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Rifampin/isoniazid FDC

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · FDA-approved active Small molecule

Rifampin/isoniazid FDC is a Antituberculous 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 (pulmonary and extrapulmonary), Latent tuberculosis infection (as part of combination therapy).

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 nameRifampin/isoniazid FDC
SponsorAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Drug classAntituberculous agent (fixed-dose combination)
TargetBacterial RNA polymerase (rifampin); mycolic acid biosynthesis (isoniazid)
ModalitySmall molecule
Therapeutic areaInfectious Disease
PhaseFDA-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

Common side effects

Key clinical trials

Primary sources

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SourceUsed for
ClinicalTrials.govTrial enrolment, design, endpoints, results

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Frequently asked questions about Rifampin/isoniazid FDC

What is Rifampin/isoniazid FDC?

Rifampin/isoniazid FDC is a Antituberculous agent (fixed-dose combination) drug developed by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, indicated for Tuberculosis (pulmonary and extrapulmonary), Latent tuberculosis infection (as part of combination therapy).

How does Rifampin/isoniazid FDC work?

Rifampin and isoniazid are bactericidal antibiotics that inhibit bacterial RNA polymerase and mycolic acid synthesis, respectively, to kill Mycobacterium tuberculosis.

What is Rifampin/isoniazid FDC used for?

Rifampin/isoniazid FDC is indicated for Tuberculosis (pulmonary and extrapulmonary), Latent tuberculosis infection (as part of combination therapy).

Who makes Rifampin/isoniazid FDC?

Rifampin/isoniazid FDC is developed and marketed by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (see full Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections pipeline at /company/advancing-clinical-therapeutics-globally-for-hiv-aids-and-other-infections).

What drug class is Rifampin/isoniazid FDC in?

Rifampin/isoniazid FDC belongs to the Antituberculous agent (fixed-dose combination) class. See all Antituberculous agent (fixed-dose combination) drugs at /class/antituberculous-agent-fixed-dose-combination.

What development phase is Rifampin/isoniazid FDC in?

Rifampin/isoniazid FDC is FDA-approved (marketed).

What are the side effects of Rifampin/isoniazid FDC?

Common side effects of Rifampin/isoniazid FDC include Hepatotoxicity, Peripheral neuropathy, Gastrointestinal disturbance, Rash, Drug-induced lupus-like syndrome.

What does Rifampin/isoniazid FDC target?

Rifampin/isoniazid FDC targets Bacterial RNA polymerase (rifampin); mycolic acid biosynthesis (isoniazid) and is a Antituberculous agent (fixed-dose combination).

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