Clinical Trials

Multiple Phase 1 clinical trials sponsored by Thomas Jefferson University are evaluating the therapeutic potential of pyrvinium pamoate in resectable pancreatic ductal adenocarcinoma spanning AJCC v8 stages 0 through IIB. These dose-escalation studies target human antigen R to assess treatment safety and feasibility in early-stage disease, with recruitment statuses currently reported as recruiting and active, not recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05055323 ACTIVE_NOT_RECRUITING
Resectable Pancreatic Ductal Adenocarcinoma; Stage 0 Pancreatic Cancer AJCC v8; Stage I Pancreatic Cancer AJCC v8; Stage IA Pancreatic Cancer AJCC v8; Stage IB Pancreatic Cancer AJCC v8; Stage II Pancreatic Cancer AJCC v8; Stage IIA Pancreatic Cancer AJCC v8; Stage IIB Pancreatic Cancer AJCC v8
Thomas Jefferson University
2021-07-29 PHASE1
NCT05055323 Recruiting
Resectable Pancreatic Ductal Adenocarcinoma|Stage 0 Pancreatic Cancer AJCC v8|Stage I Pancreatic Cancer AJCC v8|Stage IA Pancreatic Cancer AJCC v8|Stage IB Pancreatic Cancer AJCC v8|Stage II Pancreatic Cancer AJCC v8|Stage IIA Pancreatic Cancer AJCC v8|Stage IIB Pancreatic Cancer AJCC v8
Thomas Jefferson University
2021-07-29 Phase 1

(data from https://clinicaltrials.gov, updated on 2026-07-21)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pyrvinium pamoate binds to regulatory proteins such as human antigen R, inhibiting downstream messenger RNA stability and disrupting essential cellular signaling networks. This inhibition blocks critical proliferative pathways and triggers selective cell death, providing the biochemical basis for suppressing pancreatic ductal adenocarcinoma in early-phase clinical evaluations.

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.