Clinical Trials

PRI-724 (foscenvivint) has been evaluated in numerous clinical trials across Phase 1, Phase 1/2, and Phase 2 for oncologic and fibrotic hepatic indications, including liver cirrhosis, primary biliary cholangitis, pancreatic adenocarcinoma, myeloid leukemias, and colorectal cancer. Sponsored by pharmaceutical companies such as Prism Pharma Co. Ltd. and Ohara Pharmaceutical Co. Ltd. in collaboration with academic and government entities, trial recruitment statuses across the portfolio range from completed to withdrawn or terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03620474 COMPLETED
Hepatitis C; Hepatitis B; Liver Cirrhoses
Kiminori Kimura, MD
2018-07-24 PHASE1; PHASE2
NCT04688034 Completed
Liver Cirrhosis
Kiminori Kimura MD|Japan Agency for Medical Research and Development|Ohara Pharmaceutical Co. Ltd.|Komagome Hospital
2021-03-15 Phase 1
NCT04047160 Completed
Primary Biliary Cholangitis (PBC)|Liver Cirrhosis Biliary
Kiminori Kimura MD|Ohara Pharmaceutical Co. Ltd.|Japan Agency for Medical Research and Development|Komagome Hospital
2019-08-29 Phase 1
NCT02413853 WITHDRAWN
Colorectal Adenocarcinoma; Stage IVA Colorectal Cancer; Stage IVB Colorectal Cancer
University of Southern California
2015-11 PHASE2
NCT02195440 COMPLETED
Hepatitis C Virus-infected Cirrhosis
Komagome Hospital
2014-08 PHASE1
NCT01606579 COMPLETED
Acute Myeloid Leukemia; Chronic Myeloid Leukemia
Prism Pharma Co., Ltd.
2012-07 PHASE1; PHASE2
NCT01764477 COMPLETED
Advanced Pancreatic Cancer; Metastatic Pancreatic Cancer; Pancreatic Adenocarcinoma
Prism Pharma Co., Ltd.
2013-04 PHASE1
NCT01302405 TERMINATED
Advanced Solid Tumors
Prism Pharma Co., Ltd.
2011-02 PHASE1
NCT02195440 Completed
Hepatitis C Virus-infected Cirrhosis
Komagome Hospital|Prism Pharma Co. Ltd.|Japan Agency for Medical Research and Development
2014-08 Phase 1
NCT01764477 Completed
Advanced Pancreatic Cancer|Metastatic Pancreatic Cancer|Pancreatic Adenocarcinoma
Prism Pharma Co. Ltd.|inVentiv Health Clinical
2013-04 Phase 1

(data from https://clinicaltrials.gov, updated on 2024-10-10)

Check the PRI-724 (Foscenvivint) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

PRI-724 acts as a selective inhibitor that directly disrupts the binding interaction between β-catenin and CREB-binding protein (CBP), thereby blocking canonical Wnt downstream transcriptional activation and promoting differentiation or apoptosis in target cells. This inhibition of Wnt-mediated stemness and fibrotic gene expression provides the mechanistic basis for suppressing tumor proliferation in pancreatic and colorectal cancers and attenuating extracellular matrix deposition in viral and biliary liver cirrhosis.

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.