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Rifampin/isoniazid/pyrazinamide/ethambutol FDC
Rifampin/isoniazid/pyrazinamide/ethambutol FDC is a Anti-tuberculosis agent (fixed-dose combination) Small molecule drug developed by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections. It is currently FDA-approved for Tuberculosis (drug-susceptible, pulmonary and extrapulmonary), Tuberculosis treatment in HIV-coinfected patients.
This fixed-dose combination of four first-line anti-tuberculosis agents inhibits bacterial cell wall and protein synthesis to kill Mycobacterium tuberculosis.
This fixed-dose combination of four first-line anti-tuberculosis agents inhibits bacterial cell wall and protein synthesis to kill Mycobacterium tuberculosis. Used for Tuberculosis (drug-susceptible, pulmonary and extrapulmonary), Tuberculosis treatment in HIV-coinfected patients.
At a glance
| Generic name | Rifampin/isoniazid/pyrazinamide/ethambutol FDC |
|---|---|
| Sponsor | Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections |
| Drug class | Anti-tuberculosis agent (fixed-dose combination) |
| Target | Bacterial RNA polymerase (rifampin), mycolic acid synthesis (isoniazid), membrane potential/energy metabolism (pyrazinamide), arabinosyl transferase (ethambutol) |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
Rifampin inhibits bacterial RNA polymerase, isoniazid disrupts mycolic acid synthesis in the cell wall, pyrazinamide is converted to pyrazinoic acid which disrupts membrane potential and energy metabolism, and ethambutol inhibits arabinosyl transferases involved in cell wall synthesis. Together, these agents provide synergistic bactericidal and bacteriostatic activity against tuberculosis.
Approved indications
- Tuberculosis (drug-susceptible, pulmonary and extrapulmonary)
- Tuberculosis treatment in HIV-coinfected patients
Common side effects
- Hepatotoxicity
- Peripheral neuropathy
- Hyperuricemia
- Optic neuritis (ethambutol-related)
- Gastrointestinal disturbance
- Rash
- Drug-induced lupus
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)
- 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
- Pharmacokinetic Study of Linezolid for TB Meningitis (PHASE2)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Rifampin/isoniazid/pyrazinamide/ethambutol FDC CI brief — competitive landscape report
- Rifampin/isoniazid/pyrazinamide/ethambutol FDC updates RSS · CI watch RSS
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections portfolio CI
Frequently asked questions about Rifampin/isoniazid/pyrazinamide/ethambutol FDC
What is Rifampin/isoniazid/pyrazinamide/ethambutol FDC?
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Related
- Drug class: All Anti-tuberculosis agent (fixed-dose combination) drugs
- Target: All drugs targeting Bacterial RNA polymerase (rifampin), mycolic acid synthesis (isoniazid), membrane potential/energy metabolism (pyrazinamide), arabinosyl transferase (ethambutol)
- Manufacturer: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Tuberculosis (drug-susceptible, pulmonary and extrapulmonary)
- Indication: Drugs for Tuberculosis treatment in HIV-coinfected patients
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