Data updated: May 26, 2026
PYRAZINAMIDE
Trial Activity: Expansion 11 active trials
Infectious Disease
Approved 1971-06-03
PYRAZINAMIDE is indicated for the treatment of Tuberculosis.
Source: FDA Label • NOVITIUM PHARMA
Development Insights
Global Alliance for TB Drug Development conducting 5 trials (14%)
24 indications explored (Broad Platform)
→ tuberculosis (14 trials)
→ tuberculosis, pulmonary (11 trials)
→ pulmonary tuberculosis (7 trials)
3
Indications
--
Phase 3 Trials
54
Years on Market
Details
- Status
- Prescription
- First Approved
- 1971-06-03
- Routes
- ORAL
- Dosage Forms
- TABLET
PYRAZINAMIDE Approval History
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Original
New Indication
New Form
Label Update
34 FDA actions from 1971 to 2020
Jul 2020 ORIGINAL
Update
Aug 2002 SUPPL
Mfg · Manufacturing (CMC)
May 2001 SUPPL
Mfg · Manufacturing (CMC)
Feb 2001 SUPPL
Mfg
Mar 1999 SUPPL
Mfg
Jul 1998 SUPPL
Mfg
Jun 1996 SUPPL
Mfg
Feb 1995 SUPPL
Mfg
Sep 1994 SUPPL
Label
May 1994 SUPPL
Label
May 1994 SUPPL
Mfg
Feb 1994 SUPPL
Mfg
Nov 1992 SUPPL
Mfg
Jun 1992 ORIGINAL
Update
Apr 1992 SUPPL
Label
Oct 1991 SUPPL
Mfg
Oct 1990 SUPPL
Label
Oct 1987 SUPPL
Mfg
Aug 1982 SUPPL
Mfg
Jun 1971 ORIGINAL
Update
What PYRAZINAMIDE Treats
1 indicationsPYRAZINAMIDE is approved for 1 conditions since its original approval in 1971. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Tuberculosis
Source: FDA Label
PYRAZINAMIDE Competitive Set
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Indication competitors
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Drugs Similar to PYRAZINAMIDE
3 of 5FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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Clinical Trial Registry
35 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06192160 RAD-TB | A5409 DOH-27-032024-5399 | Ph 2 | recruiting | Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis |
| NCT04930744 METHOD | AUR1-1-199 5U01AI134585 | Ph 2 | completed | Safety and Tolerability of Metformin in People With Tuberculosis (TB) and Human Immunodeficiency Virus (HIV) |
| NCT06253715 SMILE-TB | IRB00388853 | Ph 3 | recruiting | Shortened Regimen for Drug-susceptible TB in Children |
| NCT05556746 PRESCIENT | 2022p003075 U01AI170426 | Ph 2 | active not recruiting | Ultra-Short Course Bedaquiline, Clofazimine, Pyrazinamide and Delamanid Versus Standard Therapy for Drug-Susceptible TB |
| NCT05807399 | PanACEA - STEP2C -01 | Ph 2 | recruiting | PanACEA - STEP2C -01 |
| NCT02563327 S31PK/PD | CDC-NCHHSTP-6719 | Ph 3 | completed | Pharmacokinetic and Pharmacodynamic Study of High-Dose Rifapentine and Moxifloxacin for Treatment of Tuberculosis |
| NCT05766267 CRUSH-TB | 7406 | Ph 2, Ph 3 | active not recruiting | Short-course Regimens for the Treatment of Pulmonary Tuberculosis |
| NCT04311502 results posted | ACTG A5362 30148 | Ph 2 | terminated | Clofazimine- and Rifapentine-Containing Treatment Shortening Regimens in Drug-Susceptible Tuberculosis: The CLO-FAST Study |
| NCT06917495 | SDU-2024-RPT-003 | Ph 2 | not yet recruiting | Short-Course Anti-tuberculosis Regimens for Mild Spinal Tuberculosis |
| NCT06081361 INSPIRE-CODA | BJCH-202301 | Ph 3 | active not recruiting | Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis：Contezolid, Delamanid and Bedaquiline Cohort |
| NCT02754765 endTB | MSF ERB-1555 | Ph 3 | completed | Evaluating Newly Approved Drugs for Multidrug-resistant TB |
| NCT04179500 PaSEM results posted | Pa-824-CL-012 | Ph 2 | completed | A Trial to Evaluate the Male Reproductive Safety of Pretomanid in Adult Male Participants With Drug Resistant Pulmonary Tuberculosis |
| NCT02619994 MDR-END results posted | MDR-END | Ph 2 | completed | Treatment Shortening of MDR-TB Using Existing and New Drugs |
| NCT03338621 results posted | SimpliciTB (B-Pa-M-Z) NC-008 | Ph 2, Ph 3 | completed | Trial to Evaluate the Efficacy, Safety and Tolerability of BPaMZ in Drug-Sensitive (DS-TB) Adult Patients and Drug-Resistant (DR-TB) Adult Patients |
| NCT04694586 HIGHSHORT-RP | 2019-003721-25 | Ph 2 | suspended | Drug Exposure and Safety of a Shorter Tuberculosis Treatment Based on High-Dose Rifampicin and Pyrazinamide |
| NCT05917340 INSHORT | NIRT-IEC No:2023 003 | Ph 3 | not yet recruiting | Intensified Short Course Regimen for TBM in Adults |
| NCT02409290 STREAM results posted | 78372190/18148631 (Stage 1/2) | Ph 3 | completed | The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB |
| NCT03474198 TRUNCATE-TB | TRUNCATE-TB | Ph 2, Ph 3 | completed | Two-month Regimens Using Novel Combinations to Augment Treatment Effectiveness for Drug-sensitive Tuberculosis |
| NCT02256696 results posted | NA_00093014 #FD-R-004794-01 | Ph 2 | completed | Assessing PA-824 for Tuberculosis (the APT Trial) |
| NCT02581527 RIFASHORT | 15.0190 | Ph 3 | completed | A Randomised Trial to Evaluate Toxicity and Efficacy of 1200mg and 1800mg Rifampicin for Pulmonary Tuberculosis |
| NCT05454345 | yzhang207 | Ph 3 | not yet recruiting | Sitafloxacin-containing Regimens for Shortening Tuberculosis Treatment |
| NCT04629378 TB_COMBO_01 | TASK-005_TB_COMBO_01 | Ph 2 | completed | Evaluating the EBA of Meropenem With Amoxicillin/Clavulanate and Pyrazinamide or Bedaquiline in Adults With PTB |
| NCT02454205 NEXT | NExT-5001 | Ph 2, Ph 3 | completed | An Open-label RCT to Evaluate a New Treatment Regimen for Patients With Multi-drug Resistant Tuberculosis |
| NCT04485156 Hi-DoRi-3 | Hi-DoRi-3 | Ph 3 | not yet recruiting | Treatment Shortening of Drug-Sensitive Pulmonary Tuberculosis Using High Dose Rifampicin (Hi-DoRi-3) |
| NCT00816426 | 999909061 09-I-N061 | Ph 1 | completed | Measurement of Anti-TB Drugs in Lung Tissue From Patients Having Surgery to Treat Tuberculosis |
| NCT02193776 NC-005 results posted | NC-005-(J-M-Pa-Z) | Ph 2 | completed | A Phase 2 to Evaluate the Efficacy, Safety and Tolerability of Combinations of Bedaquiline, Moxifloxacin, PA-824 and Pyrazinamide in Adult Subjects With Drug-Sensitive or Multi Drug-Resistant Pulmonary Tuberculosis. |
| NCT02342886 STAND results posted | NC-006-(M-PA-Z) | Ph 3 | completed | Shortening Treatment by Advancing Novel Drugs |
| NCT01589497 results posted | ACTG A5307 1U01AI068636 | Ph 2 | completed | Essentiality of INH in TB Therapy |
| NCT01601626 results posted | ACTG A5290 1U01AI068636 | Ph 2 | terminated | Rifampin-Based Tuberculosis Treatment Versus Rifabutin-Based Tuberculosis Treatment in Persons With HIV |
| NCT01785186 results posted | PanACEA-MAMS-TB-01 | Ph 2 | completed | Evaluation of SQ109, High-dose Rifampicin, and Moxifloxacin in Adults With Smear-positive Pulmonary TB in a MAMS Design |
| NCT02975570 DAZZLE | H-36160 | Ph 3 | withdrawn | Efficacy and Tolerability of Delamanid, Linezolid, Pyrazinamide and Levofloxacin |
| NCT02700347 | PZA_WBA | Ph 1 | completed | Whole Blood Bactericidal Activity Against Mycobacterium Tuberculosis of Pyrazinamide Plus Allopurinol in Healthy Volunteers |
| NCT02602509 | Celecoxib_WBA | Ph 1 | completed | Evaluating Celecoxib Activity in Mycobacterium Tuberculosis: A Whole Blood Bactericidal Activity Study in Healthy Volunteers |
| NCT01215851 results posted | NC-001-(J-M-Pa-Z) | Ph 2 | completed | Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With(J-M-Pa-Z) (NC-001) |
| NCT07595042 | A5414 38987 | Ph 2 | not yet recruiting | A Trial of Stratified Patient-Centered Treatment Regimens for Active TB (SPECTRA-TB) |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PYRAZINAMIDE FDA Label Details
Indications & Usage
PYRAZINAMIDE is indicated for the treatment of Tuberculosis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment