NDAORALSUSPENSION
Approved
Oct 2006
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
NOXAFIL (posaconazole) by Merck & Co. is [see clinical pharmacology (12. First approved in 2006.
Drug data last refreshed 8h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NOXAFIL (posaconazole) is an oral azole antifungal agent approved by FDA in October 2006 for the treatment of invasive fungal infections, particularly in immunocompromised patients. It works by inhibiting fungal cell wall synthesis through inhibition of lanosterol 14α-demethylase, a key enzyme in ergosterol biosynthesis. The drug is indicated for prophylaxis of invasive Aspergillus and Candida infections in high-risk hematologic malignancy patients and those undergoing hematopoietic stem cell transplantation.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30/100), indicating defensive market strategy and potential team restructuring ahead.
Mechanism of Action
[see Clinical Pharmacology (12.4)] .
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
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
Pharmacokinetic of Posaconazole in Critically Ill Patients
Started Feb 2021
10 enrolled
Therapeutic Drug MonitoringCritical Illness
Posaconazole (MK-5592) Intravenous and Oral in Children With Invasive Aspergillosis (IA) (MK-5592-104)
Started Jul 2020
31 enrolled
Invasive Aspergillosis
Posaconazole Prophylaxis for CAPA Prevention in Critically-Ill Patients
Started Mar 2020
249 enrolled
COVID-19 Respiratory InfectionAspergillosis
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.