Several clinical trials investigate conditions and biological processes associated with kynurenine pathway signaling and tryptophan metabolites, focusing on therapeutic areas such as delayed graft function, acute kidney injury, adult migraine disorders, and pediatric migraine. The landscape encompasses Phase II, Phase III, and observational designs sponsored by academic medical centers and public research institutions. Recruitment statuses across these protocols include completed, actively recruiting, and not yet recruiting.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05513807 | Not yet recruiting | Delayed Graft Function |
Assistance Publique - Hôpitaux de Paris|Institut National de la Santé Et de la Recherche Médicale France|Centre National de la Recherche Scientifique France |
2022-11 | Phase 3 |
| NCT05718310 | Recruiting | Migraine|Migraine Disorders|Pain |
IRCCS National Neurological Institute C. Mondino Foundation|University of Pavia |
2022-11-01 | Not Applicable |
| NCT05969990 | Recruiting | Migraine in Children |
Qilu Hospital of Shandong University |
2022-01-01 | -- |
| NCT04342975 | Completed | AKI |
Mayo Clinic|Elysium Health |
2020-12-01 | Phase 2 |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
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>).