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.
Background
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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/03/05 | Phase 3 | Not yet 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 | Recruiting | |||
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 | ||
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 |