Ferric Citrate

also known as Ferric Sulfate · Ferric Sulphate · Astringedent · KRX-0502 · PBF-1681 · Quickstat-FS

Developed for: hyperphosphatemia · end stage renal failure · iron deficiency anemia · chronic kidney disease · anemia · anemia due to chronic disorder · disorder of iron metabolism and transport · kidney failure
+7 more
· dental caries · dental pulp disorder · periapical periodontitis · pulpitis · teeth present at birth · unexplained long-lasting fever/inflammatory syndrome · dental pulp calcification
Investigated by: Keryx Biopharmaceuticals · Panion & BF Biotech Inc. · Akebia Therapeutics · Collaborative Study Group (CSG) · USRC Kidney Research · Dhaka Medical College
+16 more
· Foundation University Islamabad · Inonu University · Kaiser Permanente · Loma Linda University · Mugdha Medical College and Hospital · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Sacide Duman · Shaheed Suhrawardy Medical College and Hospital · Shaheed Zulfiqar Ali Bhutto Medical University · Shandong Weigao Panion Pharmaceutical Co. Ltd. · Sinomune Pharmaceutical Co., Ltd · Sir Salimullah Medical College and Midford Hospital · Sreedhar Mandayam · University of Alabama at Birmingham · University of California, Los Angeles · Winthrop University Hospital

Regulatory milestones approvals, filings & regulatory actions · 4 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Filed iron deficiency anemia 1 milestone
Filed	Japan (PMDA)	Riona	iron deficiency anemia	2020-05-18	“has filed a supplemental New Drug Application (NDA) with the Pharmaceuticals and Medical Devices Agency (PMDA) seeking an additional indication for Riona® Tablets 250mg” akebia.com ↗
Approved Indication not stated 3 milestones
Label expansion	US (FDA)	AURYXIA	—	2017-11-06	fda.gov ↗
Approved	US (FDA)	AURYXIA	—	2014-09-05	fda.gov ↗
Filed	EU (EMA)	—	—	—	“In April, Akebia's licensee Averoa, a biopharmaceutical company, submitted a marketing authorization application to the European Medicines Agency for Ferric Citrate Coordination Complex” akebia.com ↗

Trials 25

today

US approved 2014

NCT07853183 · not/applicable NCT07381426 · Ph 3 NCT04649411 · Ph 3 NCT04741646 · Ph 2 NCT04523727 · Ph 3 NCT05085275 · Ph 3 NCT07120321 · not/applicable NCT04922645 · Ph 4 NCT04543812 · Ph 3 NCT03984760 · Ph 3 NCT07522268 · Ph 3 NCT04456803 · Ph 3 NCT03055598 · Ph 4 NCT03079869 · Ph 4 NCT03256838 · Ph 4 NCT02888171 · not/applicable NCT02661295 · Ph 4 NCT02783911 · not/applicable NCT02268994 · Ph 3 NCT01736397 · Ph 2 NCT01554982 · Ph 3 NCT01191255 · Ph 3 NCT01503736 · Ph 3 NCT01074125 · Ph 3 NCT00648167 · Ph 2

200820092010201120122013201420152016201720182019202020212022202320242025202620272028

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 23 trials · 1 met primary
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	Met primary
Phase 2	NCT00648167	Mar 2008 → Jan 2009	end stage renal failure, hyperphosphatemia	Keryx Biopharmaceuticals	Completed	No outcome recorded
Phase 313 trials · 2 met primary
Phase 3	NCT07381426	Feb → Dec 2026 expected	anemia	Dhaka Medical College	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 Stop: Business
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 3	NCT01191255	Oct 2010 → Jan 2013	hyperphosphatemia, kidney failure	Keryx Biopharmaceuticals	Completed	Met primary
Phase 3	NCT01503736	Jun 2010 → Jun 2012	end stage renal failure, hyperphosphatemia	Panion & BF Biotech Inc.	Completed	No outcome recorded
Phase 3	NCT01074125	May → Nov 2010	end stage renal failure, hyperphosphatemia	Keryx Biopharmaceuticals	Completed	Met primary

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 Stop: Enrollment
Phase not applicable4 trials · 1 met primary · 1 missed
—	NCT07853183	Oct 2026 → Apr 2027 expected	periapical periodontitis	Foundation University Islamabad	Not yet recruiting	No outcome recorded
—	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	Met primary
—	NCT02783911	Jan 2015 → Mar 2017	dental pulp disorder, teeth present at birth	Loma Linda University	Terminated	Missed primary
Comparator or background therapy6 trials
Phase 0	NCT05557812 Background	Feb 2023 → Feb 2025	pulpitis	Virginia Commonwealth University	Completed	No outcome recorded
Phase 2	NCT07541976 Comparator	Mar 2024 → Sep 2026	dental pulp calcification	Al-Mustansiriyah University	Completed	No outcome recorded
Phase 2/3	NCT03824587 Background	Feb → Jul 2019	hyperphosphatemia	Ardelyx	Completed	Met primary
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 4	NCT05358509 Comparator	Mar 2021 → Dec 2023	iron deficiency anemia	Thomas Jefferson University	Completed	No outcome recorded
—	NCT06403306 Comparator	Apr 2018	dental pulp disorder, teeth present at birth	Tokat Gaziosmanpasa University	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 5

Date	Issuer	Release
2025-04-03	Akebia Therapeutics	Regulatory Akebia Therapeutics Announces Positive Opinion of European Medicines Agency for XOANACYL®, an Oral Therapy for Chronic Kidney Disease Licensed to Averoa akebia.com ↗
2023-06-29	Akebia Therapeutics	Results Akebia Therapeutics Announces Positive Top-Line Results of Phase 4 IMPACT Study of Auryxia® (ferric citrate) for In-Center and Home Dialysis Patients akebia.com ↗
2021-03-24	Akebia Therapeutics	Regulatory Akebia Therapeutics Announces Approval for Additional Indication of Riona® (ferric citrate hydrate) for the Treatment of Iron Deficiency Anemia in Adult Patients in Japan akebia.com ↗
2020-05-18	Akebia Therapeutics	Regulatory Akebia Therapeutics Announces Collaboration Partner's Submission of Supplemental New Drug Application for Use of Riona® (ferric citrate hydrate) to Treat Adult Patients with Iron Deficiency Anemia in Japan akebia.com ↗
2019-07-10	Akebia Therapeutics	Results Akebia Therapeutics Announces Collaboration Partner’s Positive Top-line Results of Phase 3 Clinical Study of Riona® (ferric citrate hydrate) in Adult Patients with Iron Deficiency Anemia in Japan akebia.com ↗ reported positive top-line results from a pivotal Phase 3 comparative study

All press releases naming this drug 6 releases

Date	Issuer	Release
2025-04-03	Akebia Therapeutics	Akebia Therapeutics Announces Positive Opinion of European Medicines Agency for XOANACYL®, an Oral Therapy for Chronic Kidney Disease Licensed to Averoa akebia.com ↗
2023-06-29	Akebia Therapeutics	Akebia Therapeutics Announces Positive Top-Line Results of Phase 4 IMPACT Study of Auryxia® (ferric citrate) for In-Center and Home Dialysis Patients akebia.com ↗
2021-03-24	Akebia Therapeutics	Akebia Therapeutics Announces Approval for Additional Indication of Riona® (ferric citrate hydrate) for the Treatment of Iron Deficiency Anemia in Adult Patients in Japan akebia.com ↗
2020-06-10	Akebia Therapeutics	Akebia Therapeutics Announces Data on Different Dosing Regimens of Ferric Citrate for Iron Deficiency Anemia Presented at 57th ERA-EDTA Virtual Congress akebia.com ↗
2020-05-18	Akebia Therapeutics	Akebia Therapeutics Announces Collaboration Partner's Submission of Supplemental New Drug Application for Use of Riona® (ferric citrate hydrate) to Treat Adult Patients with Iron Deficiency Anemia in Japan akebia.com ↗
2019-07-10	Akebia Therapeutics	Akebia Therapeutics Announces Collaboration Partner’s Positive Top-line Results of Phase 3 Clinical Study of Riona® (ferric citrate hydrate) in Adult Patients with Iron Deficiency Anemia in Japan akebia.com ↗

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 32 sources stand behind the page.

Field	Value	Cited text
Known as	Ferric citrate	“ferric citrate” NCT03824587 ↗ 22 NCT04456803 ↗ NCT01503736 ↗ NCT02888171 ↗ NCT02661295 ↗ NCT05085275 ↗ NCT04741646 ↗ NCT03984760 ↗ NCT01074125 ↗ NCT03079869 ↗ NCT03256838 ↗ Show 12 more sources
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 NCT05358509 ↗ 5 NCT07541976 ↗ NCT07120321 ↗ NCT02783911 ↗ NCT05557812 ↗ NCT06403306 ↗
Known as	Ferric Sulphate	“Evaluation of Pulpotomy Techniques (Formocresol, Ferric Sulphate, Mineral Trioxide Aggregate)” NCT07853183 ↗ 1 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