Clinical Trials

The clinical trial landscape for All trans-Retinal currently comprises a clinical trial focused on critical care management. Sponsored by Shanghai Zhongshan Hospital, this completed investigation was designated as Phase Not Applicable and evaluated targeted dietary and metabolic support regimens in critically ill patients to determine safety and efficacy. Overall, clinical evaluation of this retinoid cycle intermediate remains limited, with no further research reported across other disease areas or development phases.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02106624 Completed
Critically Ill
Shanghai Zhongshan Hospital
2015-03 Not Applicable

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the All trans-Retinal product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

All trans-Retinal serves as a crucial retinoid cycle intermediate that is enzymatically converted by retinal dehydrogenase into retinoic acid, which subsequently binds retinoic acid receptors (RAR) and retinoid X receptors (RXR) to modulate target gene transcription. This activation of retinoid receptor-mediated signaling regulates cellular differentiation and tissue metabolic homeostasis, providing functional relevance for managing physiological stress and nutritional state in critically ill patients.

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.