NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Mar 2014
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
NOXAFIL (posaconazole) by Merck & Co.. Approved for azole antifungal [epc]. First approved in 2014.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NOXAFIL (posaconazole) is an IV azole antifungal agent that inhibits fungal cell wall ergosterol synthesis, used to treat invasive fungal infections including aspergillosis and invasive candidiasis in immunocompromised patients. It is a broad-spectrum azole approved for patients at high risk of serious fungal infections, particularly those undergoing hematopoietic stem cell or solid organ transplantation.
Peak6.8 years to LOE
NOXAFIL is in peak commercial phase with moderate competitive pressure (30%), indicating stable demand but increasing need for differentiation and managed care strategy.
Mechanism of Action
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)
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
Worked on NOXAFIL at Merck & Co.? Share your interview experience or compensation data (+7 days Pro)
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.