Isoniazid

Overview

Antibacterial agent used primarily as a tuberculostatic. It remains the treatment of choice for tuberculosis.

Indication

Isoniazid is used for the treatment of all forms of tuberculosis in which organisms are susceptible. It is also used in combination with rifampin and pyrazinamide.

Associated Conditions

Active Tuberculosis
Mycobacterium kansasii infection
Late phase Tuberculosis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Ultra-Short Regimen for Elderly DS-TB	2025/07/22	NCT07076225	Not Applicable	Not yet recruiting	Shenzhen Third People's Hospital
Short-Course Anti-tuberculosis Regimens for Mild Spinal Tuberculosis	2025/04/08	NCT06917495	Phase 2	Not yet recruiting	Shandong University
A PAN-USR TB Multi-Center Trial	2025/04/01	NCT06905522	Phase 3	Not yet recruiting	Shenzhen Third People's Hospital
Latent Tuberculosis in Type 2 Diabetes	2025/03/13	NCT06874725	Phase 4	Active, not recruiting	Taichung Veterans General Hospital
Isoniazid Prophylaxis Based on Risk Factors of Tuberculosis in Living Kidney Transplantation Recipients	2024/07/22	NCT06512831	Not Applicable	Completed	West China Hospital
Shortened Regimen for Drug-susceptible TB in Children	2024/02/12	NCT06253715	Phase 3	Recruiting	Johns Hopkins University
1HP Versus 3HR in the Treatment of Tuberculosis Infection in Vietnam	2024/01/05	NCT06191692	Phase 3	Not yet recruiting	Freundeskreis Für Internationale Tuberkulosehilfe e.V
Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis	2024/01/05	NCT06192160	Phase 2	Suspended	National Institute of Allergy and Infectious Diseases (NIAID)
Platform Assessing Regimens and Durations In a Global Multisite Consortium for TB	2023/11/02	NCT06114628	Phase 2	Recruiting	University College, London
TB YOUTH - TB sYstemic Management Using One-month, Ultra-short TPT Regimen for scHool Contacts	2023/09/01	NCT06022146	Phase 3	Recruiting	Huashan Hospital

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Isoniazid	Blenheim Pharmacal, Inc.	10544-218	ORAL	300 mg in 1 1	4/20/2010
Isoniazid	Physicians Total Care, Inc.	54868-2416	ORAL	300 mg in 1 1	3/4/2013
Isoniazid	Department of State Health Services, Pharmacy Branch	55695-033	ORAL	300 mg in 1 1	3/11/2016
Isoniazid	Rebel Distributors Corp	21695-627	ORAL	300 mg in 1 1	1/20/2010
Isoniazid	Contract Pharmacy Services-PA	67046-333	ORAL	300 mg in 1 1	10/20/2006
Isoniazid	Sandoz Inc	0781-3056	INTRAMUSCULAR	100 mg in 1 mL	10/11/2022
Isoniazid	VersaPharm Incorporated	61748-016	ORAL	100 mg in 1 1	8/12/2010
Isoniazid	Liberty Pharmaceuticals, Inc.	0440-1655	ORAL	300 mg in 1 1	4/3/2014
Isoniazid	H.J. Harkins Company, Inc.	52959-145	ORAL	300 mg in 1 1	1/20/2010
Isoniazid	Aphena Pharma Solutions - Tennessee, LLC	71610-395	ORAL	300 mg in 1 1	3/23/2020

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
PDP-ISONIAZID TABLET 300 mg	Pharmascience Inc.	SIN06651P	TABLET	300 mg	10/29/1991
ISONIAZID TABLET 100 mg	ATLANTIC LABORATORIES CORPN LTD	SIN01302P	TABLET	100 mg	5/19/1988

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
PHARMASERVE INAH TAB 100MG	N/A	AMERICAN UNICORN LABORATORIES LIMITED	N/A	N/A	2/16/1995

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
NOUMED ISONIAZID 100mg tablet bottle	483125	NOUMED PHARMACEUTICALS PTY LTD	Medicine	A	3/19/2025
ISONIAZID 100mg tablet bottle	13455	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	8/30/1991
Rifinah 300/150mg	345792	Sanofi-Aventis Australia Pty Ltd	Medicine	A	10/12/2020

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
PMS-ISONIAZID	Pharmascience Inc	02514907	Tablet - Oral	100 MG	N/A
PDP-ISONIAZID	pendopharm division of pharmascience inc	00577790	Tablet - Oral	100 MG	12/31/1984
ISONIAZID TAB 300MG	sands pharm	00310247	Tablet - Oral	300 MG / TAB	12/31/1974
ISONIAZID SYRUP 50MG/5ML	carolina medical products company	00722464	Syrup - Oral	50 MG / 5 ML	12/31/1987
ISOTAMINE	bausch health, canada inc.	00261289	Powder - Oral	500 G / BOTTLE	12/31/1976
PMS-ISONIAZID	Pharmascience Inc	02514893	Tablet - Oral	50 MG	N/A
PMS-ISONIAZID	Pharmascience Inc	02514923	Solution - Oral	50 MG / 5 ML	N/A
ISOTAMINE	bausch health, canada inc.	00261270	Tablet - Oral	100 MG	12/31/1972
ISOTAMINE B 300	bausch health, canada inc.	00236799	Tablet - Oral	300 MG	12/31/1967
ISONIAZIDE 100MG TABLETS	Laboratoires Confab Inc	02232756	Tablet - Oral	100 MG / TAB	N/A

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
CEMIDON B6 300 MG/50 MG COMPRIMIDOS	Chiesi España S.A.U.	63335	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Commercialized
RIFINAH 300 MG/150 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA	Sanofi Aventis S.A.	54213	COMPRIMIDO RECUBIERTO	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Commercialized
CEMIDON B6 150 MG/25 MG COMPRIMIDOS	Chiesi España S.A.U.	40689	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Commercialized
CEMIDON B6 50 MG/15 MG COMPRIMIDOS	Chiesi España S.A.U.	38394	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Commercialized
RIMSTAR COMPRIMIDOS RECUBIERTOS CON PELICULA	Sandoz Gmbh	65904	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Commercialized
CEMIDON 60 MG/ML SOLUCIÓN INYECTABLE	Chiesi España S.A.U.	18697	SOLUCIÓN INYECTABLE	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Commercialized
RIFATER COMPRIMIDOS RECUBIERTOS	Sanofi Aventis S.A.	58299	COMPRIMIDO RECUBIERTO	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Commercialized

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.

Related News

Philippines FDA Expands VAT-Free Medicine List to Include New Cancer, Diabetes, and Cardiovascular Treatments

2 months ago

The Philippines FDA has expanded its VAT-exempt medicine list to include additional treatments for cancer, diabetes, hypertension, and other conditions under President Marcos's directive to reduce medicine costs.

Phase 2 Trial Evaluates Host-Directed Therapies for Rifampicin-Resistant Tuberculosis

2 months ago

A randomized controlled trial is testing metformin and dovramilast as adjunctive host-directed therapies to improve lung function and accelerate bacterial clearance in rifampicin-resistant tuberculosis patients.

Gates Foundation Awards Evotec $2.5M Grant to Advance Next-Generation Tuberculosis Treatments

3 months ago

The Gates Foundation has awarded Evotec a $2.5 million grant to support the development of next-generation tuberculosis treatment regimens, building on their five-year partnership.

Experimental Cancer Drug Navitoclax Shows Promise in Enhancing Tuberculosis Treatment

3 months ago

Johns Hopkins researchers found that navitoclax, an experimental cancer drug, significantly enhanced tuberculosis treatment effectiveness when combined with standard antibiotics in mouse models.

Quabodepistat Combination Shows Promise for Tuberculosis Treatment

8 months ago

A recent study published in _The Lancet Infectious Diseases_ explores the safety and efficacy of quabodepistat in combination with delamanid and bedaquiline for treating pulmonary tuberculosis.

Help Us Improve

Your feedback helps us provide better drug information and insights.

AI-Powered Research

Premium Access