Most Robust TB Drug Pipeline in History

For World TB Day 2024, the WGND is spotlighting a monumental achievement in TB drug research and development: the Global TB Drug Pipeline has never been bigger than it is today. The number of drug candidates being clinically evaluated for use in the treatment of adult pulmonary TB has surpassed that of all previous years. The WGND is tracking 19 drug candidates that have initiated or completed a Phase 1 clinical trial for use in treating Tuberculosis. Most have been or are currently being evaluated in a Phase 2 clinical trial and one has made it to Phase 3.

PanACEA - STEP2C-01

Submitted by zaidtanvir on

This is a phase 2B/C, open label platform study that will compare the efficacy, safety of 3 experimental regimens with a standard control regimen in participants with newly diagnosed, drug sensitive pulmonary tuberculosis. In stage 1, participants will be randomly allocated to the control or one of the 2 rifampicin-containing experimental regimens in the ratio 1:1:1. In stage 2, the experimental arm 4 containing sutezolid will be added. Participants will be allocated to control or one of the three experimental regimens in the ratio 1:1:1:1.

CRUSH-TB

Submitted by zaidtanvir on

Phase 2C Clinical Trial of Novel, Short-course Regimens for the Treatment of Pulmonary Tuberculosis: CRUSH-TB (Combination Regimens for Shortening TB Treatment). The purpose of this study is to determine whether one or two 17-week regimens of tuberculosis treatment bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z)-- (BMZ) plus either Rifabutin (Rb) or Delamanid (D or DLM) are as effective as a standard six-month regimen for treatment of pulmonary tuberculosis (TB). All three regimens are administered daily, seven days each week.

Experimental Arms: 

PRESCIENT Trial

Submitted by zaidtanvir on

The PRESCIENT trial is a Phase IIc, open-label, randomized trial that will compare a 12-week regimen of bedaquiline (BDQ), clofazimine (CFZ), pyrazinamide (PZA), and delamanid (DLM) with standard treatment for drug-susceptible pulmonary tuberculosis. Eligible participants will be randomized in a 1:1 ratio to BDQ, CFZ, PZA, and DLM (BCZD) or standard anti-TB therapy. Randomization will be stratified by presence of lung cavitation and HIV status. Medications will be given daily in fixed dose combinations at standard weight-based doses.

DRAMATIC Trial

Submitted by zaidtanvir on

DRAMATIC (Duration Randomized Anti-MDR-TB And Tailored Intervention Clinical) Trial is a multicenter, randomized, partially blinded, four-arm, phase 2 trial that will examine an injectable- and pyrazinamide-sparing regimen of bedaquiline, delamanid, levofloxacin, linezolid, and clofazimine for treatment of MDR-TB. The DRAMATIC regimen limits the administration of linezolid to the initial 8 weeks of treatment, the window before linezolid-related neuropathy occurs.

NC-009 Trial

Submitted by zaidtanvir on

TB Alliance launched a new Pan-Phase 2 clinical trial incorporating elements of Phase 2a, b and c, identified as NC-009, to evaluate the safety and efficacy of a combination of a new experimental compound, TBAJ-876, with pretomanid and linezolid, components of TB Alliance’s BPaL regimen. This regimen has the potential to shorten and improve treatment for both drug-sensitive and drug-resistant tuberculosis (TB)—one of the world’s deadliest infectious diseases.

PAN-TB XBQS Trial

Submitted by zaidtanvir on

Known as "PAN-TB XBQS" for the two regimens being evaluated (PBQS & DBQS), this multicenter, two-stage, open-label, randomized trial will aim to assess the efficacy, safety, optimal duration, and pharmacokinetics (PK) of Delamanid, Bedaquiline, Quabodepistat (previously OPC-167832), and Sutezolid (DBQS) and Pretomanid, Bedaquiline, Quabodepistat, and Sutezolid (PBQS) in adult participants with drug sensitive tuberculosis (DS-TB) and rifampicin or multi-drug resistant TB (RR/MDR-TB).

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