GNT Pharma, a late-stage biopharmaceutical company with operations in Seoul and New York, announced on Thursday that its IND application to commence a Phase 3 clinical trial of its lead drug, Nelonemdaz, has been approved by MFDS, South Korea's regulatory body.

Nelonemdaz is a first-in-class dual-action neuroprotectant aimed at reducing death and long-term disability following ischemic stroke. This approval is a significant step in accelerating the drug's path towards global regulatory approvals and commercialisation.

The company claims that Nelonemdaz is the world's first stroke therapy to simultaneously inhibit NR2B-selective NMDA receptors and scavenge free radicals -- two critical drivers of brain cell death following ischemic stroke. The drug is designed to complement existing revascularisation therapies and overcome their clinical limitations.

The Phase 3 trial will enrol 378 patients with severe ischemic stroke eligible for thrombectomy within 12 hours of symptom onset. It will be conducted across more than 20 global stroke centres in Korea, the United States and Australia.

Dr. BJ Gwag, GNT Pharma CEO, stated: "Nelonemdaz offers a transformative approach to stroke treatment by combining neuroprotection with revascularisation. We are excited to partner with world-renowned stroke experts to expand its global reach."

Developed with support from the Korean Ministry of Science, ICT and other government agencies, Nelonemdaz represents a novel dual-action neuroprotective agent targeting both acute and diffuse neuronal damage.