Our Technology

Development & Pipeline

Research and development

Ferric pyrophosphate citrate has a unique mechanism of action to deliver bioavailable iron and potentially improve the treatment of iron deficiency and anemia in many disease states. The development and FDA approval of our IV-delivered product for use in hemodialysis patients is a building block for future formulations and presentations of the drug to transform anemia management in patients with other underlying conditions, beyond ESKD patients receiving hemodialysis.

Home infusion development program

We are initiating a clinical trial program of FPC for the treatment of iron deficiency anemia in the home-infusion setting. Many patient groups requiring home infusion therapies suffer from chronic diseases that are associated with a high incidence of iron deficiency and anemia. Home infusion represents a large and rapidly-growing segment of healthcare where we believe FPC may have distinct advantages over currently available iron replacement therapy options.

Learn more about our Home Infusion Program and the first ever randomized controlled trial of a treatment for iron deficiency anemia in the home infusion setting.

senior patient with doctor

Pipeline

Through research and development, we are exploring the application of FPC in the treatment of hospitalized acute heart failure patients. More than one million people in the United States are hospitalized each year for acute heart failure. Clinical improvement in heart failure has already been demonstrated with traditional forms of IV iron (iron carbohydrate complexes) in clinical trials in the outpatient setting. We believe that FPC may deliver rapidly bioavailable iron to the heart and improve cardiac energetics during hospitalization. This effect could help patients recover faster resulting in shorter hospital stays and reduce risk of 30-day re-admissions. If so, these outcomes would translate into a meaningful reduction in healthcare costs and human suffering. We expect to communicate with the FDA in 2021 regarding a development pathway for this indication.

Progress chart of Rockwell Medical's development pipeline. In regards to Chronic Kidney Disease: Dialysis Concentrates are approved/commercial on the US and International level. Triferic Dialysate (U.S.) and Triferic AVNU are also approved/commercial. Triferic Canada and Triferic Korea (Jeil Pharma) are in-progress of being approved/commercial. Triferic China (Wanbang BioPharm Fosun) is at the end of Phase III. Triferic India (Sun Pharma) is in the middle of Phase III. In regards to IDA: Iron Deficiency Anemia in the Home Infusion Setting FPC HI-01, FPC HI-02 (U.S.) is at the end of Phase I. In regards to AHF: Iron Deficiency in Acute Heart Failure FPC AHF-01 (U.S.) is at the end of Phase I.