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Neu2000KWL group
Neu2000KWL group is a NMDA receptor antagonist with antioxidant properties Small molecule drug developed by GNT Pharma. It is currently in Phase 3 development for Acute ischemic stroke, Traumatic brain injury. Also known as: Salfaprodil for injection.
Neu2000KWL is a neuroprotective agent designed to reduce excitotoxic and oxidative damage in the central nervous system.
Neu2000KWL is a vaccine component that induces an immune response, as indicated by its mechanism of action. It is being studied in a Phase II clinical trial for the treatment of ischemic stroke, cardiac arrest, stroke, and cerebral infarction.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Neu2000KWL group |
|---|---|
| Also known as | Salfaprodil for injection |
| Sponsor | GNT Pharma |
| Drug class | NMDA receptor antagonist with antioxidant properties |
| Target | NMDA receptor; free radical scavenger |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 3 |
Mechanism of action
Neu2000KWL combines NMDA receptor antagonism with free radical scavenging properties to protect neurons from ischemic and excitotoxic injury. The dual mechanism targets both glutamate-mediated excitotoxicity and reactive oxygen species generation, which are key pathological processes in acute brain injury. This combination approach aims to provide superior neuroprotection compared to single-mechanism agents.
Approved indications
- Acute ischemic stroke
- Traumatic brain injury
Common side effects
- Dizziness
- Nausea
- Headache
Key clinical trials
- Rescues On Reperfusion Damage In Cerebral Infarction by Nelonemdaz (PHASE3)
- Efficacy and Safety Study of Neu2000KWL for Acute Ischemic Stroke Patients Within 6 Hours of Onset (PHASE2)
- Antioxidant and NMDA Receptor Blocker Wins Anoxic Brain Damage of KorEa OHCA Patients (PHASE2)
- Safety and Optimal Neuroprotection of neu2000 in Ischemic Stroke With Endovascular reCanalizion (SONIC) (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Neu2000KWL group CI brief — competitive landscape report
- Neu2000KWL group updates RSS · CI watch RSS
- GNT Pharma portfolio CI
Frequently asked questions about Neu2000KWL group
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Related
- Drug class: All NMDA receptor antagonist with antioxidant properties drugs
- Target: All drugs targeting NMDA receptor; free radical scavenger
- Manufacturer: GNT Pharma — full pipeline
- Therapeutic area: All drugs in Neurology
- Indication: Drugs for Acute ischemic stroke
- Indication: Drugs for Traumatic brain injury
- Also known as: Salfaprodil for injection
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing