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
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2019-07-03 | Lupin Limited | Regulatory Lupin receives U.S. FDA approval for Cinacalcet Tablets lupin.com ↗
Mumbai, Baltimore: Pharma major Lupin Limited (Lupin) announced that it has received approval for its Cinacalcet Tablets, 30 mg, 60 mg, and 90 mg from the United States Food and Drug Administration (U.S. FDA). |
| 2017-11-06 | Kyowa Kirin, Inc. | Results Kyowa Hakko Kirin Presented Results of Japan Phase III Clinical Study of Evocalcet at Kidney Week 2017 of the American Society of Nephrology kyowakirin.com ↗
The proportion was 72.7% and 76.7% in the evocalcet and cinacalcet groups, respectively. |
| 2017-08-31 | Amgen | Regulatory 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 ↗
The EC approved Mimpara based on studies Amgen began in 2007 to assess the use of Mimpara in pediatric patients with secondary HPT, who have very few treatment options. |
| 2017-06-23 | Amgen | Regulatory 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 ↗
Amgen (NASDAQ:AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the Marketing Authorization of a pediatric formulation (granules in capsule for opening) of Mimpara ® (cinacalcet). |
| 2015-11-07 | Amgen | Results Amgen Presents Detailed Data Comparing Etelcalcetide With Cinacalcet In Patients With Secondary Hyperparathyroidism Receiving Hemodialysis amgen.com ↗
There was no difference between the treatment arms in the mean number of days of vomiting or nausea per week |
| 2015-02-25 | Amgen | Results 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 ↗
Further, AMG 416 was statistically significantly superior to cinacalcet in the secondary endpoints of the proportion of patients achieving greater than 50 percent (52.4 percent versus 40.2 percent) and greater than 30 percent (68.2 percent versus 57.7 percent) PTH reduction from baseline during the EAP. |
| 2015-02-16 | Kyowa Kirin, Inc. | Regulatory Approval of REGPARA® Tablets 12.5mg in Japan kyowakirin.com ↗
Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") announced today that REGPARA® Tablets 12.5mg (generic name: cinacalcet hydrochloride) has been approved for manufacturing and marketing in Japan on February 10 as an additional formulation. |
| 2014-03-25 | Kyowa Kirin, Inc. | Regulatory Kyowa Hakko Kirin Submits Application for Approval of REGPARA® Tablets 12.5mg in Japan kyowakirin.com ↗
Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") announced today that it has filed an application for marketing approval to Japan's Ministry of Health, Labour and Welfare (MHLW) for REGPARA® Tablets 12.5mg(generic name: cinacalcet hydrochloride). |
| 2014-02-21 | Kyowa Kirin, Inc. | Regulatory Approval for Additional Indication of REGPARA® Tablets 25mg and 75mg kyowakirin.com ↗
it has been obtained an approval for additional dosage and administration for hypercalcemia in patients with parathyroid carcinoma |
| 2013-06-27 | Kyowa Kirin, Inc. | Regulatory Application Seeking Approval for Additional Indication for REGPARA® Tablets 25mg and 75mg kyowakirin.com ↗ |
| 2010-05-14 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Tentative Approval of Generic Sensipar® tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announced today that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Cinacalcet HCl Tablets 30, 60 & 90 mg. |
All press releases naming this drug 14 releases
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” NCT01479088 ↗ “Drug: Cinacalcet HCl” NCT00415584 ↗ |
| 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 ↗ |