Drugs / Patiromer
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Veltassa | — | 2017-07-19 | europa.eu ↗ |
Trials 21
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 28 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT05766839 | Apr 2025 → Dec 2029 expected | — | Vifor Pharma | Recruiting | No outcome recorded |
| Phase 2 | NCT03799926 | Feb → Nov 2019 | — | Zeria Pharmaceutical | Completed | No outcome recorded |
| Phase 2 | NCT03326583 | Nov 2017 → Dec 2020 | end stage renal failure | Dominic Raj | Completed | Missed primary |
| Phase 2 | NCT03087058 | Jul 2017 → Jan 2021 | — | Vifor Pharma | Terminated | No outcome recorded |
| Phase 2 | NCT03071263 | Jan 2017 → Nov 2018 | resistant hypertension | Relypsa, Inc. | Completed | Met primary |
| Phase 2 | NCT01371747 | Jun 2011 → May 2013 | chronic kidney disease, hypertensive disorder | Relypsa, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01130597 | May → Sep 2010 | heart failure | Relypsa, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02033317 | Aug → Dec 2008 | — | Relypsa, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 34 trials · 1 met primary | ||||||
| Phase 3 | NCT06858280 | Jul 2025 → Jul 2026 overdue | chronic kidney disease | Mario Negri Institute for Pharmacological Research | Recruiting | No outcome recorded |
| Phase 3 | NCT05786469 | Aug 2023 → Nov 2024 | — | Mario Negri Institute for Pharmacological Research | Terminated | No outcome recorded |
| Phase 3 | NCT05136664 | Feb 2022 → Nov 2025 | chronic kidney disease | Vifor Fresenius Medical Care Renal Pharma | Completed | No outcome recorded |
| Phase 3 | NCT03888066 | Apr 2019 → Sep 2021 | — | Vifor Pharma | Completed | Met primary |
| Phase 49 trials · 1 met primary | ||||||
| Phase 4 | NCT06256991 | Apr 2024 → Dec 2026 expected | chronic kidney disease, hypertensive disorder | University Medical Center Groningen | Recruiting | No outcome recorded |
| Phase 4 | NCT05029310 | Sep 2021 → Feb 2023 | — | Oslo University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT04585542 | Oct 2020 → Jan 2025 | — | University of California, Irvine | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT04142788 | Aug 2020 → Dec 2022 | congestive heart failure | NHS Greater Glasgow and Clyde | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03781089 | Jun 2019 → Mar 2023 | end stage renal failure | Duke University | Completed | Met primary |
| Phase 4 | NCT03597035 | Jul 2018 → Jul 2020 | type 2 diabetes mellitus | University Hospitals Cleveland Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03183778 | Mar 2018 → Aug 2019 | chronic kidney disease | NYU Langone Health | Completed | No outcome recorded |
| Phase 4 | NCT03229265 | Aug 2017 → Aug 2019 | — | The Rogosin Institute | Completed | No outcome recorded |
| Phase 4 | NCT02694744 | Feb → Jul 2016 | — | Relypsa, Inc. | Completed | No outcome recorded |
| Comparator or background therapy5 trials | ||||||
| Phase 2 | NCT00868439 Comparator | Apr → Nov 2009 | heart failure | Relypsa, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03740048 Background | Jun 2019 → Nov 2021 | end stage renal failure | Wake Forest University Health Sciences | Completed | No outcome recorded |
| Phase 3 | NCT01810939 Comparator | Feb → Jul 2013 | chronic kidney disease | Relypsa, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT04443608 Comparator | Oct 2020 → Mar 2023 | — | Comprehensive Research Associates | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02933450 Comparator | Aug 2016 → Aug 2017 | chronic renal failure syndrome | Baylor College of Medicine | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2024-09-24 | Zeria Pharmaceutical | Regulatory 高カリウム血症治療薬(ビルタサ)製造販売承認取得のお知らせ zeria.co.jp ↗ |
| 2024-09-24 | CSL Behring | Regulatory Veltassa® (patiromer) approved in Japan for the treatment of adults with hyperkalemia csl.com ↗ |
| 2022-04-04 | CSL Behring | Results DIAMOND trial: Veltassa® enables patients to achieve long-term potassium control and optimized RAASi therapy csl.com ↗
Vifor Pharma today announced full results from its phase-IIIb DIAMOND trial showing that Veltassa® allowed patients to achieve long-term potassium control, reduced the risk of recurrent hyperkalemia and prolonged optimized and guideline recommended renin-angiotensin aldosterone system inhibitor (RAASi) therapy. |
| 2021-12-21 | CSL Behring | Results Vifor Pharma reports positive outcome of the phase-IIIb DIAMOND trial of Veltassa® csl.com ↗
Vifor Pharma today announced positive findings in the completed phase-IIIb DIAMOND trial of Veltassa® in heart failure patients with either manifest hyperkalemia or with a history of hyperkalemia while treated with renin-angiotensin aldosterone system inhibitor (RAASi) therapy. |
| 2019-05-10 | CSL Behring | Results Vifor Pharma Press Release Phase Ii Amber Study csl.com ↗
Veltassa® was shown to enable persistent use of spironolactone by controlling blood potassium levels. |
| 2018-03-08 | CSL Behring | Regulatory US FDA Approves use of VELTASSA® with or without food csl.com ↗
THE UNITED STATES (US) FOOD AND DRUG ADMINISTRATION (FDA) HAS APPROVED A SUPPLEMENTAL NEW DRUG APPLICATION (SNDA) FOR VELTASSA® (PATIROMER) FOR ORAL SUSPENSION |
| 2018-01-04 | CSL Behring | Regulatory Veltassa® approved for marketing in Switzerland for the treatment of Hyperkalaemia csl.com ↗
SWISSMEDIC HAS APPROVED PATIROMER TO BE MARKETED IN SWITZERLAND AS VELTASSA® FOR THE TREATMENT OF HYPERKALAEMIA (ELEVATED SERUM POTASSIUM LEVELS) IN ADULTS. |
All press releases naming this drug 8 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-09-24 | Zeria Pharmaceutical | 高カリウム血症治療薬(ビルタサ)製造販売承認取得のお知らせ zeria.co.jp ↗ |
| 2024-09-24 | CSL Behring | Veltassa® (patiromer) approved in Japan for the treatment of adults with hyperkalemia csl.com ↗ |
| 2022-04-04 | CSL Behring | DIAMOND trial: Veltassa® enables patients to achieve long-term potassium control and optimized RAASi therapy csl.com ↗ |
| 2021-12-21 | CSL Behring | Vifor Pharma reports positive outcome of the phase-IIIb DIAMOND trial of Veltassa® csl.com ↗ |
| 2021-04-28 | CSL Behring | First patient enrolled in CARE-HK in HF to evaluate role of Veltassa® (patiromer) in enabling RAASi treatment csl.com ↗ |
| 2019-05-10 | CSL Behring | Vifor Pharma Press Release Phase Ii Amber Study csl.com ↗ |
| 2018-03-08 | CSL Behring | US FDA Approves use of VELTASSA® with or without food csl.com ↗ |
| 2018-01-04 | CSL Behring | Veltassa® approved for marketing in Switzerland for the treatment of Hyperkalaemia csl.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 27 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | patiromer | “The addition of Patiromer will enable introduction of MRA therapy at therapeutic doses and avoidance of hyperkalemia.” NCT03597035 ↗25“A newer potassium binder, patiromer, has been approved by FDA and EMA for the treatment of hyperkalemia.” NCT05786469 ↗ |
| Known as | Veltassa | “Patiromer Powder for Oral Suspension [Veltassa]” NCT04443608 ↗ |
| Modality | Other / unclassified | “a non-absorbed, orally administered, potassium [K+]-binding polymer” PMID 21208974 ↗ Jan 2011 |
| Route | Oral | “orally administered” PMID 21208974 ↗ Jan 2011 |