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)
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>).
- Ifenprodil Tartrate Solubility in DMSO
- Ifenprodil Tartrate Stock Solution
- Ifenprodil Tartrate Storage
- Ifenprodil Tartrate Stability
- Ifenprodil Tartrate Molecular Weight
- Ifenprodil Tartrate SMILES
- Ifenprodil Tartrate CAS Number
- Ifenprodil Tartrate Chemical Structure (2D and 3D)
- Ifenprodil Tartrate SDS|MSDS