Clinical Trials

Neflamapimod (VX-745), a targeted p38 MAP kinase inhibitor, has been evaluated in several Phase 2 clinical trials assessing its therapeutic potential, safety, and biomarker impact in central nervous system inflammatory disorders. Sponsored by EIP Pharma Inc. alongside academic institutions such as University Hospital, Toulouse, these studies target neurodegenerative and cerebrovascular conditions, including Alzheimer's disease, dementia with Lewy bodies, Huntington disease, ischemic stroke, and nonfluent variant primary progressive aphasia. Trial recruitment statuses across these protocols range from completed and active non-recruiting to terminated investigations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06987643 ACTIVE_NOT_RECRUITING
Moderate to Severe Acute Ischaemic Stroke; Ischaemic Stroke
EIP Pharma Inc
2025-06-20 PHASE2
NCT07033481 ACTIVE_NOT_RECRUITING
Nonfluent Variant Primary Progressive Aphasia (nfvPPA)
EIP Pharma Inc
2025-10-02 PHASE2
NCT06815965 COMPLETED
Dementia With Lewy Bodies (DLB)
EIP Pharma Inc
2024-10-16 PHASE2
NCT05869669 COMPLETED
Dementia With Lewy Bodies
EIP Pharma Inc
2023-05-01 PHASE2
NCT03435861 COMPLETED
Alzheimer Disease
University Hospital, Toulouse
2018-10-08 PHASE2
NCT03980938 TERMINATED
Huntington Disease
EIP Pharma Inc
2019-07-08 PHASE2
NCT04001517 COMPLETED
Dementia With Lewy Bodies (DLB)
EIP Pharma Inc
2019-09-30 PHASE2
NCT03402659 COMPLETED
Alzheimer Disease
EIP Pharma Inc
2017-12-29 PHASE2
NCT02423200 COMPLETED
Alzheimer's Disease
EIP Pharma Inc
2015-04 PHASE2
NCT02423122 COMPLETED
Alzheimer's Disease; Mild Cognitive Impairment
EIP Pharma Inc
2015-04 PHASE2
NCT02423200 Completed
Alzheimer''s Disease
EIP Pharma Inc
2015-04 Phase 2

(data from https://clinicaltrials.gov, updated on 2026-07-08)

Check the Neflamapimod (VX-745) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Neflamapimod (VX-745) selectively binds to p38α mitogen-activated protein kinase (MAPK) to inhibit its catalytic activity, thereby preventing the phosphorylation and downstream production of pro-inflammatory cytokines such as interleukin-1 beta, interleukin-6, and tumor necrosis factor-alpha. By reducing neuroinflammation and cytokine-mediated microglial activation, this p38α-targeted pathway blockade aims to alleviate neurodegenerative pathology and cognitive impairment in clinical trial conditions such as Alzheimer's disease and dementia with Lewy bodies.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Note: Technical data last updated: Sep 1, 2026.