Drugs / sevelamer
sevelamer
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | RENVELA | — | 2016-11-25 | fda.gov ↗ |
| Approved | EU (EMA) | Renvela | — | 2009-06-09 | europa.eu ↗ |
| Approved | US (FDA) | RENVELA | — | 2007-10-19 | fda.gov ↗ |
Trials 21 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT01308242 | Mar 2011 → Feb 2014 | chronic kidney disease | Milton S. Hershey Medical Center | Completed | No outcome recorded |
| Phase 14 trials | ||||||
| Phase 1 | NCT04299633 | Jun → Aug 2020 | — | Akebia Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT02346890 | Apr 2013 | — | Ardelyx | Completed | No outcome recorded |
| Phase 1 | NCT00925704 | Jun → Jul 2009 | — | Shire | Completed | No outcome recorded |
| Phase 1 | NCT00967629 | Jun 2009 → Feb 2010 | diabetic kidney disease | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT01574326 | May 2012 → Jun 2015 | chronic kidney disease, hyperphosphatemia | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 2 | NCT01493050 | Feb 2012 → Dec 2013 | diabetic kidney disease | Gary Striker | Completed | No outcome recorded |
| Phase 2 | NCT01543958 | Nov 2011 → Sep 2012 | HIV infectious disease | Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections | Completed | No outcome recorded |
| Phase 2 | NCT01231438 | Oct 2010 → Mar 2011 | kidney failure | Helse Stavanger HF | Completed | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT03596749 | Sep 2018 → May 2019 | chronic kidney disease | Fan Fan Hou | Unknown | No outcome recorded |
| Phase 3 | NCT02332811 | Oct 2013 → Jul 2014 | chronic renal failure syndrome | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 3 | NCT01220843 | Oct 2010 → Apr 2013 | chronic renal failure syndrome | Centre Hospitalier Universitaire, Amiens | Completed | No outcome recorded |
| Phase 3 | NCT01191255 | Oct 2010 → Jan 2013 | hyperphosphatemia, kidney failure | Keryx Biopharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01736150 | Mar → Sep 2010 | chronic kidney disease | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 3 | NCT00681941 | Jan 2006 → Jan 2007 | chronic kidney disease, hyperphosphatemia | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 3 | NCT00268957 | Jan 2006 → Mar 2007 | chronic renal failure syndrome, end stage renal failure | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT04485039 | Jun → Dec 2022 | smallpox | SIGA Technologies | Completed | No outcome recorded |
| Phase 4 | NCT03988920 | Jun 2019 → Jun 2021 | end stage renal failure, hyperphosphatemia | Ardelyx | Completed | No outcome recorded |
| Phase 4 | NCT01277497 | Jan 2011 → Jan 2016 | chronic kidney disease | Albany College of Pharmacy and Health Sciences | Terminated | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT02644486 | Jan 2016 → Feb 2018 | glomerular disorder | Zhi-Hong Liu, M.D. | Terminated | No outcome recorded |
| — | NCT00999037 | Oct 2009 → Jun 2015 | secondary hyperparathyroidism of renal origin | University of California, Los Angeles | Completed | No outcome recorded |
Also used as a comparator or background therapy in 16 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02965053 Background | Dec 2016 → Aug 2018 | hyperphosphatemia | Chugai Pharmaceutical | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT06664125 Comparator | Dec 2024 → Jun 2025 overdue | hyperphosphatemia | Jemincare | Recruiting | No outcome recorded |
| Phase 2 | NCT05764590 Comparator | Feb → Aug 2023 | chronic kidney disease, hyperphosphatemia | Alebund Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT04551300 Comparator | Oct 2020 → Jun 2022 | hyperphosphatemia | Shanghai Alebund Pharmaceuticals Limited | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03824587 Background | Feb → Jul 2019 | hyperphosphatemia | Ardelyx | Completed | No outcome recorded |
| Phase 39 trials | ||||||
| Phase 3 | NCT07030595 Comparator | Jun 2023 → Oct 2024 | end stage renal failure, hyperphosphatemia | Alebund Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT03984760 Comparator | Jun 2019 → Feb 2021 | end stage renal failure, hyperphosphatemia | Panion & BF Biotech Inc. | Completed | No outcome recorded |
| Phase 3 | NCT04456803 Comparator | May 2019 → Sep 2022 | end stage renal failure, hyperphosphatemia | Sinomune Pharmaceutical Co., Ltd | Completed | No outcome recorded |
| Phase 3 | NCT03644264 Comparator | Aug 2018 → Aug 2020 | chronic kidney disease, hyperphosphatemia | Vifor Fresenius Medical Care Renal Pharma | Completed | No outcome recorded |
| Phase 3 | NCT03427125 Comparator | Jan 2018 → Nov 2019 | hyperphosphatemia | Ardelyx | Completed | No outcome recorded |
| Phase 3 | NCT01464190 Comparator | Sep 2011 → Oct 2012 | chronic kidney disease | Vifor Pharma | Completed | No outcome recorded |
| Phase 3 | NCT01324128 Comparator | Mar 2011 → Apr 2012 | chronic kidney disease | Vifor Pharma | Completed | No outcome recorded |
| Phase 3 | NCT01191762 Comparator | Apr 2010 → Aug 2012 | chronic kidney disease, secondary hyperparathyroidism | Kenneth R. Phelps, M.D. | Completed | No outcome recorded |
| Phase 3 | NCT00833768 Comparator | Jan → Sep 2009 | chronic kidney disease, hyperphosphatemia | Genzyme, a Sanofi Company | Terminated | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT01427907 Comparator | Sep 2011 → Jul 2012 | chronic kidney disease | Fresenius Medical Care North America | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00785629 Comparator | Feb 2009 → Jul 2011 | chronic kidney disease | Denver Nephrologists, P.C. | Completed | No outcome recorded |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 39 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | sevelamer | “Sucroferric oxyhydroxide (SFOH) is a non-calcium, iron-based phosphate binder that demonstrated sustained serum phosphorus (sP) control, good tolerability, and lower pill...” PMID 29656600 ↗ Apr 2018 |
| Known as | GT-335-012 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314349 ↗ |
| Known as | Renvela | “Multi-Center Study of the Effect of Sevelamer Carbonate (Renvela®) on Metabolic/Inflammatory/ROS in Diabetics With Nephropathy” NCT01493050 ↗7“Lanthanum Carbonate (FOSRENOL®) or Sevelamer Carbonate (RENVELA®)” NCT00925704 ↗ “Drug: Sevelamer carbonate (Renvela®)” NCT00681941 ↗ “Sevelamer carbonate (Renvela®)” NCT00268957 ↗ “Sevelamer carbonate (Renvela®)” NCT07030595 ↗ |
| Known as | Sevelamer anhydrous | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314349 ↗ |
| Known as | Sevelamer carbonate | “sevelamer carbonate” NCT03824587 ↗33 |
| Known as | Sevelamer carbonate winthrop (previously sevelamer carbonate zentiva) | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314349 ↗ |
| Known as | Sevelamer carbonate zentiva | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314349 ↗ |
| Known as | Sevelamero | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314349 ↗ |
| Modality | Other / unclassified | “A double-blind trial of the intestinal phosphate binder sevelamer carbonate will be employed” NCT01191762 ↗ |
| Route | Oral | “800mg tablets to be taken orally with meals three times per day” NCT00833768 ↗ |