Pyrazinamide

Overview

A pyrazine that is used therapeutically as an antitubercular agent.

Indication

For the initial treatment of active tuberculosis in adults and children when combined with other antituberculous agents.

Associated Conditions

Active Tuberculosis
Pulmonary Tuberculosis (TB)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Short-Course Regimen With Bedaquiline, Moxifloxacin and Pyrazinamide for Early Bactericidal Activity in Drug-Susceptible Tuberculosis	2025/08/19	NCT07129629	Not Applicable	Not yet recruiting	Shanghai Pulmonary Hospital, Shanghai, China
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
Shortened Regimen for Drug-susceptible TB in Children	2024/02/12	NCT06253715	Phase 3	Recruiting	Johns Hopkins University
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
Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis：Contezolid, Delamanid and Bedaquiline Cohort	2023/10/13	NCT06081361	Phase 3	Active, not recruiting	Beijing Chest Hospital
Intensified Short Course Regimen for TBM in Adults	2023/06/23	NCT05917340	Phase 3	Not yet recruiting	Indian Council of Medical Research
PanACEA - STEP2C -01	2023/04/11	NCT05807399	Phase 2	Recruiting	Michael Hoelscher

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Pyrazinamide	A-S Medication Solutions	50090-5963	ORAL	500 mg in 1 1	5/12/2021
Pyrazinamide	REMEDYREPACK INC.	70518-2534	ORAL	500 mg in 1 1	3/1/2024
Pyrazinamide	Akorn	61748-012	ORAL	500 mg in 1 1	7/14/2022
Pyrazinamide	Novitium Pharma LLC	70954-484	ORAL	500 mg in 1 1	5/12/2021
Pyrazinamide	Department of State Health Services, Pharmacy Branch	55695-026	ORAL	500 mg in 1 1	2/9/2016
Pyrazinamide	A-S Medication Solutions	50090-0520	ORAL	500 mg in 1 1	7/14/2022
Pyrazinamide	REMEDYREPACK INC.	70518-3661	ORAL	500 mg in 1 1	3/27/2024
PYRAZINAMIDE	MARLEX PHARMACEUTICALS, INC	10135-735	ORAL	500 mg in 1 1	12/4/2023
Pyrazinamide	Macleods Pharmaceuticals Limited	33342-447	ORAL	500 mg in 1 1	12/6/2022
Pyrazinamide	American Health Packaging	60687-789	ORAL	500 mg in 1 1	2/12/2024

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
PYRAZINAMIDE TABLET 500 mg	SUNWARD PHARMACEUTICAL PRIVATE LIMITED	SIN00900P	TABLET	500 mg	5/9/1988

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
PYRAFAT TAB 500MG	N/A	MEKIM PLANT HIRE PTY LTD	N/A	N/A	5/18/1991

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
Pyrazinamide-AFT pyrazinamide 500 mg tablet bottle	413090	AFT Pharmaceuticals Pty Ltd	Medicine	A	5/2/2025

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
RIFATER	sanofi-aventis canada inc	02148625	Tablet - Oral	300 MG	12/31/1995
TEBRAZID	bausch health, canada inc.	00283991	Tablet - Oral	500 MG	12/31/1973
PDP-PYRAZINAMIDE	pendopharm division of pharmascience inc	00618810	Tablet - Oral	500 MG	12/31/1984
PMS-PYRAZINAMIDE	Pharmascience Inc	02520583	Tablet - Oral	500 MG	N/A

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
RIMSTAR COMPRIMIDOS RECUBIERTOS CON PELICULA	Sandoz Gmbh	65904	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Commercialized
PIRAZINAMIDA PRODES 250 mg COMPRIMIDOS	Kern Pharma S.L.	43418	COMPRIMIDO	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.

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