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
| 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 · 1 met primary | ||||||
| Phase 2 | NCT01574326 | May 2012 → Jun 2015 | chronic kidney disease, hyperphosphatemia | Genzyme, a Sanofi Company | Completed | Met primary |
| 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 · 1 met primary · 1 missed | ||||||
| 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 | Missed primary |
| Phase 3 | NCT01191255 | Oct 2010 → Jan 2013 | hyperphosphatemia, kidney failure | Keryx Biopharmaceuticals | Completed | Met primary |
| 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 · 1 missed | ||||||
| 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 | Missed primary |
| Phase 4 | NCT01277497 | Jan 2011 → Jan 2016 | chronic kidney disease | Albany College of Pharmacy and Health Sciences | Terminated | No outcome recorded Stop: Enrollment |
| Phase not applicable2 trials | ||||||
| — | NCT02644486 | Jan 2016 → Feb 2018 | glomerular disorder | Zhi-Hong Liu, M.D. | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT00999037 | Oct 2009 → Jun 2015 | secondary hyperparathyroidism of renal origin | University of California, Los Angeles | Completed | No outcome recorded |
| Comparator or background therapy16 trials | ||||||
| Phase 1 | NCT02965053 Background | Dec 2016 → Aug 2018 | hyperphosphatemia | Chugai Pharmaceutical | Completed | No outcome recorded |
| 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 | Met primary |
| Phase 2 | NCT04551300 Comparator | Oct 2020 → Jun 2022 | hyperphosphatemia | Shanghai Alebund Pharmaceuticals Limited | Completed | Met primary |
| Phase 2/3 | NCT03824587 Background | Feb → Jul 2019 | hyperphosphatemia | Ardelyx | Completed | Met primary |
| 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 | Met primary |
| Phase 3 | NCT03427125 Comparator | Jan 2018 → Nov 2019 | hyperphosphatemia | Ardelyx | Completed | Met primary |
| 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 4 | NCT01427907 Comparator | Sep 2011 → Jul 2012 | chronic kidney disease | Fresenius Medical Care North America | Completed | No outcome recorded |
| — | NCT00785629 Comparator | Feb 2009 → Jul 2011 | chronic kidney disease | Denver Nephrologists, P.C. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2024-05-10 | Halcygen Pharmaceuticals Limited | Regulatory Strides receives USFDA approval for Sevelamer Carbonate Tablets, 800 mg strides.com ↗ |
| 2023-11-03 | Ardelyx | Results Ardelyx Shares Positive Data from Studies of XPHOZAH® (tenapanor), a First-in-Class Phosphate Absorption Inhibitor, at ASN Kidney Week 2023 ardelyx.com ↗
The study showed that a lower proportion of patients treated with tenapanor versus sevelamer experienced a serious adverse event (SAE) |
| 2023-04-12 | Ardelyx | Results Ardelyx Presents Positive Data Further Supporting Efficacy and Safety of XPHOZAH® (tenapanor) at National Kidney Foundation 2023 Spring Clinical Meetings ardelyx.com ↗
Patients with chronic kidney disease (CKD) on maintenance dialysis who responded to treatment for hyperphosphatemia had comparable serum phosphate reductions with XPHOZAH or sevelamer |
| 2021-12-25 | Lupin Limited | Regulatory Lupin Receives Approval from U.S. FDA for Sevelamer Carbonate for Oral Suspension lupin.com ↗
Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) Sevelamer Carbonate for Oral Suspension, 0.8 g and 2.4 g packets to market a generic equivalent of Renvela® for Oral Suspension, 0.8 g and 2.4 g Packets of Genzyme. |
| 2021-06-07 | Ardelyx | Results Ardelyx Announces Presentations at ERA-EDTA Virtual Congress 2021 ardelyx.com ↗
In a separate presentation, the company reported that patients who were on tenapanor had a smaller percentage of deaths and hospitalizations than those on the phosphate binder, sevelamer, in the long-term Phase 3 PHREEDOM study. |
| 2021-01-25 | Lupin Limited | Regulatory Lupin Receives Approval for Sevelamer Carbonate Tablets lupin.com ↗
Lupin Limited (Lupin), global pharmaceutical company, announced today that it has received approval for its Sevelamer Carbonate Tablets, 800 mg, from the United States Food and Drug Administration, to market a generic equivalent of Renvela® Tablets, 800 mg, of Genzyme Corporation. |
| 2020-08-13 | Zydus Lifesciences Limited | Regulatory Zydus Cadila receives final approval from the USFDA for Sevelamer Carbonate Tablets zyduslife.com ↗
Zydus Cadila has received final approval from the USFDA to market Sevelamer Carbonate Tablets (US RLD - Renvela Tablets) in the strength of 800 mg. |
| 2020-06-15 | Ardelyx | Results Ardelyx Announces Positive Second Data Analysis from Ongoing NORMALIZE Phase 4 Study Evaluating Tenapanor in CKD Patients on Dialysis ardelyx.com ↗
Foundational use of tenapanor as monotherapy or with sevelamer enabled up to 47.4% of patients to achieve normal serum phosphorus levels (<4.6 mg/dL), a 58% improvement over current standard of care |
| 2018-10-26 | Ardelyx | Results Ardelyx Presents New Preclinical Data Demonstrating Synergy between Tenapanor and Sevelamer When Dosed in Combination for Elevated Serum Phosphorus ardelyx.com ↗
The data, showing that the combination meaningfully reduced serum phosphorus, were presented today in a poster titled "Combination treatment with tenapanor and sevelamer synergistically reduces urinary phosphorus excretion in rats," at the American Society of Nephrology (ASN) Annual Meeting. |
| 2017-10-23 | Impax Laboratories, LLC | Regulatory Impax Announces FDA Approval and Launch of Generic Renvela® (Sevelamer Carbonate) Tablets, 800 mg amneal.com ↗
HAYWARD, Calif. , Oct. 23, 2017 /PRNewswire/ -- Impax Laboratories, Inc. (NASDAQ: IPXL), a specialty pharmaceutical company, today announced it has received final U.S. Food and Drug Administration (" FDA ") approval on its Abbreviated New Drug Application ("ANDA") for a generic version of Renvela ® (sevelamer carbonate) tablets, 800 mg. |
| 2010-07-02 | Impax Laboratories, LLC | Regulatory Impax Laboratories Confirms Patent Challenge Relating to RENVELA(R), 2.4 g and 0.8 g (For Suspension) amneal.com ↗
Impax filed its Abbreviated New Drug Application ("ANDA") containing a paragraph IV certification for a generic version of RENVELA(R) with the U.S. Food & Drug Administration ("FDA"). |
| 2009-04-06 | Impax Laboratories, LLC | Regulatory Impax Confirms Patent Challenge Relating to Renvela(R) 800 mg Tablets amneal.com ↗
Impax filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic version of Renvela(R) with the U.S. Food & Drug Administration (FDA). |
All press releases naming this drug 14 releases
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®)” NCT07030595 ↗ “Sevelamer carbonate (Renvela®)” NCT00268957 ↗ |
| Known as | Sevelamer anhydrous | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314349 ↗ |
| Known as | Sevelamer Carbonate | “sevelamer carbonate” NCT03824587 ↗ |
| 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 ↗ |