PYRAZINAMIDE

Post-LOE

pyrazinamide

Hikma

ANDAORALTABLET

Approved

Jun 1992

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

5/8 — Partial

PYRAZINAMIDE (pyrazinamide) by Hikma is clinical pharmacology pyrazinamide is well absorbed from the gi tract and attains peak plasma concentrations within 2 hours. Approved for antimycobacterial [epc]. First approved in 1992.

Drug data last refreshed 21h ago

$0.0BPart D

Mechanism of Action

CLINICAL PHARMACOLOGY Pyrazinamide is well absorbed from the GI tract and attains peak plasma concentrations within 2 hours. Plasma concentrations generally range from 30 to 50 mcg/mL with doses of 20 to 25 mg/kg. It is widely distributed in body tissues and fluids including the liver, lungs and…

Pharmacologic Class:

Antimycobacterial

Indications

Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.

Clinical Trials (7)

NCT05383742Phase 2Recruiting

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

NCT05556746Phase 2Active Not Recruiting

Ultra-Short Course Bedaquiline, Clofazimine, Pyrazinamide and Delamanid Versus Standard Therapy for Drug-Susceptible TB

Started Nov 2023

94 enrolled

Tuberculosis, PulmonaryHIV

NCT03800381N/ACompleted

Adequacy of the New Pediatric Isoniazid/Rifampin/Pyrazinamide (HRZ) Tablet

Started Jan 2019

92 enrolled

TuberculosisHuman Immunodeficiency VirusCoinfection

NCT02193776Phase 2Completed

A Phase 2 to Evaluate the Efficacy, Safety and Tolerability of Combinations of Bedaquiline, Moxifloxacin, PA-824 and Pyrazinamide in Adult Subjects With Drug-Sensitive or Multi Drug-Resistant Pulmonary Tuberculosis.

Started Oct 2014

240 enrolled

Tuberculosis

NCT01691534Phase 2Completed

Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With Clofazimine (C)-TMC207 (J)-PA-824 (Pa)-Pyrazinamide (Z)

Started Oct 2012

105 enrolled

Pulmonary Tuberculosis

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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.