Triferic

(Ferric pyrophosphate)

Small molecule

RRockwell Medical Technologies, Inc.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Clinical

Trials by Indication[1]

Dialysis Patients3 trials

Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients (CRUISE 2)

Completed·RRockwell Medical Technologies, Inc.·Phase 3·NCT01322347·294 enrolled

Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients

Completed·RRockwell Medical Technologies, Inc.·Phase 3·NCT01320202·305 enrolled

Delivery of Soluble Ferric Pyrophosphate (SFP) Via the Dialysate to Maintain Iron Balance in Hemodialysis Patients

Terminated·—·N/A·NCT00604565·11 enrolled

CKD1 trial

Quantitative Mass Transfer of SFP-iron From Dialysate to Blood in CKD-HD Patients

Completed·RRockwell Medical Technologies, Inc.·Phase 1/2·NCT01894906·12 enrolled

Single Ascending Dose1 trial

A Single Ascending Dose Study of Soluble Ferric Pyrophosphate Administered Intravenously in Healthy Volunteers.

Completed·RRockwell Medical Technologies, Inc.·Phase 1·NCT01920854·48 enrolled

End Stage Renal Disease (ESRD)1 trial

Dose Ranging Study of Dialysate Containing Soluble Iron to Treat Subjects With End Stage Renal Disease (ESRD) Receiving Chronic Hemodialysis

Completed·RRockwell Medical Technologies, Inc.·Phase 2·NCT00548249·131 enrolled

Unspecified1 trial

Ferrous Fumarate and Ferric Pyrophosphate as Food Fortificants in Developing Countries

Completed·IInternational Centre for Diarrhoeal Disease Research, Bangladesh·Phase 1·NCT00867867·235 enrolled

Regulatory

FDA Approval Timeline[3]

Jan 23, 2015

TRIFERIC

NDA NDA206317

Apr 25, 2016

TRIFERIC

NDA NDA208551

Mar 27, 2020

TRIFERIC AVNU

NDA NDA212860

Sources

References

[1]
ClinicalTrials.gov — 7 trial records for Ferric pyrophosphate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Ferric pyrophosphate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA212860). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Triferic. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Rockwell Medical Technologies, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: RRockwell Medical Technologies, Inc.

Patent Landscape[4]

Patent Cliff

Sep 8, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7857977Sep 8, 2027

7816404Apr 17, 2029