Triferic
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed end stage renal failure 2 milestones | |||||
| Filed | Other | Triferic AVNU | end stage renal failure | 2023-04-27 | “submitted a Marketing Authorization application and GMP application for Triferic ® AVNU TM to the Turkish Medicines and Medical Devices Agency” rockwellmed.com ↗ “In May 2020, Rockwell Medical announced the filing of a New Drug Submission with Health Canada for Triferic AVNU.” rockwellmed.com ↗ “In February 2021, Jeil filed a New Drug Application for Triferic (dialysate) and Triferic AVNU in Korea.” rockwellmed.com ↗ “The Company filed a New Drug Submission (“NDS”) for Triferic AVNU in Canada in May 2020.” rockwellmed.com ↗ |
| Filed | US (FDA) | Triferic | end stage renal failure | 2019-05-29 | “submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the Intravenous (I.V.) formulation of Triferic” rockwellmed.com ↗ “the timing and regulatory approval process for our NDA filing for I.V. Triferic as filed with the FDA” rockwellmed.com ↗ “I.V. Triferic, for which the Company filed a New Drug Application in May 2019.” rockwellmed.com ↗ “I.V. Triferic, for which the Company filed a New Drug Application in May 2019” rockwellmed.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Filed | Other | Triferic AVNU | hemodialysis-dependent chronic kidney disease | 2021-02-01 | “filed New Drug Applications (NDA) with the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea for Triferic AVNU and Triferic Dialysate” rockwellmed.com ↗ “filed New Drug Applications (NDA) with the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea for Triferic AVNU” rockwellmed.com ↗ |
| Filed | Other | Triferic AVNU | hemodialysis-dependent chronic kidney disease | 2020-05-26 | “today announced the filing of a New Drug Submission (“NDS”) with Health Canada for Triferic AVNU (ferric pyrophosphate citrate).” rockwellmed.com ↗ |
| Approved | US (FDA) | TRIFERIC | — | 2015-01-23 | fda.gov ↗ |
Trials 18
News releases announcing trial results or a regulatory action · 18
| Date | Issuer | Release |
|---|---|---|
| 2023-04-27 | Rockwell Medical Technologies, Inc. | Regulatory Rockwell Medical's Partner Drogsan Pharmaceuticals Submits Marketing Authorization Application in Turkey for Triferic AVNU rockwellmed.com ↗
today announced that its international partner, Drogsan Pharmaceuticals, submitted a Marketing Authorization application and GMP application for Triferic ® AVNU TM to the Turkish Medicines and Medical Devices Agency ("TMMDA"), for which Drogsan received priority status and high priority status, respectively. |
| 2022-01-20 | Rockwell Medical Technologies, Inc. | Regulatory Rockwell Medical Announces Regulatory Approval of Triferic® Dialysate in South Korea rockwellmed.com ↗
Two product forms of Triferic® are now approved in South Korea |
| 2022-01-13 | Rockwell Medical Technologies, Inc. | Regulatory Rockwell Medical Announces Regulatory Approval of Triferic® AVNU in South Korea rockwellmed.com ↗ |
| 2021-11-16 | Rockwell Medical Technologies, Inc. | Results Rockwell Medical Study Demonstrates No Drug-drug Interaction Between Ferric Pyrophosphate Citrate and Unfractionated Heparin rockwellmed.com ↗ |
| 2021-11-11 | Rockwell Medical Technologies, Inc. | Regulatory Rockwell Medical Submits Investigational New Drug Application with FDA for its Proposed Clinical Trial of FPC as a Treatment for Iron Deficiency Anemia in Patients Receiving Home Infusion rockwellmed.com ↗ |
| 2021-11-04 | Rockwell Medical Technologies, Inc. | Results Rockwell Medical Presents Triferic® Real World Evidence Update at ASN Kidney Week 2021 rockwellmed.com ↗
Results indicated that Triferic (Ferric Pyrophosphate Citrate, FPC) is well-tolerated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD), findings which are consistent with prior Real World Evidence of Triferic and pivotal clinical trials. |
| 2021-04-27 | Rockwell Medical Technologies, Inc. | Regulatory Rockwell Medical Announces Marketing Approval of Triferic® AVNU™ in Canada rockwellmed.com ↗
The approval of Triferic AVNU by Health Canada is the first international regulatory approval for our intravenous therapy and marks important progress for our strategy to bring Triferic to markets around the world, |
| 2021-02-01 | Rockwell Medical Technologies, Inc. | Regulatory Rockwell Medical Announces Submission of Triferic® New Drug Application in South Korea by Partner, Jeil Pharmaceutical Co., Ltd. rockwellmed.com ↗ |
| 2021-02-01 | Jeil Pharmaceutical Co., Ltd. | Regulatory 제일약품, 美 FDA 승인 ‘트리페릭 주’, 식약처에 품목허가 신청서 제출 jeilpharm.co.kr ↗
제일약품(271980, 대표이사 사장 성석제)은 혈액투석환자의 ‘철(Iron)’대체와 헤모글로빈 유지 기전으로 유일하게 미국 FDA 승인을 받은 신장질환치료제 ‘트리페릭 주’의 품목허가신청서를 식품의약품안전처에 제출하였다고 밝혔다. |
| 2020-05-26 | Rockwell Medical Technologies, Inc. | Regulatory Rockwell Medical, Inc. Files New Drug Submission with Health Canada for Marketing Approval of Triferic® AVNU™ rockwellmed.com ↗
today announced the filing of a New Drug Submission (“NDS”) with Health Canada for Triferic AVNU (ferric pyrophosphate citrate). |
| 2020-05-11 | Rockwell Medical Technologies, Inc. | Results Rockwell Medical, Inc. Provides First Quarter 2020 Financial and Operational Update and Top-line Real-World Triferic Data rockwellmed.com ↗
Retrospective real-world analysis over 18 months shows reduction in ESA and traditional IV iron use, stable-to-increasing hemoglobin levels, reductions in missed treatments, and quality-of-life improvements following clinical adoption of Triferic |
| 2020-03-27 | Rockwell Medical Technologies, Inc. | Regulatory Rockwell Medical, Inc. Receives FDA Approval for Triferic® AVNU (Ferric Pyrophosphate Citrate), Intravenous Formulation of Triferic for Replacement of Iron and Maintenance of Hemoglobin in Hemodialysis Patients rockwellmed.com ↗
Rockwell Medical, Inc. (NASDAQ:RMTI) (“Rockwell Medical” or the “Company”), a biopharmaceutical company dedicated to transforming anemia management and improving outcomes for patients around the world, today announced that the U.S. Food and Drug Administration (“FDA”) has approved its New Drug Application (“NDA”) for its intravenous formulation of Triferic, Triferic AVNU. |
| 2019-08-08 | Rockwell Medical Technologies, Inc. | Results Rockwell Medical, Inc. Announces Completion of Two Clinical Pharmacology Studies of TRIFERIC® in China rockwellmed.com ↗
Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company"), a biopharmaceutical company dedicated to improving outcomes for patients with anemia, with an initial focus on end-stage renal disease (ESRD) and chronic kidney disease (CKD), announced today the positive results of two clinical pharmacology trials of Triferic (ferric pyrophosphate citrate) in China. |
| 2019-08-06 | Rockwell Medical Technologies, Inc. | Regulatory Rockwell Medical, Inc. Announces Acceptance by FDA of New Drug Application for I.V. TRIFERIC® rockwellmed.com ↗
Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company"), a biopharmaceutical company dedicated to improving outcomes for patients with anemia, with an initial focus on end-stage renal disease (ESRD) and chronic kidney disease (CKD), announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s New Drug Application (NDA) for its Intravenous (I.V.) formulation of TRIFERIC ® with a PDUFA (Prescription Drug User Fee Act) date of March 28, 2020. |
| 2019-05-29 | Rockwell Medical Technologies, Inc. | Regulatory Rockwell Medical, Inc. Announces Submission of New Drug Application for I.V. Triferic® rockwellmed.com ↗ |
| 2019-05-01 | Rockwell Medical Technologies, Inc. | Regulatory CMS Issues Preliminary Recommendation to Establish a New J-Code for Triferic® Powder Packet rockwellmed.com ↗
In its preliminary recommendation, CMS proposes an effective date of July 1, 2019 for establishing J1444, and proposes the following descriptor: "Injection, ferric pyrophosphate citrate powder, 0.1 mg of iron". |
| 2019-03-18 | Rockwell Medical Technologies, Inc. | Results Rockwell Medical Announces I.V. Triferic® and Peritoneal Dialysis Study Abstracts Selected as Best-in-Category at the Annual Dialysis Conference rockwellmed.com ↗
“We are encouraged by the data from this study, which demonstrates that I.V. Triferic delivers the same quantity of iron to patients as Triferic delivered via hemodialysate,” said Raymond D. Pratt, M.D., Chief Medical Officer of Rockwell Medical. |
| 2018-05-02 | Rockwell Medical Technologies, Inc. | Results Rockwell Medical Announces Triferic® Presentations at the 2018 International Congress on Peritoneal Dialysis rockwellmed.com ↗
This peritoneal dialysis (PD) study demonstrates that Triferic can deliver iron to PD patients via the dialysis fluid. |
All press releases naming this drug 32 releases
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 24 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Triferic | “Ferric pyrophosphate citrate (Triferic™) administration via the dialysate” PMID 26175145 ↗ Jul 2015 |
| 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 ↗ |
| 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 Citrate” NCT04239391 ↗ |
| 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 20152“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 | 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)” NCT00604565 ↗1“Soluble Ferric Pyrophosphate (SFP)” NCT01320202 ↗ |
| Known as | Soluble Ferric Pyrophosphate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00548249 ↗ |
| 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 ↗ |
| Modality | Other / unclassified | “Triferic is an iron salt” NCT02909153 ↗ |
| Route | Other | “administered via dialysate” PMID 26154926 ↗ Jul 2015 |