®") to a maximum dose of 90 mg/day.” NCT02273570 ↗ “Cinacalcet hydrochloride” NCT00135304 ↗ |
| Known as | AMG 073 | “A Multicenter, Open-label Extension Study to Assess the Long-term Safety and Efficacy of an Oral Calcimimetic Agent AMG 073 (Cinacalcet) in Primary Hyperparathyroidism” NCT00936988 ↗8“A Study to Assess the Efficacy and Safety of Twice-Daily Dose Regimens of an Oral Calcimimetic Agent AMG 073 (Cinacalcet) in Primary Hyperparathyroidism (PHPT)” NCT00936650 ↗ “Drug: cinacalcet (AMG 073)” NCT00042432 ↗ |
| Known as | AMG-073 HCL | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201284 ↗ |
| Known as | AMG073 HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201284 ↗ |
| Known as | Cinacalcet accordpharma | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201284 ↗ |
| Known as | cinacalcet HCl | “This multicenter, randomized, double-blind, placebo-controlled study assessed the ability of the oral calcimimetic cinacalcet HCl to achieve long-term reductions in serum...” PMID 15522938 ↗ Nov 20047“The purpose of this study is to evaluate the effects of cinacalcet (cinacalcet HCl or Sensipar®/Mimpara®) on cardiovascular events and death in chronic kidney disease (CKD)...” NCT00345839 ↗ “Cinacalcet HCl, an oral calcimimetic agent for the treatment of secondary hyperparathyroidism in hemodialysis and peritoneal dialysis: a randomized, double-blind, multicenter study.” PMID 15689407 ↗ Feb 2005 “Cinacalcet HCl is a calcimimetic agent that has recently become a standard therapy in the treatment of SHPT in ESRD.” NCT01011114 ↗ “The calcimimetic cinacalcet HCl lowers parathyroid hormone (PTH) and tends to decrease Ca x P.” PMID 17699221 ↗ Jan 2006 “Sensipar (Cinacalcet HCl)” NCT00261950 ↗ “Drug: Cinacalcet HCl” NCT00415584 ↗ “Drug: Cinacalcet HCl” NCT01479088 ↗ |
| Known as | cinacalcet hydrochloride | “I. To test the hypothesis that once-daily treatment with 30 mg of cinacalcet hydrochloride (Sensipar) will reduce the rate of rise of serum prostate-specific antigen (PSA)...” NCT01054079 ↗4“Cinacalcet hydrochloride is a calcimimetic agent indicated for the treatment of secondary hyperparathyroidism in dialysis-dependent patients with chronic kidney disease.” PMID 23222688 ↗ Feb 2013 “Cinacalcet hydrochloride (Sensipar) in hemodialysis patients on active vitamin D derivatives with controlled PTH and elevated calcium x phosphate.” PMID 17699221 ↗ Jan 2006 “Cinacalcet hydrochloride is an effective treatment for secondary hyperparathyroidism in patients with CKD not receiving dialysis.” PMID 15983958 ↗ Jul 2005 “Drug: Cinacalcet hydrochloride” NCT01439867 ↗ |
| Known as | Cinacalcet mylan | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201284 ↗ |
| Known as | KRN1493 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00952094 ↗ |
| Known as | Mimpara | “The purpose of this study is to evaluate the effects of cinacalcet (cinacalcet HCl or Sensipar®/Mimpara®) on cardiovascular events and death in chronic kidney disease (CKD)...” NCT00345839 ↗2“The OPTIMA study: assessing a new cinacalcet (Sensipar/Mimpara) treatment algorithm for secondary hyperparathyroidism.” PMID 18178780 ↗ Jan 2008 “a flexible dose of cinacalcet("Mimpara®") to a maximum dose of 90 mg/day.” NCT02273570 ↗ |
| Known as | Parareg | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201284 ↗ |
| Known as | Sensipar | “The purpose of this study is to evaluate the effects of cinacalcet (cinacalcet HCl or Sensipar®/Mimpara®) on cardiovascular events and death in chronic kidney disease (CKD)...” NCT00345839 ↗5“This study will measure the effect of cinacalcet (Sensipar) on parathyroid hormone (PTH) secretion in children and adolescents with hypophosphatemic rickets (XLH).” NCT00195936 ↗ “Cinacalcet hydrochloride (Sensipar) in hemodialysis patients on active vitamin D derivatives with controlled PTH and elevated calcium x phosphate.” PMID 17699221 ↗ Jan 2006 “The OPTIMA study: assessing a new cinacalcet (Sensipar/Mimpara) treatment algorithm for secondary hyperparathyroidism.” PMID 18178780 ↗ Jan 2008 “Sensipar (Cinacalcet HCl)” NCT00261950 ↗ |
| Action | Activate | “Calcimimetics are compounds that allosterically modulate the CaR, thereby enhancing its sensitivity to circulating serum calcium concentrations and consequently decreasing PTH...” NCT00195936 ↗1“Calcium sensing receptor positive allosteric modulator” CHEMBL1201284 ↗ |
| Modality | Other / unclassified | “Cinacalcet is a calcimimetic agent recently approved by the FDA for treating hypercalcemia in patients with parathyroid carcinoma and secondary HPT in patients with chronic...” NCT00195936 ↗ |
| Route | Oral | “30 mg QD orally” NCT00037635 ↗ |
| Target | CASR | “Calcium sensing receptor positive allosteric modulator” CHEMBL1201284 ↗ |