Clinical Trials

Emricasan (IDN-6556) has been evaluated in numerous Phase 1, Phase 2, and combined Phase 1/2 clinical trials primarily focused on chronic liver disorders—including non-alcoholic steatohepatitis, liver cirrhosis, portal hypertension, and acute alcoholic hepatitis—as well as clinical islet transplantation in diabetes and mild COVID-19. These studies were sponsored by both pharmaceutical companies, such as Conatus Pharmaceuticals and Histogen, and academic institutions like the University of Alberta. Overall recruitment statuses across the trial portfolio range from completed to terminated or unknown.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04803227 TERMINATED
Covid19
Histogen
 2021-03-11 PHASE1
NCT03205345 UNKNOWN
Decompensated Cirrhosis
Conatus Pharmaceuticals Inc.
 2017-06-28 PHASE2
NCT02686762 COMPLETED
Non-alcoholic Steatohepatitis; Fibrosis; Liver Diseases
Conatus Pharmaceuticals Inc.
 2016-01-26 PHASE2
NCT02960204 COMPLETED
Cirrhosis; Portal Hypertension; Non-alcoholic Steatohepatitis
Histogen
 2016-10-17 PHASE2
NCT02138253 COMPLETED
Liver Fibrosis; Hepatic Fibrosis; Liver Cirrhosis; Hepatic Cirrhosis
Conatus Pharmaceuticals Inc.
 2014-05 PHASE2
NCT03205345 Unknown status
Decompensated Cirrhosis
Conatus Pharmaceuticals Inc.
 2017-06-28 Phase 2
NCT01653899 COMPLETED
Diabetes
University of Alberta
 2012-06 PHASE1; PHASE2
NCT02230670 COMPLETED
Liver Cirrhosis; Hepatic Cirrhosis
Conatus Pharmaceuticals Inc.
 2014-08 PHASE2
NCT01912404 TERMINATED
Alcoholic Hepatitis
Conatus Pharmaceuticals Inc.
 2013-07 PHASE2
NCT02230683 COMPLETED
Liver Cirrhosis; Hepatic Cirrhosis; Portal Hypertension
Conatus Pharmaceuticals Inc.
 2014-08 PHASE2
NCT02077374 COMPLETED
Nonalcoholic Steatohepatitis; Non-alcoholic Fatty Liver Disease
Conatus Pharmaceuticals Inc.
 2014-03 PHASE2
NCT01937130 TERMINATED
Acute on Chronic Hepatic Failure; Acute Liver Failure; Liver Cirrhosis; Acute Alcoholic Hepatitis
Conatus Pharmaceuticals Inc.
 2013-09 PHASE2
NCT02121860 COMPLETED
Hepatic Impairment; Liver Diseases; Digestive System Diseases
Conatus Pharmaceuticals Inc.
 2014-04 PHASE1
NCT02039817 COMPLETED
Renal Impairment; Renal Insufficiency; Kidney Disease; Kidney Diseases
Conatus Pharmaceuticals Inc.
 2014-01 PHASE1
NCT01653899 Completed
Diabetes
University of Alberta|Conatus Pharmaceuticals Inc.
 2012-06 Phase 1|Phase 2
NCT00080236 COMPLETED
Liver Transplantation; Hepatitis; Cholestasis; Carcinoma, Hepatocellular
Conatus Pharmaceuticals Inc.
 2003-11 PHASE2
NCT00088140 COMPLETED
Hepatitis C, Chronic
Conatus Pharmaceuticals Inc.
 2004-07 PHASE2

(data from https://clinicaltrials.gov, updated on 2022-01-04)

Check the Emricasan (IDN-6556) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Emricasan functions as a potent, irreversible pan-caspase inhibitor that selectively binds to the active catalytic sites of caspase enzymes, thereby inhibiting downstream proteolytic cleavage cascades required for apoptotic programmed cell death and excessive pro-inflammatory signaling. By preventing caspase-mediated hepatocyte apoptosis and severe tissue inflammation, emricasan attenuates parenchymal degeneration and fibrotic progression, providing a direct mechanistic rationale for its clinical investigation in liver diseases such as non-alcoholic steatohepatitis, portal hypertension, and 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>).

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Note: Technical data last updated: Sep 1, 2026.