Emricasan

Overview

Emricasan is the first caspase inhibitor tested in human which has received orphan drug status by FDA. It is developed by Pfizer and made in such a way that it protects liver cells from excessive apoptosis.

Indication

Investigated for use/treatment in hepatitis (viral, C), liver disease, and transplantation (organ or tissue).

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Safety and Tolerability of Emricasan in Symptomatic Outpatients Diagnosed With Mild-COVID-19	2021/03/17	NCT04803227	Phase 1	Terminated	Histogen
Companion Protocol for Methacetin Breath Test (MBT) in Conatus Protocol IDN-6556-17	2018/03/12	NCT03462576	N/A	Terminated	Meridian Bioscience, Inc.
Companion Protocol for Methacetin Breath Test (MBT) in Conatus Protocol IDN-6556-14	2018/02/20	NCT03439189	N/A	Completed	Meridian Bioscience, Inc.
Emricasan, a Caspase Inhibitor, for Treatment of Subjects With Decompensated NASH Cirrhosis	2017/07/02	NCT03205345	Phase 2	UNKNOWN	Conatus Pharmaceuticals Inc.
Emricasan, an Oral Caspase Inhibitor, in Subjects With NASH Cirrhosis and Severe Portal Hypertension	2016/11/09	NCT02960204	Phase 2	Completed	Histogen
Emricasan, a Caspase Inhibitor, for Evaluation in Subjects With Non-Alcoholic Steatohepatitis (NASH) Fibrosis	2016/02/19	NCT02686762	Phase 2	Completed	Conatus Pharmaceuticals Inc.
A Study of IDN-6556 in Subjects With Liver Cirrhosis	2014/09/03	NCT02230670	Phase 2	Completed	Conatus Pharmaceuticals Inc.
A Study of IDN-6556 in Cirrhotic Subjects With Portal Hypertension	2014/09/03	NCT02230683	Phase 2	Completed	Conatus Pharmaceuticals Inc.
A Trial of IDN-6556 in Post Orthotopic Liver Transplant for Chronic HCV	2014/05/14	NCT02138253	Phase 2	Completed	Conatus Pharmaceuticals Inc.
PK and PD Study of IDN-6556 in Subjects With Hepatic Impairment and Matched Healthy Volunteers	2014/04/24	NCT02121860	Phase 1	Completed	Conatus Pharmaceuticals Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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