Overview
A pyrazine that is used therapeutically as an antitubercular agent.
Background
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 |
|---|---|---|---|---|---|
2025/04/08 | Phase 2 | Not yet recruiting | Shandong University | ||
2025/04/01 | Phase 3 | Not yet recruiting | Shenzhen Third People's Hospital | ||
2024/02/12 | Phase 3 | Recruiting | |||
2024/01/05 | Phase 2 | Suspended | |||
2023/11/02 | Phase 2 | Recruiting | |||
2023/10/13 | Phase 3 | Active, not recruiting | Beijing Chest Hospital | ||
2023/06/23 | Phase 3 | Not yet recruiting | |||
2023/04/11 | Phase 2 | Recruiting | Michael Hoelscher | ||
2023/03/13 | Phase 2 | Recruiting | |||
2022/09/27 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| A-S Medication Solutions | 50090-5963 | ORAL | 500 mg in 1 1 | 5/12/2021 | |
| REMEDYREPACK INC. | 70518-2534 | ORAL | 500 mg in 1 1 | 3/1/2024 | |
| Akorn | 61748-012 | ORAL | 500 mg in 1 1 | 7/14/2022 | |
| Novitium Pharma LLC | 70954-484 | ORAL | 500 mg in 1 1 | 5/12/2021 | |
| Department of State Health Services, Pharmacy Branch | 55695-026 | ORAL | 500 mg in 1 1 | 2/9/2016 | |
| A-S Medication Solutions | 50090-0520 | ORAL | 500 mg in 1 1 | 7/14/2022 | |
| REMEDYREPACK INC. | 70518-3661 | ORAL | 500 mg in 1 1 | 3/27/2024 | |
| MARLEX PHARMACEUTICALS, INC | 10135-735 | ORAL | 500 mg in 1 1 | 12/4/2023 | |
| Macleods Pharmaceuticals Limited | 33342-447 | ORAL | 500 mg in 1 1 | 12/6/2022 | |
| 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 | SIN00900P | TABLET | 500 mg | 5/9/1988 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Pyrazinamide Tablets | 国药准字H31020136 | 化学药品 | 片剂 | 12/23/2019 | |
| Pyrazinamide Tablets | 国药准字H13020807 | 化学药品 | 片剂 | 8/13/2020 | |
| Pyrazinamide Tablets | 国药准字H14024115 | 化学药品 | 片剂 | 6/22/2020 | |
| Pyrazinamide Tablets | 国药准字H14021721 | 化学药品 | 片剂 | 8/11/2020 | |
| Pyrazinamide Tablets | 国药准字H44021711 | 化学药品 | 片剂 | 8/8/2019 | |
| Pyrazinamide Tablets | 国药准字H32023109 | 化学药品 | 片剂 | 8/11/2020 | |
| Pyrazinamide Tablets | 国药准字H31020635 | 化学药品 | 片剂 | 2/26/2020 | |
| Pyrazinamide Tablets | 国药准字H15020260 | 化学药品 | 片剂 | 4/12/2020 | |
| Pyrazinamide Tablets | 国药准字H11021652 | 化学药品 | 片剂 | 1/28/2021 | |
| Pyrazinamide Tablets | 国药准字H20073366 | 化学药品 | 片剂 | 7/28/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| PYRAFAT TAB 500MG | N/A | 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 | Medicine | A | 5/2/2025 |