#South Korea #Seoul #GNT Pharma #Nelonemdaz #Stroke Therapy

GNT Pharma Advances Its Groundbreaking Stroke Treatment

In a remarkable development in the field of neuropharmaceuticals, GNT Pharma, a late-stage biopharmaceutical company with operational bases in Seoul and New York, has received regulatory approval from the Ministry of Food and Drug Safety (MFDS) in South Korea to commence international Phase 3 clinical trials for its revolutionary stroke therapy, Nelonemdaz™. This milestone not only marks a significant advancement for the company but also holds the potential to redefine stroke treatment protocols across the globe.

What Is Nelonemdaz™?

Nelonemdaz™ is the world's first dual-action neuroprotectant targeting the aftermath of ischemic stroke—a condition that arises from restricted blood flow to the brain. This innovative therapy operates on two critical fronts; it inhibits NR2B-selective NMDA receptors, which are associated with neuronal cell death, while simultaneously scavenging free radicals, a common cause of further brain cell damage after an ischemic stroke. This two-pronged approach aims to enhance existing revascularization therapies, addressing their limitations and significantly improving patient outcomes.

The Significance of the Phase 3 Trials

The upcoming Phase 3 clinical trial will involve 378 participants suffering from severe ischemic strokes who are eligible for thrombectomy within 12 hours of the onset of symptoms. The structured trial design includes administering Nelonemdaz intravenously within 60 minutes of a patient's arrival at the emergency room, with a total of 10 doses delivered over a 5-day period, culminating in a thrombectomy procedure within 90 minutes post-admission. The primary metric for evaluating effectiveness will be the degree of functional independence that participants achieve in their daily lives after 12 weeks.

Dr. BJ Gwag, CEO of GNT Pharma, emphasized, "Nelonemdaz presents a transformative solution in stroke treatment by merging neuroprotection with revascularization. We are enthusiastic about collaborating with elite stroke specialists worldwide to maximize its therapeutic reach."

Proven Safety and Efficacy Data

Nelonemdaz™ has already demonstrated notable efficacy during earlier Phase 2 and 3 trials, which included a cohort of 704 stroke patients in South Korea. The results revealed that when administered within 60 minutes of emergency care, the drug improved disability outcomes by an impressive 4.3 times in comparison to a placebo, and by 2.22 times for treatments initiated within 70 minutes. These compelling results have been published in the Journal of Stroke (May 2025, Vol. 27(2)).

A Paradigm Shift in Stroke Management

The development of Nelonemdaz™ has received invaluable support from the Korean Ministry of Science and ICT, along with various government agencies, showcasing a robust commitment to advancing medical innovations that target both acute and chronic neuronal damage. By addressing the critical aspects of stroke recovery—neuroprotective therapy and immediate intervention—Nelonemdaz is poised to shift the paradigm in how stroke is treated moving forward.

About GNT Pharma

Founded in 1998, GNT Pharma stands out as a late-stage biopharmaceutical company committed to the advancement of innovative treatments that address neurological, inflammatory, and respiratory conditions. The company is recognized for leading-edge drug candidates like Nelonemdaz™ for stroke and cardiac arrest and Crisdesalazine for Alzheimer’s disease. Furthermore, GNT Pharma also runs GNT Animal Health, producing treatments for conditions like Canine Cognitive Dysfunction Syndrome. With a promising pipeline of clinical research, GNT Pharma merges translational science with global cooperation to expedite the delivery of life-altering therapies.

For more information, visit GNT Pharma's official website.