Drugs / rencofilstat
rencofilstat
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05737433 | Mar → May 2023 | metabolic dysfunction-associated steatohepatitis | Hepion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 11 trial · 1 met primary | ||||||
| Phase 1 | NCT03596697 | Jul 2019 → Sep 2020 | hepatitis B virus infection | Hepion Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 23 trials · 2 met primary | ||||||
| Phase 2 | NCT05402371 | Oct 2022 → May 2025 | NAFLD1, fibrotic liver disease, metabolic dysfunction-associated steatohepatitis | Hepion Pharmaceuticals, Inc. | Unknown | No outcome recorded |
| Phase 2 | NCT05461105 | Mar 2022 → Apr 2023 | metabolic dysfunction-associated steatohepatitis | Hepion Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 2 | NCT04480710 | Jun 2020 → Jun 2021 | NAFLD1, fibrotic liver disease, metabolic dysfunction-associated steatohepatitis | Hepion Pharmaceuticals, Inc. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 47
| Date | Issuer | Release |
|---|---|---|
| 2023-11-13 | ContraVir Pharmaceuticals, Inc. | Results Hepion Pharmaceuticals Announces Major Reductions in Liver Stiffness with Rencofilstat Treatment in 17-week Phase 2 Study of Advanced (F3) MASH Liver Disease hepionpharma.com ↗
Dr. Mayo’s presentation indicated that 17 weeks of rencofilstat treatment was associated with significant reduction in liver stiffness (FibroScan ® ) in MASH subjects with advanced F3, an outcome suggesting reduction in hepatic fibro-inflammation. |
| 2023-10-25 | ContraVir Pharmaceuticals, Inc. | Results Hepion Pharmaceuticals’ Rencofilstat Demonstrates Anti-Cancer Activity in Hepatitis C-Associated Cancer Model hepionpharma.com ↗
today announced the publication of a new research study in mice, where Hepion’s lead drug candidate, rencofilstat, prevented the growth of liver tumors that occurred as a result of chronic infection with the human hepatitis C virus (“HCV”). |
| 2023-09-21 | ContraVir Pharmaceuticals, Inc. | Results New Anti-Cancer Opportunities Revealed for Hepion Pharmaceuticals’ Rencofilstat in Cancer Screening Program hepionpharma.com ↗
Defining “anti-cancer responsiveness” as 50% or greater reduction in viability following treatment, 26% of all tested cancer cell lines (220/850) spanning 86% of cancer cell types (24/28) were responsive to rencofilstat. |
| 2023-09-19 | ContraVir Pharmaceuticals, Inc. | Results Hepion Pharmaceuticals Discovers Novel Rencofilstat Action in Liver Cancer hepionpharma.com ↗
Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”), fibrotic diseases, hepatocellular carcinoma (“HCC”), and other chronic diseases, today announced new research findings uncovering a previously unknown mechanism by which Hepion’s lead drug candidate, rencofilstat, may exert anti-cancer activity. |
| 2023-09-14 | ContraVir Pharmaceuticals, Inc. | Results Rencofilstat Produces Positive Outcomes in Translational Study on Idiopathic Pulmonary Fibrosis hepionpharma.com ↗
Proteomic quantitation of nearly 2,000 proteins showed that rencofilstat shifted protein profiles of IPF tissue towards normalized expression more robustly than the two standard-of-care drugs, nintedanib and pirfenidone, and with strong combinational effects especially when co-administered with nintedanib. |
| 2023-06-15 | ContraVir Pharmaceuticals, Inc. | Results Hepion Pharmaceuticals to Present Two Posters at EASL International Liver Congress™ 2023 hepionpharma.com ↗
The second poster, to be presented by Hepion’s Chief Scientific Officer, Daren Ure, PhD, demonstrates that rencofilstat positively changes gene expression networks and lipid profiles in preclinical models toward resolution of NASH. |
| 2023-06-15 | ContraVir Pharmaceuticals, Inc. | Results Hepion Pharmaceuticals Announces Passing of Key Safety Milestone in Phase 2b ‘ASCEND-NASH’ Trial of Rencofilstat hepionpharma.com ↗
Having an external group of experts review unblinded safety data from the ongoing and larger ASCEND-NASH biopsy trial and issue this clearance to continue without changes is reassuring for both Hepion and those subjects currently enrolled in the trial. |
| 2023-05-22 | ContraVir Pharmaceuticals, Inc. | Results Hepion Pharmaceuticals’ Phase 2 ‘ALTITUDE-NASH’ Trial Achieves Primary and Secondary Endpoints, Including Improvement in Liver Function and Multiple NASH Biomarkers hepionpharma.com ↗
Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on artificial Intelligence (“AI”)-assisted therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”), fibrotic diseases, hepatocellular carcinoma (“HCC”), and other chronic diseases, today announced positive topline results from its recently completed Phase 2 ALTITUDE-NASH clinical trial. |
| 2023-01-18 | ContraVir Pharmaceuticals, Inc. | Results Anti-Cancer Potential of Rencofilstat Expanded with Results from Preclinical Multiple Myeloma Studies hepionpharma.com ↗
Rencofilstat exerted anti-cancer activity across a large panel of MM cell lines, and most potently, in combination with bortezomib, a proteosome inhibitor and first-line treatment for MM. |
| 2023-01-10 | ContraVir Pharmaceuticals, Inc. | Results Presentation of Preclinical Study Highlighting Anti-Cancer Activity of Rencofilstat in Combination with Proteosome Inhibitors hepionpharma.com ↗
The present study showed that rencofilstat could synergistically increase the proteotoxic stress and in vitro cancer killing properties of ixazomib. |
| 2022-11-02 | ContraVir Pharmaceuticals, Inc. | Results Hepion Pharmaceuticals to Present Two Posters at Upcoming AASLD The Liver Meeting® 2022 hepionpharma.com ↗
Using multi-omics, our pharmacology and analytics team was able to show that rencofilstat works on the several key pathways involved in NASH and could augment the effects of other potential NASH drugs. |
| 2022-10-26 | ContraVir Pharmaceuticals, Inc. | Results Hepion Pharmaceuticals Announces Publication of Phase 2a ‘AMBITION’ Clinical Trial Results hepionpharma.com ↗
As previously reported, the AMBITION clinical trial demonstrated rencofilstat was safe and well tolerated. |
| 2022-10-20 | ContraVir Pharmaceuticals, Inc. | Results Hepion Pharmaceuticals Announces Publication of Food Effect Study with Rencofilstat hepionpharma.com ↗
Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”), hepatocellular carcinoma (“HCC”), and other fibrotic diseases, today announced that the peer-reviewed journal, Clinical Pharmacology in Drug Development , has published the results of a clinical trial examining the effect of food on the oral bioavailability of rencofilstat, the Company’s lead drug candidate. |
| 2022-09-14 | ContraVir Pharmaceuticals, Inc. | Results Upcoming Presentation at Joint Meeting of ISBRA and ESBRA to Highlight Potential of Hepion Pharmaceutical’s Rencofilstat to Treat Alcohol-Related Liver Disease hepionpharma.com ↗ |
| 2022-06-20 | ContraVir Pharmaceuticals, Inc. | Regulatory Hepion Pharmaceuticals Receives FDA Orphan Drug Status Designation for Rencofilstat for the Treatment of Hepatocellular Carcinoma hepionpharma.com ↗
today announced that the U.S. Food and Drug Administration (“FDA”) has granted Orphan Drug Designation to rencofilstat, a liver-targeting, orally administered, novel cyclophilin inhibitor, for the treatment of HCC. |
| 2022-01-26 | ContraVir Pharmaceuticals, Inc. | Results Hepion Pharmaceuticals’ Rencofilstat, in Combination with an Immune Checkpoint Inhibitor, Demonstrates Synergistic Anti-Tumor Activity in a Nonclinical Liver Cancer Study hepionpharma.com ↗
Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”) and hepatocellular carcinoma (“HCC”), today announced the results of a nonclinical research study showing that its clinical phase drug candidate, rencofilstat (Rencofilstat), synergistically decreased liver tumor growth and extended mouse survival when combined with an anti-PD1 antibody, an immune checkpoint inhibitor (“ICI”). |
| 2022-01-06 | ContraVir Pharmaceuticals, Inc. | Regulatory Hepion Pharmaceuticals Announces USAN Selection of “Rencofilstat” as Nonproprietary Name for CRV431 hepionpharma.com ↗
Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”) and other liver diseases, today announced the United States Adopted Names (“USAN”) Council has adopted the nonproprietary name “rencofilstat” for the Company’s lead drug candidate, CRV431. |
| 2021-12-21 | ContraVir Pharmaceuticals, Inc. | Regulatory Hepion Pharmaceuticals Announces FDA Clearance of IND Application for CRV431 in the Treatment of Liver Cancer hepionpharma.com ↗ |
| 2021-11-30 | ContraVir Pharmaceuticals, Inc. | Regulatory Hepion Pharmaceuticals Receives FDA Fast Track Designation for CRV431 for the Treatment of NASH hepionpharma.com ↗ |
| 2021-11-16 | ContraVir Pharmaceuticals, Inc. | Results Hepion Pharmaceuticals and FibroFind Announce Anti-Cancer Activity of CRV431 in a Nonclinical Liver Cancer Study hepionpharma.com ↗
today announced the results of a nonclinical research study showing that Rencofilstat significantly decreased the growth of liver tumors in a mouse model of liver cancer. |
| 2021-11-10 | ContraVir Pharmaceuticals, Inc. | Results Hepion Pharmaceuticals Announces Poster Details for the Upcoming AASLD The Liver Meeting® 2021 hepionpharma.com ↗
All primary endpoints of the AMBITION NASH trial (safety, tolerability and pharmacokinetics) were met, and changes in select biomarkers indicated efficacy of Rencofilstat. |
| 2021-09-29 | ContraVir Pharmaceuticals, Inc. | Results All Endpoints Met in Hepion Pharmaceuticals’ Drug-Drug Interaction Study with CRV431 hepionpharma.com ↗
As expected, following five daily oral doses of ketoconazole, the maximum blood concentration (‘Cmax’) of Rencofilstat increased approximately five-fold, while the exposure, as measured by the area-under-the-curve from time of dosing to 24 hours (‘AUC0-24’), increased almost four-fold. |
| 2021-09-13 | ContraVir Pharmaceuticals, Inc. | Results Additional Data from Hepion Pharmaceuticals’ Phase 2a ‘AMBITION’ Trial Further Strengthens CRV431 Clinical Profile and Paves Way for Initiation of Phase 2b ‘ASCEND-NASH’ Clinical Program hepionpharma.com ↗
Today, Hepion reports additional data on biomarkers, alanine aminotransferase (“ALT”) and N-terminal type III collagen pro-peptide (“Pro-C3”), as well as advanced pharmacologic and bioinformatic analyses that indicate Rencofilstat efficacy in treating NASH patients. |
| 2021-07-13 | ContraVir Pharmaceuticals, Inc. | Results Hepion Pharmaceuticals Announces Positive Topline Data from Phase 2a ‘AMBITION’ NASH Trial; All Primary Endpoints Achieved hepionpharma.com ↗
Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on the development of therapeutic drugs for the treatment of liver disease arising from non-alcoholic steatohepatitis (“NASH”), today announced positive topline results from its Phase 2a ‘AMBITION’ NASH clinical trial. |
| 2021-03-23 | ContraVir Pharmaceuticals, Inc. | Results DIAMOND Mouse Model is Latest in a String of Nonclinical Studies Confirming the Antifibrotic Effects of Hepion Pharmaceutical’s Lead Drug, CRV431 hepionpharma.com ↗
today announced positive results from an in vivo study of Rencofilstat in a Diet-Induced Animal Model Of Non-alcoholic fatty liver Disease (“DIAMOND”). |
| 2020-12-29 | ContraVir Pharmaceuticals, Inc. | Results Hepion Pharmaceuticals Data Safety Monitoring Board Recommends Continuation with Final Dose Cohort in Phase 2a ‘AMBITION’ Clinical Trial for Treatment of Advanced NASH hepionpharma.com ↗
The first analysis occurred half-way through the first dosing cohort and this, the second analysis, occurred at the completion of the first dosing cohort. |
| 2020-12-29 | ContraVir Pharmaceuticals, Inc. | Results Hepion Pharmaceuticals Announces Positive Top Line Data for Low Dose CRV431 in Phase 2a ‘AMBITION’ Clinical Trial for Treatment of Advanced NASH hepionpharma.com ↗
The results of the low dose group indicated that Rencofilstat was generally safe and well tolerated. |
| 2020-12-22 | ContraVir Pharmaceuticals, Inc. | Regulatory Hepion Pharmaceuticals Announces FDA Clearance of IND Application for CRV431 for COVID-19 hepionpharma.com ↗
Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA)(“Hepion”), a clinical-stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”) and liver disease, today announced that the U.S. Food and Drug Administration (“FDA”) has accepted its investigational new drug (“IND”) application for Rencofilstat, a novel cyclophilin inhibitor for the treatment of COVID-19. |
| 2020-12-02 | ContraVir Pharmaceuticals, Inc. | Results Hepion Pharmaceuticals’ CRV431 Demonstrates Additional Potential Advantage in Liver Disease hepionpharma.com ↗
Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”) and liver disease, today announced results from a translational research study in which its lead drug candidate, Rencofilstat, decreased formation of a novel class of human blood platelets, called ‘procoagulant platelets.’ |
| 2020-11-18 | ContraVir Pharmaceuticals, Inc. | Results Hepion Pharmaceuticals Data Safety Monitoring Board Recommends Continuation of Phase 2a ‘AMBITION’ Clinical Trial for Treatment of Advanced NASH hepionpharma.com ↗
The DSMB review of the first Rencofilstat dose cohort in the Phase 2a AMBITION trial affirmed there were no safety or tolerability concerns. |
| 2020-11-12 | ContraVir Pharmaceuticals, Inc. | Results Hepion Pharmaceuticals to Present at The Liver Meeting Digital Experience(TM) 2020 hepionpharma.com ↗
We look forward to discussing the study’s findings, which suggest that Rencofilstat has the potential to complement other therapies to decrease NASH-related liver fibrosis. |
| 2020-09-17 | ContraVir Pharmaceuticals, Inc. | Results Hepion Pharmaceuticals Reports Positive Activity of CRV431 Against Coronavirus SARS-2 in Study Conducted by the National Institute of Allergy and Infectious Diseases hepionpharma.com ↗
Rencofilstat treatment was found to inhibit production of infectious virus in these cells with almost five-times greater potency than the positive control compound in this study. |
| 2020-08-12 | ContraVir Pharmaceuticals, Inc. | Results Hepion Pharmaceuticals Announces Publication of Preclinical Study Evaluating CRV431’s Antiviral Properties hepionpharma.com ↗
Vehicle-treated mice demonstrated HCV replication reaching peak viremia at nine weeks post infection, whereas HCV infection was completely abolished in mice treated with Rencofilstat or NV556. |
| 2020-07-07 | ContraVir Pharmaceuticals, Inc. | Results Hepion Pharmaceuticals Announces Preclinical Data Supporting Novel Two-Pronged Approach to Treating COVID-19 with CRV431 hepionpharma.com ↗
These results indicate the potential of Rencofilstat to simultaneously address the two most important objectives in the development of a therapeutic drug for COVID-19. |
| 2020-06-29 | ContraVir Pharmaceuticals, Inc. | Results Hepion Pharmaceuticals Announces Advancement to Final Dose Level in Ongoing Multiple Ascending Dose Clinical Study of CRV431 hepionpharma.com ↗
The Clinical Trial Management team has reviewed the 300 mg cohort data and determined this dosing level to be safe and well tolerated, authorizing advancement to the final dosing level of 375 mg daily for 28 days. |
| 2020-05-20 | ContraVir Pharmaceuticals, Inc. | Results Hepion Pharmaceuticals Announces Advancement to Fourth Dose Level in Ongoing Multiple Ascending Dose Clinical Study of CRV431 hepionpharma.com ↗
The Clinical Trial Management team has reviewed the 225 mg cohort data and determined this dosing level to be safe and well tolerated, authorizing advancement to the next dosing level of 300 mg daily for 28 days. |
| 2020-03-12 | ContraVir Pharmaceuticals, Inc. | Results Hepion Pharmaceuticals’ CRV431 Demonstrates Efficacy in Human Idiopathic Pulmonary Fibrosis Translational Research Study hepionpharma.com ↗ |
| 2020-02-19 | ContraVir Pharmaceuticals, Inc. | Results Anti-Fibrotic Activity of Hepion Pharmaceuticals’ CRV431 Shows Potential to Extend to Multiple Organs and Fibrotic Diseases hepionpharma.com ↗
Rencofilstat dose-dependently decreased ECM production by up to 55% at clinically relevant concentrations, without causing any reduction in cell viability. |
| 2020-02-12 | ContraVir Pharmaceuticals, Inc. | Results Hepion Pharmaceuticals Announces Advancement to Third Dose Level in Ongoing Multiple Ascending Dose Clinical Study of CRV431 hepionpharma.com ↗
The Clinical Trial Management team has reviewed the 150 mg cohort data and determined this dosing level to be safe and well tolerated, authorizing advancement to the next dosing level of 225 mg daily for 28 days. |
| 2020-01-28 | ContraVir Pharmaceuticals, Inc. | Results Hepion’s NASH Drug Candidate, CRV431, Demonstrates Superior Antifibrotic Efficacy in Expanded Human Liver Study hepionpharma.com ↗ |
| 2020-01-08 | ContraVir Pharmaceuticals, Inc. | Results Hepion Pharmaceuticals Presents Update on CRV431 Nonclinical Studies at NASH-TAG 2020 Conference hepionpharma.com ↗
The presentation will provide further data from four nonclinical studies demonstrating that Rencofilstat decreases liver fibrosis in animal and human tissue experimental models. |
| 2019-12-10 | ContraVir Pharmaceuticals, Inc. | Results Hepion Pharmaceuticals Successfully Advances to Next Dosing Level in Ongoing Multiple Ascending Dose Clinical Study of CRV431 hepionpharma.com ↗
The team’s review of the 75 mg cohort data showed this dosing level to be safe and well tolerated, which authorized escalation to the next dosing level of 150 mg daily for 28 days. |
| 2019-12-09 | ContraVir Pharmaceuticals, Inc. | Results Hepion Pharmaceuticals to Present Clinical and Scientific Updates at HEP DART 2019 hepionpharma.com ↗ |
| 2019-11-20 | ContraVir Pharmaceuticals, Inc. | Results Hepion Pharmaceuticals’ CRV431 Prevents Cirrhosis in Experimental Model of Severe Liver Disease hepionpharma.com ↗
today announced that Rencofilstat, an anti-fibrotic agent, prevented the development of liver cirrhosis in a highly aggressive, preclinical model of liver disease. |
| 2019-11-07 | ContraVir Pharmaceuticals, Inc. | Results Hepion Pharmaceuticals to Present at The Liver Meeting(R) 2019 hepionpharma.com ↗
Rencofilstat was found to concentrate in the liver, the intended site of action, which helps to explain its efficacious activity. |
| 2019-11-07 | ContraVir Pharmaceuticals, Inc. | Results Hepion Pharmaceuticals’ CRV431 Reduces Liver Fibrosis in a Western Diet Model of NASH hepionpharma.com ↗
Rencofilstat reduced liver fibrosis by 82% (p<0.0001), whereas OCA reduced fibrosis by 49% (p=0.002), compared to mice that did not receive WD + CCl 4 . |
| 2019-10-16 | ContraVir Pharmaceuticals, Inc. | Results Hepion Pharmaceuticals Announces Publication of Data Highlighting CRV431’s Potential as a Treatment for Chronic Liver Diseases hepionpharma.com ↗
Rencofilstat Decreased Liver Fibrosis and Tumor Burden in Experimental Models |
All press releases naming this drug 66 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | rencofilstat | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05737433 ↗ |
| Known as | Cpi-431 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297487 ↗ |
| Known as | Cpi-431-32 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297487 ↗ |
| Known as | CRV431 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03596697 ↗ |
| Action | Inhibit | “Rencofilstat inhibits cyclophilin to reduce hepatic inflammation and fibrosis” PMID 39982177 ↗ Mar 2025 |
| Modality | Small molecule | — CHEMBL4297487 ↗ |
| Route | Oral | “single 225 mg oral dose” NCT05737433 ↗ |