Drugs / Bixalomer
Bixalomer
Trials 14
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT01124747 | Apr → May 2010 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01115972 | Mar → Apr 2010 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01115985 | Mar → Apr 2010 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01115946 | Mar → Apr 2010 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT00756860 | May → Aug 2008 | — | Amgen Research (Munich) GmbH | Completed | No outcome recorded |
| Phase 24 trials · 1 met primary | ||||||
| Phase 2 | NCT00530114 | Mar → Nov 2008 | end stage renal failure, hyperphosphatemia | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT02753894 | Jan → Jun 2008 | hyperphosphatemia, polyuria, and seizures | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 2 | NCT00505037 | Oct 2007 → Sep 2008 | chronic kidney disease, hyperphosphatemia | Astellas Pharma Inc | Completed | Met primary |
| Phase 2 | NCT00358046 | Jun 2006 → ? | impaired renal function disease | Ilypsa | Unknown | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT01742611 | Mar 2013 → Apr 2015 | chronic kidney disease, hyperphosphatemia, impaired renal function disease | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT01742585 | Oct 2012 → May 2014 | chronic kidney disease, hyperphosphatemia, impaired renal function disease | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT01057407 | Jan → Sep 2010 | chronic kidney disease, impaired renal function disease | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT01017276 | Nov 2009 → Sep 2010 | chronic kidney disease, impaired renal function disease | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT00892749 | May 2009 → Sep 2010 | chronic kidney disease, hyperphosphatemia, impaired renal function disease | Astellas Pharma Inc | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2016-09-28 | Astellas Pharma Inc | Regulatory Astellas Receives Approval for Kiklin® Granules, a Treatment for Hyperphosphatemia, in Japan astellas.com ↗
Astellas Receives Approval for Kiklin® Granules, a Treatment for Hyperphosphatemia, in Japan |
| 2015-09-30 | Astellas Pharma Inc | Regulatory Submission of a Supplemental New Drug Application for ASP1585 Granule,a Treatment for Hyperphosphatemia, in Japan astellas.com ↗
today announced that it submitted a supplemental new drug application for ASP1585 granule |
| 2015-03-17 | Astellas Pharma Inc | Regulatory Astellas Submits Supplemental New Drug Application for Kiklin® Capsules, a Treatment for Hyperphosphatemia, in Japan astellas.com ↗
Astellas Pharma Inc. (“Astellas”; Tokyo:4503; President and CEO: Yoshihiko Hatanaka) today announced that it submitted a supplemental new drug application for “Kiklin® Capsules 250mg (generic name: Bixalomer)” to the Ministry of Health, Labour and Welfare in Japan. |
| 2012-03-30 | Astellas Pharma Inc | Regulatory Astellas Pharma Obtains Approval in Japan for Treating Hyperphosphatemiawith Kiklin® Capsules astellas.com ↗
Kiklin® Capsules (development code: ASP1585, generic name:Bixalomar) were granted Japanese marketing approval today for the indication of hyperphosphatemia in patients on dialysis with chronic kidney disease. |
| 2011-03-14 | Astellas Pharma Inc | Regulatory Astellas Pharma Inc.: Submits Application for Marketing Approval of Bixalomer (ASP1585) for Treatment of Hyperphosphatemia, in Japan astellas.com ↗
Astellas Pharma Inc. (“Astellas”; headquarters: Tokyo; President and CEO: Masafumi Nogimori) announced today that it submitted a market authorization application for an amine-functional phosphate-binding polymer bixalomer (generic name; development code: ASP1585) to the Ministry of Health, Labour and Welfare in Japan. |
All press releases naming this drug 7 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Bixalomer | “Bixalomer (Kiklin® Capsules) is a non-absorbable polymer that decreases serum phosphate levels by binding phosphate in the gastrointestinal tract.” PMID 24975892 ↗ Jun 2014 |
| Known as | AMG 223 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00756860 ↗ |
| Known as | ASP1585 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00892749 ↗ |
| Known as | Bixalomere | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297202 ↗ |
| Known as | Bixalomero | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297202 ↗ |
| Known as | ILY101 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00358046 ↗ |
| Known as | Kiklin | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297202 ↗ |
| Known as | Kiklin Capsules | “Bixalomer (Kiklin® Capsules) is a non-absorbable polymer that decreases serum phosphate levels by binding phosphate in the gastrointestinal tract.” PMID 24975892 ↗ Jun 2014 |
| Modality | Other / unclassified | “a non-absorbed, metal-free polymer” NCT00358046 ↗ |
| Modality | Small molecule | — CHEMBL4297202 ↗ |
| Route | Oral | “Oral” NCT00505037 ↗ |