Multiple clinical trials are currently investigating infectious, cardiovascular, and oncological indications, focusing on Chlamydia trachomatis infection, Neisseria gonorrhoeae infection, asymptomatic conditions, coronary heart disease in coronary artery bypass grafting patients, and breast cancer. Spanning Phase 1, Phase 2, and non-applicable phase evaluations, these studies are sponsored by industrial entities such as Abbott Rapid Dx and Novartis Pharmaceuticals alongside academic institutions like the University of California, Los Angeles. Currently listed with a recruitment status of not yet recruiting, these records capture an early-stage clinical evaluation landscape across diverse therapeutic areas.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06395675 | Not yet recruiting | Chlamydia Trachomatis Infection|Neisseria Gonorrheae Infection|Asymptomatic Condition |
Abbott Rapid Dx |
2024-07-09 | Not Applicable |
| NCT06326996 | Not yet recruiting | Coronary Heart Disease|Coronary Artery Bypass Grafting |
University of California Los Angeles |
2024-05 | Not Applicable |
| NCT06247995 | Not yet recruiting | Breast Cancer |
Novartis Pharmaceuticals|Novartis |
2024-05-16 | Phase 1|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>).
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