Drugs / Lanthanum Carbonate
Lanthanum Carbonate
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | FOSRENOL | — | 2004-10-26 | fda.gov ↗ |
Trials 29
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials · 2 met primary | ||||||
| Phase 1 | NCT02952040 | Nov → Dec 2016 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01289626 | Feb 2011 → Mar 2013 | calciphylaxis | University of Wisconsin, Madison | Completed | No outcome recorded |
| Phase 1 | NCT00925704 | Jun → Jul 2009 | — | Shire | Completed | No outcome recorded |
| Phase 1 | NCT00875017 | Apr → Jun 2009 | chronic renal failure syndrome | Shire | Completed | Met primary |
| Phase 1 | NCT00880750 | Jan → Jun 2009 | end stage renal failure | Shire | Completed | Met primary |
| Phase 26 trials · 2 missed | ||||||
| Phase 2 | NCT02258074 | Mar 2015 → Nov 2018 | chronic kidney disease | The Cleveland Clinic | Completed | Missed primary |
| Phase 2 | NCT01696279 | Feb 2013 → Nov 2018 | chronic kidney disease, hyperphosphatemia | Shire | Completed | No outcome recorded |
| Phase 2 | NCT01128179 | Dec 2010 → Apr 2012 | chronic kidney disease | Shire | Completed | Missed primary |
| Phase 2 | NCT00234702 | Jan 2006 → Jun 2007 | chronic kidney disease | Shire | Completed | No outcome recorded |
| Phase 2 | NCT00767637 | Jun 2005 → Oct 2008 | hyperphosphatemia | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT00769496 | Jan 2005 → May 2008 | hyperphosphatemia | Bayer | Completed | No outcome recorded |
| Phase 311 trials · 1 met primary · 2 missed | ||||||
| Phase 3 | NCT03346369 | Aug 2017 → Dec 2022 | nephrolithiasis | University Hospital Brussels | Unknown | No outcome recorded |
| Phase 3 | NCT01578200 | Dec 2011 → Mar 2019 | hyperphosphatemia | Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan | Completed | Missed primary |
| Phase 3 | NCT01187628 | Sep 2010 → Apr 2013 | hyperphosphatemia | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT01110629 | Jun 2010 → Nov 2011 | hyperphosphatemia | Bayer | Completed | Met primary |
| Phase 3 | NCT00441545 | Jan 2007 → Jul 2008 | end stage renal failure | Shire | Completed | Missed primary |
| Phase 3 | NCT01514851 | Jan → May 2006 | hyperphosphatemia | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT01518387 | Jan → Jul 2006 | hyperphosphatemia | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00151918 | Jan → Aug 2005 | chronic renal failure syndrome | Shire | Completed | No outcome recorded |
| Phase 3 | NCT00151931 | May 2004 → Jan 2006 | end stage renal failure | Shire | Completed | No outcome recorded |
| Phase 3 | NCT00150566 | Feb 2004 → Oct 2005 | end stage renal failure | Shire | Completed | No outcome recorded |
| Phase 3 | NCT00150540 | Oct 2002 → Jun 2005 | chronic renal failure syndrome | Shire | Completed | No outcome recorded |
| Phase 45 trials · 1 missed | ||||||
| Phase 4 | NCT04485039 | Jun → Dec 2022 | smallpox | SIGA Technologies | Completed | No outcome recorded |
| Phase 4 | NCT02209636 | Sep 2014 → Jun 2019 | cardiovascular disorder, chronic kidney disease | VA Office of Research and Development | Completed | Missed primary |
| Phase 4 | NCT02237534 | Sep 2014 → Mar 2023 | chronic kidney disease, hyperphosphatemia, metabolic bone disorder | Osaka University | Unknown | No outcome recorded |
| Phase 4 | NCT00452478 | May → Dec 2007 | kidney disorder | Shire | Terminated | No outcome recorded |
| Phase 4 | NCT00160121 | Jan → Dec 2005 | chronic renal failure syndrome | Shire | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT01581996 | Mar 2012 → May 2017 | chronic renal failure syndrome, end stage renal failure | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Completed | No outcome recorded |
| — | NCT01341678 | Apr → Oct 2011 | chronic kidney disease | Geoffrey Block | Completed | No outcome recorded |
| Comparator or background therapy11 trials | ||||||
| Phase 1 | NCT03136705 Comparator | Feb 2016 → Dec 2017 | — | Northwestern University | Completed | No outcome recorded |
| Phase 1/2 | NCT04440696 Background | Oct 2020 → Jun 2022 | hyperphosphatemia | Grand Life Science (Liaoning) Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT00660530 Comparator | Jan 2008 → Nov 2009 | hyperphosphatemia, kidney disorder | University of Illinois at Chicago | Completed | No outcome recorded |
| Phase 3 | NCT01357317 Comparator | Jun 2011 → Oct 2013 | chronic kidney disease | Salem Veterans Affairs Medical Center | Unknown | No outcome recorded |
| Phase 3 | NCT00841126 Comparator | Jul 2009 → Jul 2011 | chronic renal failure syndrome | Ineos Healthcare Limited | Terminated | No outcome recorded |
| Phase 4 | NCT01845090 Comparator | Aug 2011 → Jul 2014 | — | Camillians Saint Mary's Hospital Luodong | Unknown | No outcome recorded |
| — | NCT02273570 Background | Mar 2015 → Dec 2016 | secondary hyperparathyroidism of renal origin | Azienda Ospedaliera Sant'Anna | Unknown | No outcome recorded |
| — | NCT01002872 Comparator | Oct 2009 → May 2012 | metabolic bone disorder | Endeavor Health | Completed | No outcome recorded |
| — | NCT00843349 Comparator | Jul 2009 → Feb 2012 | kidney disorder | Myles Wolf | Completed | No outcome recorded |
| — | NCT00785629 Comparator | Feb 2009 → Jul 2011 | chronic kidney disease | Denver Nephrologists, P.C. | Completed | No outcome recorded |
| — | NCT00438932 Comparator | Jan 2007 → Jan 2010 | chronic kidney disease | Massachusetts General Hospital | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2024-12-17 | Unicycive Therapeutics, Inc | Results Unicycive Therapeutics Announces Publication of Oxylanthanum Carbonate (OLC) Positive Bioequivalence Data in Clinical Therapeutics unicycive.com ↗ |
| 2018-02-15 | Upsher-Smith Laboratories | Regulatory Sawai Pharmaceutical Receives Approvals for Eight Molecules in 19 Presentations of Generic Drugs upsher-smith.com ↗
Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka, Japan, President: Mitsuo Sawai) today received approvals by the Ministry of Health, Labour and Welfare for eight molecules in 19 presentations of generic drugs. |
| 2017-08-14 | Lupin Limited | Regulatory Lupin’s alliance partner Natco receives FDA approval for generic Fosrenol Chewable Tablets lupin.com ↗
Mumbai: Pharma major Lupin Limited (Lupin) and Natco announced the final ANDA approval of Lanthanum Carbonate Chewable Tablets 500 mg (base), 750 mg (base), and 1000 mg (base) from the United States Food and Drug Administration (FDA). |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-12-17 | Unicycive Therapeutics, Inc | Unicycive Therapeutics Announces Publication of Oxylanthanum Carbonate (OLC) Positive Bioequivalence Data in Clinical Therapeutics unicycive.com ↗ |
| 2018-02-15 | Upsher-Smith Laboratories | Sawai Pharmaceutical Receives Approvals for Eight Molecules in 19 Presentations of Generic Drugs upsher-smith.com ↗ |
| 2017-08-31 | Lupin Limited | Lupin launches generic Fosrenol Chewable Tablets in the US lupin.com ↗ |
| 2017-08-14 | Lupin Limited | Lupin’s alliance partner Natco receives FDA approval for generic Fosrenol Chewable Tablets lupin.com ↗ |
| 2013-10-17 | Prasco LLC | Prasco announces agreement with Shire for the Authorized Generic of FOSRENOL® (lanthanum carbonate) prasco.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 40 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lanthanum Carbonate | “Changes With Lanthanum Carbonate, Calcium Acetate, and Phosphorus Restriction in CKD: A Randomized Controlled Trial.” PMID 29989014 ↗ Mar 201838“lanthanum carbonate "Foznol®"). A rescue therapy with aluminum("Maalox®") is allowed” NCT02273570 ↗ “Fosrenol (Lanthanum Carbonate, BAY77-1931)” NCT01110629 ↗ “Fosrenol (Lanthanum Carbonate, BAY77-1931)” NCT01187628 ↗ “Lanthanum Carbonate (BAY 77-1931)” NCT00769496 ↗ |
| Known as | BAY77-1931 | “Fosrenol (Lanthanum Carbonate, BAY77-1931)” NCT01187628 ↗5“Fosrenol (Lanthanum Carbonate, BAY77-1931)” NCT01110629 ↗ “Lanthanum Carbonate (BAY 77-1931)” NCT00769496 ↗ “Lanthanum carbonate (BAY77-1931)” NCT01514851 ↗ “Lanthanum Carbonate (BAY77-1931)” NCT00767637 ↗ “Lanthanum Carbonate (BAY77-1931)” NCT01518387 ↗ |
| Known as | FOSRENOL | “Fosrenol (lanthanum carbonate, manufactured by Shire Pharmaceuticals) is a gastrointestinal phosphate binder” NCT01581996 ↗5“Lanthanum carbonate (FOSRENOL®) is a potent non-aluminum, non-calcium phosphate binder” NCT01289626 ↗ “Lanthanum Carbonate (FOSRENOL®) or Sevelamer Carbonate (RENVELA®)” NCT00925704 ↗ “Fosrenol (Lanthanum carbonate)” NCT00441545 ↗ |
| Known as | Foznol | “lanthanum carbonate "Foznol®"). A rescue therapy with aluminum("Maalox®") is allowed” NCT02273570 ↗ |
| Known as | Lanthanum carbonate hydrate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02952040 ↗ |
| Modality | Other / unclassified | “Lanthanum carbonate is another efficacious and well-tolerated non-calcium phosphate binder.” NCT01578200 ↗ |
| Route | Oral | “Chewable tablets will be administered orally with meals.” NCT00441545 ↗ |