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Rifampin/isoniazid FDC
Rifampin and isoniazid are bactericidal antibiotics that inhibit bacterial RNA polymerase and mycolic acid synthesis, respectively, to kill Mycobacterium tuberculosis.
Rifampin and isoniazid are bactericidal antibiotics that inhibit bacterial RNA polymerase and mycolic acid synthesis, respectively, to kill Mycobacterium tuberculosis. Used for Tuberculosis (pulmonary and extrapulmonary), Latent tuberculosis infection (as part of combination therapy).
At a glance
| Generic name | Rifampin/isoniazid FDC |
|---|---|
| Sponsor | Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections |
| Drug class | Antituberculous agent (fixed-dose combination) |
| Target | Bacterial RNA polymerase (rifampin); mycolic acid biosynthesis (isoniazid) |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
Rifampin inhibits bacterial RNA polymerase, blocking transcription and RNA synthesis in mycobacteria. Isoniazid is a prodrug that is activated by mycobacterial catalase-peroxidase and inhibits mycolic acid synthesis, which is essential for the mycobacterial cell wall. Together, they provide synergistic bactericidal activity against tuberculosis.
Approved indications
- Tuberculosis (pulmonary and extrapulmonary)
- Latent tuberculosis infection (as part of combination therapy)
Common side effects
- Hepatotoxicity
- Peripheral neuropathy
- Gastrointestinal disturbance
- Rash
- Drug-induced lupus-like syndrome
Key clinical trials
- Determination of Adequate Tuberculosis Regimen in Patients Hospitalized With HIV-associated Severe Immune Suppression (PHASE3)
- Novel Triple-dose Tuberculosis Retreatment Regimen (PHASE3)
- Efficacy and Safety Evaluation of Two to Four Months of Treatment With the Combination Regimens of DBOS and PBOS in Adults With Pulmonary Tuberculosis (PHASE2)
- The Effectivity of Anti Tuberculosis Therapy in Idiopathic Uveitis with Positive IGRA (PHASE2)
- Adequacy of the New Pediatric Isoniazid/Rifampin/Pyrazinamide (HRZ) Tablet
- REMEMBER: Reducing Early Mortality & Morbidity by Empiric Tuberculosis (TB) Treatment (PHASE4)
- Proportion of Clinical Improvement & Type 1 Interferon (IFN) Score Changes in Idiopathic Uveitis Patients With Interferon Gamma Release Assay (IGRA) Positive
- Four Months Moxifloxacin Containing Daily Regimen Study Among New Pulmonary Tuberculosis Patients
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
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