Ethionamide

Overview

A second-line antitubercular agent that inhibits mycolic acid synthesis. It also may be used for treatment of leprosy. (From Smith and Reynard, Textbook of Pharmacology, 1992, p868)

Indication

For use in the treatment of pulmonary and extrapulmonary tuberculosis when other antitubercular drugs have failed.

Associated Conditions

Active Tuberculosis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Phase 2 Trial to Evaluate the EBA, Safety and Tolerability of Eto Alone and in Combination With BVL-GSK098	2022/07/25	NCT05473195	Phase 2	Completed	TASK Applied Science
An Open-label RCT to Evaluate a New Treatment Regimen for Patients With Multi-drug Resistant Tuberculosis	2015/05/27	NCT02454205	Phase 2	Completed	University of Cape Town
A Prospective Study of Multidrug Resistance and a Pilot Study of the Safety of and Clinical and Microbiologic Response to Levofloxacin in Combination With Other Antimycobacterial Drugs for Treatment of Multidrug-Resistant Pulmonary Tuberculosis (MDRTB) in HIV-Infected Patients.	2001/08/31	NCT00000796	Not Applicable	Completed	National Institute of Allergy and Infectious Diseases (NIAID)

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Trecator	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	0008-4117	ORAL	250 mg in 1 1	9/15/2023

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
Antiradon for Injection	山西普德药业有限公司	国药准字H20066741	化学药品	注射剂	8/4/2021
Antiradon for Injection	西安海欣制药有限公司	国药准字H20057554	化学药品	注射剂	6/19/2020
Antiradon for Injection	上海上药新亚药业有限公司	国药准字H31022655	化学药品	注射剂(粉针)	7/30/2020
Antiradon for Injection	山西普德药业有限公司	国药准字H20066742	化学药品	注射剂	8/4/2021
Antiradon for Injection	广东健信制药股份有限公司	国药准字H20054289	化学药品	注射剂	10/9/2023
Antiradon for Injection	酒泉大得利制药股份有限公司	国药准字H20055580	化学药品	注射剂	11/17/2020
Antiradon for Injection	吉林敖东洮南药业股份有限公司	国药准字H20059724	化学药品	注射剂	10/10/2020
Antiradon for Injection	广东健信制药股份有限公司	国药准字H20054288	化学药品	注射剂	10/9/2023
Antiradon for Injection	上海上药新亚药业有限公司	国药准字H31022656	化学药品	注射剂(粉针)	7/30/2020

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.

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