Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07517445 | Bactericidal Activity and Safety of Nicotinamide in Combination With Bedaquiline, Pretomanid, and Linezolid in Drug-susceptible Pulmonary Tuberculosis | PHASE2 | RECRUITING | 165 | — | — | Apr 13, 2026 | Jun 14, 2027 | Apr 22, 2026 | 4 | South Africa |
| NCT07525427 | Bactericidal Activity of TBD09 in Combination With Other Drugs in Pulmonary Tuberculosis | PHASE2 | RECRUITING | 150 | — | — | Apr 10, 2026 | Nov 5, 2026 | Apr 30, 2026 | 13 | South Africa |
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 *...