NDAORALTABLET
Approved
Nov 1952
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
ISONIAZID (isoniazid) by GenexGen is mechanism of action isoniazid inhibits the synthesis of mycoloic acids, an essential component of the bacterial cell wall. First approved in 1952.
Drug data last refreshed Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Isoniazid is a first-generation oral bactericidal antimycobacterial agent approved in 1952 for treatment of active and latent tuberculosis. It inhibits synthesis of mycoloic acids essential to the bacterial cell wall of Mycobacterium tuberculosis. The drug remains a cornerstone of TB therapy globally despite its age and approaching loss of exclusivity.
LOE Approaching
With loss of exclusivity approaching and minimal commercial spending data available, team size and investment are likely modest; career growth tied to pipeline innovation rather than brand expansion.
Mechanism of Action
Mechanism of Action Isoniazid inhibits the synthesis of mycoloic acids, an essential component of the bacterial cell wall. At therapeutic levels isoniazid is bactericidal against actively growing intracellular and extracellular Mycobacterium tuberculosis organisms.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Started May 2026
144 enrolled
Tuberculosis
Safety and Tolerability of 1 Month Daily (1HP) and 3 Months Weekly (3HP) Isoniazid and Rifapentine With Pharmacokinetics of Dolutegravir (DTG) in Pregnant People With HIV
Started Jan 2024
252 enrolled
HIV SeropositivityPregnancyTuberculosis Infection
Trial of a Six-Month Regimen of High-Dose Rifampicin, High-Dose Isoniazid, Linezolid, and Pyrazinamide Versus a Standard Nine-Month Regimen for the Treatment of Adults and Adolescents With Tuberculous Meningitis
Started Dec 2023
330 enrolled
Tuberculous Meningitis
Comparing Treatment Completion Of Daily Rifapentine & Isoniazid For One Month (1HP) To Weekly High Dose Rifapentine & Isoniazid For 3 Months (3HP) In Persons Living With HIV and in Household Contacts of Recently Diagnosed Tuberculosis Patients
Started Jul 2023
1,000 enrolled
HIV SeropositivityTuberculosisHousehold Contact
Rifapentine and Isoniazid TB Preventive Therapy (3HP) for Children Taking Dolutegravir-based Antiretroviral Treatment (DOLPHIN KIDS)
Started May 2023
92 enrolled
TuberculosisHIV
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.