Tag: GNT Pharma

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…

GNT Pharma Provides Update on Two Phase III Studies of Nelonemdaz for Acute Ischemic Stroke Patients Treated with tPA (ENIS-3) or Endovascular Thrombectomy (RODIN)

Promising efficacy and safety profiles were observed in prior Phase II studies in acute ischemic stroke patients treated with recanalization therapies. The ENIS-3 trial has achieved >33% of target enrollment (948 patients). The independent data monitoring committee (IDMC) has completed interim analysis and indicated that the trial should continue. The […]

GNT Pharma Announces Approval of IND Application for the Phase III RODIN Trial of Nelonemdaz for Acute Ischemic Stroke Patients

PIII Study for 496 ischemic stroke patients treated with endovascular thrombectomy First multi-target neuroprotectant for the intervention of ischemic brain injury Safety and efficacy verified in two phase II studies for ischemic stroke patients with recanalization therapy YONGIN, South Korea, Sept. 08, 2021 (GLOBE NEWSWIRE) — GNT Pharma Inc. today […]

GNT Pharma Announces Positive Top-Line Results in a Phase II Study of Nelonemdaz for Acute Ischemic Stroke Patients Treated With Endovascular Thrombectomy

Safety and Tolerability Established Good and Excellent Functional Outcome Increased YONGIN, South Korea–(BUSINESS WIRE)–GNT Pharma Inc. today reports positive top-line results from a phase II, double-blind, randomized, placebo-controlled, multi-center study assessing the safety and efficacy of nelonemdaz in acute ischemic stroke patients treated with endovascular thrombectomy within 8 hours of symptom […]