Approval Probability
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Also known as Bedaquiline, pretomanid, linezolid
Bedaquiline, pretomanid and TBD09 · 2 trials · 1 indication
Proportion of participants with sputum culture conversion SCC to negative for Mtb in MGIT liquid culture by Week 8 (Day 56, End of Treatment \[EOTx\]), defined as two consecutive Mtb-negative culture results, collected at least 1 day apart (i.e., not collected on the same day), occurring by Week 9 (Day 64) with no subsequent Mtb-positive cultures through Week 9 (Day 64)
Proportion of participants with this event
Proportion of participants with this event
Proportion of participants with this event
Proportion of participants with this event
Proportion of participants with this event
Proportion of participants with this event
| Arm | Type | Description |
|---|---|---|
| BPAL/NAM1500 | EXPERIMENTAL | Nicotinamide, bedaquiline, pretomanid, linezolid |
| BPAL/NAM2500 | EXPERIMENTAL | Nicotinamide, bedaquiline, pretomanid, linezolid |
| BPAL | ACTIVE_COMPARATOR | Bedaquiline, pretomanid, linezolid |
| Group 1 | EXPERIMENTAL | The combination of TBD09 (100 mg three times weekly, TIW), bedaquiline and pretomanid |
| Group 2 | EXPERIMENTAL | The combination of TBD09 (100 mg QD), bedaquiline and pretomanid |
| Group 3 | EXPERIMENTAL | The combination of TBD09 (300 mg QD), bedaquiline and pretomanid |
| Group 4 | EXPERIMENTAL | The combination of TBD09 (500 mg QD), bedaquiline and pretomanid |
| Group 5 | ACTIVE_COMPARATOR | The combination of linezolid (600 mg QD), bedaquiline and pretomanid |
| Name | Type | Description |
|---|---|---|
| Bedaquiline, pretomanid, linezolid | DRUG | Group 1 (Approximately 55 participants), Combination of NAM 1500 mg twice daily (BID) with bedaquiline (200 mg once daily \[QD\]), pretomanid (200 mg QD), and linezolid (600 mg QD), 56 days |
| Nicotinamide (NAM) | DIETARY_SUPPLEMENT | Group 1 (Approximately 55 participants), Combination of NAM 2500 mg twice daily (BID) with bedaquiline (200 mg once daily \[QD\]), pretomanid (200 mg QD), and linezolid (600 mg QD), 56 days |
| Bedaquiline, pretomanid and TBD09 | DRUG | Group 1 (30 participants): The combination of TBD09 (100 mg three times weekly, TIW), bedaquiline (200 mg daily, QD), and pretomanid (200 mg QD), 28 days |
| Bedaquiline, pretomanid and linezolid | DRUG | Group 5 (30 participants): The combination of linezolid (600 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days |
Inclusion Criteria: * Age 18-65 years at consent * Body weight 40-100 kg at screening * Written informed consent obtained * Newly diagnosed pulmonary TB, rifampicin- and isoniazid-sensitive * ≥1+ AFB smear OR positive Xpert semi-quantitative result * Molecular confirmation of M. tuberculosis *...
Bedaquiline, pretomanid and TBD09 is an investigational combination being studied for the treatment of drug susceptible pulmonary tuberculosis. It is in Phase 2 clinical development and is not yet approved by regulatory authorities.
Bedaquiline, pretomanid and TBD09 is being developed by IQVIA Holdings, Inc., which trades under the ticker symbol IQV. The company is conducting clinical trials to evaluate this combination in patients with drug susceptible pulmonary tuberculosis.
Bedaquiline, pretomanid and TBD09 is in Phase 2 clinical development. It is an investigational combination therapy and has not been approved by the FDA or other regulatory agencies. Two Phase 2 trials are currently recruiting participants.
Bedaquiline, pretomanid and TBD09 is being studied in two Phase 2 trials in South Africa. NCT07517445 evaluates nicotinamide combined with bedaquiline, pretomanid, and linezolid in 165 patients, and NCT07525427 evaluates TBD09 in combination with other drugs in 150 patients.
Bedaquiline, pretomanid and TBD09 is also known as Bedaquiline, pretomanid, linezolid. The combination includes bedaquiline, pretomanid, and linezolid, with TBD09 being an additional component studied in certain trials.