Drugs / EVOCALCET
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Japan (PMDA) | — | non-renal secondary hyperparathyroidism | 2017-04-27 | “it has been filed an application of manufacturing and marketing approval to Japan's Ministry of Health, Labor and Welfare (MHLW)” kyowakirin.com ↗ |
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT04206657 | Dec 2019 → Jun 2021 | — | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02143271 | May → Dec 2014 | secondary hyperparathyroidism | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01935856 | Aug 2013 → Mar 2014 | hyperparathyroidism | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT02216656 | Jul 2014 → Feb 2015 | secondary hyperparathyroidism of renal origin | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02549391 | Sep 2015 → Nov 2016 | secondary hyperparathyroidism | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT03822507 | Apr 2019 → Sep 2021 | secondary hyperparathyroidism of renal origin | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03280264 | Aug 2017 → Apr 2019 | parathyroid gland carcinoma, primary hyperparathyroidism | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02549417 | Sep 2015 → Dec 2016 | secondary hyperparathyroidism of renal origin | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02549404 | Sep 2015 → Dec 2016 | secondary hyperparathyroidism | Kyowa Kirin, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2019-12-20 | Kyowa Kirin, Inc. | Regulatory Kyowa Kirin Receives Partial Change Approval for ORKEDIA® in Japan kyowakirin.com ↗
it has received the partial change approval for ORKEDIA® |
| 2019-04-24 | Kyowa Kirin, Inc. | Regulatory Kyowa Hakko Kirin Submits the Partial Change Approval Application of KHK7580 (evocalcet) in Japan kyowakirin.com ↗
Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Masashi Miyamoto, "Kyowa Hakko Kirin") announces today that it has submitted a supplemental application of KHK7580 (evocalcet)*1 for the treatment of hypercalcemia in patients with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy*2 to the Ministry of Health, Labor and Welfare (MHLW) in Japan. |
| 2018-05-22 | Kyowa Kirin, Inc. | Regulatory Kyowa Hakko Kirin Launches ORKEDIA® TABLETS (Evocalcet) for the Treatment of Secondary Hyperparathyroidism in Patients on Maintenance Dialysis in Japan kyowakirin.com ↗
Tokyo, Japan, May 22, 2018 ---Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and COO: Masashi Miyamoto, "Kyowa Hakko Kirin") announced today that ORKEDIA® TABLETS (generic name: evocalcet, code name: KHK7580) has been listed on the National Health Insurance (NHI) Drug Price List and launched for the treatment of secondary hyperparathyroidism in patients on maintenance dialysis in Japan. |
| 2018-03-23 | Kyowa Kirin, Inc. | Regulatory Kyowa Hakko Kirin Receives Approval for ORKEDIA® Tablets (Evocalcet) for the Treatment of Secondary Hyperparathyroidism in Patients on Maintenance Dialysis in Japan kyowakirin.com ↗
"We are very pleased to announce the approval for ORKEDIA® TABLETS in Japan," said Mitsuo Satoh, Ph.D., Head of Research and Development Division of Kyowa Hakko Kirin. |
| 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. |
| 2017-04-27 | Kyowa Kirin, Inc. | Regulatory Kyowa Hakko Kirin Submits Application for Approval of Evocalcet (KHK7580) for Secondary Hyperparathyroidism in Maintenance Dialysis Patients in Japan kyowakirin.com ↗
Tokyo, Japan, April 27, 2017 --- Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") announced today that it has been filed an application of manufacturing and marketing approval to Japan's Ministry of Health, Labor and Welfare (MHLW) seeking approval of evocalcet (generic name, code name: KHK7580) which has been developed for secondary hyperparathyroidism in maintenance dialysis patients. |
| 2017-01-31 | Kyowa Kirin, Inc. | Results Kyowa Hakko Kirin Announces Top-Line Results of Phase 3 Clinical Study of KHK7580 with Secondary Hyperparathyroidism in Japan kyowakirin.com ↗
Tokyo, Japan, January 31, 2017 --- Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") announced today that top-line results of the Japanese Phase 3 trial of KHK7580 met its primary endpoint. |
All press releases naming this drug 10 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | EVOCALCET | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297621 ↗ |
| Known as | KHK7580 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01935856 ↗ |
| Known as | MT-4580 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297621 ↗ |
| Action | Activate | “Calcium sensing receptor positive allosteric modulator” CHEMBL4297621 ↗ |
| Modality | Small molecule | — CHEMBL4297621 ↗ |
| Route | Oral | “Oral administration” NCT01935856 ↗ |
| Target | CASR | “Calcium sensing receptor positive allosteric modulator” CHEMBL4297621 ↗ |