Takeda has been conducting Phase I clinical studies of Hematide for the treatment of chemotherapy-induced anemia in the US and Japan. However, the companies have decided to suspend development of Hematide in oncology and not to enroll new patients in the ongoing Phase I clinical trial of the product in chemotherapy-induced anemia given the uncertain regulatory landscapes for erythropoiesis-stimulating agents in oncology indications, despite the potential for Hematide in this indication.
Takeda and Affymax are continuing to investigate Hematide for the treatment of anemia related to chronic renal failure. Registrational Phase III trials are ongoing in the US and Europe, with Phase I/Phase II trials ongoing in Japan.
Enrollment for one of the four Phase III trials has been completed and enrollment for the remaining Phase III trials is expected to be completed within this year.