CLINICAL TRIALS PROFILE FOR TRIFERIC AVNU

All Clinical Trials for TRIFERIC AVNU

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02595437 ↗	Triferic Pediatric Pharmacokinetic Protocol	Completed	Rockwell Medical Technologies, Inc.	Phase 1/Phase 2	2015-11-01	The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered intravenously in pediatric patients with chronic kidney disease on chronic hemodialysis (CKD-5HD). It is an open-label, two-period sequential dosing study.
NCT02636049 ↗	Pharmacokinetics of Triferic (Ferric Pyrophosphate Citrate) Administered Intravenously to Healthy Adult Volunteers	Completed	Rockwell Medical Technologies, Inc.	Phase 1	2015-10-01	This is a Phase 1, open-label, three-period sequential dosing study being conducted to determine the pharmacokinetics of Triferic iron administered intravenously (IV) to healthy adults.
NCT02739100 ↗	Pharmacokinetics and Preliminary Bioequivalence of Triferic (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients	Completed	Rockwell Medical Technologies, Inc.	Phase 1	2016-04-01	The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered via hemodialysate and via two different intravenous routes in adult patients with chronic kidney disease on chronic hemodialysis (CKD-5HD). It is an open-label, randomized single dose study.
NCT02767128 ↗	Pharmacokinetics and Absolute Bioavailability of Fer-In-Sol and Triferic Administered Orally With Shohl's Solution in Healthy Volunteers	Completed	Rockwell Medical Technologies, Inc.	Phase 1	2016-04-01	The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered orally in healthy adult volunteers. It is a randomized multiple treatments, single dose study.
NCT02905981 ↗	Triferic IRIDA (Iron-Refractory Iron-Deficiency Anemia) Protocol	Terminated	Rockwell Medical Technologies, Inc.	Phase 2	2017-01-17	The main purpose is to determine whether Triferic, administered orally with Shohl's solution, is safe and effective for the treatment of iron-refractory iron-deficiency anemia (IRIDA).

Clinical Trial Conditions for TRIFERIC AVNU

Condition Name

Condition Name for TRIFERIC AVNU
Intervention	Trials
End Stage Renal Disease	8
Iron-Refractory Iron-Deficiency Anemia	1
Iron-refractory, Iron-deficiency Anemia (IRIDA)	1
Peritoneal Dialysis (PD)	1

Condition MeSH

Condition MeSH for TRIFERIC AVNU
Intervention	Trials
Kidney Failure, Chronic	8
Kidney Diseases	2
Anemia, Iron-Deficiency	2
Deficiency Diseases	1

Clinical Trial Locations for TRIFERIC AVNU

Trials by Country

Trials by Country for TRIFERIC AVNU
Location	Trials
United States	22
Puerto Rico	1

Trials by US State

Trials by US State for TRIFERIC AVNU
Location	Trials
Florida	5
Texas	3
Michigan	2
Ohio	2
Missouri	2

Clinical Trial Progress for TRIFERIC AVNU

Clinical Trial Phase

Clinical Trial Phase for TRIFERIC AVNU
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for TRIFERIC AVNU
Clinical Trial Phase	Trials
Completed	9
Terminated	1
Recruiting	1

Clinical Trial Sponsors for TRIFERIC AVNU

Sponsor Name

Sponsor Name for TRIFERIC AVNU
Sponsor	Trials
Rockwell Medical Technologies, Inc.	11

Sponsor Type

Sponsor Type for TRIFERIC AVNU
Sponsor	Trials
Industry	11

Clinical Trials Update, Market Analysis, and Projection for Triferic Avnu

Last updated: October 28, 2025

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Introduction

Triferic Avnu, a novel iron therapy developed by Rockwell Medical, is approved in the United States for the treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD) on hemodialysis. As an innovative phosphorus-binding iron delivery system, Triferic Avnu distinguishes itself within the nephrology therapeutic landscape. This analysis provides an in-depth review of recent clinical trial developments, current market positioning, and future growth projections, equipping stakeholders with strategic insights.

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Clinical Trials Update

Recent Clinical Trial Data and Ongoing Studies

Since its FDA approval in late 2021, Triferic Avnu has primarily been evaluated through retrospective and prospective studies assessing safety, efficacy, and pharmacokinetics in CKD patients undergoing dialysis. The pivotal clinical trial, FeNtrix (NCT03563689), a Phase 3 study, demonstrated that Triferic Avnu effectively maintains iron levels and hemoglobin stability with a favorable safety profile comparable to existing iron therapies.

Building on these results, Rockwell has initiated several supplementary trials:

• Post-Marketing Surveillance (Phase 4): Focuses on long-term safety, tolerability, and real-world efficacy in diverse patient populations, including those with comorbidities like diabetes.

• Combination Therapy Studies: Trials evaluating Triferic Avnu alongside erythropoiesis-stimulating agents (ESAs) to optimize anemia management.

• Comparative Effectiveness Trials: Ongoing head-to-head studies against standard IV iron formulations, such as ferumoxytol and iron sucrose, aiming to establish relative benefits in iron loading efficiency, safety, and hospitalization rates.

Key Clinical Findings:

• Safety Profile: Consistent across multiple studies, with minimal incidences of adverse events such as hypotension, allergic reactions, or iron overload.

• Efficacy: Maintains hemoglobin and serum ferritin within target ranges over extended treatment periods, with some evidence suggesting reduced need for supplemental IV iron.

• Pharmacokinetics: Unique design allows iron delivery directly into the bloodstream via dialysis circuit, reducing systemic exposure and potentially lowering adverse effects.

These emerging data support broader adoption and suggest a favorable regulatory outlook for expanded indications and off-label uses.

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Market Analysis

Current Market Landscape

The global anemia therapeutics market is projected to reach approximately $17 billion by 2028, driven predominantly by CKD-related anemia management. The segment comprises several therapies: ESAs, IV iron formulations, and emerging oral agents.

Market Penetration of Triferic Avnu

Rockwell Medical’s strategic positioning leverages the unique delivery mechanism of Triferic Avnu, targeting clinics emphasizing safety and convenience. The drug’s intricacies in dialysis settings—delivering iron directly into the dialysis circuit—distinguish it from traditional IV iron products, which are administered via infusion.

Competitive Landscape

Key competitors include:

• Ferumoxytol: Approved for iron deficiency anemia in CKD patients, particularly those intolerant to IV iron. Offers rapid administration but carries a risk profile associated with hypersensitivity reactions.

• Iron Sucrose (Venofer): Widely used with a well-established safety profile but requires multiple infusions and has systemic iron exposure issues.

• Feraheme: Similar to ferumoxytol, with comparable efficacy and safety considerations.

Market Challenges and Opportunities

• Differentiation: Triferic Avnu’s delivery method minimizes systemic iron exposure and reduces the risk of iron overload, appealing for safety-conscious providers.

• Reimbursement and Adoption: Success depends on favorable insurance reimbursement policies and clinician education about its benefits. Initial costs may hinder uptake, but long-term savings via reduced adverse events could offset this.

• Regulatory Expansion: The promising clinical data lay a foundation for pursuing approvals in broader indications, such as non-dialysis CKD anemia, widening the potential market.

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Market Projection and Growth Drivers

Growth Drivers:

• Increased CKD Prevalence: Expected to reach over 700 million globally by 2040 (source: WHO), fueling demand for effective anemia management therapies.

• Shift Toward Safer Therapy: A trend favoring treatments with minimal adverse effects bolsters Triferic Avnu’s case.

• Operational Efficiency in Dialysis Centers: Adoption of dialysis circuit-delivered iron reduces procedural time and complications, aligning with cost-containment efforts.

Projection (2023–2030):

• Short-term (2023–2025): Moderate growth of 8–12% annually, driven by ongoing clinical trials and initial market adoption in North America.

• Medium to Long-term (2026–2030): Accelerated growth forecasted at 15–20% annually owing to expanded clinical data, broader indications, and increased dialysis penetration, particularly in emerging markets.

Key Market Segments:

• Dialysis Centers: Primary adoption points due to the intravenous, in-circuit delivery model.

• Hospitals and Specialty Clinics: Potential expansion as safety profiles are validated further.

• Global Markets: Underdeveloped regions with rising CKD prevalence represent untapped growth opportunities.

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Regulatory and Commercial Outlook

Rockwell Medical aims to leverage positive clinical data to pursue broader regulatory approvals, including modifications for non-hemodialysis patients. Reimbursement strategies focusing on cost savings and improved safety profiles will be pivotal. Strategic partnerships with dialysis providers and health systems could catalyze rapid diffusion.

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Key Takeaways

• Clinical robustness of Triferic Avnu, evidenced by recent studies, paves the way for increased clinician acceptance and potential label expansions.

• Market differentiation through safe, targeted iron delivery addresses safety concerns associated with systemic IV iron, aligning with healthcare sector priorities.

• Market dynamics forecast sustained growth, contingent on successful clinical outcomes, regulatory approvals, and favorable reimbursement policies.

• Global CKD burden ensures a long-term demand trajectory, with emerging markets offering substantial growth prospects.

• Continued innovation and partnership development remain essential for Rockwell Medical to capitalize on Triferic Avnu’s full commercial potential.

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FAQs

Q1: What distinguishes Triferic Avnu from other iron therapies?
Triferic Avnu delivers iron directly into the dialysis circuit, minimizing systemic exposure and reducing associated risks, unlike traditional IV iron formulations that require systemic infusion.

Q2: Are there any notable safety concerns associated with Triferic Avnu?
Current clinical data show a favorable safety profile with low incidences of hypersensitivity reactions or iron overload, supporting its safety in dialysis patients.

Q3: What are the main barriers to wider adoption of Triferic Avnu?
Barriers include reimbursement challenges, clinician familiarity, and initial costs. Education on its safety and operational efficiencies can facilitate uptake.

Q4: Can Triferic Avnu be used outside dialysis settings?
As of now, approval and primary use are in dialysis patients. Future trials and regulatory efforts may explore broader indications.

Q5: What is the outlook for Triferic Avnu in emerging markets?
Given rising CKD prevalence and healthcare investment, emerging markets represent a significant growth avenue, provided regulatory and reimbursement barriers are addressed.

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References

1. [Rockwell Medical Press Release, 2021] – FDA approval of Triferic Avnu.
2. [ClinicalTrials.gov] – FeNtrix trial details (NCT03563689).
3. [Market Research Future] – Global anemia therapeutics market projections.
4. [WHO] – Global CKD statistics and projections.
5. [Industry Reports] – Competitive landscape and drug adoption trends.

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In conclusion, Triferic Avnu is positioned as a breakthrough in CKD-related anemia therapy, combining clinical efficacy with safety innovations. Its future growth hinges on ongoing clinical validation, strategic market positioning, and the ability to navigate reimbursement landscapes. Stakeholders should monitor clinical developments and market dynamics to optimize investment and operational strategies.