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Triferic (FERRIC PYROPHOSPHATE CITRATE)
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.
At a glance
| Generic name | FERRIC PYROPHOSPHATE CITRATE |
|---|---|
| Sponsor | Rockwell Medical Inc |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
| First approval | 2015 |
Approved indications
- Iron supplement therapy
Common side effects
- Procedural hypotension
- Headache
- Muscle spasms
- Dyspnea
- Peripheral edema
- Pain in extremity
- Pyrexia
- Urinary tract infection
- Back pain
- Asthenia
- Fatigue
- Arteriovenous fistula thrombosis
Serious adverse events
- Hypersensitivity reactions
- Intradialytic hypotension
- Arteriovenous fistula thrombosis
- Arteriovenous fistula site hemorrhage
Key clinical trials
- Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients (CRUISE 2) (PHASE3)
- Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients (PHASE3)
- Triferic AVNU Infusion Via Freedom Pump During Hemodialysis (PHASE4)
- Treatment of (IDA) by (FPC) Delivered Via Infusion Pump in Patients Receiving Home Infusion Therapy (PHASE2)
- Study to Investigate the Pharmacokinetic Comparability of Dosing Triferic AVNU IV by Continuous Infusion and IV Bolus. (PHASE1,PHASE2)
- Hemoglobin Maintenance in Pediatric ESRD (End-stage Renal Disease) Patients by Ferric Pyrophosphate Citrate (FPC) (PHASE3)
- A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients (PHASE1,PHASE2)
- Equivalence of Triferic® (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients (PHASE1,PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Triferic CI brief — competitive landscape report
- Triferic updates RSS · CI watch RSS
- Rockwell Medical Inc portfolio CI