Multiple clinical trials evaluate interventions associated with Propylparaben across diverse indications, including osteoarthritis, salivary gland neoplasms such as adenoid cystic carcinoma, midshaft clavicle fractures, and malignant gliomas. Sponsored by both academic institutions and industry entities, these studies encompass early-phase evaluations—including Phase 1 and Phase 2 trials—alongside non-applicable phase observational designs. Recruitment statuses across these trials range from withdrawn and suspended to not yet recruiting.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT02217202 | Withdrawn | Osteoarthritis |
Golden Jubilee National Hospital|ConvaTec Inc. |
2050-01 | Not Applicable |
| NCT04832438 | Withdrawn | Salivary Gland Carcinoma|Adenoid Cystic Carcinoma|Salivary Gland Cancer|Salivary Gland Neoplasms |
Actuate Therapeutics Inc. |
2030-12-18 | Phase 2 |
| NCT05454306 | Suspended | Clavicle Fracture |
University of Minnesota |
2028-01-09 | Not Applicable |
| NCT04903795 | Not yet recruiting | Malignant Glioma|Glioblastoma |
Duke University |
2026-12 | Phase 1 |
(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>).