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A Phase 2 Randomized, Open-label Trial to Evaluate the Early Bactericidal Activity, Safety, Tolerability, and Dose-Response of Oral Alpibectir in Combination with Ethionamide, and with Ethionamide, Rifampicin, Pyrazinamide, and Ethambutol in Adults with Newly Diagnosed, Drug-Susceptible Pulmonary Tuberculosis

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Trial Profile

A Phase 2 Randomized, Open-label Trial to Evaluate the Early Bactericidal Activity, Safety, Tolerability, and Dose-Response of Oral Alpibectir in Combination with Ethionamide, and with Ethionamide, Rifampicin, Pyrazinamide, and Ethambutol in Adults with Newly Diagnosed, Drug-Susceptible Pulmonary Tuberculosis

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 15 May 2026

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At a glance

  • Drugs Alpibectir (Primary) ; Ethionamide (Primary) ; Ethambutol; Pyrazinamide; Rifampicin; Rifampicin/isoniazid/pyrazinamide/ethambutol
  • Indications Pulmonary tuberculosis; Tuberculosis
  • Focus Therapeutic Use
  • Acronyms ENABLE

Most Recent Events

  • 13 Apr 2026 According to a BioVersys media release, Alpibectir is a small-molecule antibacterial therapeutic being developed in collaboration with GSK to reduce the effective human dose of Ethionamide. The approach is intended to limit dose-related side effects while also helping overcome ethionamide resistance. The company plans to develop Alpibectir as a fixed-dose combination (FDC) with ethionamide, with Alpibectir serving as an ethionamide booster.
  • 18 Mar 2026 According to a BioVersys media release, FPFV for the phase 2a part was reported in Mar 2025 and for the Phase 2b part -was reported in March 2026.
  • 11 Dec 2025 According to a BioVersys media release, The trial is progressing well and remains on track to report topline data for the first part of the trial by Q2 2026.

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