Drugs / PA21
PA21
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed hyperphosphatemia 1 milestone | |||||
| Filed | Japan (PMDA) | — | hyperphosphatemia | 2014-11-19 | “高リン血症治療薬「PA21（開発番号）」の製造販売承認申請を行いました” kissei.co.jp ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Velphoro | — | 2014-08-26 | europa.eu ↗ |
Trials 17
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT01477424 | Nov 2011 → Feb 2012 | — | Vifor Pharma | Completed | No outcome recorded |
| Phase 1 | NCT01477411 | Nov 2011 → Jan 2012 | — | Vifor Pharma | Completed | No outcome recorded |
| Phase 1 | NCT01452906 | Sep → Dec 2011 | — | Vifor Pharma | Completed | No outcome recorded |
| Phase 1 | NCT01438359 | Jul → Sep 2011 | — | Vifor Pharma | Completed | No outcome recorded |
| Phase 1 | NCT01324752 | Mar → Jun 2011 | — | Vifor Pharma | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT01521494 | Jan → Jul 2012 | chronic kidney disease | Kissei Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT00824460 | Dec 2008 → Oct 2009 | chronic kidney disease | Vifor Pharma | Completed | No outcome recorded |
| Phase 38 trials · 2 met primary · 1 missed | ||||||
| Phase 3 | NCT03644264 | Aug 2018 → Aug 2020 | chronic kidney disease, hyperphosphatemia | Vifor Fresenius Medical Care Renal Pharma | Completed | Met primary |
| Phase 3 | NCT02688764 | May 2016 → Feb 2019 | hyperphosphatemia | Vifor Fresenius Medical Care Renal Pharma | Terminated | Missed primary |
| Phase 3 | NCT01850641 | Apr → Dec 2013 | hyperphosphatemia | Kissei Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT01850602 | Apr → Dec 2013 | hyperphosphatemia | Kissei Pharmaceutical Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT01833494 | Mar 2013 → Aug 2014 | hyperphosphatemia, polyuria, and seizures | Kissei Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT01464190 | Sep 2011 → Oct 2012 | chronic kidney disease | Vifor Pharma | Completed | No outcome recorded |
| Phase 3 | NCT01324128 | Mar 2011 → Apr 2012 | chronic kidney disease | Vifor Pharma | Completed | No outcome recorded |
| Phase 3 | NCT01852682 | ? → Mar 2014 | hyperphosphatemia | Kissei Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT04485039 | Jun → Dec 2022 | smallpox | SIGA Technologies | Completed | No outcome recorded |
| Phase 4 | NCT04046263 | Feb 2020 → Jul 2021 | hyperphosphatemia | University of Colorado, Denver | Completed | Mixed |
| Comparator or background therapy2 trials | ||||||
| Phase 2 | NCT03010072 Comparator | Jun 2017 → Dec 2018 | end stage renal failure | Prim. Priv. Doz. Dr. Daniel Cejka | Completed | No outcome recorded |
| Phase 2/3 | NCT03824587 Background | Feb → Jul 2019 | hyperphosphatemia | Ardelyx | Completed | Met primary |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2021-04-30 | CSL Behring | Results VFMCRP announces positive results of phase-III clinical trial of Velphoro® in China csl.com ↗
The study met its primary endpoint demonstrating non-inferiority versus sevelamer carbonate in the change from baseline in serum phosphorus levels at week 12. |
| 2018-09-26 | Kissei Pharmaceutical Co., Ltd. | Regulatory 高リン血症治療薬「ピートル®顆粒分包」製造販売承認取得のお知らせ kissei.co.jp ↗
この度、高リン血症治療薬「ピートル ® チュアブル錠」（一般名：スクロオキシ水酸化鉄）の新しい剤形となる「ピートル ® 顆粒分包250mg」及び「ピートル ® 顆粒分包500mg」の製造販売承認を取得しましたので、お知らせいたします。 |
| 2015-09-28 | Kissei Pharmaceutical Co., Ltd. | Regulatory 高リン血症治療薬「ピートル®チュアブル錠」製造販売承認取得のお知らせ kissei.co.jp ↗
キッセイ薬品工業株式会社（本社：長野県松本市、代表取締役会長兼最高経営責任者：神澤陸雄）は、本日、厚生労働省より高リン血症治療薬「ピートル ® チュアブル錠250mg」及び「ピートル ® チュアブル錠500mg」（開発番号：PA21、一般名：スクロオキシ水酸化鉄、以下本剤）の製造販売承認を取得しましたのでお知らせ致します。 |
| 2014-11-19 | Kissei Pharmaceutical Co., Ltd. | Regulatory 高リン血症治療薬「PA21（開発番号）」製造販売承認申請のお知らせ kissei.co.jp ↗
この度、高リン血症治療薬「PA21（開発番号）」の製造販売承認申請を行いましたのでお知らせ致します。 |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-08-22 | CSL Behring | VFMCRP announces U.S. Court upholds validity of Velphoro® patent csl.com ↗ |
| 2021-04-30 | CSL Behring | VFMCRP announces positive results of phase-III clinical trial of Velphoro® in China csl.com ↗ |
| 2018-09-26 | Kissei Pharmaceutical Co., Ltd. | 高リン血症治療薬「ピートル®顆粒分包」製造販売承認取得のお知らせ kissei.co.jp ↗ |
| 2015-09-28 | Kissei Pharmaceutical Co., Ltd. | 高リン血症治療薬「ピートル®チュアブル錠」製造販売承認取得のお知らせ kissei.co.jp ↗ |
| 2014-11-19 | Kissei Pharmaceutical Co., Ltd. | 高リン血症治療薬「PA21（開発番号）」製造販売承認申請のお知らせ kissei.co.jp ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 20 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PA21 | “This is a Phase 3, randomised, active controlled, multicentre study to investigate the safety and efficacy of PA21, a phosphate binder, for control of hyperphosphataemia in...” NCT01324128 ↗15“The Effect of Phosphate Lowering Using Sucroferric Oxyhydroxide (PA21) on Calcification Propensity of Serum” NCT03010072 ↗ |
| Known as | PA21-1 | “PA21-1 (1.25 g tablet containing 250 mg iron)” NCT01324128 ↗ |
| Known as | Sucroferric Oxyhydroxide | “Sucroferric oxyhydroxide (SFOH) is a non-calcium, iron-based phosphate binder that demonstrated sustained serum phosphorus (sP) control, good tolerability, and lower pill...” PMID 29656600 ↗ Apr 2018 |
| Known as | Velphoro | “PA21 (Velphoro®), chewable tablets 500 mg iron” NCT02688764 ↗ |
| Route | Oral | “One PA21 tablet will be taken orally with the largest meal of the day.” NCT00824460 ↗ |