AWAKEAntioxidant and NMDA receptor blocker Weans Anoxic brain damage of KorEa OHCA patients

• Phase II clinical study in Korea to examine the safety and efficacy of nelonemdaz in 150 patients resuscitated after out-of-hospital cardiac arrest, with restoration of spontaneous circulation achieved within 4 hours post arrest.
• Participating Hospitals (Department of Emergency Medicine): 6 hospitals including Samsung Medical Center
• Designated by the Ministry of Food and Drug Safety in December 2019 as an orphan drug under development for cardiac arrest patients who are given artificial resuscitation.
• Selected by the Ministry of Health and Welfare in 2020 as a new drug development project for rare disease and supported for research funding.
• Clinical trial completed
• A new drug application (NDA) was submitted to the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea for Conditional Approval, Orphan Drug Designation, Import Approval, and Accelerated Review for Gantinel Injection (Nelonemdaz).