Drugs / Ferric Citrate

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) AURYXIA 2017-11-06 fda.gov
Approved US (FDA) AURYXIA 2014-09-05 fda.gov

Trials 24 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 23 trials
Phase 2 NCT04741646 Jun 2022 → Oct 2027 expected chronic kidney disease University of California, Los Angeles Recruiting No outcome recorded
Phase 2 NCT01736397 Nov 2012 → Nov 2013 disorder of iron metabolism and transport, iron deficiency anemia Keryx Biopharmaceuticals Completed No outcome recorded
Phase 2 NCT00648167 Mar 2008 → Jan 2009 end stage renal failure, hyperphosphatemia Keryx Biopharmaceuticals Completed No outcome recorded
Phase 313 trials
Phase 3 NCT07381426 Feb → Dec 2026 expected anemia Dhaka Medical College Not yet recruiting No outcome recorded
Phase 3 NCT04649411 Jan 2025 → Jan 2027 iron deficiency anemia Keryx Biopharmaceuticals Withdrawn No outcome recorded
Phase 3 NCT04523727 Jun 2022 → Dec 2026 hyperphosphatemia Keryx Biopharmaceuticals Suspended No outcome recorded
Phase 3 NCT05085275 Mar 2022 → Jan 2024 cardiovascular disorder, chronic kidney disease, hyperphosphatemia, iron deficiency anemia USRC Kidney Research Completed No outcome recorded
Phase 3 NCT04543812 Oct 2020 → Oct 2022 anemia due to chronic disorder Panion & BF Biotech Inc. Completed No outcome recorded
Phase 3 NCT03984760 Jun 2019 → Feb 2021 end stage renal failure, hyperphosphatemia Panion & BF Biotech Inc. Completed No outcome recorded
Phase 3 NCT07522268 Jun 2019 → Jan 2021 Shaheed Zulfiqar Ali Bhutto Medical University Completed No outcome recorded
Phase 3 NCT04456803 May 2019 → Sep 2022 end stage renal failure, hyperphosphatemia Sinomune Pharmaceutical Co., Ltd Completed No outcome recorded
Phase 3 NCT02268994 Oct 2014 → Jan 2016 anemia due to chronic disorder Keryx Biopharmaceuticals Completed No outcome recorded
Phase 3 NCT01554982 Aug 2012 → Jun 2014 end stage renal failure, hyperphosphatemia, kidney failure Keryx Biopharmaceuticals Completed No outcome recorded
Phase 45 trials
Phase 4 NCT04922645 Jun 2021 → Sep 2022 hyperphosphatemia, impaired renal function disease, iron deficiency anemia USRC Kidney Research Completed No outcome recorded
Phase 4 NCT03055598 May 2017 → Sep 2019 overdue end stage renal failure Sreedhar Mandayam Active not recruiting No outcome recorded
Phase 4 NCT03079869 May 2017 → Sep 2019 hyperphosphatemia Kaiser Permanente Completed No outcome recorded
Phase 4 NCT03256838 Apr 2017 → Dec 2018 chronic renal failure syndrome, end stage renal failure, hyperphosphatemia Panion & BF Biotech Inc. Completed No outcome recorded
Phase 4 NCT02661295 Jul 2015 → Sep 2017 end stage renal failure, hyperphosphatemia, unexplained long-lasting fever/inflammatory syndrome Winthrop University Hospital Terminated No outcome recorded
Phase not applicable3 trials
NCT07120321 Jan 2022 → Jan 2025 dental caries, pulpitis Sacide Duman Completed No outcome recorded
NCT02888171 Sep 2016 → Feb 2019 anemia, chronic kidney disease, disorder of iron metabolism and transport University of Alabama at Birmingham Completed No outcome recorded
NCT02783911 Jan 2015 → Mar 2017 dental pulp disorder, teeth present at birth Loma Linda University Terminated No outcome recorded
Also used as a comparator or background therapy in 6 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT05557812 Background Feb 2023 → Feb 2025 pulpitis Virginia Commonwealth University Completed No outcome recorded
Phase 21 trial
Phase 2 NCT07541976 Comparator Mar 2024 → Sep 2025 overdue dental pulp calcification Al-Mustansiriyah University Active not recruiting No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT03824587 Background Feb → Jul 2019 hyperphosphatemia Ardelyx Completed No outcome recorded
Phase 31 trial
Phase 3 NCT02492620 Comparator Mar 2015 → Nov 2017 chronic kidney disease, hyperphosphatemia, impaired renal function disease, iron deficiency anemia Denver Nephrologists, P.C. Completed No outcome recorded
Phase 41 trial
Phase 4 NCT05358509 Comparator Mar 2021 → Dec 2023 iron deficiency anemia Thomas Jefferson University Completed No outcome recorded
Phase not applicable1 trial
NCT06403306 Comparator Apr 2018 dental pulp disorder, teeth present at birth Tokat Gaziosmanpasa University Completed No outcome recorded

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 31 sources stand behind the page.

FieldValueCited text
Known as Ferric Citrate ferric citrateNCT03824587
22

NCT05085275

NCT01074125

NCT03256838

NCT07381426

NCT01191255

NCT04922645

NCT02268994

NCT04523727

NCT04543812

NCT02492620

NCT01554982

NCT00648167

NCT01736397

NCT02888171

NCT04456803

NCT02661295

NCT01503736

NCT03055598

NCT04649411

NCT03984760

NCT03079869

NCT04741646

Known as Astringedent “Ferric Sulfate (FS): Astringedent® 15.5% ferric sulfate solution (Ultradent Products Inc., South Jordan, UT, USA) was applied via a saturated cotton pellet to the pulp stumps...” NCT07541976
Known as Ferric Sulfate ClinicalTrials.gov intervention name — accepted as the source's own label NCT06403306
5

NCT05557812

NCT05358509

NCT07120321

NCT02783911

NCT07541976

Known as Ferric Sulphate ClinicalTrials.gov intervention name — accepted as the source's own label NCT07522268
Known as KRX-0502 “The purpose of this study is to see if KRX-0502 (ferric citrate) is safe and effective as a phosphate binder.” NCT01074125
Known as PBF-1681 “where all subjects receive PBF-1681 (ferric citrate) ("Extension Period")” NCT04543812
Known as Quickstat-FS “After hemostasis was achieved a sterile cotton pellet soaked in 15.5% ferric sulphate solution (Quickstat-FS, USA) was placed over amputated root stumps for 15-20 seconds.” NCT07522268
Route Oral “INTERVENTION: Fixed dose of ferric citrate taken orally as a phosphate binder for up to 28 days” PMID 23369827 Jan 2013