Drugs / Sodium Ferric Gluconate Complex
Sodium Ferric Gluconate Complex
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | FERRLECIT | — | 2001-02-02 – 2004-08-13 | fda.gov ↗ |
| Approved | US (FDA) | FERRLECIT | — | 1999-02-18 | fda.gov ↗ |
Trials 12 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00223977 | Dec 2003 → Nov 2004 | iron deficiency anemia | Watson Pharmaceuticals | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT00661999 | Jan 2006 → Mar 2009 | anemia, cancer of unknown primary site, leukemia, lymphoproliferative syndrome +2 | Mayo Clinic | Completed | No outcome recorded |
| Phase 410 trials | ||||||
| Phase 4 | NCT04063033 | Sep 2019 → Dec 2021 | heart failure | Rambam Health Care Campus | Completed | No outcome recorded |
| Phase 4 | NCT02399449 | Sep 2017 → Mar 2019 | anemia | University of Maryland, Baltimore | Completed | No outcome recorded |
| Phase 4 | NCT01925703 | Apr 2011 → Dec 2013 | heart failure, iron deficiency anemia | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 4 | NCT00354692 | Jun → Nov 2006 | chronic kidney disease, iron deficiency anemia | Watson Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00223938 | Dec 2003 → Apr 2007 | anemia | Sanofi | Terminated | No outcome recorded |
| Phase 4 | NCT00223964 | Jun → Oct 2003 | anemia | Watson Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00224055 | Apr 2003 → Sep 2004 | chronic renal failure syndrome, iron deficiency anemia | Watson Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00224003 | Apr 2003 → Mar 2004 | anemia | Watson Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00224042 | Apr 2003 → May 2005 | chronic renal failure syndrome, iron deficiency anemia | Watson Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00224068 | May 2002 → Dec 2003 | anemia | Watson Pharmaceuticals | Completed | No outcome recorded |
Also used as a comparator or background therapy in 3 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00534144 Comparator | Sep 2007 → Nov 2008 | chronic renal failure syndrome, iron deficiency anemia | Watson Pharmaceuticals | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT00704353 Comparator | Jun 2008 → Jul 2009 | anemia | American Regent, Inc. | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT04797832 Comparator | Oct 2020 → Oct 2024 | aortic valve stenosis, iron deficiency anemia | Rambam Health Care Campus | Unknown | No outcome recorded |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 19 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | sodium ferric gluconate complex | “PURPOSE: To evaluate the safety and efficacy of intravenous (IV) sodium ferric gluconate complex (FG), oral ferrous sulfate, or no iron to increase hemoglobin (Hb) in anemic...” PMID 17296819 ↗ Feb 2007 |
| Known as | ferric gluconate | “This study evaluates the safety and efficacy of Ferrlecit® (ferric gluconate; a form of intravenous iron) or ferrous sulfate” NCT00224068 ↗ |
| Known as | Ferrlecit | “This study evaluates the safety and efficacy of Ferrlecit® (ferric gluconate; a form of intravenous iron) or ferrous sulfate” NCT00224068 ↗6“Study of the Safety and Efficacy of Ferrlecit® Maintenance Dosing in Pediatric Hemodialysis Patients” NCT00224003 ↗ “Sodium Ferric Gluconate Complex in Sucrose Injection (Ferrlecit®), 250 mg IV weekly for 4 weeks” NCT00224055 ↗ “One common IV iron product is sodium ferric gluconate (SFG) sold as brand name Ferrlecit.” NCT02399449 ↗ “intravenous sodium ferric gluconate complex (Ferrlecit)” PMID 41870899 ↗ Mar 2026 “Ferrous Sulfate, Venofer, Ferrlecit, Infed, Dexferrum” NCT00704353 ↗ |
| Known as | SFG | “One common IV iron product is sodium ferric gluconate (SFG) sold as brand name Ferrlecit.” NCT02399449 ↗ |
| Known as | SFGC | “Therefore, we conducted a prospective, multicenter, open-label trial of maintenance therapy with sodium ferric gluconate complex (SFGC) in iron-replete pediatric HD patients...” PMID 16520948 ↗ Mar 20061“IV sodium ferric gluconate complex (SFGC) has been found to be safe and affordable but has not been studied in this population in a randomized trial.” PMID 35503997 ↗ Aug 2022 |
| Known as | sodium ferric gluconate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00223938 ↗ |
| Known as | Sodium Ferric Gluconate complex in sucrose | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00224042 ↗ |
| Known as | sodium ferric gluconate complex in sucrose injection | “Ferrlecit (sodium ferric gluconate complex in sucrose injection)” NCT00223964 ↗ |
| Route | Intravenous | “weekly intravenous injection Dose 1” NCT00223938 ↗ |