POSACONAZOLE

Post-LOESM

posaconazole

Hikma

ANDAORALSUSPENSION1 Generic Approved

Approved

May 2020

Lifecycle

Post-LOE

Competitive Pressure

45/100

Clinical Trials

Data completeness

4/8 — Partial

POSACONAZOLE (posaconazole) by Hikma is [see clinical pharmacology (12. Approved for azole antifungal [epc]. First approved in 2020.

Drug data last refreshed 19h ago

Mechanism of Action

[see Clinical Pharmacology (12.4)] .

Pharmacologic Class:

Azole Antifungal

Indications

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

Clinical Trials (20)

NCT04665037Phase 2Recruiting

Posaconazole (MK-5592) Intravenous and Oral in Children (<2 Years) With Invasive Fungal Infection (MK-5592-127)

Started Feb 2022

40 enrolled

Invasive Fungal Infection

NCT05275179N/ACompleted

Pharmacokinetic of Posaconazole in Critically Ill Patients

Started Feb 2021

10 enrolled

Therapeutic Drug MonitoringCritical Illness

NCT04218851Phase 2Completed

Posaconazole (MK-5592) Intravenous and Oral in Children With Invasive Aspergillosis (IA) (MK-5592-104)

Started Jul 2020

31 enrolled

Invasive Aspergillosis

NCT05065658N/ACompleted

Posaconazole Prophylaxis for CAPA Prevention in Critically-Ill Patients

Started Mar 2020

249 enrolled

COVID-19 Respiratory InfectionAspergillosis

NCT03717623Phase 4Recruiting

Posaconazole Pharmacokinetics in Patients Receiving Chemotherapy or Stem Cell Transplants

Started Aug 2019

100 enrolled

PosaconazolePharmacokineticsInvasive Candidiases+4 more

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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.