Isoniazid is a first-line antimycobacterial drug used in combination regimens for active tuberculosis and in preventive treatment for latent tuberculosis infection in selected populations. Labeling emphasizes resistance prevention and hepatotoxicity monitoring risk management. It is a long-established human prescription antibacterial medicine.
New research reveals how TB bacteria resist drugs via PE/PPE proteins and evade immune defenses by stiffening cell membranes. TB remains the leading infectious killer, with 1.23 million deaths in 2024.
Three advances in TB diagnostics: a portable $300 device delivering results in 30 minutes, a Quick DNA kit detecting drug resistance in 5 minutes, and an ultrasensitive test finding TB DNA in 12-16% of hospitalized US patients.
A vaccine and two novel tuberculosis treatments are advancing through Phase III trials, marking renewed momentum in TB research. Tuberculosis claims over 1.25 million lives annually with 10.6 million new cases in 2023, while current treatments face challenges of high pill burden, toxicity, and rising resistance.
NEJM-published Phase 2a results show alpibectir enabled a two-thirds dose reduction of ethionamide and clinical proof of concept in pulmonary TB. First patient dosed in the Phase 2b STEP2C Stage 3 trial within UNITE4TB.
BioVersys has dosed the first patient in a Phase 2b trial evaluating alpibectir-ethionamide (AlpE) in combination with first-line TB drugs, following promising Phase 2a results published in the New England Journal of Medicine.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07708779 |
A Phase I Study Investigating the Local Tolerability and Pharmacokinetics of Isoniazid (INH) Inhalation by Wet Nebulization in Patients With Tuberculosis |
RECRUITING | PHASE1 |
| NCT07656012 |
Re-evaluating the Duration in Children of TB Treatment |
NOT_YET_RECRUITING | PHASE2 |
| NCT07595042 |
A Trial of Stratified Patient-Centered Treatment Regimens for Active TB (SPECTRA-TB) |
NOT_YET_RECRUITING | PHASE2 |
| NCT07124559 |
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT06253715 |
Shortened Regimen for Drug-susceptible TB in Children |
RECRUITING | PHASE3 |
| NCT06192160 |
Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis |
RECRUITING | PHASE2 |
| NCT05383742 |
Trial of a Six-Month Regimen of High-Dose Rifampicin, High-Dose Isoniazid, Linezolid, and Pyrazinamide Versus a Standard Nine-Month Regimen for the Treatment of Adults and Adolescents With Tuberculous Meningitis |
RECRUITING | PHASE2 |
| NCT05221502 |
Safety and Efficacy Evaluation of 4-month Regimen of OPC-167832, Delamanid and Bedaquiline in Participants With Drug-Susceptible Pulmonary TB |
COMPLETED | PHASE2 |
| NCT04930744 |
Safety and Tolerability of Metformin in People With Tuberculosis (TB) and Human Immunodeficiency Virus (HIV) |
COMPLETED | PHASE2 |
| NCT04311502 |
Clofazimine- and Rifapentine-Containing Treatment Shortening Regimens in Drug-Susceptible Tuberculosis: The CLO-FAST Study |
TERMINATED | PHASE2 |
