Drugs / Triferic

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) TRIFERIC 2015-01-23 fda.gov

Trials 19 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 14 trials
Phase 1 NCT02909153 Jan → Jul 2017 anemia, chronic kidney disease Rockwell Medical Technologies, Inc. Completed No outcome recorded
Phase 1 NCT02767128 Apr 2016 IRIDA syndrome Rockwell Medical Technologies, Inc. Completed No outcome recorded
Phase 1 NCT02636049 Oct 2015 end stage renal failure Rockwell Medical Technologies, Inc. Completed No outcome recorded
Phase 1 NCT01920854 Jun → Sep 2013 chronic renal failure syndrome Rockwell Medical Technologies, Inc. Completed No outcome recorded
Phase 1/25 trials
Phase 1/2 NCT04409132 Jun 2020 → Apr 2021 end stage renal failure Rockwell Medical Technologies, Inc. Completed No outcome recorded
Phase 1/2 NCT04042324 Sep 2019 → Jan 2020 end stage renal failure Rockwell Medical Technologies, Inc. Completed No outcome recorded
Phase 1/2 NCT03303144 Oct → Dec 2017 end stage renal failure Rockwell Medical Technologies, Inc. Completed No outcome recorded
Phase 1/2 NCT02595437 Nov 2015 → Dec 2016 end stage renal failure Rockwell Medical Technologies, Inc. Completed No outcome recorded
Phase 1/2 NCT01894906 Jul → Sep 2013 kidney failure Rockwell Medical Technologies, Inc. Completed No outcome recorded
Phase 23 trials
Phase 2 NCT05110768 Nov 2021 → Apr 2022 iron deficiency anemia Rockwell Medical Technologies, Inc. Unknown No outcome recorded
Phase 2 NCT02905981 Jan 2017 → Mar 2018 IRIDA syndrome Rockwell Medical Technologies, Inc. Terminated No outcome recorded
Phase 2 NCT00548249 Aug 2007 → Oct 2009 end stage renal failure Rockwell Medical Technologies, Inc. Completed No outcome recorded
Phase 31 trial
Phase 3 NCT04239391 Sep 2020 → Aug 2023 end stage renal failure Rockwell Medical Technologies, Inc. Unknown No outcome recorded
Phase 43 trials
Phase 4 NCT04689932 Apr → Jun 2021 end stage renal failure Rockwell Medical Technologies, Inc. Completed No outcome recorded
Phase 4 NCT02760940 Aug 2016 → Aug 2017 anemia, inflammatory bowel disease Federal University of Juiz de Fora Unknown No outcome recorded
Phase 4 NCT02242188 Sep 2015 → Jan 2019 disorder of iron metabolism and transport Medical University of Warsaw Unknown No outcome recorded
Phase not applicable3 trials
NCT02916654 Apr 2015 → Aug 2016 celiac disease, iron deficiency anemia Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Unknown No outcome recorded
NCT01634945 Apr 2012 → May 2013 anemia Swiss Federal Institute of Technology Completed No outcome recorded
NCT00604565 Jan 2008 → Dec 2010 end stage renal failure Charles Drew University of Medicine and Science Terminated No outcome recorded
Also used as a comparator or background therapy in 4 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT00867867 Comparator Oct 2003 → Jun 2008 Helicobacter pylori infectious disease International Centre for Diarrhoeal Disease Research, Bangladesh Completed No outcome recorded
Phase 21 trial
Phase 2 NCT01286012 Comparator Jan 2011 → Jan 2013 end stage renal failure Rockwell Medical Technologies, Inc. Completed No outcome recorded
Phase 32 trials
Phase 3 NCT01322347 Comparator Apr 2011 → Jan 2014 end stage renal failure Rockwell Medical Technologies, Inc. Completed No outcome recorded
Phase 3 NCT01320202 Comparator Mar 2011 → May 2013 chronic renal failure syndrome Rockwell Medical Technologies, Inc. Completed No outcome recorded

Evidence & citations 15 cited values

Every value below carries the sentence it was read from. 25 sources stand behind the page.

FieldValueCited text
Known as Triferic “Ferric pyrophosphate citrate (Triferic™) administration via the dialysate” PMID 26175145 Jul 2015
8

NCT04409132

NCT02909153

NCT02905981

NCT03303144

NCT02595437

NCT02767128

NCT04042324

NCT02636049

Known as Actiferol “Ferric pyrophosphate (powder preparation in sachets: Actiferol, SunActive Fe, Sequoia, Poland) in a single daily dose.” NCT02242188
Known as FePP “a complementary food (CF) fortified with sodium iron EDTA (NaFeEDTA) plus either ferrous fumarate (FeFum) or ferric pyrophosphate (FePP)” PMID 28708072 Jul 2017
Known as Ferric pyrophosphate “Sucrosomial iron (Sideral® Forte) is a preparation of ferric pyrophosphate conveyed within a phospholipid membrane associated with ascorbic acid, is a new-generation oral iron...” NCT02916654
3

“The current premix contains 3.8 mg in the form of ferric pyrophosphate, which is less bioavailable than the 3.8 mg ferrous fumarate in the optimized formula.” NCT01634945

Ferric pyrophosphate (powder preparation in sachets: Actiferol, SunActive Fe, Sequoia, Poland) in a single daily dose.” NCT02242188

NCT00867867

Known as ferric pyrophosphate citrate “Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate.” NCT04042324
3

Ferric pyrophosphate citrate (FPC) is a water-soluble iron salt administered via dialysate to supply iron directly to transferrin.” PMID 26154926 Jul 2015

Ferric pyrophosphate citrate (Triferic™) administration via the dialysate” PMID 26175145 Jul 2015

Ferric Pyrophosphate CitrateNCT04239391

Known as FPC “Administration of ferric pyrophosphate citrate (FPC, Triferic™) via hemodialysate may allow replacement of ongoing uremic and hemodialysis-related iron losses.” PMID 26175145 Jul 2015
2

“Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate.” NCT04042324

“Ferric pyrophosphate citrate (FPC) is a water-soluble iron salt administered via dialysate to supply iron directly to transferrin.” PMID 26154926 Jul 2015

Known as Iron Iron (micronized microencapsulated ferric pyrophosphate), 1 mg/kg, or placebo (maltodextrin) once daily from age 4 to 9 months.” PMID 38739382 Jul 2024
Known as oral liposomal iron ClinicalTrials.gov intervention name — accepted as the source's own label NCT02760940
Known as Sequoia “Ferric pyrophosphate (powder preparation in sachets: Actiferol, SunActive Fe, Sequoia, Poland) in a single daily dose.” NCT02242188
Known as SFP “Soluble Ferric Pyrophosphate (SFP)” NCT01320202
1

“soluble ferric pyrophosphate (SFP)” NCT00604565

Known as Soluble Ferric Pyrophosphate ClinicalTrials.gov intervention name — accepted as the source's own label NCT01320202
4

NCT01894906

NCT01920854

NCT00548249

NCT00604565

Known as SunActive Fe “Ferric pyrophosphate (powder preparation in sachets: Actiferol, SunActive Fe, Sequoia, Poland) in a single daily dose.” NCT02242188
Known as Triferic AVNU ClinicalTrials.gov intervention name — accepted as the source's own label NCT05110768
1

NCT04689932

Modality Other / unclassified “Triferic is an iron salt” NCT02909153
Route Other “administered via dialysate” PMID 26154926 Jul 2015