NOXAFIL

PeakSM

posaconazole

Merck & Co.
NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Mar 2014
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20

Mechanism of Action

12.1 Mechanism of Action Posaconazole is an azole antifungal agent [see ] . 12.2 Pharmacodynamics Exposure Response Relationship: Prophylaxis of invasive Aspergillus and Candida Infections in Adults Who Are at High Risk of Developing These Infections Due to Being Severely Immunocompromised In…

Pharmacologic Class:

Azole Antifungal

Indications (13)

invasive aspergillosisoldergreater Noxafil delayed-release tablets: adultssuchthose with hematologic malignancies with prolonged neutropenia from chemotherapygreateroropharyngeal candidiasis (OPC)including OPC refractory (rOPC) to itraconazole and/or fluconazole in adultsolder () 1invasive Aspergillusolder Noxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years of ageoropharyngeal candidiasisincluding oropharyngeal candidiasis refractory to itraconazole and/or fluconazole in adults

Clinical Trials (5)

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
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
NCT03614455Phase 1Completed

Pharmacokinetics (PK) Drug Interaction Study of Milademetan and Itraconazole or Posaconazole in Healthy Participants

Started Jul 2018
36 enrolled
Pharmacokinetics

Loss of Exclusivity

LOE Date
Feb 27, 2033
85 months away
Patent Expiry
Feb 27, 2033
Exclusivity Expiry
Jan 27, 2029

Patent Records (5)

Patent #ExpiryTypeUse Code
10117951
Mar 13, 2029
Product
—
8410077
Mar 13, 2029
Product
—
9750822
Mar 13, 2029
Product
—
9358297
Jun 24, 2031
Product
U-3160
9023790
Jul 4, 2031
Product
U-3160
Company
M&
Merck & Co.
RAHWAY, NJ
636 open jobs
External Resources
DailyMed
Full prescribing information
FDA Drugs@FDA
FDA approval history
RxNorm
Drug nomenclature & identifiers