Overview
Sevelamer is a phosphate binding drug used to prevent hyperphosphataemia in patients with chronic renal failure. It is marketed by Genzyme under the trade name Renagel.
Background
Sevelamer is a phosphate binding drug used to prevent hyperphosphataemia in patients with chronic renal failure. It is marketed by Genzyme under the trade name Renagel.
Indication
For the control of serum phosphorus in patients with Chronic Kidney Disease (CKD) on hemodialysis.
Associated Conditions
- Hyperphosphataemia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/22 | Phase 3 | Completed | Alebund Pharmaceuticals | ||
2024/10/29 | Phase 2 | Recruiting | Jemincare | ||
2024/10/28 | Phase 4 | Recruiting | China National Center for Cardiovascular Diseases | ||
2023/03/10 | Phase 2 | Completed | Alebund Pharmaceuticals | ||
2020/09/16 | Phase 2 | Completed | Shanghai Alebund Pharmaceuticals Limited | ||
2020/07/24 | Phase 4 | Completed | |||
2020/07/07 | Phase 3 | Completed | |||
2020/03/09 | Phase 1 | Completed | |||
2019/06/18 | Phase 4 | Completed | |||
2019/06/13 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Precision Dose, Inc. | 68094-034 | ORAL | 800 mg in 1 1 | 6/30/2021 | |
| Amneal Pharmaceuticals of New York LLC | 0115-1365 | ORAL | 800 mg in 1 1 | 12/31/2020 | |
| Genzyme Corporation | 58468-0131 | ORAL | 2400 mg in 1 1 | 9/25/2023 | |
| Amneal Pharmaceuticals of New York LLC | 0115-1366 | ORAL | 2400 mg in 1 1 | 12/31/2020 | |
| Hangzhou Anprime Biopharm Co., Ltd. | 72823-301 | ORAL | 800 mg in 1 1 | 3/24/2023 | |
| Winthrop U.S, a business of sanofi-aventis U.S. LLC | 0955-1048 | ORAL | 800 mg in 1 1 | 12/16/2022 | |
| Exelan Pharmaceuticals Inc. | 76282-407 | ORAL | 800 mg in 1 1 | 9/8/2017 | |
| Winthrop U.S, a business of sanofi-aventis U.S. LLC | 0955-1052 | ORAL | 0.8 g in 1 1 | 12/7/2023 | |
| Glenmark Pharmaceuticals Inc., USA | 68462-447 | PARENTERAL | 800 mg in 1 1 | 6/30/2020 | |
| Micro Labs Limited | 42571-378 | ORAL | 800 mg in 1 1 | 2/14/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 6/9/2009 | ||
Authorised | 1/15/2015 | ||
Authorised | 1/15/2015 | ||
Authorised | 1/28/2000 | ||
Authorised | 1/15/2015 | ||
Authorised | 1/15/2015 | ||
Authorised | 1/28/2000 | ||
Authorised | 6/9/2009 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Renvela ® Tablet 800mg | SIN13725P | TABLET, FILM COATED | 800 mg | 11/6/2009 | |
| SEVELA FILM COATED TABLET 800MG | SIN16105P | TABLET, FILM COATED | 800mg | 2/16/2021 | |
| CAVSAMIR FILM COATED TABLET 800MG | SIN16993P | TABLET, FILM COATED | 800 mg | 4/26/2024 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Sevelamer Carbonate for Suspension | 国药准字H20253566 | 化学药品 | 干混悬剂 | 3/4/2025 | |
| Sevelamer Carbonate for Suspension | 国药准字H20243078 | 化学药品 | 干混悬剂 | 1/23/2024 | |
| Sevelamer Carbonate for Suspension | 国药准字H20243077 | 化学药品 | 干混悬剂 | 1/23/2024 | |
| Sevelamer Carbonate for Suspension | 国药准字H20244815 | 化学药品 | 干混悬剂 | 9/3/2024 | |
| Sevelamer Carbonate Tablets | 国药准字H20203303 | 化学药品 | 片剂 | 7/8/2020 | |
| Sevelamer Carbonate Tablets | 国药准字H20233203 | 化学药品 | 片剂 | 2/21/2023 | |
| Sevelamer Carbonate Tablets | 国药准字HJ20230122 | 化学药品 | 片剂 | 12/29/2023 | |
| Sevelamer Carbonate Tablets | 国药准字H20234169 | 化学药品 | 片剂 | 9/19/2023 | |
| Sevelamer Carbonate Tablets | 国药准字HJ20181039 | 化学药品 | 片剂 | 8/5/2022 | |
| Sevelamer Carbonate Tablets | 国药准字HJ20181037 | 化学药品 | 片剂 | 8/5/2022 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| SEVELAMER CARBONATE TABLETS 800MG | N/A | hong kong medical supplies ltd | N/A | N/A | 2/11/2025 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| RENAGEL sevelamer hydrochloride 800 mg tablet bottle | 101553 | Medicine | A | 6/30/2005 | |
| SEVELAMER LUPIN sevelamer carbonate 800 mg film-coated tablet bottle | 286651 | Medicine | A | 11/9/2018 | |
| ARX-SEVELAMER sevelamer carbonate 800 mg film-coated tablet bottle | 286648 | Medicine | A | 11/9/2018 | |
| SEVELAMER-DRLA sevelamer carbonate 800 mg film-coated tablet bottle | 286650 | Medicine | A | 11/9/2018 | |
| SEVELAMER-REDDY'S sevelamer carbonate 800 mg film-coated tablet bottle | 286649 | Medicine | A | 11/9/2018 |