Pharmacological and toxicological studies on an iron succinyl-protein complex (ITF282) for oral treatment of iron deficiency anemia.

ITF282, a soluble iron succinyl-protein complex, orally administered to the rat elevates the concentration of iron in the serum to a greater extent than ferritin. The serum iron increase induced by ITF282 is delayed when compared with ferrous sulphate. The ITF282 absorption process, like that of ferritin, proceeds along the physiological pathways without bypassing the transfer system of the intestinal mucosal cells since no further increase of serum metal is observed when giving high doses of ITF282 to the rat pretreated with a saturating dose of ferrous sulphate. Hypochromic and microcytic anemia induced in growing rats by bleeding and feeding a low iron diet is sensitive to both prophylactic and therapeutic oral treatment with ITF282. Iron deficiency anemia and cardiomegaly induced in suckling rats by feeding the pregnant and lactating dams with the low iron diet are reversed by oral treatment of the dams with ITF282. Comparative investigations of the therapeutic efficacy of ITF282 and ferritin made on uncomplicated iron deficiency anemia show that the drugs, p.o. administered during 4 weeks, are equally effective. Preliminary toxicological data in the rat, after single and chronic administrations, show that ITF282 is well tolerated. These findings prove that ITF282 gives an adequate supply of iron from which to make hemoglobin.