Clinical Trials

Multiple clinical trials spanning Phase 1 through Phase 3 evaluate ifenprodil tartrate across various neurological and inflammatory conditions, including multiple sclerosis, posttraumatic stress disorder, idiopathic pulmonary fibrosis, and COVID. Sponsored by organizations such as Assistance Publique - Hôpitaux de Paris, Chiba University, and Algernon Pharmaceuticals, several clinical trials investigating posttraumatic stress disorder, idiopathic pulmonary fibrosis, and COVID have been completed. Meanwhile, a clinical trial assessing remyelination in relapsing-remitting multiple sclerosis is listed as not yet recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06330077 NOT_YET_RECRUITING
Multiple Sclerosis; Remitting Relapsing Multiple Sclerosis
Assistance Publique - Hôpitaux de Paris
2024-03 PHASE2
NCT04318704 COMPLETED
Idiopathic Pulmonary Fibrosis
Algernon Pharmaceuticals
2020-07-29 PHASE2
NCT04382924 COMPLETED
COVID
Algernon Pharmaceuticals
2020-08-05 PHASE2; PHASE3
NCT01896388 COMPLETED
Posttraumatic Stress Disorders
Chiba University
2014-01-21 PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2024-03-26)

Check the Ifenprodil Tartrate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ifenprodil Tartrate acts as an atypical, noncompetitive antagonist that selectively binds to NMDA receptors, blocking receptor hyperactivation and suppressing excessive intracellular calcium influx. This attenuation of excitotoxicity and downstream inflammatory signaling provides the biochemical rationale for its clinical evaluation in conditions such as multiple sclerosis, posttraumatic stress disorders, idiopathic pulmonary fibrosis, and COVID.

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.