stroquinan (SP-8203) / Shin Poong Pharma - LARVOL DELTA

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

SP-8203-3001: Efficacy and Safety of SP-8203 (Otaplimastat) in Patients With Acute Ischemic Stroke Receiving Thrombolytic Standard of Care (clinicaltrials.gov) - P3 | N=852 | Recruiting | Sponsor: Shin Poong Pharmaceutical Co. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Ischemic stroke

Shin Poong Pharmaceutical, ’otaplimastat’ Phase 2 Integrated Analysis Results Announced at the International Stroke Conference [Google translation] (HIT News) - "Shin Poong Pharmaceutical...announced on the 12th that it presented the results of the integrated phase 2 clinical analysis of its new stroke drug candidate otaplimastat (code name SP-8203) at the '2025 International Stroke Conference (ISC2025)'...As a result, functional disability (90-day modified Ranking Score, mRS 0–2 points) and neurological disability (National Institutes of Health Stroke Scale, NIHSS) improved more rapidly than the placebo group, and a decrease in cerebral infarction size (magnetic resonance imaging MRI analysis results) was also confirmed...In this presentation, the results of the late phase 2 (subject to 178 people) conducted with the same trial design as the electric phase 2 (except that the upper age limit was adjusted upward from 80 to 85 years old) were integrated....A tendency for cerebral infarction volume to be suppressed by 89% compared to the placebo was also confirmed."

Retrospective data • Ischemic stroke

EFFICACY OF OTAPLIMASTAT IN ACUTE STROKE PATIENTS REQUIRING REPERFUSION THERAPY STANDARD OF CARE: A POOLED ANALYSIS OF TWO DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDIES (ISC 2025) - P2a, P2b, P3 | "Otaplimastat demonstrated safety and efficacy in improving neurological and functional outcomes in moderate to severe AIS patients receiving reperfusion therapy, suggesting its potential as a promising therapeutic strategy to be advanced to a phase 3 study (NCT06660719)."

Late-breaking abstract • Retrospective data • Cardiovascular • CNS Disorders

SP-8203-3001: Efficacy and Safety of SP-8203 (otaplimastat) in Patients with Acute Ischemic Stroke Receiving Thrombolytic Standard of Care (clinicaltrials.gov) - P3 | N=852 | Not yet recruiting | Sponsor: Shin Poong Pharmaceutical Co. Ltd.

New P3 trial • Cardiovascular • Ischemic stroke

EFFICACY AND SAFETY OF OTAPLIMASTAT IN PATIENTS WITH ACUTE ISCHEMIC STROKE REQUIRING TPA: A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 STUDY (ESOC 2024) - "The study will provide high-quality randomized data supporting the efficacy and safety of otaplimastat in AIS patients requiring tPA as a new therapeutic strategy."

Clinical • P3 data • Cardiovascular • Ischemic stroke

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

Neuroprotection for Nonarteritic Central Retinal Artery Occlusion: Lessons from Acute Ischemic Stroke. (PubMed, Clin Ophthalmol) - "Also, neuroprotective research in AIS has been extensive, and newer drugs tested, including Uric acid, Nerinetide, and Otaplimastat, with promising results...Efforts in the field of neuroprotection for NA-CRAO should focus on better imaging to delineate the penumbra after an acute episode of NA-CRAO (using a combination of high-definition optical coherence angiography and electrophysiology). Also, research should explore details of pathophysiologic mechanisms involved in NA-CRAO, allowing for further neuroprotective intervention, and closing the gap between preclinical and clinical neuroprotection."

Journal • Review • Age-related Macular Degeneration • Cardiovascular • Gene Therapies • Ischemic stroke • Macular Degeneration • Ophthalmology • Retinal Disorders • ANGPT1 • XIAP

The Quinazoline Otaplimastat (SP-8203) Reduces the Hemorrhagic Transformation and Mortality Aggravated after Delayed rtPA-Induced Thrombolysis in Cerebral Ischemia. (PubMed, Int J Mol Sci) - "In oxygen-glucose-deprived endothelial cells, otaplimastat suppressed the activity rather than protein expression of MMPs by restoring the level of tissue inhibitor of metalloproteinase (TIMP) suppressed in ischemia, and consequently reduced vascular permeation. This paper shows that otaplimastat under clinical trials is a new drug which can inhibit stroke on its own and extend the therapeutic time window of rtPA, especially when administered in combination with rtPA."

Journal • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Ischemic stroke • Vascular Neurology

Efficacy and Safety of SP-8203 in Patients With Ischemic Stroke Requiring rtPA (clinicaltrials.gov) - P2b; N=178; Completed; Sponsor: Shin Poong Pharmaceutical Co. Ltd.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Cardiovascular • Ischemic stroke

Efficacy and Safety of SP-8203 in Patients With Ischemic Stroke Requiring rtPA (clinicaltrials.gov) - P2b; N=178; Active, not recruiting; Sponsor: Shin Poong Pharmaceutical Co. Ltd.; Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Ischemic stroke

The future of neuroprotection in stroke. (PubMed, J Neurol Neurosurg Psychiatry) - "At the bedside in the last 5 years, uric acid and nerinetide are the only compounds tested for clinical efficacy in randomised controlled trials (RCTs), where all patients had to receive reperfusion therapies, either intravenous thrombolysis and/or mechanical thrombectomy. In addition, otaplimastat, 3K3A-activated protein C (APC), intra-arterial verapamil and intra-arterial hypothermia were also assessed in combination with reperfusion therapy, but in RCTs that only included feasibility or safety outcomes. Some of these compounds yielded promising results which are discussed in this review. Altogether, a deeper knowledge of the mechanisms involved in the ischaemic death process at the neurovascular unit, an improved preselection and evaluation of drugs at the preclinical stage and the testing of putative neuroprotectants in enriched clinical studies of patients receiving reperfusion therapies, might prove more effective than in the past to reverse a dismal situation that..."

Journal • Review • Cardiovascular

SP-8203-2002: Efficacy and Safety of SP-8203 in Patients With Ischemic Stroke Requiring rtPA (clinicaltrials.gov) - P2b; N=178; Recruiting; Sponsor: Shin Poong Pharmaceutical Co. Ltd.

Clinical • New P2b trial • Cardiovascular • Ischemic stroke • Reperfusion Injury

Safety and Efficacy of Two Doses of SP-8203 in Patients With Ischemic Stroke Requiring rtPA (clinicaltrials.gov) - P2a; N=80; Completed; Sponsor: Shin Poong Pharmaceutical Co. Ltd.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Cardiovascular • Ischemic stroke • Reperfusion Injury

Identification of new fluorophores in coelomic fluid of Eisenia andrei earthworms. (PubMed, PLoS One) - "This compound was earlier indentified in Eisenia andrei as SP-8203...However, our results indicate that this metabolite is also present in E. andrei in significant amounts. The possible origin and function of these new metabolites is discussed."

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