August 14, 2019 - FDA Approval of Pretomanid in combination with bedaquiline and linezolid for treating a limited and specific population of adult patients with extensively drug resistant, treatment-intolerant or nonresponsive multidrug resistant pulmonary TB.

June 6, 2019 - FDA advisory committee meeting

NDA filed with FDA

Open Label Phase 3 study - Enrollment ended November 15, 2017.  Interim results presented at UNION conference in Guadalajara 2017 and at CROI 2017. Transition to ZeNix with first patient screened 11/16/2017.

From Clinical Trials.gov 11 March 2017:  The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.  Verified June 2014 by Radboud University.Recruitment status was:  Active, not recruiting

Efficacy and Safety of High-Dose Rifampin in Pulmonary Tuberculosis: A Randomized Controlled Trial.

Velásquez GE, Brooks MB, Coit JM, Pertinez H, Vargas Vásquez D, Sánchez Garavito E, Calderón RI, Jiménez J, Tintaya K, Peloquin CA, Osso E, Tierney DB, Seung KJ, Lecca L, Davies GR, Mitnick CD.

Am J Respir Crit Care Med. 2018 Jun 29. doi: 10.1164/rccm.201712-2524OC. [Epub ahead of print]  PMID:  29954183

Updated enrollment June 2018.  Anticipated full accrual late 2018/early 2019.  Data analysis 2020. 

The purpose of this study is to determine whether one or two four-month regimens of tuberculosis treatment 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, with direct observation of each dose by a health-care worker at least five of the seven days of each week.