TAK-779 is a CCR5 antagonist under investigation by Takeda and Kagoshima University for the potential treatment of HIV [324663], [342114]. TAK-779 inhibits chemokine binding to the CCR5 receptor at nanomolar concentrations. However, it has no effect on the binding of chemokines to the CXCR4 receptor [346835]. A US IND for injectable TAK-779 was filed in june 1999, with Takeda initially planning to commence phase I trials in August 1999. However, the FDA did not clear the IND and recommended that Takeda altered the study protocol to include non-invasive measurement of local toxicities and to evaluate other routes of administration. By September 1999, Takeda had conducted some studies in response to the FDA's recommendations and had made efforts to develop an oral formulation. At this time, the company planned to file a new IND application upon completion of the oral formulation [342114]. In August 1995, Lehman Brothers predicted potential worldwide peak sales of US $300 million in