Rockwell Medical
| Company type | Public |
|---|---|
| Industry | Pharmaceutical |
| Founded | 1996 |
| Headquarters | Wixom, Michigan , United States |
| Products | Triferic, Calcitriol, Hemodialysis concentrates, Iron (III) pyrophosphate |
Rockwell Medical Inc. is a pharmaceutical firm publicly listed and headquartered in Wixom, Michigan. Established in 1996, the company focuses on therapies targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD). Its main clientele comprises providers of dialysis services.
Triferic
In January 2015, Triferic became the sole FDA-approved treatment designed to replace iron and sustain hemoglobin levels in adult patients undergoing hemodialysis for chronic kidney disease. This therapy compensates for iron depletion occurring during hemodialysis by delivering iron directly to transferrin, which then transports it to the bone marrow to support hemoglobin synthesis. Rockwell pursued active marketing of Triferic within the U.S. hemodialysis sector.
The commercial launch of Triferic (dialysate) commenced in the United States in late 2019, followed by the introduction of Triferic AVNU (intravenous formulation) in early 2021. Nevertheless, due to limited adoption in the market, difficulties with reimbursement, and absence of partner engagement despite extensive outreach, Rockwell ceased its New Drug Applications (NDAs) for both Triferic variants in the U.S. by the fourth quarter of 2022.
Calcitriol
Calcitriol, the active form of vitamin D, holds FDA approval for managing secondary hyperparathyroidism and hypocalcemia in patients receiving hemodialysis.
Hemodialysis Concentrates
Rockwell produces hemodialysis concentrates and dialysates utilized by dialysis providers and distributors both nationally and internationally. These products facilitate toxin removal and replenish vital nutrients during hemodialysis treatments. The company operates three manufacturing and distribution sites across the United States.
Iron (III) pyrophosphate
The company develops iron (III) pyrophosphate as an iron supplementation therapy essential for red blood cell generation. Licensed since 2011, this product targets anemia affecting nearly 90% of individuals undergoing dialysis.
International Partnerships
Despite halting U.S. commercialization efforts for Triferic, Rockwell continues to engage in international collaborations to advance and market Triferic worldwide.
In South Korea, both Triferic and Triferic AVNU have secured regulatory approval, with partner Jeil Pharmaceutical initiating the launch of Triferic in the third quarter of 2022.
In April 2023, partner Drogsan filed marketing authorization and Good Manufacturing Practice (GMP) applications for Triferic AVNU with Turkey’s Medicines and Medical Devices Agency (TMMDA), which granted priority review status. With this expedited regulatory process, Rockwell expects approval for Triferic AVNU in Turkey during 2024. Drogsan oversees regulatory submissions and commercialization activities within that market.