GNT Pharma Receives Regulatory Approval to Initiate Multinational Phase 3 Clinical Trials for its Breakthrough Stroke Therapy ' Nelonemdaz™ '

NEW YORK, July 24, 2025 /PRNewswire/ -- GNT Pharma, a late-stage biopharmaceutical company with operations in Seoul and New York, today announced its IND Application to commence Global Phase 3 Clinical Trials 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 trajectory towards global regulatory approvals and commercialization.

** World's First Dual-Action Stroke Therapy **
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 revascularization therapies and overcome their clinical limitations.

** Global Clinical Collaboration **
The Phase 3 trial will enroll 378 patients with severe ischemic stroke eligible for thrombectomy within 12 hours of symptom onset. The protocol calls for intravenous administration of Nelonemdaz within 60 minutes of ER arrival, repeated 10 times over a 5-day period. Thrombectomy will be performed within 90 minutes of admission. The primary efficacy endpoint is functional independence in daily living at 12 weeks post-treatment.

The trial will be conducted across more than 20 world-leading stroke centers in Korea, USA, and Australia. Dr. BJ Gwag, CEO of GNT Pharma, stated, "Nelonemdaz offers a transformative approach to stroke treatment by combining neuroprotection with revascularization. We are excited to partner with world-renowned stroke experts to expand its global reach."

** Proven Safety & Efficacy **
Nelonemdaz demonstrated strong clinical promise in previous Phase 2 and 3 trials involving 704 stroke patients in Korea. When administered within 60 minutes of emergency room arrival, the drug improved disability outcomes by a factor of 4.3 compared to placebo, and by 2.22 times when administered within 70 minutes. These results were published in the Journal of Stroke (May 2025, Vol. 27(2)).

** A Paradigm Shift in Stroke Therapy **
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.

About GNT Pharma Co., Ltd.

GNT Pharma is a late-stage biopharma company founded in 1998, with offices in Seoul and New York, focused on developing innovative drugs for neurological, inflammatory and respiratory diseases. The company is well known for its work on novel drug candidates like Nelonemdaz (for stroke and cardiac arrest), and Crisdesalazine (for Alzheimer's disease). GNT Pharma also has a veterinary medicine division, GNT Animal Health, which has a commercially available treatment for Canine Cognitive Dysfunction Syndrome . With a deep portfolio of clinical research, GNT Pharma combines translational science with global collaboration to accelerate delivery of life-changing treatments.  Further information at www.gntpharma.com

Further Information:

Dr. Peter Holden , GNT Pharma International(USA)     Mr. Sam Cho, President, GNT Pharma (Korea)
(C) +1 917-601-1388; (E) [email protected]        (M) +82 -108948-7142;(E) [email protected]

SOURCE GNT Pharma