Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.D-Pharm has received approval from the Korean Food & Drug Administration (KFDA) for its investigational new drug (IND) application to initiate Phase III Macsi study of DP-b99 in Korea.
Subscribe to our email newsletter
The IND was filed by D-Pharm’s co-development partner in South Korea, Yungjin Pharmaceutical (YJP).
YJP gets license to develop, register and market DP-b99 from D-Pharm in South Korea to treat patients with acute ischemic stroke.
The IND was submitted on the basis of a study evaluating DP-b99 completed in early 2011 and demonstrated no safety issues.
D-Pharm CEO Alex Kozak said success of the study in Asian volunteers and extension of Macsi to South Korea is of strategic value, paving the way for DP-b99 to reach vast Asian markets.