nelonemdaz (Neu2000KL) / GNT Pharma, Zhejiang Apeloa Medical Technology - LARVOL DELTA

Early Administration of Nelonemdaz May Improve the Stroke Outcomes in Patients With Acute Stroke. (PubMed, J Stroke) - No abstract available

Journal • Cardiovascular

COMPARISON OF NEUROPROTECTIVE ADJUVANT TREATMENTS IN PATIENTS WITH ACUTE ISCHEMIC STROKE AFTER REPERFUSION THERAPY: A SYSTEMIC REVIEW AND NETWORK META-ANALYSIS (ESOC 2025) - "The efficacy of these treatments, ranked in order of mean RD, was as follows: RH, transcranial direct current stimulation, NBO, imatinib, uric acid, nelonemdaz, butylphthalide, cerebrolysin, ApTOLL, nerinetide, theophylline, remote ischemic conditioning, otaplimastat, simvastatin and albumin. RH and NBO were associated with better functional outcome. Cerebrolysin was linked to reduced risk of sICH, and NBO was associated with lower risk of mortality."

Retrospective data • Review • Cardiovascular • Ischemic stroke

NEUROPROTECTIVE RESPONDER POPULATION IN POOLED NELONEMDAZ TRIALS THROUGH SEQUENTIAL STRATIFICATION IN ACUTE ISCHEMIC STROKE (ESOC 2025) - "This systematic analysis identified a distinct responder population for nelonemdaz after mechanical thrombectomy. The selection criteria are pathophysiologically plausible: diabetes may accelerate infarct progression, exclusion of ASPECTS 10 may remove ceiling effects in functional outcomes, and stent retrievers may ensure immediate bypass effects of the treatment drug. These findings warrant a confirmatory randomized trial with renewed selection criteria."

Clinical • Cardiovascular • Ischemic stroke

Nelonemdaz as a Neuroprotective Agent in Acute Ischemic Stroke: A Meta-analysis of RODIN and SONIC Trials. (PubMed, Am J Ther) - No abstract available

Journal • Retrospective data • Cardiovascular • Ischemic stroke

Nelonemdaz Treatment in Out-of-Hospital Cardiac Arrest: The Quest for the Grail Continues. (PubMed, Crit Care Med) - No abstract available

Journal • Cardiovascular

Nelonemdaz Treatment for Patients With Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial. (PubMed, Crit Care Med) - "Nelonemdaz treatment of patients after OHCA did not reduce serum NSE levels compared with controls. Patients treated with high-dose nelonemdaz showed higher brain MRI fractional anisotropy suggesting less cerebral white matter damage."

Clinical • Journal • Cardiovascular • CNS Disorders • Vascular Neurology

Nelonemdaz and Patients With Acute Ischemic Stroke and Mechanical Reperfusion: The RODIN Randomized Clinical Trial. (PubMed, JAMA Netw Open) - P3 | "In this randomized clinical trial, nelonemdaz did not meet the primary efficacy end point compared with placebo. ClinicalTrials.gov Identifier: NCT05041010."

Clinical • Journal • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Ischemic stroke

GNT Pharma submits IND to MFDS for Phase 3 stroke clinical trial [Google translation] (Hankyung) - "GNT Pharma announced on the 9th that it submitted an Investigational New Drug (IND) for a phase 3 clinical trial to confirm the efficacy of 'nelonemadaz', which is under development as a stroke treatment, to the Ministry of Food and Drug Safety. GNT Pharma completed a multinational phase 3 clinical trial (RENEW) protocol to confirm the efficacy of nelonemdaz, which was confirmed in domestic phase 2 and 3 stroke clinical trials, and decided to proceed with clinical trials in Korea, the United States, Australia, and other countries...The multinational phase 3 clinical trial of nelonemdaz will be conducted on 788 patients with severe stroke who will undergo thrombectomy within 12 hours of onset....An interim analysis by the Independent Data Monitoring Committee (IDMC) will be conducted when 50% of the total trial subjects are enrolled."

DSMB • New P3 trial • Ischemic stroke

Effect of nelonemdaz for patients with out-of-hospital cardiac arrest: the AWAKE phase II randomised clinical trial (ESC 2024) - "Patients treated with nelonemdaz also showed a favourable tendency of neurological recovery at day 90 without significant adverse effects. These results justify the initiation of a large-scale phase III trial."

Clinical • P2 data • Cardiovascular • S100B

Rescue on Reperfusion Damage in Cerebral Infarction by Nelonemdaz: A Phase III Trial (ISC 2024) - P3 | "The RODIN trial will clarify the efficacy and safety of nelonemdaz in patients with acute ischemic stroke and endovascular thrombectomy (ClinicalTrials.gov: NCT05041010)."

Late-breaking abstract • P3 data • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Ischemic stroke • Reperfusion Injury

Neuroprotection during Thrombectomy for Acute Ischemic Stroke: A Review of Future Therapies. (PubMed, Int J Mol Sci) - "Advances in multiple neuroprotective therapies, including uric acid, activated protein C, nerinetide, otaplimastat, imatinib, verapamil, butylphthalide, edaravone, nelonemdaz, ApTOLL, regional hypothermia, remote ischemic conditioning, normobaric oxygen, and especially nuclear factor erythroid 2-related factor 2, have promising evidence for improving stroke care. Sedation and blood pressure management in endovascular thrombectomy also play crucial roles in improved stroke outcomes. A hand-in-hand approach with both endovascular therapy and neuroprotection may be the key to targeting disability due to stroke."

Journal • Review • Anesthesia • Cardiovascular • Ischemic stroke • Reperfusion Injury

Rationale And Ongoing Status In A Phase 3 Trial Of Nelonemdaz, A Novel Neuroprotection Drug, For Patients With Acute Ischemic Stroke And Reperfusion (ISC 2023) - P3 | "This trial will clarify the efficacy and safety of nelonemdaz in patients with acute ischemic stroke and endovascular thrombectomy. This study was registered in ClinicalTrials.gov, number NCT05041010."

Clinical • P3 data • Cardiovascular • CNS Disorders • Immunology • Ischemic stroke • Reperfusion Injury

The Rescue on Reperfusion Damage in Cerebral Infarction by Nelonemdaz (RODIN) Trial: Protocol for a Double-Blinded Clinical Trial of Nelonemdaz in Patients with Hyperacute Ischemic Stroke and Endovascular Thrombectomy. (PubMed, J Stroke) - P3 | "This trial will clarify the efficacy and safety of nelonemdaz in patients with acute ischemic stroke and endovascular thrombectomy. This study has been registered at ClinicalTrials. gov (NCT05041010)."

Journal • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Immunology • Ischemic stroke • Reperfusion Injury

RODIN: Rescues On Reperfusion Damage In Cerebral Infarction by Nelonemdaz (clinicaltrials.gov) - P3 | N=496 | Recruiting | Sponsor: GNT Pharma | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • CNS Disorders • Ischemic stroke • Reperfusion Injury

Nelonemdaz for Patients With Acute Ischemic Stroke Undergoing Endovascular Reperfusion Therapy: A Randomized Phase II Trial. (PubMed, Stroke) - P2 | "The study arms showed no significant difference in the proportion of patients achieving modified Rankin Scale scores of 0-2 at 12 weeks. Nevertheless, nelonemdaz-treated patients showed a favorable tendency toward achieving these scores at 12 weeks, without serious adverse effects. Thus, a large-scale phase III trial is warranted."

Journal • P2 data • Cardiovascular • CNS Disorders • Ischemic stroke • Reperfusion Injury

RODIN: Rescues On Reperfusion Damage In Cerebral Infarction by Nelonemdaz (clinicaltrials.gov) - P3; N=496; Not yet recruiting; Sponsor: GNT Pharma

Clinical • New P3 trial • Cardiovascular • CNS Disorders • Ischemic stroke • Reperfusion Injury • MRI

Safety and Optimal Neuroprotection of neu2000 in acute Ischemic stroke with reCanalization: study protocol for a randomized, double-blinded, placebo-controlled, phase-II trial. (PubMed, Trials) - P2; "The trial results may provide information on new therapeutic options as multi-target neuroprotection might mitigate reperfusion injury in patients with acute ischemic stroke before EVT."

Clinical • Journal • P2 data • Biosimilar • Cardiovascular • Gene Therapies • Genetic Disorders • Hematological Disorders • Immunology • Reperfusion Injury • Venous Thromboembolism