{"id":"ferric-pyrophosphate-citrate","rwe":[{"pmid":"39603148","year":"2025","title":"Physiological iron chelators pyrophosphate and citrate have different effects on the proportions of monoferric transferrin metalloforms.","finding":"","journal":"Journal of inorganic biochemistry","studyType":"Clinical Study"},{"pmid":"29999819","year":"2006","title":"Ferric Pyrophosphate Citrate.","finding":"","journal":"","studyType":"Clinical Study"},{"pmid":"36585122","year":"2022","title":"Innovations thérapeutiques dans la prise en charge de l’anémie de la maladie rénale chronique Therapeutic innovations in the management of chronic kidney disease-associated anemia.","finding":"","journal":"Nephrologie & therapeutique","studyType":"Clinical Study"},{"pmid":"36418453","year":"2022","title":"Individualized anemia management enhanced by ferric pyrophosphate citrate protocol.","finding":"","journal":"Scientific reports","studyType":"Clinical Study"},{"pmid":"35726771","year":"2022","title":"Ferric pyrophosphate citrate for parenteral administration of maintenance iron: structure, mechanism of action, clinical efficacy and safety.","finding":"","journal":"Current medical research and opinion","studyType":"Clinical Study"}],"tags":[{"label":"Small Molecule","category":"modality"},{"label":"Parenteral","category":"route"},{"label":"Intravenous","category":"route"},{"label":"Powder","category":"form"},{"label":"Solution","category":"form"},{"label":"LOE Approaching","category":"status"},{"label":"Iron supplement therapy","category":"indication"},{"label":"Rockwell Medical Inc","category":"company"},{"label":"Approved 2010s","category":"decade"}],"phase":"marketed","safety":{"safetySignals":[{"llr":450.212,"date":"","count":57,"signal":"Thrombosis in device","source":"DrugCentral FAERS","actionTaken":"Reported 57 times (LLR=450)"}],"commonSideEffects":[{"effect":"Procedural hypotension","drugRate":"21.6%","severity":"common","organSystem":""},{"effect":"Headache","drugRate":"9.2%","severity":"common","organSystem":""},{"effect":"Muscle spasms","drugRate":"9.6%","severity":"common","organSystem":""},{"effect":"Dyspnea","drugRate":"5.8%","severity":"common","organSystem":""},{"effect":"Peripheral edema","drugRate":"6.8%","severity":"common","organSystem":""},{"effect":"Pain in extremity","drugRate":"6.8%","severity":"common","organSystem":""},{"effect":"Pyrexia","drugRate":"4.5%","severity":"common","organSystem":""},{"effect":"Urinary tract infection","drugRate":"4.5%","severity":"common","organSystem":""},{"effect":"Back pain","drugRate":"4.5%","severity":"common","organSystem":""},{"effect":"Asthenia","drugRate":"4.1%","severity":"common","organSystem":""},{"effect":"Fatigue","drugRate":"3.8%","severity":"common","organSystem":""},{"effect":"Arteriovenous fistula thrombosis","drugRate":"3.4%","severity":"common","organSystem":""},{"effect":"Arteriovenous fistula site hemorrhage","drugRate":"3.4%","severity":"common","organSystem":""}],"specialPopulations":{"Pregnancy":"There are no available data on Triferic AVNU use in pregnant women to inform drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. No teratogenicity was observed in animal reproduction studies with administration of ferric pyrophosphate citrate to pregnant rats and rabbits during organogenesis at doses 96 and 128 times, respectively, the maximum recommended human dose (MRHD) of 27.2 mg per dialysis.","Geriatric use":"In controlled clinical trials, 99 (29%) patients >= 65 years of age were treated with ferric pyrophosphate citrate. No overall differences in safety and efficacy were observed between older and younger patients in these trials.","Paediatric use":"Safety and effectiveness have not been established in pediatric patients."},"seriousAdverseEvents":[{"effect":"Hypersensitivity reactions","drugRate":"","severity":"serious"},{"effect":"Intradialytic hypotension","drugRate":"","severity":"serious"},{"effect":"Arteriovenous fistula thrombosis","drugRate":"3.4%","severity":"serious"},{"effect":"Arteriovenous fistula site hemorrhage","drugRate":"3.4%","severity":"serious"}]},"trials":[],"aliases":[],"company":"Rockwell Medical Inc","patents":[{"applNo":"N208551","source":"FDA Orange Book","status":"Active","expires":"Apr 17, 2029","useCode":"U-1656","territory":"US","drugProduct":false,"patentNumber":"7816404","drugSubstance":false},{"applNo":"N208551","source":"FDA Orange Book","status":"Active","expires":"Sep 8, 2027","useCode":"U-1656","territory":"US","drugProduct":false,"patentNumber":"7857977","drugSubstance":false}],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=FERRIC PYROPHOSPHATE CITRATE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:18:15.845846+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T03:18:12.227360+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Ferric Pyrophosphate Citrate","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T03:18:24.603765+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:18:23.118827+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=FERRIC PYROPHOSPHATE CITRATE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:18:23.352601+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL3833317/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:18:24.271189+00:00"}},"allNames":"triferic","offLabel":[],"synonyms":["ferric pyrophosphate citrate","ferric pyrophosphate soluble","sodium ferricitropyrophosphate","soluble ferric pyrophosphate","triferic"],"timeline":[{"date":"2015-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from ROCKWELL MEDICAL INC to Rockwell Medical Inc"},{"date":"2020-03-27","type":"positive","source":"FDA Orange Book","milestone":"Triferic Avnu approved — 6.75MG IRON/4.5ML (1.5MG IRON/ML)"}],"aiSummary":"Triferic (FERRIC PYROPHOSPHATE CITRATE) is a small molecule iron supplement therapy developed by Rockwell Medical Inc. It is used to treat iron deficiency in patients undergoing hemodialysis. Triferic is a patented medication with no generic manufacturers available. The safety considerations for Triferic include potential gastrointestinal side effects and the need for regular monitoring of iron levels. It was FDA approved in 2015 for its approved indications.","approvals":[{"date":"2015-01-23","orphan":false,"company":"ROCKWELL MEDICAL INC","regulator":"FDA"}],"brandName":"Triferic","ecosystem":[{"indication":"Iron supplement therapy","otherDrugs":[],"globalPrevalence":null}],"mechanism":{"modality":"Small Molecule","explanation":"","oneSentence":"","technicalDetail":"Triferic is a ferric pyrophosphate citrate complex that is administered intravenously during hemodialysis sessions, allowing for a controlled release of iron into the bloodstream."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Iron(III)_pyrophosphate","title":"Iron(III) pyrophosphate","extract":"Iron(III) pyrophosphate is an inorganic chemical compound with the formula Fe4(P2O7)3."},"commercial":{"launchDate":"2015","_launchSource":"DrugCentral (FDA 2015-01-23, ROCKWELL MEDICAL 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Disease"],"enrollment":12,"completionDate":"2020-01-16"},{"nctId":"NCT03303144","phase":"PHASE1,PHASE2","title":"Equivalence of Triferic® (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients","status":"COMPLETED","sponsor":"Rockwell Medical Technologies, Inc.","startDate":"2017-10-01","conditions":["End Stage Renal Disease"],"enrollment":27,"completionDate":"2017-12-28"},{"nctId":"NCT02905981","phase":"PHASE2","title":"Triferic IRIDA (Iron-Refractory Iron-Deficiency Anemia) Protocol","status":"TERMINATED","sponsor":"Rockwell Medical Technologies, Inc.","startDate":"2017-01-17","conditions":["Iron-Refractory Iron-Deficiency Anemia"],"enrollment":1,"completionDate":"2018-03-15"},{"nctId":"NCT02636049","phase":"PHASE1","title":"Pharmacokinetics of Triferic (Ferric Pyrophosphate Citrate) Administered Intravenously to Healthy Adult Volunteers","status":"COMPLETED","sponsor":"Rockwell Medical Technologies, 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