Clinical Trials

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 Recruitment statuses across these trials range from withdrawn and suspended to not yet recruiting.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NCT02217202 Withdrawn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NCT04832438 Withdrawn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)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Propylparaben disrupts microbial cell membrane integrity and inhibits essential metabolic enzyme activity, leading to compromised membrane potential and cellular death. This broad antimicrobial and cellular inhibitory action prevents microbial contamination in surgical contexts such as clavicle fracture repair and joint replacement, while also contributing to tumor cell growth inhibition in oncology conditions like glioblastoma and salivary gland carcinoma.

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.