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)
Mechanism and Biochemical Profile
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>).
- Neflamapimod (VX-745) Solubility in DMSO
- Neflamapimod (VX-745) Stock Solution
- Neflamapimod (VX-745) Storage
- Neflamapimod (VX-745) Stability
- Neflamapimod (VX-745) Molecular Weight
- Neflamapimod (VX-745) SMILES
- Neflamapimod (VX-745) CAS Number
- Neflamapimod (VX-745) Chemical Structure (2D and 3D)
- Neflamapimod (VX-745) SDS|MSDS