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with academic and government entities, trial recruitment statuses across the portfolio range from completed to withdrawn or terminated.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| NCT02413853 | WITHDRAWN | Colorectal Adenocarcinoma; Stage IVA Colorectal Cancer; Stage IVB Colorectal Cancer |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)
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>).
- PRI-724 (Foscenvivint) Solubility in DMSO
- PRI-724 (Foscenvivint) Stock Solution
- PRI-724 (Foscenvivint) Storage
- PRI-724 (Foscenvivint) Stability
- PRI-724 (Foscenvivint) Molecular Weight
- PRI-724 (Foscenvivint) SMILES
- PRI-724 (Foscenvivint) CAS Number
- PRI-724 (Foscenvivint) Chemical Structure (2D and 3D)
- PRI-724 (Foscenvivint) SDS|MSDS