Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Isoniazid · 1 trial · 4 indications
Non-inferiority will be assessed by comparing the upper bound of a 95%, 2-sided confidence interval for the difference between the proportion of participants who are classified as having an unsuccessful outcome on the control regimen (HRZ(E)) and the intervention regimen (HPZM) to the predefined non-inferiority margin of 6% at 48 weeks.
The proportion of participants with a Grade 3 or higher adverse event and the corresponding 95% confidence intervals will be generated. An exact test for equality of proportions will be used to compare safety outcomes between the arms.
| Arm | Type | Description |
|---|---|---|
| Regimen 1: Isoniazid (H), Rifampin (R), Pyrazinamide (Z), Ethambutol (E) | ACTIVE_COMPARATOR | 8 weeks of daily HRZ(E) followed by either 16 or 24 weeks of daily HR, per local standard of care |
| Regimen 2: Isoniazid (H), Rifapentine (P), Pyrazinamide (Z), Moxifloxacin (M) | EXPERIMENTAL | 8 weeks of daily HPZM |
| Name | Type | Description |
|---|---|---|
| Isoniazid | DRUG | Once daily weight-based dose |
| Rifampin | DRUG | Once daily weight-based dose |
| Pyrazinamide | DRUG | Once daily weight-based dose |
| Ethambutol | DRUG | Once daily weight-based dose |
| Rifapentine | DRUG | Once daily weight-based dose |
| Moxifloxacin | DRUG | Once daily weight-based dose |
Inclusion Criteria: * Parent or guardian is willing and able to provide written informed consent for potential participant's study participation; in addition, when applicable per Ethics Committee/Institutional Review Board (EC/IRB) policies and procedures, potential participant is willing and able ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Viatris, Inc. | VTRS | 1 | PHASE3 | Bedaquiline |
| Johnson & Johnson | JNJ | 1 | PHASE2 | Bedaquiline, Background Regimen |
| BioNTech SE Sponsored ADR | BNTX | 1 | PHASE1 | BNT164a1, BNT164b1 |
Isoniazid is used for the treatment of tuberculosis, including pulmonary and lymph node tuberculosis caused by Mycobacterium tuberculosis. It is being studied as part of a shortened regimen for drug-susceptible TB in children.
Isoniazid is being developed by United Therapeutics Corporation, a company traded on the NASDAQ under the ticker symbol UTHR.
Isoniazid is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA for the studied indication.
Isoniazid is being evaluated in a Phase 3 trial with the identifier NCT06253715, titled 'Shortened Regimen for Drug-susceptible TB in Children'. The trial is recruiting and aims to enroll 860 participants across countries including India, Indonesia, Mozambique, South Africa, Uganda, Zambia, and Zimbabwe.
Yes, Isoniazid is a small molecule therapeutic. It is being studied in an active-controlled, randomized Phase 3 trial that uses a biomarker-selected approach for patient enrollment.