Overview
Patiromer is a powder for suspension in water for oral administration, approved in the U.S. as Veltassa in October, 2015. Patiromer is supplied as patiromer sorbitex calcium which consists of the active moiety, patiromer, a non-absorbed potassium-binding polymer, and a calcium-sorbitol counterion. Each gram of patiromer is equivalent to a nominal amount of 2 grams of patiromer sorbitex calcium. The chemical name for patiromer sorbitex calcium is cross-linked polymer of calcium 2-fluoroprop-2-enoate with diethenylbenzene and octa-1,7-diene, combination with D-glucitol. Patiromer sorbitex calcium is an amorphous, free-flowing powder that is composed of individual spherical beads.
Indication
Patiromer is indicated for the treatment of hyperkalemia.
Associated Conditions
- Hyperkalemia
Research Report
A Comprehensive Monograph on Patiromer (DB09263) for the Management of Hyperkalemia
Executive Summary & Drug Profile
Overview of Patiromer: A Novel Polymer for Hyperkalemia Management
Patiromer is a non-absorbed, cation exchange polymer developed for the oral treatment of hyperkalemia, a condition characterized by elevated potassium levels in the blood.[1] Marketed under the brand name Veltassa, it represents a significant therapeutic advancement, being one of the first new medications approved for this indication in over five decades.[1] This development addresses a long-standing clinical need for effective and well-tolerated agents to manage chronic hyperkalemia, particularly as an alternative to older resins like sodium polystyrene sulfonate, which are often associated with poor tolerability and safety concerns.[4]
Patiromer is classified as a small molecule potassium binder and is specifically indicated for the management of hyperkalemia in adults and pediatric patients aged 12 years and older.[2] A critical limitation of its use, however, is that it is not intended for the emergency treatment of life-threatening hyperkalemia due to its delayed onset of action, which is approximately seven hours.[1] Acute, severe hyperkalemia requires immediate interventions such as intravenous calcium, insulin and glucose infusions, or hemodialysis to rapidly stabilize cardiac cell membranes and shift potassium intracellularly.[1] Patiromer's role is therefore firmly established in the chronic or sub-acute management of elevated potassium levels, where sustained control is the primary therapeutic goal.[4]
Key Therapeutic Attributes and Clinical Role
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/03/05 | Phase 3 | Recruiting | Mario Negri Institute for Pharmacological Research | ||
2024/02/13 | Phase 4 | Recruiting | |||
2023/03/27 | Phase 3 | Terminated | Mario Negri Institute for Pharmacological Research | ||
2023/03/13 | Phase 2 | Recruiting | |||
2021/11/29 | Phase 3 | Recruiting | Vifor Fresenius Medical Care Renal Pharma | ||
2021/08/31 | Phase 4 | Completed | Oslo University Hospital | ||
2020/10/14 | Phase 4 | Terminated | |||
2020/09/28 | N/A | Completed | |||
2020/06/23 | Phase 4 | Terminated | Comprehensive Research Associates | ||
2019/10/29 | Phase 4 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Vifor Pharma, Inc. | 53436-252 | ORAL | 25.2 g in 1 1 | 10/10/2023 | |
Vifor Pharma, Inc. | 53436-084 | ORAL | 8.4 g in 1 1 | 10/10/2023 | |
Vifor Pharma, Inc. | 53436-168 | ORAL | 16.8 g in 1 1 | 10/10/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 7/19/2017 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
VELTASSA patiromer (as sorbitex calcium)16.8 g powder for oral suspension sachet | 281014 | Medicine | A | 12/12/2017 | |
VELTASSA patiromer (as sorbitex calcium) 25.2 g powder for oral suspension sachet | 281013 | Medicine | A | 12/12/2017 | |
VELTASSA patiromer (as sorbitex calcium) 8.4 g powder for oral suspension sachet | 281012 | Medicine | A | 12/12/2017 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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