Trial reportSignal transduction and targeted therapy2025
A novel antituberculosis agent exhibits potent clinical efficacy and good safety profile: an open-label, randomized-controlled, multicenter, phase 2a trial.
Trial report in Signal transduction and targeted therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06224036 (A Randomized, Open, Multicenter, Phase IIa Clinical Study on the Early Bactericidal Activity, Safety, Tolerance and Pharmacokinetics of JDB0131 Benzenesulfonate Tablets in Drug Sensitive Pulmonary Tuberculosis Patients), which is not on this map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Open, Multicenter, Phase IIa Clinical Study on the Early Bactericidal Activity, Safety, Tolerance and Pharmacokinetics of JDB0131 Benzenesulfonate Tablets in Drug Sensitive Pulmonary Tuberculosis Patients
Who cites it
3 citing papers in PubMed.
- Hepatic drug transporters in pharmacotherapy: mechanisms, therapeutic targeting, and clinical translation.Naunyn-Schmiedeberg's archives of pharmacology · 2026Review
- Safety pharmacology and toxicology of a novel nitroimidazooxazole antitubercular agent in SD rat and Beagle dogs.Molecular biomedicine · 2026Article
- Chronic and non-canonical cGAS-STING activation: implications for health, disease, cancer, and emerging therapeutic opportunities.Apoptosis : an international journal on programmed cell death · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Tuberculosis (TB) is a contagious disease that threatens human health worldwide. Combination chemotherapy is usually recommended for this disease. Recently, 2 nitroimidazole-based agents, namely, delamanid and pretomanid, have been approved by regulatory agencies. JDB0131 is a novel, structurally optimized third-generation nitroimidazole antituberculosis agent that incorporates the advantages of earlier compounds. This multicenter, prospective, randomized phase 2a trial was conducted to evaluate its efficacy and safety in patients with tuberculosis (NCT06224036). In total, 52 patients with newly diagnosed TB were recruited. JDB0131 was tested in a dose escalation manner (cohort 1: 100 mg bid, cohort 2: 200 mg qd, and cohort 3: 200 mg bid). For comparison, delamanid (100 mg bid) and classic fixed-dose combination (FDC) regimens were included as controls. The primary endpoint was logarithmic changes in the number of colony formation units (CFUs) in the solid media culture of sputum TB (log10 CFU). The early bactericidal activity (EBA) of JDB0131 was better than that of delamanid. During the time interval between days 0 and 14, JDB0131 at a dose of 200 mg bid (cohort 3) showed superior efficacy over delamanid. At the end of drug intervention (day 14), JDB0131 (all 3 dose levels) achieved superior time to positivity (TTP) over delamanid. Ninety-one adverse events (AEs), including no serious AEs, were attributed to JDB0131 in 30 patients. This trial identified a promising new drug for the increasing TB burden worldwide.
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