sevelamer
Trade name: renagel
Approved
Oct 30, 1998
Sevelamer (rINN) is a phosphate binding medication used to treat hyperphosphatemia in patients with chronic kidney disease. When taken with meals, it binds to dietary phosphate and prevents its absorption. Sevelamer was invented and developed by GelTex Pharmaceuticals. Sevelamer is marketed by Sanofi under the brand names Renagel and Renvela. — Wikipedia
Clinical trial activity
82 trials · 90 clinical orgs · 32 marketing orgs
Earliest trial started Nov 1, 2000 (NCT00560300)
Timeline
1990s
- Oct 30, 1998
Earliest FDA Approval
- Oct 30, 1998
Genzyme — NDA Secondary Org
2000s
2010s
- Jun 13, 2017
Aurobindo Pharma — Marketing Organization
- Sep 29, 2017
Dr. Reddy's Laboratories — Marketing Organization
- Oct 23, 2017
Impax Laboratories — Marketing Organization
- Oct 26, 2017
Invagen Pharms — Marketing Organization
- Oct 26, 2017
Cipla — Marketing Organization
- Nov 28, 2017
Amneal Pharmaceuticals — Marketing Organization
- Mar 20, 2018
TWi Biotechnology, Inc. — Marketing Organization
- Mar 20, 2018
Salarius Pharmaceuticals, LLC — Marketing Organization
- Nov 29, 2018
Rising Pharmaceuticals — Marketing Organization
- Nov 29, 2018
Wilshire Pharmaceuticals — Marketing Organization
- Nov 29, 2018
Indicus Pharma — Marketing Organization
- Feb 8, 2019
Glenmark Pharmaceuticals — Marketing Organization
2020s
- Apr 9, 2020
Anxin — Marketing Organization
- Apr 9, 2020
Sinotherapeutics — Marketing Organization
- Apr 9, 2020
Epic Pharma Llc — Marketing Organization
- Aug 5, 2020
Strides Pharma Science — Marketing Organization
- Aug 5, 2020
Mylan — Marketing Organization
- Aug 11, 2020
Zydus Discovery DMCC — Marketing Organization
- Jan 14, 2021
Lupin — Marketing Organization
- May 17, 2021
Bionpharma Inc — Marketing Organization
- Feb 7, 2022
Micro Labs Ltd India — Marketing Organization
- Mar 2, 2023
HANGZHOU ANPRIME — Marketing Organization
- Mar 2, 2023
Chartwell Pharmaceuticals — Marketing Organization
- Apr 19, 2023
Macleods Pharmaceuticals, Ltd — Marketing Organization
- Apr 19, 2023
Neogen — Marketing Organization
- Oct 24, 2024
Shandong Xinhua Pharmaceutical Company — Marketing Organization
- Feb 3, 2025
Navinta — Marketing Organization
- Feb 27, 2025
Torrent Pharmaceuticals Limited — Marketing Organization
Indications
Approved for
Studied for
- Arteriosclerosis · Phase 4
- Calcinosis · Phase 4
- Calcium Metabolism Disorders · Phase 4
- Cardiovascular Diseases · Phase 4
- Chronic Kidney Disease-Mineral and Bone Disorder · Phase 4
- Diabetic Nephropathies · Phase 2
- Dialysis · Phase 3
- Endothelium · Phase 4
- Healthy Volunteers · Phase 1
- Heart Valve Diseases · Phase 4
- HIV Infections · Phase 2
- Hypercholesterolemia · Phase 2
- Hyperparathyroidism · Phase 3
- Hyperparathyroidism, Secondary · Phase 4
- Hyperphosphatemia · Phase 4
- Insulin Resistance · Phase 2
- Kidney Diseases · Phase 3
- Kidney Failure, Chronic · Phase 4
- Peritoneal Dialysis · Phase 3
- Renal Dialysis · Phase 4
- Renal Insufficiency · Phase 3
- Vascular Diseases · Phase 4
Mechanism of action
- Unspecified targetOTHER
Unknown
- PhosphateSEQUESTERING AGENT
Phosphate sequestering agent
It's a non-absorbed binding crosslinked polymer which binds to phosphate and removes it from circulation in case of hyperphosphatemia
Approval history
- approvedOct 30, 1998
Chemistry & pharmacology
SMILES
NCC=C.ClCC1CO1- Mol. weight
- 149.62 g/mol
- Chirality
- Racemic Mixture
- Inorganic
- No
- Polymer
- Yes
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL1201798 ↗
- WikipediaSevelamer ↗
- NCATS941N5DUU5C ↗
- ChEMBLCHEMBL5314349 ↗
- ChEMBLCHEMBL1201492 ↗
- ChEMBLCHEMBL5314347 ↗
- ChEMBLCHEMBL1201799 ↗
Also known as
- gt16-026a
- gt335-012
- gt335-012
- renagel
- renagel
- renagel
- renagel
- renagel
- renvela
- renvela
- renvela
- sevelamer
- sevelamer
- sevelamer
- sevelamer
- sevelamer
- sevelamer
- sevelamer
- sevelamer
- sevelamer
- sevelamer
- sévélamer
- sévélamer
- sevelamer carbonate
- sevelamer carbonate
- sevelamer carbonate
- sevelamer carbonate
- sevelamer carbonate
- sevelamer carbonate
- sevelamer carbonate
- sevelamer hcl
- sevelamer hcl
- sevelamer hcl
- sevelamer hydrochloride
- sevelamer hydrochloride
- sevelamer hydrochloride
- sevelamer hydrochloride
- sevelamer hydrochloride
- sevelamer hydrochloride
- sevelamero
- sevelamero
- sevelamerum
- sevelamerum
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06664125 | Phase 2 | Dec 30, 2024 | Jemincare |
| NCT06660524 | Phase 4 | Mar 1, 2024 | Chinese Academy of Medical Sciences |
| NCT07030595 | Phase 3 | Jun 12, 2023 | Alebund Pharmaceuticals |
| NCT05764590 | Phase 2 | Feb 20, 2023 | Alebund Pharmaceuticals, Sichuan University |
| NCT04551300 | Phase 2 | Oct 13, 2020 | Alebund Pharmaceuticals |
| NCT04299633 | Phase 1 | Mar 31, 2020 | Akebia Therapeutics |
| NCT04120922 | N/A | Nov 30, 2019 | University of London |
| NCT03988920 | Phase 4 | Jun 30, 2019 | Ardelyx |
| NCT03984760 | Phase 3 | Jun 30, 2019 | Changhai Hospital, China Medical University, Dalian Medical University, Daping Hospital, Guangdong Pharmaceutical University, Guangzhou Medical University, Henan Provincal People's Hospital, Jiangxi Provincial People's Hospital, Jilin University, Meihekou Central Hospital, Panion & BF Biotech Inc., People's Liberation Army of China, Qingdao University, Tonghua Central Hospital, Wuhan University |
| NCT04456803 | Phase 3 | May 24, 2019 | Sinomune Pharmaceutical Co., Ltd |
| NCT03739268 | N/A | Sep 1, 2018 | Sanofi, Steno Diabetes Center Copenhagen |
| NCT03596749 | Phase 3 | Sep 1, 2018 | Southern Medical University |
| NCT03644264 | Phase 3 | Aug 31, 2018 | Fresenius, Southern Medical University |
| NCT03427125 | Phase 3 | Jan 8, 2018 | Ardelyx |
| NCT03305471 | Phase 1 | Aug 17, 2017 | Daiichi Sankyo |
| NCT03202407 | Phase 3 | Aug 1, 2017 | Assiut University |
| NCT03001011 | Phase 3 | Jun 7, 2017 | Sanofi |
| NCT02965053 | Phase 1 | Dec 1, 2016 | Chugai |
| NCT02644486 | N/A | Jan 1, 2016 | Nanjing University |
| NCT02822131 | N/A | Jan 1, 2016 | University of Zurich |
Organizations
Research & Development (90)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Genzyme | For profit | 20 | 13 | 4 | 2001 |
| Sanofi | For profit | 5 | 1 | 2 | 2013 |
| Shire | For profit | 5 | 3 | 4 | 2007 |
| Fresenius | For profit | 4 | 1 | 2 | 2009 |
| Alebund Pharmaceuticals | For profit | 3 | 3 | 2 | 2020 |
| Ardelyx | For profit | 3 | 3 | 3 | 2013 |
| Novartis | For profit | 3 | 2 | 2 | 2008 |
| University of Texas, San Antonio | Academic/Hospital | 3 | 2 | 2 | 2005 |
| Vifor Inc. | For profit | 3 | 3 | 2 | 2008 |
| American Diabetes Association | Academic/Hospital | 2 | 0 | 1 | 2014 |
| Astellas | For profit | 2 | 2 | 2 | 2007 |
| China Medical University | Academic/Hospital | 2 | 0 | 2 | 2007 |
| Chugai | For profit | 2 | 2 | 2 | 2007 |
| Harvard University | Academic/Hospital | 2 | 1 | 2 | 2010 |
| Icahn School of Medicine at Mount Sinai | Academic/Hospital | 2 | 2 | 2 | 2009 |
| Ineos Healthcare Limited | For profit | 2 | 2 | 2 | 2007 |
| Mitsubishi | For profit | 2 | 0 | 1 | 2007 |
| Mitsubishi Tanabe | For profit | 2 | 2 | 1 | 2007 |
| Saglik Bilimleri Universitesi | Academic/Hospital | 2 | 2 | 1 | 2007 |
| Southern Medical University | Academic/Hospital | 2 | 1 | 1 | 2018 |
Marketing (39)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Amneal Pharmaceuticals | For profit | MKTG | Nov 28, 2017 |
| Anxin | For profit | MKTG | Apr 9, 2020 |
| Aurobindo Pharma | For profit | MKTG | Jun 13, 2017 |
| Aurobindo Pharma | For profit | SYN | Jun 13, 2017 |
| Bionpharma Inc | For profit | MKTG | May 17, 2021 |
| Bionpharma Inc | For profit | SYN | May 17, 2021 |
| Chartwell Pharmaceuticals | For profit | MKTG | Mar 2, 2023 |
| Cipla | For profit | MKTG | Oct 26, 2017 |
| Dr. Reddy's Laboratories | For profit | SYN | Sep 29, 2017 |
| Dr. Reddy's Laboratories | For profit | MKTG | Sep 29, 2017 |
| Epic Pharma Llc | For profit | MKTG | Apr 9, 2020 |
| GelTex Pharmaceuticals | For profit | NDA | — |
| GelTex Pharmaceuticals | For profit | IND | — |
| Genzyme | For profit | NDA2 | Oct 30, 1998 |
| Glenmark Pharmaceuticals | For profit | MKTG | Feb 8, 2019 |
| HANGZHOU ANPRIME | For profit | MKTG | Mar 2, 2023 |
| Impax Laboratories | For profit | MKTG | Oct 23, 2017 |
| Impax Laboratories | For profit | SYN | Nov 20, 2020 |
| Indicus Pharma | For profit | MKTG | Nov 29, 2018 |
| Invagen Pharms | For profit | MKTG | Oct 26, 2017 |
| Lupin | For profit | MKTG | Jan 14, 2021 |
| Macleods Pharmaceuticals, Ltd | For profit | MKTG | Apr 19, 2023 |
| Micro Labs Ltd India | For profit | MKTG | Feb 7, 2022 |
| Mylan | For profit | SYN | Dec 15, 2020 |
| Mylan | For profit | MKTG | Aug 5, 2020 |
| Navinta | For profit | MKTG | Feb 3, 2025 |
| Neogen | For profit | MKTG | Apr 19, 2023 |
| Rising Pharmaceuticals | For profit | SYN | Dec 15, 2020 |
| Rising Pharmaceuticals | For profit | MKTG | Nov 29, 2018 |
| Salarius Pharmaceuticals, LLC | For profit | MKTG | Mar 20, 2018 |
| Sanofi | For profit | NDA2 | Oct 19, 2007 |
| Sanofi-Aventis | For profit | NDA2 | Oct 19, 2007 |
| Shandong Xinhua Pharmaceutical Company | For profit | MKTG | Oct 24, 2024 |
| Sinotherapeutics | For profit | MKTG | Apr 9, 2020 |
| Strides Pharma Science | For profit | MKTG | Aug 5, 2020 |
| TWi Biotechnology, Inc. | For profit | MKTG | Mar 20, 2018 |
| Torrent Pharmaceuticals Limited | For profit | MKTG | Feb 27, 2025 |
| Wilshire Pharmaceuticals | For profit | MKTG | Nov 29, 2018 |
| Zydus Discovery DMCC | For profit | MKTG | Aug 11, 2020 |